Drugs / Insulin
Insulin
also known as
Actrapid · Humulin R · Humulin-RU-100 · Technosphere Insulin · Afrezza · Exubera · Humalog · Humulin · +22 more
Regulatory milestones approvals, filings & regulatory actions · 13 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed diabetes mellitus, congenital autoimmune 8 milestones | |||||
| Filed | US (FDA) | Afrezza | diabetes mellitus, congenital autoimmune | 2025-10-13 | “the U.S. Food and Drug Administration (FDA) has accepted the supplemental biologics license application (sBLA) seeking approval for Afrezza (insulin human) Inhalation Powder” mannkindcorp.com ↗ |
| Filed | US (FDA) | — | diabetes mellitus, congenital autoimmune | 2017-03-29 | “resubmitted the new drug application (NDA) for fast-acting insulin aspart as a class II re-submission to the US Food and Drug Administration (FDA).” novonordisk.com ↗ |
| Filed | US (FDA) | — | diabetes mellitus, congenital autoimmune | 2015-12-09 | “Novo Nordisk meddeler i dag, at virksomheden har indsendt registreringsansøgning for hurtigerevirkende insulin aspart til de amerikanske sundhedsmyndigheder (FDA).” novonordisk.com ↗ “Novo Nordisk today announced the submission of the New Drug Application (NDA) for faster-acting insulin aspart to the US Food and Drug Administration (FDA).” novonordisk.com ↗ |
| Filed | EU (EMA) | — | diabetes mellitus, congenital autoimmune | 2013-07-08 | “LY2963016 is a new insulin glargine product and has been filed through the EMA's biosimilar pathway.” lilly.com ↗ |
| Filed | Japan (PMDA) | — | diabetes mellitus, congenital autoimmune | 2011-12-22 | “indsendt ansøgning til de japanske sundhedsmyndigheder, Pharmaceuticals and Medical Devices Agency (PMDA), om godkendelse af den ultralangtidsvirkende insulinanalog, Degludec.” novonordisk.com ↗ “submission to the Japanese Pharmaceuticals and Medical Devices Agency, PMDA, of a new drug application for the approval of ultra-long-acting insulin Degludec” novonordisk.com ↗ “This new insulin glargine product was also submitted in Japan.” lilly.com ↗ |
| Filed | US (FDA) | — | diabetes mellitus, congenital autoimmune | 2011-09-29 | “indsendelsen af registreringsansøgningerne for vores nye generation af insuliner, ultralangtidsvirkende Degludec og DegludecPlus, i USA og Europa” novonordisk.com ↗ “submission to the US Food and Drug Administration of two new drug applications for the approval of ultra-long-acting insulin Degludec” novonordisk.com ↗ “The filing of our new-generation insulins, ultra-long-acting Degludec and DegludecPlus, in the US and Europe is a major milestone” novonordisk.com ↗ |
| Filed | EU (EMA) | — | diabetes mellitus, congenital autoimmune | 2011-09-26 | “submission to the European Medicines Agency of two marketing authorisation applications for the approval of ultra-long acting insulin Degludec and the insulin combination...” novonordisk.com ↗ “indsendelsen af registreringsansøgningerne for vores nye generation af insuliner, ultralangtidsvirkende Degludec og DegludecPlus, i USA og Europa” novonordisk.com ↗ “submission to the European Medicines Agency of two marketing authorisation applications for the approval of ultra-long acting insulin Degludec” novonordisk.com ↗ “The filing of our new-generation insulins, ultra-long-acting Degludec and DegludecPlus, in the US and Europe is a major milestone” novonordisk.com ↗ |
| Rejected (CRL) | US (FDA) | — | diabetes mellitus, congenital autoimmune | — | “In October 2016, Novo Nordisk announced that it had received a Complete Response Letter from the FDA regarding the NDA for fast-acting insulin aspart.” novonordisk.com ↗ |
| Filed type 2 diabetes mellitus 2 milestones | |||||
| Filed | China (NMPA) | — | type 2 diabetes mellitus | 2023-08-02 | “HTIT has successfully completed a Phase 3 oral insulin trial and submitted a New Drug Application (“NDA”) to the National Medical Products Administration (“NMPA”)” oramed.com ↗ “HTIT has already submitted a Marketing Authorization Application to China’s regulators for the oral insulin capsule in China .” oramed.com ↗ “sales of oral insulin in China , where a Marketing Authorization Application has been submitted” oramed.com ↗ |
| Filed | US (FDA) | Tresiba | type 2 diabetes mellitus | 2017-05-27 | “today announced the submission of a supplemental application to the US Food and Drug Administration (FDA) for including data in the label for Tresiba®” novonordisk.com ↗ |
| Filed Indication not stated 3 milestones | |||||
| Filed | US (FDA) | Afrezza | — | 2025-08-06 | “Afrezza adult label update, India launch, and supplemental Biologics License Application submitted for pediatrics” mannkindcorp.com ↗ “Submitted an sBLA for Afrezza® (insulin human) Inhalation Powder in the pediatric population” mannkindcorp.com ↗ “Application submitted to FDA to update labeling regarding initial Afrezza conversion dose” mannkindcorp.com ↗ |
| Filed | EU (EMA) | — | — | 2023-10-09 | “submitted the Marketing Authorization Application (hereinafter referred to as "MAA") of Insulin lispro biosimilar to the European Medicines Agency” ganlee.com ↗ “submitted the Marketing Authorization Application (hereinafter referred to as “MAA”) of Insulin aspart biosimilar to the European Medicines Agency” ganlee.com ↗ |
| Filed | EU (EMA) | — | — | 2023-08-21 | “submitted the Marketing Authorization Application (hereinafter referred to as “MAA”) of Insulin glargine biosimilar to the European Medicines Agency” ganlee.com ↗ |
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News releases announcing trial results or a regulatory action · 266
| Date | Issuer | Release |
|---|---|---|
| 2026-10-09 | Gan and Lee Pharmaceuticals, USA | Regulatory Gan & Lee Pharmaceuticals’ Insulin Glargine Approved in South Africa ganlee.com ↗
Gan & Lee Pharmaceuticals (stock code: 603087.SH) recently received registration approval from the South African Health Products Regulatory Authority (SAHPRA) for its independently developed insulin glargine injection in both cartridge and prefilled pen presentations. |
| 2026-09-30 | Eli Lilly and Company | Results Lilly's oral GLP-1, Foundayo (orforglipron), demonstrated cardiovascular safety alongside sustained A1C reduction and weight loss in its largest and longest type 2 diabetes study lilly.com ↗
In ACHIEVE-4, participants taking Foundayo experienced a 16% lower risk of MACE-4 and a 23% lower risk of MACE-3, meeting the primary objective for non-inferiority compared to insulin glargine |
| 2026-08-25 | Gan and Lee Pharmaceuticals, USA | Regulatory Gan & Lee’s Insulin Glargine Prefilled Pen Receives Marketing Approval in Thailand ganlee.com ↗
Gan & Lee Pharmaceuticals. (stock code: 603087.SH) has recently obtained marketing approval from the Thai Food and Drug Administration (Thai FDA) for its independently developed insulin glargine prefilled pen, which is indicated for the treatment of diabetes. |
| 2026-08-13 | Arecor Limited | Results Peer-Reviewed Publication of AT278 Study in Diabetes, Obesity and Metabolism journal arecor.com ↗
The study demonstrated that AT278, Arecor’s investigational ultra-concentrated (500U/mL or U500) insulin aspart formulation, maintained its ultra-rapid pharmacokinetic (PK) and pharmacodynamic (PD) profile regardless of body mass index (BMI) levels, supporting its potential as the first ultra-rapid U500 insulin for people with insulin-resistant type 2 diabetes who require high-dose therapy. |
| 2026-07-30 | Meitheal Pharmaceuticals, Inc. | Regulatory Meitheal Pharmaceuticals Announces FDA Approval of Garzulys™ (insulin aspart-fsan) Injection meithealpharma.com ↗
today announced that the U.S. Food and Drug Administration (“FDA”) has approved Garzulys™ (insulin aspart-fsan) injection, a biosimilar to NovoLog® (insulin aspart). |
| 2026-07-30 | Arecor Limited | Results Diabetes, Obesity and Metabolism article – A New Highly Concentrated Insulin Aspart AT278 (500 U/mL) Demonstrates Ultra-Rapid Pharmacokinetic and Pharmacodynamic Properties in Type 2 Diabetes Regardless of BMI arecor.com ↗
A New Highly Concentrated Insulin Aspart AT278 (500 U/mL) Demonstrates Ultra-Rapid Pharmacokinetic and Pharmacodynamic Properties in Type 2 Diabetes Regardless of BMI |
| 2026-07-28 | Gan and Lee Pharmaceuticals, USA | Regulatory Gan & Lee’s Insulin Aspart 30 Injection Approved in India ganlee.com ↗
Gan & Lee Pharmaceuticals (Gan & Lee, stock code: 603087.SH) recently announced that its manufactured insulin aspart 30 injection has been granted import and marketing approval by India's Central Drugs Standard Control Organization (CDSCO). |
| 2026-07-16 | Gan and Lee Pharmaceuticals, USA | Regulatory Gan & Lee Secures Dual Approvals for Insulin Glargine Injection and Prefilled Pen in Honduras ganlee.com ↗
July 9, 2026, Gan & Lee Pharmaceuticals ("Gan & Lee"; stock code: 603087.SH) announced that its independently developed insulin glargine prefilled pen was granted a drug registration certificate by the Agencia de Regulación Sanitaria (ARSA). |
| 2026-06-30 | Gan and Lee Pharmaceuticals, USA | Regulatory Gan & Lee’s Insulin Glargine Injection Approved in Honduras ganlee.com ↗
Gan & Lee Pharmaceuticals (stock code: 603087.SH) announced that its independently developed insulin glargine injection has officially obtained a drug registration certificate issued by Agencia de Regulación Sanitaria (ARSA). |
| 2026-06-10 | Gan and Lee Pharmaceuticals, USA | Results Gan & Lee Showcases Multiple Innovative Research Achievements at the American Diabetes Association’s 86th Scientific Sessions ganlee.com ↗
The findings further support the use of bofanglutide injection and insulin ludefen injection in patients with renal impairment. |
| 2026-06-08 | Diasome Pharmaceuticals | Results Medscape Covers Diasome's OPTI-2 Liver-Directed Insulin Data from ADA 2026 diasome.com ↗
New Phase 2b data presented at ADA 2026 suggest that Diasome's investigational liver-directed insulin may reduce the risk of hypoglycemia in people with type 1 diabetes. |
| 2026-06-07 | Diasome Pharmaceuticals | Results Diasome Presents Phase 2b Data Demonstrating HDV™-Insulin Lispro Maintains Glycemic Control While Reducing Hypoglycemia in Adults with Type 1 Diabetes diasome.com ↗
In an oral presentation today at the American Diabetes Association (ADA) 86th Scientific Sessions, Diasome reported that HDV-LIS maintained glycemic control with an A1C non-inferiority margin of <0.1% met at Weeks 12 and 25. |
| 2026-06-06 | Insulet Corporation | Results Insulet Reveals New Data Supporting Breakthrough Omnipod® 6 and Fully Closed-Loop AID Systems Designed to Improve Outcomes, Reduce Effort, and Unlock Barriers to Care insulet.com ↗
STRIVE pivotal trial shows Omnipod 6 achieved strong glycemic outcomes with fewer boluses, across age groups and diabetes types |
| 2026-06-05 | Mannkind Corporation | Results Data at ADA 2026 Highlights Key Findings from Clinical and Real‑World Studies of MannKind’s Afrezza® (Inhaled Insulin) Across Pediatric Care, Pregnancy, and Use with Automated Insulin Delivery (AID) Systems mannkindcorp.com ↗
Those treated with inhaled insulin reported statistically greater improvements in treatment satisfaction compared to RAA across both teens and parents, while achieving similar overall glycemic outcomes. |
| 2026-05-29 | Mannkind Corporation | Regulatory MannKind Announces FDA Approval of Afrezza®, the First and Only Inhaled Mealtime Insulin for Use in Children and Adolescents Aged 6 and Older Living with Diabetes mannkindcorp.com ↗ |
| 2026-05-15 | Sandoz | Regulatory Sandoz confirms European Commission approval for biosimilars Bysumlog® (insulin lispro) and Dazparda® (insulin aspart), strengthening position in diabetes sandoz.com ↗
Basel, 15 May 2026 – Sandoz (SIX:SDZ/OTCQX:SDZNY), the global leader in affordable medicines, today confirms that the European Commission has granted marketing authorisation for Bysumlog (insulin lispro) and Dazparda (insulin aspart). |
| 2026-05-15 | Gan and Lee Pharmaceuticals, USA | Regulatory Gan & Lee Receives European Commission Approval for Bysumlog® (Insulin Lispro) and Dazparda® (Insulin Aspart), Expanding Its Presence in Europe ganlee.com ↗
Gan & Lee Pharmaceuticals has now obtained EC marketing authorization for two rapid-acting insulin products: insulin lispro injection (EU brand name: Bysumlog ® ) and insulin aspart injection (EU brand name: Dazparda ® ). |
| 2026-04-16 | Eli Lilly and Company | Results ACHIEVE-4, the longest Phase 3 study of Lilly's Foundayo (orforglipron) to date, reaffirmed its cardiovascular and overall safety profile as well as consistent improvements across key measures of cardiometabolic health lilly.com ↗
In the trial, Foundayo met the primary endpoint by demonstrating a non-inferior risk of major adverse cardiovascular events (MACE-4), including cardiovascular death, heart attack, stroke or hospitalization for unstable and sudden chest pain, compared to insulin glargine. |
| 2026-03-26 | Novo Nordisk A/S | Regulatory Novo Nordisk A/S: Awiqli® approved in the US, the first and only once-weekly basal insulin treatment for adults with type 2 diabetes novonordisk.com ↗
Awiqli® (insulin icodec-abae) injection is the first-ever once-weekly basal insulin approved by the FDA |
| 2026-03-11 | Insulet Corporation | Results Insulet Presents Promising Study Results for Fully Closed-Loop Automated Insulin Delivery System for Adults with Type 2 Diabetes insulet.com ↗ |
| 2026-02-26 | Mannkind Corporation | Regulatory MannKind Reports Fourth Quarter and Full Year 2025 Financial Results and Provides Business Update mannkindcorp.com ↗
FDA accepted for review the supplemental Biologics License Application (sBLA) for Afrezza in pediatrics, with a PDUFA target action date of May 29, 2026 |
