Drugs / rHuPH20
rHuPH20
Regulatory milestones approvals, filings & regulatory actions · 6 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed immunodeficiency 112 1 milestone | |||||
| Filed | US (FDA) | HyQvia | immunodeficiency 112 | 2013-12-02 | “During the fourth quarter of 2013, Baxter completed submission of an amended biologics license application (BLA) to the U.S. Food and Drug Administration (FDA) to re-initiate...” halozyme.com ↗ |
| Filed non-small cell lung carcinoma 1 milestone | |||||
| Filed | US (FDA) | Opdivo | non-small cell lung carcinoma | 2024-05-06 | “has accepted the Biologics License Application (BLA) for the subcutaneous formulation of Opdivo ® (nivolumab) co-formulated with Halozyme’s proprietary recombinant human...” bms.com ↗ “submission of a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for a fixed combination of amivantamab and recombinant human hyaluronidase” jnj.com ↗ |
| Clinical hold angioedema, hereditary, 4 1 milestone | |||||
| Clinical hold | US (FDA) | Cinryze | angioedema, hereditary, 4 | 2012-08-01 | “CBER has requested that patients should no longer be dosed with rHuPH20 in the Baxter and ViroPharma clinical studies.” halozyme.com ↗ |
| Clinical hold immunodeficiency-associated lymphoproliferative disease 1 milestone | |||||
| Clinical hold | US (FDA) | HyQ | immunodeficiency-associated lymphoproliferative disease | 2012-08-01 | “CBER has requested that patients should no longer be dosed with rHuPH20 in the Baxter and ViroPharma clinical studies.” halozyme.com ↗ |
| Approved Indication not stated 2 milestones | |||||
| Filed | Other | HYDIZYME | — | 2025-12-22 | “Huonslab announced on the 22nd that it has filed for Biologics License Application with the Ministry of Food and Drug Safety (MFDS)” huonslab.com ↗ “In December 2025, Huonslab submitted Biologics License Application (BLA) with the Ministry of Food and Drug Safety (MFDS)” huonslab.com ↗ “Huonslab has submitted the Biologics License Application for Recombinant Human Hyaluronidase ‘HYDIZYME™ Injection’” huonslab.com ↗ |
| Approved | US (FDA) | HYLENEX RECOMBINANT | — | 2005-12-02 | fda.gov ↗ |
Trials 30
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 01 trial | ||||||
| Phase 0 | NCT05238831 | Jan 2023 → May 2026 | female breast carcinoma, ovarian carcinoma, pancreatic ductal adenocarcinoma, pancreatic large cell neuroendocrine carcinoma +2 | OHSU Knight Cancer Institute | Withdrawn | No outcome recorded |
| Phase 113 trials · 3 met primary | ||||||
| Phase 1 | NCT03864419 | Oct 2019 → Jul 2023 | Burkitt lymphoma, diffuse large B-cell lymphoma, multicentric Castleman disease | Fred Hutchinson Cancer Center | Terminated | No outcome recorded Stop: Enrollment |
| Phase 1 | NCT04920370 | Sep 2019 → Nov 2021 | — | Alexion Pharmaceuticals, Inc. | Completed | No outcome recorded |
| Phase 1 | NCT05396742 | Aug 2018 → May 2019 | — | Alexion Pharmaceuticals, Inc. | Completed | No outcome recorded |
| Phase 1 | NCT03538626 | Jun 2018 → Aug 2022 | — | National Institute of Allergy and Infectious Diseases (NIAID) | Completed | No outcome recorded |
| Phase 1 | NCT02667223 | Feb → Jul 2016 | hyperlipoproteinemia | Pfizer | Terminated | No outcome recorded Stop: Business |
| Phase 1 | NCT02654522 | Jan → Feb 2016 | — | Steve Yoelin M.D. Medical Associates, Inc. | Completed | No outcome recorded |
| Phase 1 | NCT01572012 | Feb 2012 → Nov 2013 | — | Halozyme Therapeutics | Completed | No outcome recorded |
| Phase 1 | NCT00979875 | Sep 2009 → Feb 2010 | — | Halozyme Therapeutics | Completed | Met primary |
| Phase 1 | NCT00862849 | Mar → Jun 2009 | diabetes mellitus | Halozyme Therapeutics | Completed | Met primary |
| Phase 1 | NCT00807963 | Dec 2008 → Sep 2009 | osteoporosis | Halozyme Therapeutics | Completed | No outcome recorded |
| Phase 1 | NCT00803972 | Nov 2008 → Aug 2009 | — | Halozyme Therapeutics | Completed | No outcome recorded |
| Phase 1 | NCT00493220 | Jun → Sep 2007 | — | Baxter Healthcare Corporation | Completed | Met primary |
| Phase 1 | NCT00435604 | Feb → May 2007 | — | Halozyme Therapeutics | Completed | No outcome recorded |
| Phase 1/22 trials | ||||||
| Phase 1/2 | NCT06697197 | Feb 2025 → Jan 2029 expected | cancer | Bristol-Myers Squibb | Recruiting | No outcome recorded |
| Phase 1/2 | NCT00318643 | Mar 2006 → Aug 2009 | urinary bladder cancer | Halozyme Therapeutics | Completed | No outcome recorded |