| 2026-01-26 | Mannkind Corporation | Regulatory MannKind Announces FDA Approval of Updated Afrezza® Label Providing Starting Dose Guidance when Switching from Multiple Daily Injections (MDI) or Insulin Pump Mealtime Therapy mannkindcorp.com ↗ |
| 2025-11-19 | DexCom, Inc. | Regulatory Dexcom Smart Basal Receives FDA Clearance Becoming the First and Only CGM-integrated Basal Insulin Dosing Optimizer for Type 2 Diabetes dexcom.com ↗
Dexcom Smart Basal is FDA cleared and now the first and only CGM-integrated basal insulin dosing optimizer for adults aged 18 and older with Type 2 diabetes who are using long-acting insulin. |
| 2025-10-15 | Adocia | Results ADOCIA and Tonghua Dongbao Announce Positive Topline Results of Phase 3 Clinical Trial on Ultra-Rapid Insulin BioChaperone® Lispro (THDB0206 injection) in people with T1D adocia.com ↗
ADOCIA and Tonghua Dongbao Announce Positive Topline Results of Phase 3 Clinical Trial on Ultra-Rapid Insulin BioChaperone® Lispro (THDB0206 injection) in people with T1D |
| 2025-10-13 | Mannkind Corporation | Regulatory MannKind Announces U.S. FDA Accepts for Review its Supplemental Biologics License Application (sBLA) for Inhaled Insulin (Afrezza) in Children and Adolescents Aged 4-17 Years Living with Diabetes mannkindcorp.com ↗
MannKind Corporation (Nasdaq: MNKD) today announced that the U.S. Food and Drug Administration (FDA) has accepted the supplemental biologics license application (sBLA) seeking approval for Afrezza (insulin human) Inhalation Powder in children and adolescents living with type 1 or type 2 diabetes. |
| 2025-07-25 | Adocia | Results ADOCIA and Tonghua Dongbao Announce Positive Topline Results of Phase 3 Clinical Trial on Ultra-Rapid Insulin BioChaperone® Lispro (THDB0206 injection) in people with T2D adocia.com ↗
Adocia (Euronext Paris: FR0011184241 – ADOC, the “Company”), a clinical -stage biopharmaceutical company focused on the research and development of innovative therapeutic solutions for the treatment of diabetes and obesity , announces that its partner Tonghua Dongbao releases today positive topline results on the Phase 3 clinical trial on BioChaperone® Lispro (THDB0206 injection), a novel Ultra-Rapid Insulin formulation. |
| 2025-03-25 | Gan and Lee Pharmaceuticals, USA | Regulatory Gan & Lee Pharmaceuticals' Insulin Aspart 30 Receives NPRA Approval in Malaysia ganlee.com ↗
Gan & Lee Pharmaceuticals, a leading global biopharmaceutical company (hereinafter referred to as Gan & Lee, stock code: 603087.SH), has announced that its insulin aspart 30, developed in collaboration with a local Malaysian pharmaceutical company, has received regulatory approval from the National Pharmaceutical Regulatory Agency (NPRA) of Malaysia. |
| 2025-02-26 | Mannkind Corporation | Results MannKind Corporation Reports Fourth Quarter and Full Year 2024 Financial Results and Provides Business Update mannkindcorp.com ↗
Reported primary endpoint of INHALE-1 for Afrezza in pediatrics |
| 2024-12-17 | Eli Lilly and Company | Regulatory Lilly and EVA Pharma announce regulatory approval and release of locally manufactured insulin in Egypt lilly.com ↗
The Egyptian Drug Authority approved the insulin glargine injection manufactured by EVA Pharma through a collaboration with Eli Lilly and Company (NYSE: LLY). |
| 2024-12-16 | Mannkind Corporation | Results MannKind Announces Six-Month Results From Phase 3 INHALE-1 Pediatric Diabetes Trial Utilizing Inhaled Insulin (Afrezza®) mannkindcorp.com ↗
MannKind Corporation (Nasdaq: MNKD), a company focused on the development and commercialization of inhaled therapeutic products and devices for patients with endocrine and orphan lung diseases, today announced six-month results from its Phase 3 INHALE-1 study of Afrezza (insulin human) Inhalation Powder in children and adolescents (aged 4-17 years of age). |
| 2024-12-11 | Mannkind Corporation | Regulatory CDSCO Approves Afrezza® (insulin human) Inhalation Powder in India mannkindcorp.com ↗
MannKind Corporation (Nasdaq: MNKD), a company focused on the development and commercialization of innovative inhaled therapeutic products and devices for patients with endocrine and orphan lung diseases, and Cipla Ltd. announced today that the Central Drugs Standard Control Organisation (CDSCO) in India has approved Afrezza (insulin human) Inhalation Powder in adults. |
| 2024-10-16 | Gan and Lee Pharmaceuticals, USA | Results Gan & Lee Pharmaceuticals’ Three Innovative Drugs: GZR18 Injection, GZR4 Injection, and GZR101 Injection Achieve Primary Endpoints in Phase 2 Clinical Studies ganlee.com ↗
After 16 weeks of treatment in patients with Type 2 diabetes, the once-weekly insulin analog GZR4 injection demonstrated superior HbA1c reduction in patients with uncontrolled diabetes on basal insulins, compared to insulin degludec (Tresiba ® ). |
| 2024-09-30 | Mannkind Corporation | Results More Adults With Type 1 Diabetes Achieved A1C Goal ( mannkindcorp.com ↗
MannKind Corporation (Nasdaq: MNKD), a company focused on the development and commercialization of inhaled therapeutic products and devices for patients with endocrine and orphan lung diseases, today announced top-level 30-week results from its Phase 4 INHALE-3 study, in which additional patients living with type 1 diabetes achieved target A1c levels during the extension phase. |
| 2024-09-10 | Eli Lilly and Company | Results Once-weekly dose of insulin efsitora alfa delivers A1C reduction consistent with the most advanced daily insulin in people with type 2 diabetes lilly.com ↗
For the efficacy estimand1,2, efsitora reduced A1C by 1.34% compared to 1.26% for insulin degludec resulting in an A1C of 6.87% and 6.95% respectively3 at 52 weeks. |
| 2024-09-10 | Eli Lilly and Company | Results With once-a-week dosing, insulin efsitora alfa delivers similar A1C reduction compared to daily insulin in adults with type 1 diabetes lilly.com ↗
In the trial, efsitora met the primary endpoint of non-inferior A1C reduction at week 26. |
| 2024-08-08 | Gan and Lee Pharmaceuticals, USA | Regulatory Gan & Lee Teams Up with Algerian Pharmaceutical Company to Pioneer New Horizons in African Market ganlee.com ↗
This approval marks the successful launch of Gan & Lee's first localization project in the African market, opening a new chapter in Gan & Lee's global pharmaceutical landscape. |
| 2024-06-22 | Mannkind Corporation | Results INHALE-3 Study Reveals Positive Readout in Head-to-Head Comparison of Inhaled Insulin vs. Usual Care in T1D; New Data Presented at American Diabetes Association’s 84th Scientific Sessions mannkindcorp.com ↗
Study proves inhaled insulin is as effective as usual care (primarily automated insulin delivery pumps or multiple daily injections) for adults living with T1D meeting the primary endpoint |
| 2024-05-16 | Eli Lilly and Company | Results With Once-a-Week Dosing, Insulin Efsitora Alfa Delivers A1C Reduction and Safety Profile Consistent with Daily Insulin lilly.com ↗
In the treat-to-target clinical trials, efsitora showed non-inferior A1C reduction compared to the most commonly used daily basal insulins globally. |
| 2024-03-11 | Mannkind Corporation | Results INHALE-3 Study’s Initial Meal Challenge Results Comparing Afrezza® Head-To-Head With Multiple Daily Injections (MDI) and Insulin Pumps mannkindcorp.com ↗
Post-meal hyperglycemia was significantly reduced by 20% with inhaled insulin compared with rapid-acting insulin delivered through MDI or insulin pumps |
| 2023-12-08 | Gan and Lee Pharmaceuticals, USA | Results IDF 2023丨Debut of the Phase III Clinical Evidence in China for Rapilin30 ganlee.com ↗
The results showed that Rapilin ® 30 is similar in efficacy and safety to the reference product, NovoMix ® 30. |
| 2023-10-23 | Adocia | Results ADOCIA’s Partner Tonghua Dongbao Announces Positive Results of Three Clinical Trials on BioChaperone® Combo adocia.com ↗ |
| 2023-10-16 | Gan and Lee Pharmaceuticals, USA | Results Gan & Lee Pharmaceuticals' Overseas Clinical Research on Three Insulin Products was Published in Journal Diabetes, Obesity and Metabolism ganlee.com ↗
Recently, Gan & Lee Pharmaceuticals published the results of the Phase I clinical trial of three insulin products – Basalin ®️ (insulin glargine), Prandilin ®️ (insulin lispro), and Rapilin ®️ (insulin aspart) - in the peer-reviewed journal Diabetes, Obesity and Metabolism. |
| 2023-10-09 | Gan and Lee Pharmaceuticals, USA | Regulatory The Scientific Evaluation from EMA on the Marketing Authorisation Application of Gan & Lee Insulin Aspart biosimilar starts upon the Positive Validation Letter ganlee.com ↗
Insulin aspart biosimilar to the European Medicines Agency (hereinafter referred to as “EMA”), and recently received the Positive validation letter (formal acceptance notice)from the EMA, entering the review stage. |
| 2023-06-20 | Oramed, Ltd. | Results Oramed to Present at the 83rd American Diabetes Association Conference oramed.com ↗
o ral i nsulin was found to potentially reduce l iver fibrosis and f at in patients with NASH and Type 2 Diabetes . |
| 2023-05-15 | Oramed, Ltd. | Regulatory Oramed Announces that its Chinese Partner, HTIT, has Successfully Completed a Phase 3 Oral Insulin Clinical Trial and Submitted a Marketing Authorization Application in China oramed.com ↗
HTIT is now moving toward regulatory approval and has submitted the data to the National Medical Products Administration (NMPA, formerly the CFDA). |
| 2023-05-10 | Gan and Lee Pharmaceuticals, USA | Regulatory Gan & Lee Pharmaceuticals Announces Approval of Insulin Glargine Pre-filled Pen in India ganlee.com ↗
Gan & Lee Pharmaceuticals Co., Ltd. (hereinafter referred to as Gan & Lee, stock code: 603087. SH) is pleased to announce its 3mL insulin glargine pre-filled pen which is in cooperation with local Indian customers has been approved for marketing in India. |
| 2023-04-24 | Gan and Lee Pharmaceuticals, USA | Regulatory Gan & Lee Pharmaceuticals Announces Approval of Insulin Glargine Injection in Bolivia ganlee.com ↗
Gan & Lee Pharmaceuticals Co., Ltd. (hereinafter referred to as Gan & Lee, stock code: 603087. SH) is pleased to announce its insulin glargine injection has been approved by the Agencia Estatal de Medicamentos y Tecnologías en Salud, AGEMED of Bolivia for the treatment of diabetes. |
| 2023-02-23 | Gan and Lee Pharmaceuticals, USA | Regulatory The First Chinese Insulin Biologics License Application Submission was Officially Accepted by the US FDA upon the Filing Notification Letter ganlee.com ↗
It is an exciting milestone that the BLA submission of Gan & Lee Insulin Glargine Injection was accepted for filing by the US FDA. |
| 2023-02-22 | Mannkind Corporation | Results MannKind to Give Oral Presentation on Meal Challenge Results From the Afrezza® With Basal Combination (ABC Study) at 16th Annual ATTD Conference mannkindcorp.com ↗
The data showed that subjects utilizing inhaled Technosphere Insulin lowered peak glucose levels 30 minutes faster (200 mg/dl at 60 minutes) than subjects utilizing a rapid-acting analogue (RAA) with an Automated Insulin Delivery (AID) system (264 mg/dl at 90 minutes). |
| 2023-01-04 | Lannett Company, Inc. | Results LANNETT PROVIDES DEVELOPMENT UPDATE ON BIOSIMILAR INSULIN PRODUCTS investorroom.com ↗
The company said results from the study of Lannett/HEC biosimilar insulin aspart versus US NovoLog® (the reference biologic) indicated the products were highly comparable when animals were dosed with equal quantities of the drugs via subcutaneous route. |
| 2022-12-26 | Gan and Lee Pharmaceuticals, USA | Regulatory Gan & Lee Pharmaceuticals Announces Approval of Two Local-filling Insulin Preparations in Indonesia ganlee.com ↗
The two locally-produced products have been approved by the Indonesia Ministry of Public Health for the treatment of diabetes. |
| 2022-12-08 | DexCom, Inc. | Regulatory Dexcom G7 Receives FDA Clearance: The Most Accurate Continuous Glucose Monitoring System Cleared in the U.S. dexcom.com ↗ |
| 2022-11-29 | Oramed, Ltd. | Results Oramed Announces Publication of Oral Insulin Study in Peer-Reviewed Journal: Diabetes, Obesity, and Metabolism oramed.com ↗
The trial met the primary endpoint of statistically significant reductions of HbA1c from baseline to Week 12. |
| 2022-11-10 | Mannkind Corporation | Results MannKind to Present Two Posters at 22nd Annual Diabetes Technology Meeting mannkindcorp.com ↗
TI peaked 30 minutes faster and significantly reduced glucose at 60 minutes compared to subcutaneous insulins – including recently approved versions. |
| 2022-10-06 | Adocia | Results ADOCIA Announces Exceptional Weight Loss for Obese People with Type 1 Diabetes using M1Pram in a post-hoc analysis adocia.com ↗
Glycemic control efficacy comparable to that obtained with the commercial reference insulin Humalog® (Eli Lilly) |
| 2022-09-13 | Oramed, Ltd. | Results Oramed Reports Positive Top-Line Results from Phase 2 NASH Trial with its ORMD-0801, Oral Insulin Candidate oramed.com ↗
All the measurements showed a consistent clinically meaningful trend in favor of ORMD-0801. |
| 2022-08-08 | Gan and Lee Pharmaceuticals, USA | Regulatory Gan & Lee Pharmaceuticals Announces U.S. FDA Clearance of Investigational New Drug (IND) Application for the innovative once-weekly ultra-long-acting insulin, GZR4 ganlee.com ↗
Gan & Lee Pharmaceuticals Co., Ltd. (hereinafter referred to as Gan & Lee, stock code: 603087. SH), is pleased to announce that the Food and Drug Administration (" FDA ") has cleared the Investigational New Drug (IND) application for GZR4 to conduct a Phase I clinical trial in the US (IND No. 159549). |
| 2022-06-21 | Adocia | Results ADOCIA announces M1Pram Phase 2 Trial Meets Primary Objective by Reducing Weight in Overweight People with Type 1 Diabetes adocia.com ↗ |
| 2022-04-27 | Mannkind Corporation | Results MannKind Presents Poster at 15th International Conference on Advanced Technologies & Treatments for Diabetes (ATTD 2022) to Be Held April 27-30 mannkindcorp.com ↗
The proof-of-concept study demonstrated that a simplified 2x dose of Technosphere® Insulin (TI) provided significant reductions in post-prandial glucose excursions (PPGE) versus the current label dosage guidelines, with no new safety concerns. |
| 2022-04-11 | Adocia | Regulatory ADOCIA Announces Start of 3 Clinical Studies for BioChaperone® Combo with Partner Tonghua Dongbao adocia.com ↗ |
| 2021-11-05 | Mannkind Corporation | Results MannKind Presents Data at 21st Annual Diabetes Technology Meeting mannkindcorp.com ↗
This feasibility study demonstrated that a TI dose – approximately double the estimated mealtime SC injection dose –provided significant reductions in PPGE without severe hypoglycemia. |
| 2021-10-19 | Eli Lilly and Company | Results Tirzepatide results published in The Lancet show superior A1C and body weight reductions compared to insulin glargine in adults with type 2 diabetes with increased cardiovascular risk lilly.com ↗ |
| 2021-10-14 | Adocia | Regulatory ADOCIA’s partner Tonghua Dongbao Receives Clearance to Start Ultra-Rapid Insulin BioChaperone® Lispro Phase 3 Trial in China adocia.com ↗ |
| 2021-09-21 | Adocia | Results ADOCIA announces Oral Presentation Reviewing M1Pram (ADO09) at the occasion of the 57th Annual Meeting of EASD adocia.com ↗
On this occasion, Adocia will be presenting Parts A and B of the Proof-of-Concept Phase I clinical trial with M1Pram, a co-formulation of pramlintide and insulin A21G that improves post-prandial glucose and body weight versus insulin aspart in type 1 diabetes. |
| 2021-08-16 | Oramed, Ltd. | Results Oramed Announces Publication of Oral Insulin Study in Peer-Reviewed Journal: Diabetes, Obesity, and Metabolism oramed.com ↗
The trial met its primary endpoint and found that in patients with T2DM, bedtime ORMD-0801 curbed increases in night-time glycemia, 24-hour glycemia, and HbA1c without increasing the risk of hypoglycemia or safety events as compared to the control arm. |
| 2021-07-02 | Gan and Lee Pharmaceuticals, USA | Results New Data on Phase 1 Proposed Biosimilar Gan & Lee Insulins Aspart (GL-ASP), Lispro (GL-LIS), and Glargine (GL-GLA) Presented at the American Diabetes Association’s 81st Scientific Sessions ganlee.com ↗
These data demonstrate pharmacokinetic and pharmacodynamic bioequivalence between each of the proposed biosimilar Gan & Lee insulins and their respective reference compounds. |
| 2021-06-28 | Sanofi | Results Media Update: New Soliqua®* data shows improved blood sugar control without weight gain versus premixed insulin sanofi.com ↗
The study met both primary endpoints with Soliqua demonstrating noninferiority of blood sugar (HbA 1c ) reduction and superiority on body weight change from baseline compared to premixed insulin. |
| 2021-06-25 | Mannkind Corporation | Results MannKind Presents Two Posters At American Diabetes Association's Virtual 81st Scientific Sessions, June 25-29 mannkindcorp.com ↗
The final results from the phase 2 pediatric study revealed that serum insulin concentrations peaked rapidly within 10-15 minutes of inhaled administration of TI, similar to the results observed previously in adults. |
| 2021-06-03 | Mannkind Corporation | Results MannKind Announces Data Presentation At 14th International Conference On Advanced Technologies & Treatments For Diabetes (ATTD 2021) To Be Held Virtually June 2-5 mannkindcorp.com ↗
The poster presents a post hoc analysis from the STAT study that demonstrates how Afrezza (Technosphere Insulin or TI) reduced nocturnal hypoglycemia compared to insulin aspart in adult patients with type 1 diabetes (T1D). |
| 2021-06-02 | Adocia | Results ADOCIA Presents Clinical Results on M1Pram at the 14th International Conference on ATTD 2021 adocia.com ↗
ADO09, A CO-FORMULATION OF PRAMLINTIDE AND INSULIN A21G IMPROVES POST-PRANDIAL GLUCOSE (PPG) VERSUS INSULIN ASPART IN TYPE 1 DIABETES (T1D) |
| 2021-05-20 | Eli Lilly and Company | Results Lilly's tirzepatide achieves all primary and key secondary study outcomes against insulin glargine in adults with type 2 diabetes and increased cardiovascular risk in SURPASS-4 trial lilly.com ↗
All three doses of tirzepatide (5 mg, 10 mg and 15 mg) led to superior A1C and body weight reductions compared to insulin glargine for both estimandsii. |
| 2021-05-04 | Gan and Lee Pharmaceuticals, USA | Regulatory Mixed Protamine Human Insulin Injection (30R) from Gan & Lee Pharmaceuticals Approved for Listing in China ganlee.com ↗
The approval of Mixed Protamine Human Insulin Injection (30R) is an important milestone for Gan & Lee in China as we strive to provide additional treatment options for patients with diabetes. |
| 2021-01-25 | Adocia | Results Adocia Announces Positive Clinical Results Confirming the Ultra-Rapid Profile of a BioChaperone® Lispro Formulation Containing Insulin from Partner Tonghua Dongbao adocia.com ↗
In this study, the BioChaperone Lispro formulation containing insulin lispro from Tonghua Dongbao demonstrated similar ultra -rapid pharmacokinetic, pharmacodynamic, and safety profiles when compared to a BioChaperone Lispro formulation containing insulin lispro Humalog® |
| 2020-10-16 | Oramed, Ltd. | Regulatory Oramed Issues Shareholder Update on Pivotal Phase 3 Oral Insulin Studies: Protocols Submitted to FDA oramed.com ↗ |
| 2020-09-15 | Adocia | Results Adocia announces Positive Topline Results of Phase 1b Study for M1Pram in People with type 1 Diabetes. adocia.com ↗ |
| 2020-07-15 | Oramed, Ltd. | Regulatory Oramed Reports Positive End of Phase 2 Meeting With the FDA for Oral Insulin oramed.com ↗
The FDA outlined its expectations for design of the ORMD-0801 Phase 3 trials as well as submission of the Biologics License Application (BLA) that would follow successful trials. |
| 2020-06-18 | Xeris Pharmaceuticals | Results Xeris Pharmaceuticals Announces Positive Topline Results from the Phase 2 Comparative Study of a Novel Pramlintide-insulin Co-formulation (XP-3924) in Adults with Type 1 Diabetes Mellitus xerispharma.com ↗
XP-3924 showed improved glucose control when compared to Humulin® R alone |
| 2020-06-15 | Oramed, Ltd. | Results Oramed Announces Positive Initial Clinical Trial Results for Treatment of NASH With Oral Insulin oramed.com ↗
The 12-week, once-daily treatment had no serious adverse events, and induced an observed mean 6.9±6.8% reduction in liver fat content (sign test p value: 0.035), and the relative reduction was 30%, [see graph] as measured by MRI-PDFF. |
| 2020-06-15 | Mannkind Corporation | Results MannKind Presents Positive Original Analyses of Afrezza® Clinical Data at American Diabetes Association (ADA) 80th Scientific Sessions mannkindcorp.com ↗
Ultra rapid-acting Afrezza can be safely and effectively dosed at 1.5 to 2.0 times that of injected mealtime insulin |
| 2020-06-13 | Mannkind Corporation | Results Investigator-Initiated Study Shows Switching to Afrezza® Improves Glucose Control with No Additional Hypoglycemia in T2DM mannkindcorp.com ↗
Study subjects experienced a significant (0.8%) reduction in A1C levels at the end of the 14-week treatment period after switching from their injected mealtime insulin to Afrezza. |
| 2020-06-08 | Adocia | Results Adocia Announces M1Pram Clinical Data Presentation at the American Diabetes Association® 80th Scientific Sessions – Virtual experience adocia.com ↗
In this study, M1Pram offered better glycemic control with less insulin consumption and also significant weight loss. |
| 2020-05-12 | Biocon Biologics UK Ltd | Regulatory Biocon Biologics Drug Substance Facilities in Bengaluru Receive EU GMP Certification bioconbiologics.com ↗ |
| 2020-04-23 | Adocia | Results Adocia announces positive topline results of the exploratory Phase 1b study of ADO09 (M1Pram) in people with type 1 diabetes adocia.com ↗ |
| 2020-04-16 | Mannkind Corporation | Results MannKind Presents Novel Scientific Data at 13th International Conference on Advanced Technologies & Treatments for Diabetes (ATTD 2020) mannkindcorp.com ↗
Clinical use of Afrezza in adults with uncontrolled type 2 diabetes on two or more glucose lowering therapies resulted in a significant (1.6%) drop in A1c levels and a significant increase in time in range (presented by Dr. Philip Levin MD, Endocrinology, MODEL Clinical Research). |
| 2020-02-26 | Oramed, Ltd. | Results Oramed Reports Positive Results in the Final Cohort of Its Phase 2b Oral Insulin Trial oramed.com ↗
Patients randomized in the trial treated with 8 mg of ORMD-0801 once daily achieved an observed mean reduction of 1.29% from baseline and a least square mean reduction of 0.95% from baseline, or 0.81% adjusted for placebo (p value = 0.028). |
| 2020-01-31 | Eli Lilly and Company | Regulatory CHMP Recommends Approval of Lilly's New Fast-Acting Mealtime Insulin to Improve Glycemic Control in Adults with Diabetes lilly.com ↗
This is the first regulatory step toward approval for this new insulin in Europe. |
| 2020-01-06 | Mannkind Corporation | Regulatory Afrezza® (insulin human) Inhalation Powder Receives Pricing Registration in Brazil Commercial activities to commence this month mannkindcorp.com ↗
MannKind Corporation (NASDAQ: MNKD) announced today that its Brazilian partner, Biomm S.A., has received written notice from the Chamber of Regulation of the Medicines Market (CMED) approving the proposed price of Afrezza in Brazil. |
| 2019-12-20 | Mannkind Corporation | Results Study 171 Shows Hypoglycemia is Reduced with Use of Afrezza® Relative to Insulin Aspart in Type 1 Diabetes mannkindcorp.com ↗
Participants treated with Afrezza experienced statistically significantly lower rates of level 1 (blood glucose ≤ 3.9 mmol/L or 70 mg/dL) and level 2 (blood glucose ≤ 3.0 mmol/L or 54 mg/dL) hypoglycemic events. |
| 2019-11-19 | Oramed, Ltd. | Results Oramed Provides Highlights and Data From Its Phase IIb Oral Insulin Study Investor Event oramed.com ↗
ORMD-0801 dosed once daily reduced A1C by 0.60% compared to only a 0.06% reduction by placebo |
| 2019-11-12 | Oramed, Ltd. | Results Oramed Announces Successful Phase IIb Study of Oral Insulin in Type 2 Diabetes oramed.com ↗
Patients randomized in the trial to once-daily ORMD-0801 achieved a reduction in mean A1C of 0.60% from baseline, or a reduction of 0.54% adjusted for placebo (p value = 0.036). |
| 2019-09-19 | Mannkind Corporation | Results MannKind Presents Positive Afrezza® Clinical Data from Type 1 Diabetes Study at 55th Annual Meeting of the EASD mannkindcorp.com ↗
When compared to injected insulin aspart, Afrezza provided significantly better glucose control in the first two hours following a standardized meal. |
| 2019-06-09 | Mannkind Corporation | Results MannKind Presents Positive Afrezza® Clinical Data from Three Studies at ADA 79th Scientific Sessions mannkindcorp.com ↗
MannKind Corporation (Nasdaq: MNKD) announced that new data from three different studies of Afrezza® (insulin human) Inhalation Powder were released at the American Diabetes Association’s 79th Scientific Sessions, being held June 7-11, in San Francisco, California. |
| 2019-06-03 | Mannkind Corporation | Regulatory Afrezza® (insulin human) Inhalation Powder Approved in Brazil mannkindcorp.com ↗
MannKind Corporation (Nasdaq:MNKD) and BIOMM SA (BVMF:BIOM3) today announced that Afrezza® (insulin human) Inhalation Powder, an ultra rapid-acting mealtime insulin to improve glycemic control in adult patients with diabetes mellitus, has been registered by the Brazilian Health Regulatory Agency (ANVISA). |
| 2019-04-25 | Mannkind Corporation | Results MannKind Presents Scientific Data at 28th Annual Scientific and Clinical Congress of the American Association of Clinical Endocrinologists (AACE 2019) mannkindcorp.com ↗
Compared to insulin lispro, the ultra-rapid absorption of Afrezza provides significantly better control of early post-prandial glucose levels due to an earlier increase in glucose disposal and a faster suppression of endogenous glucose production. |
| 2019-04-10 | Adocia | Results Adocia announces topline results for the first clinical study of ADO09, a new co-formulation of pramlintide and a prandial insulin adocia.com ↗
ADO09 showed similar glucose control over the first two hours after a meal compared to separate injections of Symlin® and Humulin® |
| 2019-03-26 | Oramed, Ltd. | Regulatory Chinese Regulatory Authority [NMPA] Approves IND Application of Oramed’s Oral Insulin Capsules oramed.com ↗
The approval of the IND by the Center For Drug Evaluation of the China National Medical Products Administration (“NMPA”, formerly the CFDA) of the oral insulin paves the way for the start of clinical trials in China . |
| 2019-02-20 | Mannkind Corporation | Results MannKind Presents New Scientific Data at 12th International Conference on Advanced Technologies & Treatments for Diabetes (ATTD 2019) mannkindcorp.com ↗
By delivering a time-action profile closer to that of physiologic insulin action, post-prandial glucose levels and other markers of glycemic control were significantly improved compared to injected insulin in meal-challenge tests in patients with type 2 diabetes. |
| 2018-10-04 | Mannkind Corporation | Results MannKind Presents Positive Afrezza® STAT Study Clinical Data at 54th Annual Meeting of the European Association for the Study of Diabetes mannkindcorp.com ↗
“We continue to advance the understanding of the potential clinical benefits of Afrezza by sharing the positive data from the STAT study at the 2018 EASD conference,” said David Kendall, M.D., Chief Medical Officer of MannKind Corporation. |
| 2018-10-03 | Mannkind Corporation | Results MannKind Presents New Scientific Data at 54th Annual Meeting of the European Association for the Study of Diabetes mannkindcorp.com ↗
Individuals on Afrezza experienced significantly lower rates of hypoglycemia vs insulin aspart |
| 2018-09-24 | Mannkind Corporation | Results MannKind Announces Completion of Cohort 1 and Opens Enrollment for Cohort 2 of Afrezza® Safety and Pharmacokinetics Study in Pediatric Patients mannkindcorp.com ↗
The study findings to date support that the single‑dose pharmacokinetic (PK) profile of insulin levels for this age group is consistent with patterns seen in adult patients. |
| 2018-09-13 | Mannkind Corporation | Results Positive Afrezza® Clinical Data from STAT Study Published in Diabetes Technology & Therapeutics mannkindcorp.com ↗
Study data show Afrezza provides greater improvement in postprandial glucose control than insulin aspart |
| 2018-09-05 | Adocia | Results Adocia announces positive topline results for the first clinical study of BioChaperone® Pramlintide Insulin in people with type 1 diabetes adocia.com ↗
BC Pram Ins showed similar glucose control over the first two hours after the meal compared to separate injections of Symlin® and Humulin® |
| 2018-06-25 | Mannkind Corporation | Results Additional Positive Afrezza® Clinical Data from STAT Study To Be Presented at ADA 78th Scientific Sessions mannkindcorp.com ↗
Afrezza provides greater improvement in post-prandial glucose control than insulin aspart |
| 2018-06-25 | Eli Lilly and Company | Results First-ever Study of Lilly's Humulin® R U-500 Administered in an Insulin Pump Shows Improved A1C in People with Type 2 Diabetes lilly.com ↗
At the study's primary endpoint of 26 weeks, Humulin R U-500 delivered in the investigational pump and through MDI led to A1C reductions from baseline in people with type 2 diabetes (-1.27 percent, -0.85 percent, respectively). |
| 2018-06-23 | Merck Sharp & Dohme LLC | Results Merck Presents New Data from the Comparative Trials with Sitagliptin (CompoSIT) Clinical Trial Program with JANUVIA® (sitagliptin) merck.com ↗
In the CompoSIT-I study, initiation of insulin therapy while continuing treatment with JANUVIA resulted in greater blood glucose reductions and more patients reaching A1C goal compared to those who discontinued JANUVIA. |
| 2018-06-23 | Mannkind Corporation | Results MannKind Presents Positive Afrezza® Clinical Data from STAT and AFFINITY Studies at ADA 78th Scientific Sessions mannkindcorp.com ↗
Significantly reduced the time spent in hypoglycemia (i.e., <70 mg/dl) by 41% or approximately 23 minutes per day |
| 2018-06-23 | Eli Lilly and Company | Results New Data Presented at the American Diabetes Association 78th Scientific Sessions® Reinforce Potential of Lilly's Ultra Rapid Lispro in People with Type 1 and Type 2 Diabetes lilly.com ↗
Across all three studies, URLi was absorbed faster than Humalog, which led to improved post-meal blood sugar control that was sustained over time. |
| 2018-04-25 | Mannkind Corporation | Regulatory FDA Determines that Afrezza REMS Communication Plan Has Met Goals and REMS No Longer Necessary mannkindcorp.com ↗
As a result, the FDA has decided that a REMS is no longer required for Afrezza. |
| 2017-11-14 | Oramed, Ltd. | Regulatory Oramed Receives Regulatory Approval to Conduct Clinical Study for Treatment of NASH with its Oral Insulin Capsule oramed.com ↗
Israel’s Ministry of Health has granted the Company approval to initiate an exploratory clinical study of its oral insulin capsule ORMD-0801 in patients with nonalcoholic steatohepatitis (NASH). |
| 2017-10-30 | Mannkind Corporation | Results Type 1 Diabetes Patients Using AFREZZA Have More Positive View of Therapy Compared to Standard Insulin Therapy mannkindcorp.com ↗
Perceptions of insulin therapy (overall, convenience, comfort and ease of regimen adherence) showed significant improvement (P<0.01) in patients using AFREZZA, with greater improvement than in patients receiving standard therapy (P<0.05). |
| 2017-10-30 | Mannkind Corporation | Results Study Shows AFREZZA(R) Controls Blood Sugar Levels in Type 1 Diabetes, Results in Weight Loss, Less Hypoglycemia Than Usual Care mannkindcorp.com ↗
Our study shows that treatment regimens incorporating AFREZZA offer glycemic control comparable to conventional regimens, with the added benefits of weight loss and less incidence of hypoglycemia, making AFREZZA a potentially important and useful new treatment option in the diabetes space. |
| 2017-10-30 | Mannkind Corporation | Results Study Shows AFRESA(R) Provides Rapid Suppression of Endogenous Glucose Production in Diabetes Patients mannkindcorp.com ↗
Results from the open-label, single-dose, three-way crossover study showed that endogenous glucose production (EGP) was suppressed earlier following AFRESA administration compared with subcutaneous insulin lispro and inhaled Exubera in adult patients with type 2 diabetes. |
| 2017-10-30 | Mannkind Corporation | Results Studies Show No Increased Risk of Cardiac Events in Diabetes Patients Treated with AFREZZA(R) mannkindcorp.com ↗
The findings of two separate studies further substantiate that treatment with the investigational ultra rapid acting mealtime insulin AFREZZA® (insulin human [rDNA origin]) Inhalation Powder does not result in excess cardiovascular events in type 1 or type 2 diabetes patients. |
| 2017-10-30 | Mannkind Corporation | Results Studies Show AFRESA(R) Controls Post-Meal Sugar Levels With Less Weight Gain and Hypoglycemia Risk for Diabetes Patients mannkindcorp.com ↗
A1C was reduced by -0.66% and -0.72% in the TI+G and BPA 70/30 groups, respectively, and the proportion of subjects achieving A1C <7.0% were comparable between treatments (22% vs 27%). |
| 2017-10-30 | Mannkind Corporation | Results New Findings Show Bioequivalence, Ease-of-Use and Efficiency of MannKind's Drug Delivery Platform mannkindcorp.com ↗
An additional study also demonstrated the bioequivalence of the Gen2 device and the clinical inhaler. |
| 2017-10-30 | Mannkind Corporation | Regulatory MannKind Updates Status of New Drug Application for AFREZZA(R) mannkindcorp.com ↗
The FDA stated that it will require approximately four additional weeks to complete its review of the NDA. |
| 2017-10-30 | Mannkind Corporation | Regulatory MannKind Updates Status of New Drug Application mannkindcorp.com ↗
MannKind Corporation (Nasdaq:MNKD) announced that it was informed today by the Food and Drug Administration that the FDA will not be able to complete the review of MannKind's new drug application (NDA) for its ultra rapid-acting insulin therapy by the action date of January 16, 2010. |
| 2017-10-30 | Mannkind Corporation | Regulatory MannKind Submits NDA for AFRESA for Treatment of Diabetes mannkindcorp.com ↗
MannKind Corporation (Nasdaq: MNKD) today announced that it has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) requesting approval of AFRESA® (insulin monomer human [rDNA origin]) Inhalation Powder and the AFRESA® Inhaler for the treatment of adults with type 1 or type 2 diabetes mellitus for the control of hyperglycemia. |
| 2017-10-30 | Mannkind Corporation | Regulatory MannKind Resubmits New Drug Application to U.S. FDA for AFREZZA for the Treatment of Adults with Diabetes mannkindcorp.com ↗
MannKind Corporation (Nasdaq: MNKD) today announced the resubmission on October 13, 2013 of a new drug application (NDA) to the U.S. Food and Drug Administration (FDA) seeking approval for the marketing and sale of AFREZZA® (insulin human [rDNA origin]) Inhalation Powder with an indication to improve glycemic control in adults with type 1 or type 2 diabetes. |
| 2017-10-30 | Mannkind Corporation | Results MannKind Reports Top-Line Results from Two Pivotal Phase 3 Clinical Studies in Type 1 and Type 2 Diabetes mannkindcorp.com ↗
MannKind Corporation (Nasdaq: MNKD) today released preliminary top-line results from two pivotal Phase 3 clinical studies of AFRESA, the company's ultra rapid acting insulin product (Studies 102 and 030). |
| 2017-10-30 | Mannkind Corporation | Results MannKind Reports Successful Completion of Device Bioequivalence Trial mannkindcorp.com ↗
MannKind Corporation (Nasdaq: MNKD) today announced successful completion of its trial to demonstrate equivalence of its commercial inhaler to the version of the device that was used in clinical trials to deliver AFRESA, MannKind's ultra rapid acting insulin that recently completed Phase 3 clinical trials. |
| 2017-10-30 | Mannkind Corporation | Results MannKind Reports Positive Results from Final Two Pivotal Phase 3 Clinical Studies in Type 1 and Type 2 Diabetes mannkindcorp.com ↗
today announced that it has met the primary endpoints of its final two pivotal Phase 3 studies of AFRESATM, the company's ultra rapid acting, inhaled insulin product. |
| 2017-10-30 | Mannkind Corporation | Results MannKind Reports Positive Data from a Phase 3 Clinical Study of AFREZZA in Patients with Type 2 Diabetes mannkindcorp.com ↗ |
| 2017-10-30 | Mannkind Corporation | Results MannKind Reports Positive Data from a Phase 3 Clinical Study of AFREZZA in Patients with Type 1 Diabetes mannkindcorp.com ↗ |
| 2017-10-30 | Mannkind Corporation | Results MannKind Reports Positive Data from a Phase 3 Clinical Study of Technosphere Insulin in Type 1 Diabetes mannkindcorp.com ↗
MannKind Corporation (Nasdaq: MNKD) today released preliminary top-line results from a Phase 3 clinical study of the Technosphere® Insulin System in patients with type 1 diabetes (Study 009). |
| 2017-10-30 | Mannkind Corporation | Results MannKind Corporation Response to Recent Market Events mannkindcorp.com ↗
By contrast, in clinical trials to date, Technosphere® Insulin has shown important advantages over the treatment that is presently considered to be the most effective meal-time therapy for patients -- rapid-acting insulin analogs. |
| 2017-10-30 | Mannkind Corporation | Results MannKind Corporation Reports 2010 First Quarter Financial Results mannkindcorp.com ↗
We also completed Study 117, an efficacy study in patients with type 1 diabetes, and are pleased to report that AFREZZA met the primary endpoint of non-inferiority in HbA1C levels compared to standard insulin therapy. |
| 2017-10-30 | Mannkind Corporation | Regulatory MannKind Corporation Receives Complete Response Letter from the FDA for AFREZZA(R) mannkindcorp.com ↗
MannKind Corporation Receives Complete Response Letter from the FDA for AFREZZA(R) |
| 2017-10-30 | Mannkind Corporation | Regulatory MannKind Corporation Announces FDA Approval of AFREZZA(R); A Novel, Rapid-Acting Inhaled Insulin for the Treatment of Diabetes mannkindcorp.com ↗
MannKind Corporation (Nasdaq:MNKD) today announced that the U.S. Food & Drug Administration (FDA) has approved AFREZZA® (insulin human) Inhalation Powder to improve glycemic control in adult patients with diabetes mellitus. |
| 2017-10-30 | Mannkind Corporation | Regulatory MannKind Announces Tentative Date of FDA Advisory Committee Review of AFREZZA mannkindcorp.com ↗ |
| 2017-10-30 | Mannkind Corporation | Results MannKind Announces Positive Clinical Data for AFREZZA; Both AFFINITY Phase 3 Studies Meet Primary Endpoints mannkindcorp.com ↗
MannKind Announces Positive Clinical Data for AFREZZA; Both AFFINITY Phase 3 Studies Meet Primary Endpoints |
| 2017-10-30 | Mannkind Corporation | Results MannKind Announces Late-Breaking Data Demonstrating Faster Onset and Shorter Duration of Action Compared to Mealtime Insulins mannkindcorp.com ↗
Data presented at ADA show Afrezza has a 25-to 35-minute faster onset of action than Lispro, with a duration that is up to two hours shorter |
| 2017-10-30 | Mannkind Corporation | Regulatory MannKind Announces FDA Acknowledgement of Resubmission of New Drug Application for AFREZZA mannkindcorp.com ↗
MannKind Corporation (Nasdaq: MNKD) today announced that the U.S. Food and Drug Administration (FDA) has acknowledged the resubmission of a New Drug Application (NDA) for AFREZZA® (insulin human [rDNA origin]) Inhalation Powder. |
| 2017-10-30 | Mannkind Corporation | Regulatory MannKind and BIOMM Submit Registration Dossier to Brazilian Health Regulatory Agency (ANVISA) mannkindcorp.com ↗
MannKind Corporation (Nasdaq:MNKD) (TASE:MNKD) and BIOMM SA (B3:BIOM3) announced the submission of a registration dossier to ANVISA, seeking the approval of Afrezza® (insulin human) inhalation powder in Brazil. |
| 2017-10-30 | Mannkind Corporation | Results Follow-up Safety Data Show AFREZZA(R) Comparable to Standard Antidiabetic Therapy in Lung Function Tests mannkindcorp.com ↗
There was also no statistical difference in FEV1 between the treatment groups when examining subjects with Type 1 and Type 2 diabetes (p=0.6158 and p=0.1795, respectively). |
| 2017-10-30 | Mannkind Corporation | Regulatory FDA Updates Afrezza® Prescribing Information mannkindcorp.com ↗ |
| 2017-10-30 | Mannkind Corporation | Regulatory FDA Requests Additional Information Regarding AFREZZA(TM) in Complete Response Letter to MannKind mannkindcorp.com ↗
FDA Requests Additional Information Regarding AFREZZA(TM) in Complete Response Letter to MannKind |
| 2017-10-30 | Mannkind Corporation | Regulatory FDA Advisory Committee Recommends Approval of AFREZZA(R), MannKind Corporation's Investigational Drug to Treat Diabetes mannkindcorp.com ↗
We are pleased with the Advisory Committee's approval recommendation in support of AFREZZA, and we appreciate the thoroughness of their review, |
| 2017-10-30 | Mannkind Corporation | Regulatory FDA Accepts MannKind's Submission and Files NDA for AFRESA mannkindcorp.com ↗
MannKind Corporation (Nasdaq:MNKD) today announced that the U.S. Food and Drug Administration (FDA) has accepted and filed MannKind’s New Drug Application (NDA) for AFRESA®, an ultra rapid-acting insulin. |
| 2017-10-30 | Mannkind Corporation | Regulatory FDA Accepts AFREZZA Complete Response Resubmission and Sets Target Action Date mannkindcorp.com ↗
MannKind Corporation (NASDAQ:MNKD) today announced that it has submitted, and the U.S. Food and Drug Administration (FDA) has accepted, MannKind's resubmission of its New Drug Application (NDA) for AFREZZA (insulin human [rDNA origin]) and classified it as a Class 2 resubmission. |
| 2017-10-30 | Mannkind Corporation | Results CORRECTING and REPLACING MannKind Reports Positive Data from a Phase 3 Clinical Study of AFREZZA in Patients with Type 1 Diabetes mannkindcorp.com ↗
MANNKIND REPORTS POSITIVE DATA FROM A PHASE 3 CLINICAL STUDY OF AFREZZA IN PATIENTS WITH TYPE 1 DIABETES |
| 2017-10-30 | Mannkind Corporation | Results American Diabetes Association/The Lancet Symposium Will Highlight Study Showing AFREZZA(R) Provides Comparable Glycemic Control with Less Weight Gain and Hypoglycemia than Standard of Care mannkindcorp.com ↗
Our findings show that mealtime AFREZZA, in combination with once-daily injected glargine, provides equivalent glucose control with fewer injections, less hypoglycemia and less weight gain than does twice-a-day, premixed insulin. |
| 2017-10-30 | Mannkind Corporation | Results AFREZZA(R) Suppresses Endogenous Glucose Production More Rapidly Than Currently Available Insulin Therapy mannkindcorp.com ↗
The highest FFA AOC was observed after AFREZZA 90U, while lispro and 60U AFREZZA were comparable. |
| 2017-10-30 | Mannkind Corporation | Results AFREZZA® Demonstrates Long-Term Efficacy in Controlling Blood Sugar Levels in Patients with Type 2 Diabetes mannkindcorp.com ↗
Additionally, AFREZZA-treated patients experienced less weight gain, 1.56 kg versus 1.75 kg for patients treated with standard diabetic care (p=0.67). |
| 2017-10-30 | Mannkind Corporation | Results AFREZZA Demonstrates Non-Inferiority Compared to Standard Therapy in Controlling Blood Sugar Levels in Type 1 Diabetes Patients mannkindcorp.com ↗
In addition, patients treated with AFREZZA had significantly lower rates of total and mild/moderate hypoglycemia (6.2 versus 8.2 events per subject month [p=0.0345] and 6.0 versus 8.0 events per subject month [p=0.0269], respectively). |
| 2017-10-30 | Mannkind Corporation | Results AFRESA(R) Phase 3 Pulmonary Function Safety Data in Patients with Diabetes Presented at ADA mannkindcorp.com ↗
Results from the prospective, multicenter, phase 3 study conducted over a two-year period showed no difference in mean change in forced expiratory volume in one second (FEV(1)) between those treated with AFRESA and those treated with standard insulin therapy. |
| 2017-10-30 | Mannkind Corporation | Results AFRESA(R) Phase 3 Data Show Sustained Glycemic Control, Normal Lung Function in Patients over Four Years of Treatment mannkindcorp.com ↗
Additionally, patients using AFRESA therapy experienced glycemic control for at least four years. |
| 2017-10-17 | Oramed, Ltd. | Results Endocrinology, Diabetes and Metabolism Journal Publishes Scientific Paper Authored by Oramed Scientists oramed.com ↗
The positive data from the study suggest an additive effect when ORMD-0801 and ORMD-0901 are given in combination. |
| 2017-09-29 | Novo Nordisk A/S | Regulatory CHMP støtter opdatering af indlægssedlen for Tresiba® i EU - ny indlægsseddel afspejler signifikant reduktion i risikoen for alvorlig hypoglykæmi novonordisk.com ↗
Med CHMP's støtte til den opdaterede indlægsseddel for Tresiba® har vi passeret en vigtig milepæl indenfor insulinbehandling. |
| 2017-09-29 | Novo Nordisk A/S | Regulatory Novo Nordisk's new fast-acting mealtime insulin Fiasp® approved in the US novonordisk.com ↗
Novo Nordisk today announced that the US Food and Drug Administration (FDA) has approved Fiasp® (fast-acting insulin aspart), a new fast-acting mealtime insulin, for the treatment of adults with diabetes. |
| 2017-09-05 | Adocia | Results Adocia Announces Two Data Presentations at the 53rd Annual Meeting of the European Association for the Study of Diabetes adocia.com ↗
The present study showed that BioChaperone Lispro improved post-prandial glycemic control compared to insulin lispro (Humalog®, Eli Lilly) when repeatedly administered to people with type 1 diabetes for 14 days. |
| 2017-08-21 | DexCom, Inc. | Results New Study Shows People with Type 2 Diabetes Benefit from Continuous Glucose Monitoring dexcom.com ↗
The results show that continuous glucose monitoring is an effective diabetes management tool that could benefit millions of people with Type 2 diabetes on insulin therapy |
| 2017-07-20 | Merck Sharp & Dohme LLC | Regulatory Merck Announces U.S. FDA Grants Tentative Approval for LUSDUNA™ Nexvue™ (insulin glargine injection), a Follow-On Biologic Basal Insulin merck.com ↗
Merck (NYSE:MRK), known as MSD outside of the United States and Canada, today announced that the U.S. Food and Drug Administration (FDA) has granted tentative approval for LUSDUNA™ Nexvue™ (insulin glargine injection) 100 units/mL, a follow-on biologic 1 basal insulin in a pre-filled dosing device. |
| 2017-07-11 | Oramed, Ltd. | Results Oramed Announces End-of-Phase 2 Meeting with FDA to Initiate Phase 3 Program oramed.com ↗
The Phase IIb trial met primary and secondary endpoints by indicating a statistically significant lowering of glucose relative to placebo. |
| 2017-06-14 | Novo Nordisk A/S | Regulatory Novo Nordisk indsender ansøgning i EU om inkludering af data fra DEVOTE-studiet i indlægssedlen for Tresiba® novonordisk.com ↗
Novo Nordisk meddeler i dag, at virksomheden har indsendt en type II-variationsansøgning til Det Europæiske Lægemiddelagentur (EMA) om inkludering af data fra DEVOTE-studiet i indlægssedlen for Tresiba® (insulin degludec). |
| 2017-06-13 | Eli Lilly and Company | Regulatory U.S. FDA Approves Humalog® Junior KwikPen® for the Treatment of Diabetes lilly.com ↗
The U.S. Food and Drug Administration (FDA) approved Eli Lilly and Company’s (NYSE: LLY) Humalog® Junior KwikPen® for the treatment of diabetes. |
| 2017-05-30 | Adocia | Results Adocia Announces Six Data Presentations at the American Diabetes Association® 77th Scientific Sessions adocia.com ↗
Ultra-rapid BioChaperone Lispro (BCLIS) Improves Postprandial Blood Glucose (PPG) Excursions vs. Insulin Lispro (LIS) in a 14-Day Treatment Study in Subjects with Type 1 Diabetes (T1DM) |
| 2017-03-18 | Novartis Pharmaceuticals | Results New analysis shows Novartis Entresto improves glycemic control in reduced ejection fraction heart failure patients with diabetes novartis.com ↗
Entresto lowered HbA1c levels - a measure of average blood glucose levels for the past two to three months - after one year of treatment for HF, and this effect was sustained over three years of study follow-up[1]. |
| 2016-12-16 | Adocia | Results Adocia and Lilly announce successful completion of an insulin pump study with BioChaperone Lispro adocia.com ↗
BioChaperone Lispro U100 demonstrated a statistically significant increase in insulin exposure over the first 30 minutes after a mealtime bolus compared to Humalog |
| 2016-11-29 | Novo Nordisk A/S | Results Novo Nordisk A/S: Tresiba® viser en sikker kardiovaskulær profil og reducerer risikoen for alvorlig hypoglykæmi sammenlignet med insulin glargin U100 i DEVOTE-studiet novonordisk.com ↗ |
| 2016-11-11 | Novo Nordisk A/S | Regulatory Novo Nordisk får positiv udtalelse fra de europæiske lægemiddelmyndigheder om Fiasp® (hurtigtvirkende insulin aspart) til behandling af diabetes novonordisk.com ↗
CHMP anbefaler, at Fiasp®, det planlagte varemærke for hurtigtvirkende insulin aspart, indiceres til brug som boluskomponenten i basal-bolus-behandling i kombination med basalinsulin og til kontinuerlig subkutan infusion via en insulinpumpe. |
| 2016-10-27 | Adocia | Results Adocia Announces Positive Topline Results from a Phase 1b Clinical Trial Measuring the Post-Meal Effect of Rapid-Acting Human Insulin, HinsBet® U100 adocia.com ↗ |
| 2016-10-07 | Novo Nordisk A/S | Regulatory Novo Nordisk modtager Complete Response Letter i USA vedrørende hurtigerevirkende insulin aspart novonordisk.com ↗
Novo Nordisk meddeler i dag, at virksomheden har modtaget et Complete Response Letter fra de amerikanske sundhedsmyndigheder, FDA, vedrørende registreringsansøgningen for hurtigerevirkende insulin aspart. |
| 2016-10-07 | Novo Nordisk A/S | Regulatory Novo Nordisk receives Complete Response Letter in the US for faster-acting insulin aspart novonordisk.com ↗
Bagsværd, Denmark 7 October 2016 - Novo Nordisk today announced that it has received a Complete Response Letter from the US Food and Drug Administration (FDA) regarding the New Drug Application for faster-acting insulin aspart. |
| 2016-09-08 | Adocia | Results Adocia to Present Clinical Data Validating BioChaperone® Technology at the 2016 EASD Annual Meeting adocia.com ↗
Lead Scientist and Chairman of Profil Germany, Dr. Tim Heise, will present findings that demonstrate superior postprandial blood glucose control in patients with type 1 diabetes using ultra -rapid BioChaperone® Lispro vs. Humalog®. |
| 2016-06-13 | Merck Sharp & Dohme LLC | Results Merck’s Investigational Insulin Glargine, MK-1293, Met Primary Endpoint in Two Phase 3 Studies, Showing Non-Inferiority to Lantus® merck.com ↗
Furthermore, in both studies, MK-1293 met its pre-specified secondary efficacy endpoints of statistical A1C equivalence to Lantus, a measure used to show that an investigational treatment is similar, within an acceptable range, to a current therapy. |
| 2016-06-12 | Eli Lilly and Company | Results New Data Show Lilly's Once-Weekly Trulicity® (dulaglutide) in Combination with Insulin Glargine Improves Glycemic Control in People with Type 2 Diabetes lilly.com ↗
After 28 weeks of treatment, Trulicity 1.5 mg plus insulin glargine significantly reduced A1C from baseline (1.44 percent) compared to placebo with insulin glargine (0.67 percent). |
| 2016-06-11 | Eli Lilly and Company | Results New Study Findings Underscore Importance of Physician/Patient Communication on Insulin Adherence and Outcomes lilly.com ↗
While the data from MOSA1c confirms these findings, more concerning is that despite less than one-third of patients achieving glycemic control in this two-year observational study, only about 40 percent of patients with sub-optimal control added additional diabetes medication. |
| 2016-06-06 | Adocia | Results Adocia to Present Data Validating the Potential of BioChaperone® Technology at the American Diabetes Association® 76th Scientific Sessions adocia.com ↗
Lead Scientist and Chairman of Profil Germany, Doctor Tim Heise, will present findings demonstrating superior postprandial blood glucose control in patients with type 1 diabetes using ultra-rapid BioChaperone® Lispro vs. Humalog®. |
| 2016-05-31 | Adocia | Results Adocia and Lilly announce positive topline results from a Phase 1 study evaluating ultra-rapid insulin BioChaperone Lispro U100 in healthy Japanese subjects adocia.com ↗ |
| 2016-04-27 | Adocia | Results Adocia and Lilly announce positive topline results from a Phase 1b study of repeated administration of ultra-rapid BioChaperone Lispro U100 in people with type 2 diabetes adocia.com ↗ |
| 2016-03-14 | Adocia | Results Adocia and Lilly announce positive topline results from a Phase 1b study of repeated administration of ultra-rapid BioChaperone Lispro in patients with type 1 diabetes adocia.com ↗ |
| 2016-01-21 | Eli Lilly and Company | Regulatory U.S. Food and Drug Administration Approves Humulin® R U-500 KwikPen® lilly.com ↗
The U.S. Food and Drug Administration (FDA) has approved Eli Lilly and Company's (NYSE: LLY) Humulin® R U-500 KwikPen®(insulin human injection) 500 units/mL, a pre-filled device containing Humulin R U-500, a highly concentrated formulation of insulin. |
| 2015-12-16 | Eli Lilly and Company | Regulatory FDA Approves Basaglar® (insulin glargine injection), a Long-Acting Insulin Treatment lilly.com ↗
Eli Lilly and Company (NYSE: LLY) and Boehringer Ingelheim Pharmaceuticals, Inc. (BIPI) today announced that the U.S. Food and Drug Administration (FDA) granted approval for Basaglar® (insulin glargine injection) 100 units/mL. |
| 2015-12-11 | Adocia | Results Adocia and Lilly report positive results of a pilot bioequivalence study comparing BioChaperone Lispro U200 to BioChaperone Lispro U100 adocia.com ↗ |
| 2015-12-04 | Novo Nordisk A/S | Regulatory Novo Nordisk indsender registreringsansøgning for hurtigerevirkende insulin aspart i EU til behandling af type 1- og type 2-diabetes novonordisk.com ↗
Novo Nordisk meddeler i dag, at virksomheden har indsendt ansøgning om markedsføringstilladelse (MAA) til Det Europæiske Lægemiddelagentur for hurtigerevirkende insulin aspart. |
| 2015-09-25 | Novo Nordisk A/S | Regulatory Novo Nordisk får FDA-godkendelse for Tresiba® og Ryzodeg® 70/30 i USA novonordisk.com ↗
Bagsværd, den 25. september 2015 - Novo Nordisk meddeler i dag, at de amerikanske sundhedsmyndigheder (FDA) efter at have afsluttet behandlingen af de genindsendte registreringsansøgninger har godkendt Tresiba® og Ryzodeg® 70/30 til behandling af diabetes hos voksne. |
| 2015-09-25 | Novo Nordisk A/S | Regulatory Novo Nordisk receives US FDA approval for Tresiba® and Ryzodeg® 70/30 novonordisk.com ↗
Novo Nordisk today announced that the US Food and Drug Administration (FDA) has approved Tresiba® and Ryzodeg® 70/30 for the treatment of diabetes mellitus in adults after review of the class II resubmissions of the New Drug Applications (NDAs). |
| 2015-06-26 | Adocia | Results Adocia and Lilly report positive Phase 1b topline results on the post-meal effect of ultra-rapid BioChaperone Lispro in patients with type 1 diabetes adocia.com ↗
Adocia and Lilly report positive Phase 1b topline results on the post-meal effect of ultra-rapid BioChaperone Lispro in patients with type 1 diabetes |
| 2015-05-27 | Eli Lilly and Company | Regulatory U.S. Food and Drug Administration Approves Humalog® 200 units/mL KwikPen® lilly.com ↗
The U.S. Food and Drug Administration (FDA) has approved Humalog® 200 units/mL KwikPen® (insulin lispro 200 units/mL; U-200), a pre-filled pen containing a concentrated formulation of Lilly's rapid-acting insulin Humalog® (insulin lispro 100 units/mL) to improve glycemic control in people with type 1 and type 2 diabetes, Eli Lilly and Company (NYSE: LLY) announced today. |
| 2015-04-07 | Novo Nordisk A/S | Regulatory Novo Nordisk A/S: Amerikanske FDA accepterer at behandle genindsendelserne af Tresiba® og Ryzodeg® novonordisk.com ↗
Novo Nordisk meddeler i dag, at de amerikanske sundhedsmyndigheder (FDA) har accepteret de genindsendte registreringsansøgninger for Tresiba® (insulin degludec) og Ryzodeg® (insulin degludec/insulin aspart) til behandling som en 'Class II Resubmission'. |
| 2015-04-07 | Novo Nordisk A/S | Regulatory US FDA accepts Tresiba® and Ryzodeg® resubmissions for review novonordisk.com ↗
Novo Nordisk today announced that the US Food and Drug Administration (FDA) has accepted for review the Class II Resubmissions for Tresiba® (insulin degludec) and Ryzodeg® (insulin degludec/insulin aspart). |
| 2015-03-25 | Novo Nordisk A/S | Results Novo Nordisk A/S : Novo Nordisk afslutter fase 3a-studier, der sammenligner hurtigerevirkende insulin aspart med NovoRapid® i type 1- og type 2-diabetes novonordisk.com ↗
Bagsværd, den 25. marts 2015 - Novo Nordisk offentliggør i dag de overordnede resultater fra de sidste fase 3a-studier med hurtigerevirkende insulin aspart, onset® 1 og onset® 2. |
| 2015-02-05 | Adocia | Results Adocia reports positive results from phase IIa clinical study of fast-acting human insulin, HinsBet adocia.com ↗
These clinical results show that HinsBet has an early effect equivalent to that of a fast-acting insulin analog, Humalog, and twice superior to that of regular recombinant human insulin, Humulin. |
| 2014-12-01 | Janssen Research & Development, LLC | Regulatory Animas® Vibe™ Insulin Pump and Continuous Glucose Monitoring System Receives FDA Approval jnj.com ↗
Animas Corporation today announced FDA approval of the Animas® Vibe™ insulin pump and Continuous Glucose Monitoring (CGM) system for the management of insulin-requiring diabetes in adults ages 18 and older. |
| 2014-09-10 | Eli Lilly and Company | Regulatory European Commission grants Lilly and Boehringer Ingelheim's insulin glargine product marketing authorisation in Europe lilly.com ↗
The European Commission (EC) granted marketing authorisation for Eli Lilly and Company and Boehringer Ingelheim's insulin glargine product, indicated to treat diabetes in adults, adolescents and children aged 2 years and above. |
| 2014-09-09 | Adocia | Results Adocia Reports Positive Preliminary Results from Dose Response Clinical Study of Ultra-fast acting BioChaperone® Lispro U100 in Patients with Type 1 Diabetes adocia.com ↗
This dose response study confirms that BioChaperone Lispro U100 more closely mimics the endogenous insulin secretion observed in healthy individuals in response to a meal than Humalog, at all tested doses. |
| 2014-08-18 | Eli Lilly and Company | Regulatory FDA Grants Tentative Approval for Lilly and Boehringer Ingelheim's Basaglar™ (insulin glargine injection) lilly.com ↗
The U.S. Food and Drug Administration (FDA) today granted tentative approval for Basaglar™ (insulin glargine injection), which is indicated to improve glycemic control in adults with type 2 diabetes and in combination with mealtime insulin in adults and pediatric patients with type 1 diabetes. |
| 2014-07-09 | Adocia | Regulatory Adocia Announces Approval to Start a Phase IIa Clinical Study of HinsBet®, its Fast-acting Human Insulin, in Type 1 Diabetes adocia.com ↗
BfArM (Bundesinstitut für Arzneimittel und Medizinprodukte ), the German regulatory agency for drugs and medical devices , has approved the initiation of a Phas e IIa clinical study of HinsBet ®, a fast -acting formulation of human insulin . |
| 2014-06-27 | Eli Lilly and Company | Regulatory CHMP Recommends Lilly and Boehringer Ingelheim's Investigational New Insulin Glargine Product for Approval in the European Union lilly.com ↗
The Committee for Medicinal Products for Human Use (CHMP) today issued a positive opinion recommending approval for the investigational compound LY2963016, a new insulin glargine product, for the treatment of type 1 and type 2 diabetes. |
| 2014-06-16 | Eli Lilly and Company | Results Lilly Announces Detailed Results from Two Phase III Studies Testing Both Doses of Dulaglutide vs. Insulin Glargine lilly.com ↗
Further, at the 26-week primary endpoint, significantly more dulaglutide-treated patients reached target HbA1c levels of less than 7 percent, and patients treated with the dulaglutide-mealtime insulin lispro combination had 30 percent less total insulin dose. |
| 2014-06-14 | Merck Sharp & Dohme LLC | Results New Post-Hoc Analysis Shows Patients with Type 2 Diabetes Undergoing Intensification of Insulin Therapy Experienced Less Nighttime Hypoglycemia While Being Treated with JANUVIA® (sitagliptin) Compared to Placebo merck.com ↗ |
| 2014-06-14 | Merck Sharp & Dohme LLC | Results Late-Breaking Observational Data Show Patients with Type 2 Diabetes Taking JANUVIA® (sitagliptin) and Metformin Initiated Insulin Therapy at a Slower Rate Compared to Patients Taking a Sulfonylurea and Metformin merck.com ↗
In this study, patients treated with a combination of JANUVIA and metformin initiated insulin therapy at a slower rate during the period of observation than patients treated with a combination of sulfonylurea and metformin. |
| 2014-06-14 | Eli Lilly and Company | Results Studies Show Investigational New Insulin Glargine Product from Lilly and Boehringer Ingelheim Similar Safety and Efficacy Profile to Lantus® lilly.com ↗
For the first time today, Eli Lilly and Company (NYSE:LLY) and Boehringer Ingelheim Pharmaceuticals Inc. presented data showing that LY2963016, the alliance's investigational new insulin glargine product, has a similar safety and efficacy profile to currently marketed insulin glargine (Lantus®). |
| 2014-06-10 | Adocia | Results Adocia Announces Positive Preclinical Results for a Concentrated Ultra-Fast insulin, BioChaperone® Lispro U300 adocia.com ↗ |
| 2014-04-10 | Adocia | Results Adocia: Ultra Fast Lispro Clinical Results adocia.com ↗
The present study met its primary endpoint, showing a significant increase in BioChaperone Lispro bioavailability in the first half-hour compared to Humalog. |
| 2014-03-17 | Adocia | Results Adocia: confirmation of positive clinical results Combo adocia.com ↗ |
| 2013-12-20 | Eli Lilly and Company | Regulatory Eli Lilly and Company and Boehringer Ingelheim announce new drug application filing in the U.S. for new insulin glargine product lilly.com ↗
Eli Lilly and Company (NYSE: LLY) and Boehringer Ingelheim today announced that the U.S. Food and Drug Administration (FDA) has accepted the filing of the New Drug Application (NDA) for LY2963016, an investigational basal (long-acting) insulin. |
| 2013-06-24 | GlaxoSmithKline | Results GSK announces data from five Phase III studies of albiglutide, an investigational once-weekly treatment for type 2 diabetes gsk.com ↗
Both groups achieved a similar reduction in HbA1c (-0.7% and -0.8% in the albiglutide and insulin glargine groups). |
| 2013-06-11 | Eli Lilly and Company | Results Boehringer Ingelheim and Eli Lilly and Company Alliance to Feature 34 Presentations on Type 1 and Type 2 Diabetes at the 73rd American Diabetes Association Scientific Sessions® lilly.com ↗
Empagliflozin as Add-On to Basal Insulin for 78 Weeks Improves Glycemic Control with Weight Loss in Insulin-Treated Type 2 Diabetes (T2DM) |
| 2013-04-16 | Eli Lilly and Company | Results Lilly Announces Positive Results of Phase III Trials of Dulaglutide in Type 2 Diabetes lilly.com ↗
The dulaglutide 1.5 mg dose in combination with insulin lispro demonstrated statistically superior reduction in HbA1c from baseline compared to insulin glargine in combination with insulin lispro at 26 weeks (AWARD-4). |
| 2013-02-10 | Novo Nordisk A/S | Regulatory Novo Nordisk receives Complete Response Letter in the US for Tresiba® and Ryzodeg® novonordisk.com ↗
Novo Nordisk today announced that on 8 February 2013 it received a Complete Response Letter from the US Food and Drug Administration (FDA) regarding the New Drug Applications for Tresiba® (insulin degludec) and Ryzodeg® (insulin degludec/insulin aspart). |
| 2013-02-10 | Novo Nordisk A/S | Regulatory Novo Nordisk modtager Complete Response Letter i USA vedrørende Tresiba® og Ryzodeg® novonordisk.com ↗
Novo Nordisk meddeler i dag, at virksomheden den 8. februar 2013 har modtaget et såkaldt Complete Response Letter fra de amerikanske sundhedsmyndigheder, FDA, vedrørende registreringsansøgningerne for Tresiba® (insulin degludec) og Ryzodeg® (insulin degludec/insulin aspart). |
| 2013-01-21 | Novo Nordisk A/S | Regulatory Tresiba® (insulin degludec) og Ryzodeg® (insulin degludec/insulin aspart) får markedsføringstilladelse i Europa novonordisk.com ↗
Bagsværd, den 21. januar 2013 - Novo Nordisk meddelte i dag, at Europa-Kommissionen har givet markedsføringstilladelse til Tresiba® (insulin degludec) og Ryzodeg® (insulin degludec/insulin aspart) til behandling af diabetes hos voksne. |
| 2013-01-21 | Novo Nordisk A/S | Regulatory Tresiba® and Ryzodeg® receive marketing authorisations in Europe novonordisk.com ↗
Novo Nordisk today announced that the European Commission has granted marketing authorisations for Tresiba® (insulin degludec) and Ryzodeg® (insulin degludec/insulin aspart) for the treatment of diabetes in adults. |
| 2012-12-03 | Novo Nordisk A/S | Regulatory Ryzodeg® (insulin degludec/insulin aspart) passed review by First Committee on Drugs of Pharmaceutical Affairs in Japan novonordisk.com ↗
Novo Nordisk today announced that Ryzodeg® (insulin degludec/insulin aspart) has passed the review by the First Committee on Drugs of Japan's Pharmaceutical Affairs. |
| 2012-11-08 | Novo Nordisk A/S | Regulatory Positiv afstemning i FDA's rådgivende komite vedrørende godkendelse af insulin degludec og insulin degludec/ insulin aspart novonordisk.com ↗ |
| 2012-11-08 | Novo Nordisk A/S | Regulatory Insulin degludec and insulin degludec/insulin aspart receive positive vote for approval from FDA Advisory Committee novonordisk.com ↗ |
| 2012-10-18 | Novo Nordisk A/S | Regulatory Japansk lægemiddelagentur offentliggør evalueringsrapport om Tresiba® novonordisk.com ↗
Novo Nordisk meddelte i dag, at det japanske lægemiddelagentur, Pharmaceuticals and Medical Devices Agency (PMDA), har offentliggjort deres evalueringsrapport om Tresiba® (insulin degludec). |
| 2012-09-28 | Novo Nordisk A/S | Regulatory Novo Nordisk A/S: Tresiba® (insulin degludec) approved in Japan novonordisk.com ↗
Novo Nordisk today announced that the Japanese Ministry of Health, Labour and Welfare has approved Tresiba® (insulin degludec) for the treatment of diabetes. |
| 2012-09-28 | Novo Nordisk A/S | Regulatory Novo Nordisk A/S: Tresiba® (insulin degludec) godkendt i Japan novonordisk.com ↗
Novo Nordisk meddelte i dag, at det japanske ministerium for sundhed, arbejde og velfærd har godkendt Tresiba® (insulin degludec) til behandling af diabetes. |
| 2012-07-18 | Novo Nordisk A/S | Regulatory Novo Nordisk A/S: FDA berammer møde i rådgivende komite om insulin degludec og insulin degludec/insulin aspart novonordisk.com ↗
Novo Nordisk meddelte i dag, at de amerikanske sundhedsmyndigheder, FDA, har oplyst, at man vil afholde et møde i FDA's rådgivende komite, hvor registreringsansøgningerne for ultralangtidsvirkende insulin degludec og insulin degludec/insulin aspart vil blive drøftet. |
| 2012-07-18 | Novo Nordisk A/S | Regulatory Novo Nordisk A/S: FDA schedules Advisory Committee meeting for insulin degludec and insulin degludec/insulin aspart novonordisk.com ↗
an FDA Advisory Committee meeting is tentatively scheduled to be held on 8 November 2012 |
| 2012-06-11 | Halozyme Therapeutics | Results Halozyme's Ultrafast Insulin Formulations Improved Postprandial Glycemic Control in Patients Living with Type 1 Diabetes: Phase 2 Study Results Presented at ADA 2012 halozyme.com ↗
The study met its primary endpoint of A1C non-inferiority (A1C is a measure of average blood sugar over three months). |
| 2012-06-09 | Halozyme Therapeutics | Results Interim Data From Pre-administration of Hylenex in Analog Insulin Pump Therapy Demonstrate Consistent Insulin Action Profile: Data Presented in Late-Breaker Poster at ADA 2012 halozyme.com ↗
Interim data from this study indicate that pre-administration of Hylenex recombinant in the SAP provided a consistent ultrafast insulin action profile over the infusion set life that resulted in improved glucose control. |
| 2012-06-09 | Halozyme Therapeutics | Results Halozyme Presents Positive Data from Two Ultrafast Insulin Clinical Trials with Human Hyaluronidase Enzyme - rHuPH20 - at ADA 2012 halozyme.com ↗
The study met the primary endpoint of showing that the Analog-PH20 formulations were non-inferior for A1C compared to lispro alone (0.4% margin) with no treatment difference (95% CI -.12, +.05). |
| 2012-06-08 | Novo Nordisk A/S | Regulatory Novo Nordisk A/S: FDA forlænger registreringssprocessen for insulin degludec og insulin degludec/insulin aspart med tre måneder novonordisk.com ↗
Novo Nordisk har i dag meddelt, at de amerikanske sundhedsmyndigheder (FDA) har forlænget registreringssprocessen for den ultralangtidsvirkende insulin degludec og insulin degludec/insulin aspart til behandling af type 1- og type 2-diabetes. |
| 2012-06-08 | Novo Nordisk A/S | Regulatory Novo Nordisk A/S: FDA extends regulatory review period for insulin degludec and insulin degludec/insulin aspart by three months novonordisk.com ↗
Novo Nordisk today announced that the US Food and Drug Administration (FDA) has extended the regulatory review period for the ultra-long-acting insulins degludec and insulin degludec/insulin aspart for the treatment of type 1 and type 2 diabetes. |
| 2012-04-03 | GlaxoSmithKline | Results GSK receives further data from phase lll studies of albiglutide in type 2 diabetes gsk.com ↗
In this study, the first of its kind for the class, albiglutide produced clinically significant reductions in HbA1c from baseline and non-inferiority versus preprandial lispro insulin after 26 weeks of treatment, achieving the primary endpoint. |
| 2011-12-22 | Novo Nordisk A/S | Regulatory Novo Nordisk files for regulatory approval of the ultra-long-acting insulin Degludec in Japan novonordisk.com ↗
Novo Nordisk today announced the submission to the Japanese Pharmaceuticals and Medical Devices Agency, PMDA, of a new drug application for the approval of ultra-long-acting insulin Degludec. |
| 2011-11-07 | Novo Nordisk A/S | Results Novo Nordisk A/S: DegludecPlus giver bedre blodsukkerregulering end insulin glargin i et fase 3a-studie med japanske type 2-diabetikere novonordisk.com ↗ |
| 2011-11-07 | Novo Nordisk A/S | Results Novo Nordisk A/S: DegludecPlus provides superior glycaemic control compared to insulin glargine in a phase 3a trial in Japanese people with type 2 diabetes novonordisk.com ↗ |
| 2011-10-27 | Halozyme Therapeutics | Results Halozyme Therapeutics Announces Positive Results From Enzyme-Augmented Insulin Pump Trial halozyme.com ↗
The data demonstrated that pre-administration of 150 units of rHuPH20 (approximately 1.3 micrograms of enzyme) led to consistent insulin exposure over the infusion set life and superior glucose control following meals. |
| 2011-10-21 | Halozyme Therapeutics | Results Halozyme Announces Positive Results From Phase 2 Ultrafast Insulin Trials in Patients with Type 1 and Type 2 Diabetes halozyme.com ↗
Both trials met the primary endpoint of non-inferiority of HbA1C compared to the insulin analog comparator, with superior reductions in post-prandial glucose excursions in the PH20 insulin analog arms. |
| 2011-09-29 | Novo Nordisk A/S | Regulatory Novo Nordisk files for regulatory approval of the ultra-long-acting insulins Degludec and DegludecPlus in the US novonordisk.com ↗
Novo Nordisk today announced the submission to the US Food and Drug Administration of two new drug applications for the approval of ultra-long-acting insulin Degludec and the insulin combination analogue DegludecPlus, respectively. |
| 2011-09-26 | Novo Nordisk A/S | Regulatory Novo Nordisk files for regulatory approval of the ultra-long-acting insulins Degludec and DegludecPlus in Europe novonordisk.com ↗
Novo Nordisk today announced the submission to the European Medicines Agency of two marketing authorisation applications for the approval of ultra-long acting insulin Degludec and the insulin combination analogue DegludecPlus, respectively. |
| 2011-09-16 | Bristol-Myers Squibb | Results ONGLYZA™ (saxagliptin) When Added to Insulin in Adults with Type 2 Diabetes Maintained Reductions in Blood Sugar Levels (HbA1c) Over 52 Weeks in Investigational Study Extension bms.com ↗
In the 52-week analysis, change from baseline in HbA1c in patients taking ONGLYZA 5 mg added to insulin (with or without metformin) was -0.75% compared to -0.38% for those taking placebo added to insulin (with or without metformin). |
| 2011-06-25 | Bristol-Myers Squibb | Results Investigational Study Reported ONGLYZA™ (saxagliptin) Added to Insulin Significantly Improved Blood Sugar Levels in Adults with Type 2 Diabetes Compared to Placebo Added to Insulin bms.com ↗ |
| 2011-06-24 | Halozyme Therapeutics | Results Halozyme's Ultrafast Insulin Demonstrates Reduced Variability of Insulin Absorption for Type 1 Diabetes Patients Using Insulin Pumps halozyme.com ↗
Insulin exposure beyond 2 hours after the bolus decreased by 42% for the combination compared to aspart alone (p = 0.0003). |
| 2011-06-24 | Eli Lilly and Company | Results Analysis Finds BYETTA® Associated with Lower Likelihood of Heart Failure Compared with Other Diabetes Therapies: Results Presented at ADA 2011 lilly.com ↗
Amylin Pharmaceuticals, Inc. (Nasdaq: AMLN) and Eli Lilly and Company (NYSE: LLY) today announced results from a retrospective analysis of more than 778,000 patients that showed the addition of BYETTA® (exenatide) injection to pre-existing diabetes treatment regimens was associated with a reduced likelihood of heart failure, especially among patients receiving insulin. |
| 2011-06-08 | Eli Lilly and Company | Regulatory FDA Approves Updates to Lilly's Humalog® (insulin lispro injection [rDNA origin]) Label lilly.com ↗
Eli Lilly and Company (NYSE: LLY) today announced that the U.S. Food and Drug Administration (FDA) approved the company's supplemental new drug application (sNDA) with the following updates to the Humalog label: continuous insulin infusion pump therapy in children 4 years of age and over with type 1 diabetes extension of the time-in-use in the external pump reservoir to a maximum of seven days; and extension of the time-in-use of the infusion set and of the infusion set subcutaneous insertion site to a maximum of three days. |
| 2011-04-14 | Halozyme Therapeutics | Results Halozyme's Ultrafast Insulin Generates Faster-In and Faster-Out Profile for Type 1 Diabetes Patients Using Insulin Pumps halozyme.com ↗
The initial results from Halozyme's first pump study show that the faster pharmacokinetic and glucodynamic findings consistently demonstrated with mealtime subcutaneous insulin injections are also observed in the CSII setting," stated Doug Muchmore, M.D., vice president of endocrinology clinical development. |
| 2010-12-22 | Novo Nordisk A/S | Results Degludec giver væsentligt nedsat risiko for natlig hypoglykæmi sammenlignet med insulin glargin i to langtidsstudier novonordisk.com ↗
Novo Nordisk har i dag rapporteret kliniske resultater fra to 52-ugers fase 3a treat-to-target-studier, der har sammenlignet Degludec, en ultralangtidsvirkende basal insulin, med insulin glargin i basal/bolus-behandling af type 1- og type 2-diabetes. |
| 2010-11-17 | Eli Lilly and Company | Results Study Highlights Incidence of Cardiovascular Disease-Related Events and All-Cause Hospitalizations Associated with BYETTA® Compared to Insulin, Thiazolidinediones, Sulfonylureas, Metformin and Januvia® lilly.com ↗
In the study, BYETTA was associated with a lower incidence of CVD-related events than insulin, thiazolidinediones (TZDs) and sulfonylureas and a comparable incidence versus metformin and Januvia® (sitagliptin). |
| 2010-11-12 | Halozyme Therapeutics | Results Halozyme's rHuPH20 With Recombinant Human Insulin Demonstrates Glycemic Control Comparable to Lispro halozyme.com ↗
Halozyme Therapeutics, Inc. (Nasdaq: HALO) today announced Phase 2 results demonstrating that Insulin-PH20 (recombinant human insulin with rHuPH20) produced glycemic control comparable to lispro, a widely prescribed prandial (mealtime) insulin analog. |
| 2010-06-28 | Halozyme Therapeutics | Results Coinjection of Halozyme's rHuPH20 Enzyme Accelerates the Absorption and Action of Mealtime Insulin Analogs halozyme.com ↗
Halozyme Therapeutics, Inc. (Nasdaq: HALO) today announced clinical trial results showing that the addition of its proprietary rHuPH20 (recombinant human hyaluronidase, PH20) enzyme to three different mealtime insulin analogs accelerated their absorption. |
| 2010-06-27 | Halozyme Therapeutics | Results Halozyme's Ultrafast Insulin Accelerates Absorption and Lowers Hyperglycemia and Hypoglycemia Risk in Type 2 Diabetes Patients halozyme.com ↗
Significantly more patients receiving lispro+PH20, 71% versus 48%, achieved the American Diabetes Association (ADA) goal of maintaining glucose below 180 mg/dL compared to lispro treatment alone, an indication of reduced hyperglycemia. |
| 2010-06-26 | Eli Lilly and Company | Results Type 2 Diabetes Patients With Long-Standing Disease Achieved Glycemic Control When BYETTA(R) Was Added to Lantus(R) lilly.com ↗
After 30 weeks of treatment, A1C decreased by 1.7 percentage points in patients adding BYETTA, compared with a decrease of 1.0 percentage point in patients treated with insulin alone. |
| 2009-11-06 | Halozyme Therapeutics | Results Halozyme Study Results Demonstrate Significantly Less Absorption Variability for Insulin Lispro Administered with PH20 Enzyme halozyme.com ↗
Halozyme Therapeutics, Inc. (Nasdaq:HALO) today announced insulin variability study results that demonstrated reduced intrasubject absorption variability for the combination of lispro, a meal time analog insulin, plus PH20 (hyaluronidase) compared to subcutaneous injection of lispro alone. |
| 2009-10-21 | Halozyme Therapeutics | Results Halozyme Study Results Show Faster Insulin Absorption when Administered in Combination with a Wide Range of PH20 Enzyme Concentrations halozyme.com ↗
Halozyme Therapeutics, Inc. (Nasdaq:HALO) today announced dose response study results that demonstrated faster insulin absorption and increased peak insulin concentrations after co-administration of its recombinant hyaluronidase enzyme (rHuPH20 or PH20) with regular human insulin and with insulin lispro. |
| 2009-10-01 | Halozyme Therapeutics | Results Halozyme Presents Phase 2 Results for Regular Insulin-PH20 Confirming Faster Insulin Absorption and Superior Glucose Control halozyme.com ↗
In addition, study results also showed a significant reduction in postprandial blood glucose levels following administration of a standardized test meal and less hypoglycemia compared to Humulin R alone. |
| 2009-07-20 | Eli Lilly and Company | Results Exenatide Once Weekly Provided Superior Glucose Control Compared To Lantus(R) in Head-to-Head DURATION-3 Study lilly.com ↗
At the end of the study, patients treated with exenatide once weekly achieved a mean A1C of 6.8 percent compared with a mean A1C of 7.0 percent in those treated with Lantus. |
| 2009-07-20 | Alkermes, Inc. | Results Exenatide Once Weekly Provided Superior Glucose Control Compared To Lantus(R) in Head-to-Head DURATION-3 Study alkermes.com ↗
Patients randomized to exenatide once weekly experienced a statistically superior reduction in A1C, a measure of average blood sugar over three months, of 1.5 percentage points from baseline, compared to a reduction of 1.3 percentage points for Lantus after completing 26 weeks of treatment. |
| 2009-06-06 | Halozyme Therapeutics | Results Halozyme's Phase 2 Insulin-PH20 Study Demonstrates Faster Insulin Absorption and Superior Glucose Control in Type 1 Diabetic Patients halozyme.com ↗
Study results also showed a significant reduction in postprandial blood glucose levels following administration of a standardized test meal, with improvements in both peak glycemic response and total hyperglycemic exposure compared to Humalog alone. |
| 2009-05-29 | Halozyme Therapeutics | Results Phase 1 Study for Halozyme's Insulin-PH20 Published, Highlights Findings for Faster Acting Insulin Formulations halozyme.com ↗
“The faster onset and faster offset of glucose effects for insulin plus PH20 observed in this study may lead to a superior treatment for diabetes,” stated Douglas B. Muchmore, M.D., vice president, endocrinology clinical development at Halozyme. |
| 2008-06-09 | Halozyme Therapeutics | Results Halozyme Therapeutics Announces Phase I Clinical Trial Results Demonstrating that the Combination of Recombinant Human Hyaluronidase (rHuPH20) With Humulin R(R) and with Humalog(R) Yields Faster, More Physiologic Insulin Kinetics and Better Predictability halozyme.com ↗
Significantly faster systemic absorption of each insulin, starting with the first observation time point of three minutes after injection |
| 2008-04-09 | Nektar Therapeutics | Results Nektar Terminates All Negotiations With Potential Partners for Inhaled Insulin; Increased Number of Lung Cancer Cases Observed in Ongoing Clinical Studies of Inhaled Insulin Patients nektar.com ↗
An increase in the number of new cases of lung cancer was observed in inhaled insulin patients as compared to the control group. |
| 2007-06-24 | Eli Lilly and Company | Results BYETTA® Study Showed Comparable Blood Glucose Control to Insulin lilly.com ↗
Study findings showed comparable improvements in blood sugar control with BYETTA and insulin glargine therapies, with weight loss and lower incidence of hypoglycemia associated with BYETTA. |
| 2007-06-21 | Novo Nordisk A/S | Results Liraglutide giver en væsentligt bedre blodsukkerregulering end insulin glargine i fase 3-studie novonordisk.com ↗
HbA1c-reduktionen i liraglutide-gruppen var mere end 0,2 procentpoint bedre end i insulin glargine-gruppen - en statistisk signifikant forskel. |
| 2007-06-21 | Novo Nordisk A/S | Results Liraglutide provides significantly better glucose control than insulin glargine in phase 3 study novonordisk.com ↗
The HbA1c reduction achieved in the liraglutide group was more than 0.2 percentage points better than in the insulin glargine group, a difference which is statistically significant. |
| 2006-09-14 | Nektar Therapeutics | Results Nektar Reports that Pfizer Announced New Analyses Showing that Exubera Is Effective in Diabetes Patients Who Have Respiratory Infections or Who are Exposed to Passive Cigarette Smoke nektar.com ↗
Pfizer announced that adult patients with diabetes who took Exubera were able to safely maintain good blood sugar control even if they developed a respiratory infection or were exposed to passive (second-hand) cigarette smoke. |
| 2006-09-14 | Eli Lilly and Company | Results Study Shows Exenatide Improves Blood Sugar Levels as Effectively as Biphasic Insulin Aspart lilly.com ↗
This long-term clinical trial is the second study conducted at European clinical centers demonstrating that exenatide can control blood sugar as effectively as insulin.(1) |
| 2006-06-10 | Nektar Therapeutics | Results Nektar Reports Pfizer Announcement of New Exubera Data; New Data from Two Large Phase III Trials Reinforce Exubera's Long-Term Efficacy and Safety in Adults with Type 1 or Type 2 Diabetes nektar.com ↗ |
| 2006-06-10 | Eli Lilly and Company | Results Data on AIR(R) Inhaled Insulin System Presented at American Diabetes Association Meeting lilly.com ↗
Eli Lilly and Company (NYSE: LLY) and Alkermes, Inc. (Nasdaq: ALKS) today reported new study results of the companies' investigational AIR(R) Inhaled Insulin System(1) (AIR insulin system), including the first published analysis of the effect of chronic obstructive pulmonary disease (COPD) on inhaled insulin absorption and action; the importance to patients of simple, patient-directed training of an inhaled insulin system; and dosing flexibility with the AIR insulin system. |
| 2006-06-10 | Alkermes, Inc. | Results Data on AIR(R) Inhaled Insulin System Presented at American Diabetes Association Meeting alkermes.com ↗
As expected in a patient population with compromised lung function, the absorption and action of AIR(R) Inhaled Insulin (AIR insulin) was reduced by a consistent amount in the presence of COPD. |
| 2006-01-27 | Nektar Therapeutics | Regulatory Pfizer Receives FDA Approval for Exubera, the First Inhaleable Form of Insulin for Controlling Type 1 and Type 2 Diabetes in Adults nektar.com ↗
Exubera(R) (insulin human (rDNA origin)) Inhalation Powder has been approved by the U.S. Food and Drug Administration for the treatment of adults with type 1 and type 2 diabetes. |
| 2006-01-26 | Nektar Therapeutics | Regulatory European Commission Approves Exubera(R) (Inhaled Human Insulin) for Treatment of Type 1 and Type 2 Diabetes nektar.com ↗
Nektar Therapeutics (Nasdaq:NKTR) today reported that Pfizer Inc said that the European Commission has approved Exubera (inhaled human insulin) for the treatment of adults with type 1 and type 2 diabetes. |
| 2005-09-12 | Eli Lilly and Company | Results Study Shows Exenatide Improves Blood Sugar Levels as Effectively as Insulin Glargine lilly.com ↗
Both treatments were effective in lowering blood sugar, and patients taking exenatide experienced weight reductions while those on insulin glargine gained weight. |
| 2005-09-12 | Eli Lilly and Company | Results Phase 2 Study Shows Lilly/Alkermes Inhaled Insulin System Achieved Blood Sugar Levels Similar to Injected Insulin lilly.com ↗
In addition, 80 percent of patients in this study expressed a preference for the Lilly/Alkermes inhaled insulin system at mealtime over injected insulin. |
| 2005-09-12 | Alkermes, Inc. | Results Phase 2 Study Shows Lilly/Alkermes Inhaled Insulin System Achieved Blood Sugar Levels Similar to Injected Insulin; 80 Percent of Diabetes Patients in Study Preferred Inhaled Insulin System to Mealtime Injections alkermes.com ↗
today presented detailed results from a Phase 2 clinical study of inhaled insulin in people with type 1 diabetes, showing that patients using the Lilly/Alkermes inhaled insulin system achieved blood sugar levels similar to patients treated with injected insulin. |
| 2005-06-14 | Eli Lilly and Company | Results Phase 2 Study Shows Lilly/Alkermes Inhaled Insulin System Achieved Blood Sugar Levels Similar to Injected Insulin lilly.com ↗
Using the standard measure of blood sugar, A1C, patients achieved an average level of 7.9 using the Lilly/Alkermes inhaled insulin system, compared to 8.0 in the injected insulin group. |
| 2005-06-14 | Alkermes, Inc. | Results Phase 2 Study Shows Lilly/Alkermes Inhaled System Achieved Blood Sugar Levels Similar to Injected Insulin; 80 Percent of Diabetes Patients in Study Preferred Inhaled Insulin System to Mealtime Injections alkermes.com ↗
Eli Lilly and Company (NYSE: LLY) and Alkermes, Inc. (Nasdaq: ALKS) today reported detailed results from a Phase 2 clinical study of inhaled insulin in people with type 1 diabetes, showing that patients using the Lilly/Alkermes inhaled insulin system achieved blood sugar levels similar to patients treated with injected insulin. |
| 2005-06-14 | Alkermes, Inc. | Results Phase 2 Study Shows Lilly/Alkermes Inhaled Insulin System Achieved Blood Sugar Levels Similar to Injected Insulin alkermes.com ↗
Eli Lilly and Company (NYSE: LLY) and Alkermes, Inc. (Nasdaq: ALKS) today reported detailed results from a Phase 2 clinical study of inhaled insulin in people with type 1 diabetes, showing that patients using the Lilly/Alkermes inhaled insulin system achieved blood sugar levels similar to patients treated with injected insulin. |
| 2005-06-10 | Eli Lilly and Company | Results Study Shows BYETTA(TM) Improves Blood Sugar Levels as Effectively as Insulin Glargine lilly.com ↗
Both treatments were effective in lowering blood sugar, and patients taking BYETTA experienced weight reductions while those on insulin glargine gained weight. |
| 2004-06-05 | Eli Lilly and Company | Results Humalog Mix75/25 vs. Lantus in Type 2 Diabetes lilly.com ↗
In two separate studies comparing Humalog® Mix75/25™ to Lantus, the former did a better job than the latter of helping patients with type 2 diabetes lower their blood sugar levels and achieve better diabetes control over time. |
| 2001-06-25 | Alkermes, Inc. | Results Alkermes Presents Results of Pulmonary Insulin Clinical Trial At Annual Meeting of the American Diabetes Association alkermes.com ↗
The poster showed that our insulin formulation showed rapid onset of therapeutic action, dose dependent glucose lowering ability and competitive biopotency. |
All press releases naming this drug 587 releases
| Date | Issuer | Release |
|---|---|---|
| Show all 587 releases opens the full record — a long page | ||
Evidence & citations 34 cited values
Every value below carries the sentence it was read from. 385 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | insulin | “Subjects will be randomized 1:1 to open-label eucaloric very-low carbohydrate ketogenic diet (<40 g of carbohydrate) or standard of care (i.e. metformin, followed by...” NCT07866846 ↗380“This study is designed to demonstrate that addition of rosiglitazone (4mg) to insulin in Type 2 diabetes mellitus subjects who have not achieved glycemic goals on insulin...” NCT00349427 ↗ “Insulin and pioglitazone resulted in a significant decrease in HbA1c (-1.6% and -1.2%, respectively) and a significant increase in total body fat mass (1+/-2.3 and 3.3+/-2.7...” PMID 19683825 ↗ Aug 2009 “Stable doses of antihyperglycemic agents (sulfonylurea agent, thiazolidinediones, dipeptidyl peptidase 4 \[DPP-4\] inhibitors, metformin, insulin \[all types\]) and their combinations” NCT01106651 ↗ “Patients with diabetes will also use antidiabetic medications (such as oral hypoglycemic drugs or insulin, depending on glycemic control needs).” NCT07074379 ↗ “Oramed Pharmaceuticals tested the capacity of its oral insulin capsule (ORMD-0801, 8 mg insulin) in addressing this resistant clinical state.” PMID 23593142 ↗ Apr 2013 “Therapy cocktail of Glucose, Insulin and Potassium. The medications will be prepared as per standard protocol. Administered intravenously.” NCT05627479 ↗ “a quantity of 5 grams of gel with hydroxypropyl-beta-cyclodextrin complexed with insulin (HPβCD-I) was placed on the pressure ulcer” NCT02418676 ↗ “56 subjects will receive metabolically active insulin by subcutaneous injections for 36 months (twice daily)” NCT00654121 ↗ “traditional therapy, such as insulin injection daily, monitoring random and postprandial blood glucose.” NCT01496339 ↗ “All patients will receive the standard of care which is a protocol based continuous insulin infusion” NCT02930044 ↗ |
| Known as | Actrapid | “There will be used individual intravenous insulin (actrapid) infusion to prevent non-intended hyperglycemia.” NCT01071772 ↗4“10 IU of human insulin (Actrapid; Novo Nordisk, Denmark)” NCT07812129 ↗ “4 units (0.1 ml) of human soluble insulin (Actrapid)” NCT07432581 ↗ “Insulin (Actrapid) diluted in normal saline” NCT04877210 ↗ “Drug: Insulin (Actrapid)” NCT00505505 ↗ |
| Known as | Actrapid HM | “Continuous insulin infusion of 50 IU Actrapid HM (Novo Nordisk) in 50 ml NaCl (0.9% using a Perfusor-FM pump) will be started only when blood glucose levels exceeded 200 mg/dl...” NCT01016509 ↗ |
| Known as | Afrezza | “Technosphere insulin (TI, Afrezza) -Treatment arm” NCT03143816 ↗1“Afrezza inhaled insulin low dose.” NCT03234491 ↗ |
| Known as | Exubera | “Inhaled Insulin (Exubera)” NCT00282971 ↗1“Exubera (inhaled insulin)” NCT00246623 ↗ |
| Known as | Humalog | “160 IU insulin (Humalog) is administered intranasally using a metered spray bottle 15 minutes prior to the PET scan.” NCT05748990 ↗1“Insulin Humalog (generic name Lispro)” NCT01406496 ↗ |
| Known as | Human actrapid insulin | “Intralesional insulin injection (Human actrapid insulin 100 IU\\ml solution)” NCT06230146 ↗ |
| Known as | Human rDNA Insulin | “Human rDNA Insulin (Insuget, local brand of Getz Pharma)” NCT05161741 ↗ |
| Known as | Huminsulin | “Insulin Dosage form : intravenous infusion, infusion period 60 minutes Dosage: continuous dose of 0.5 mU/kg/min infused intravenously over 60 min; Insulin Lilly, Huminsulin,...” NCT00814008 ↗ |
| Known as | Humulin | “Insulin (Humulin)” NCT00646581 ↗1“Insulin (Humulin)” NCT07535827 ↗ |
| Known as | Humulin R | “Topical insulin (Humulin R) will be compounded under sterile conditions at a local pharmacy at a concentration of 25 IU / ml in sterile balanced saline solution (0.9%).” NCT05321251 ↗4“those in group B will get insulin (Humulin R) subcutaneously whose dose can be adjusted within 24 hours according to blood sugar levels” NCT07582471 ↗ “Patients will receive 40 IU of intranasal insulin (Humulin R) via a metered nasal dispenser” NCT02729064 ↗ “regular insulin (Humulin R) when given intranasally (as drops in nostrils)” NCT05062785 ↗ “nasal insulin (Humulin R®)” NCT05742243 ↗ |
| Known as | Humulin S | “Insulin (Humulin S)” NCT02205996 ↗ |
| Known as | Humulin U-100 | “Participants will administer 40 IU of Humulin® U-100 insulin four times per day with an intranasal delivery device.” NCT05006599 ↗ |
| Known as | Humulin-RU-100 | “INTERVENTIONS: Participants received 40 IU of insulin (Humulin-RU-100; Lilly) or placebo (diluent) daily for 12 months (blinded phase) followed by a 6-month open-label extension phase.” PMID 32568367 ↗ Sep 20203“Insulin (Humulin® R U-100)” NCT05006599 ↗ “Insulin (Humulin® R U-100)” NCT05081219 ↗ “Insulin (Humulin® R U-100)” NCT01767909 ↗ |
| Known as | INI | “We aimed to determine the effects of intranasal insulin (INI) on cognition and motor performance in PD.” PMID 31022213 ↗ Apr 2019 |
| Known as | Insuget | “Human rDNA Insulin (Insuget, local brand of Getz Pharma)” NCT05161741 ↗ |
| Known as | Insuget 70/30 | “The investigator will recommend the dose of Insuget 70/30 (Local Insulin brand) and/or Insuget N (Local Insulin brand) and/or Insuget R (Local Insulin brand) as per standard...” NCT05161741 ↗ |
| Known as | Insuget N | “The investigator will recommend the dose of Insuget 70/30 (Local Insulin brand) and/or Insuget N (Local Insulin brand) and/or Insuget R (Local Insulin brand) as per standard...” NCT05161741 ↗ |
| Known as | Insuget R | “The investigator will recommend the dose of Insuget 70/30 (Local Insulin brand) and/or Insuget N (Local Insulin brand) and/or Insuget R (Local Insulin brand) as per standard...” NCT05161741 ↗ |
| Known as | insulin Actrapid | “insulin Actrapid” NCT02164032 ↗ |
| Known as | insulin aspart | “This will be a prospective open label study of 100 subjects who will be randomized to either an insulin aspart (study drug) infusion (intensive insulin therapy \[IIT arm\]) for...” NCT02054429 ↗ |
| Known as | Insuman Rapid | “Insulin (Insuman Rapid) is administered once as a bolus of 0,1 IU/kg.” NCT01919788 ↗ |
| Known as | Lispro | “Insulin Humalog (generic name Lispro)” NCT01406496 ↗ |
| Known as | Novolg 70/30 | “Insulin Novolg 70/30 per protocol titration” NCT00232583 ↗ |
| Known as | Novolin R | “Insulin (Novolin R) and Glutathione (INS-GSH)” NCT05266417 ↗ |
| Known as | NovoLog | “Insulin infusion through the subcutaneous pump will be continued or long acting analog, novolog will be given as per home regimen.” NCT02328040 ↗1“Saline and insulin (NovoLog) will be ordered though the UT Student Health Services Pharmacy” NCT01145482 ↗ |
| Known as | NovoLog 70/30 | “Eligible patients were started on insulin NovoLog 70/30 and metformin 1,000 mg twice daily.” PMID 17362692 ↗ Mar 2007 |
| Known as | NovoRapid | “Subcutaneous insulin (100 U/ml, NovoRapid®; Novo Nordisk, Bagsvaerd, Denmark) delivery with an insulin pump” NCT02359617 ↗ |
| Known as | regular human insulin | “A Phase 1, Randomized, 3-Way Crossover, Investigator Initiated Proof-of-Concept Study to Investigate Safety, Tolerability, Pharmacokinetic and Pharmacodynamic Properties of Two...” NCT01201278 ↗ |
| Known as | regular insulin | “using continuous intravenous insulin solutions (100 units regular insulin in 100 mL: normal saline)” PMID 21865944 ↗ Sep 20111“initial intraoperative I.V. bolus of regular insulin” PMID 26897443 ↗ Feb 2016 |
| Known as | Technosphere Insulin | “Technosphere insulin (TI, Afrezza) -Treatment arm” NCT03143816 ↗2“Technosphere® Insulin Inhalation Powder” NCT00308737 ↗ “Technosphere® Insulin (TI) Powder” NCT00757367 ↗ |
| Action | Activate | “as insulin activates peroxisome proliferator-activated receptor-alpha receptors” NCT00762190 ↗ |
| Modality | Protein / enzyme biologic | “Recombinant human intranasal insulin formulation” NCT00336674 ↗ |
| Route | Other | “intraarterial infusion of insulin” NCT00001624 ↗ |