| Phase 24 trials · 1 missed | ||||||
| Phase 2 | NCT01987609 | Jul 2015 → Mar 2017 | psoriasis | Tissa Hata, MD | Completed | No outcome recorded |
| Phase 2 | NCT01756157 | Feb → Sep 2013 | hereditary angioedema | Shire | Completed | Missed primary |
| Phase 2 | NCT01426763 | Sep → Nov 2011 | hereditary angioedema | Shire | Completed | No outcome recorded |
| Phase 2 | NCT00928447 | Jun → Sep 2009 | contact dermatitis due to nickel | Halozyme Therapeutics | Completed | No outcome recorded |
| Phase 32 trials · 1 met primary | ||||||
| Phase 3 | NCT04071457 | Aug 2019 → Sep 2032 expected | plasma cell myeloma | SWOG Cancer Research Network | Active not recruiting | No outcome recorded |
| Phase 3 | NCT00593281 | Jan → Oct 2006 | — | Halozyme Therapeutics | Completed | Met primary |
| Phase 46 trials · 2 met primary | ||||||
| Phase 4 | NCT05511428 | Nov 2022 → May 2024 | plasma cell myeloma | Thomas Jefferson University | Completed | No outcome recorded |
| Phase 4 | NCT03662334 | Oct 2013 → Feb 2014 | type 1 diabetes mellitus | Halozyme Therapeutics | Completed | Met primary |
| Phase 4 | NCT01116102 | May 2010 | — | Baxter Healthcare Corporation | Terminated | No outcome recorded Stop: Business |
| Phase 4 | NCT01139294 | Feb 2010 → Nov 2011 | — | Vanderbilt University Medical Center | Completed | No outcome recorded |
| Phase 4 | NCT00807885 | Dec 2008 → Jan 2009 | — | Baxter Healthcare Corporation | Completed | No outcome recorded |
| Phase 4 | NCT00311519 | Nov 2005 → Jan 2006 | — | Halozyme Therapeutics | Completed | Met primary |
| Phase not applicable2 trials | ||||||
| — | NCT02885259 | Sep 2016 → Dec 2017 | multifocal motor neuropathy | UMC Utrecht | Unknown | No outcome recorded |
| — | NCT00547664 | Jan 2008 → Dec 2009 | — | HPC Healthcare, Inc. | Completed | No outcome recorded |
| Comparator or background therapy40 trials | ||||||
| Phase 1 | NCT07792941 Background | Aug 2026 → Feb 2027 expected | — | Pfizer | Recruiting | No outcome recorded |
| Phase 1 | NCT07667322 Background | Dec 2024 → Feb 2028 expected | multiple sclerosis | Hoffmann-La Roche | Recruiting | No outcome recorded |
| Phase 1 | NCT06511570 Background | Jun → Sep 2024 | Alzheimer disease | Acumen Pharmaceuticals | Completed | No outcome recorded |
| Phase 1 | NCT06310551 Background | Mar 2024 → Jan 2028 expected | HIV infectious disease | ViiV Healthcare | Recruiting | No outcome recorded |
| Phase 1 | NCT05418868 Background | Jun 2022 → Jun 2027 expected | HIV infectious disease | ViiV Healthcare | Recruiting | No outcome recorded |
| Phase 1 | NCT05293249 Background | May 2022 → Jun 2025 | — | Pablo Tebas | Completed | No outcome recorded |
| Phase 1 | NCT05291520 Background | Feb 2022 → Apr 2023 | HIV infectious disease | ViiV Healthcare | Completed | No outcome recorded |
| Phase 1 | NCT04606381 Background | Nov 2020 → Jul 2024 overdue | neoplasm | Janssen Research & Development, LLC | Active not recruiting | No outcome recorded |
| Phase 1 | NCT04532125 Background | Aug 2020 → Aug 2022 | — | argenx | Completed | No outcome recorded |
| Phase 1 | NCT04311710 Background | Jun 2020 → Jan 2021 | neoplasm | Bristol-Myers Squibb | Terminated | No outcome recorded Stop: Business |
| Phase 1 | NCT04112498 Background | Oct 2019 → Feb 2023 | cancer | Bristol-Myers Squibb | Completed | No outcome recorded |
| Phase 1 | NCT03972306 Background | Aug 2019 → Jun 2025 | multiple sclerosis | Hoffmann-La Roche | Completed | No outcome recorded |
| Phase 1 | NCT04073589 Background | Jul → Sep 2019 | — | argenx | Completed | No outcome recorded |
| Phase 1 | NCT03320707 Background | Oct 2017 → Aug 2019 | — | Janssen Research & Development, LLC | Completed | No outcome recorded |
| Phase 1 | NCT03242889 Background | Aug → Nov 2017 | plasma cell myeloma | Janssen Pharmaceutical K.K. | Completed | No outcome recorded |
| Phase 1 | NCT02217917 Background | Oct 2015 → Apr 2016 | — | GlycoMimetics Incorporated | Completed | No outcome recorded |
| Phase 1 | NCT00705536 Comparator | Dec 2007 → Feb 2008 | diabetes mellitus | Halozyme Therapeutics | Completed | No outcome recorded |
| Phase 1/2 | NCT05455697 Background | Jan 2023 → Oct 2026 expected | high grade B-cell lymphoma | University of Washington | Active not recruiting | No outcome recorded |
| Phase 1/2 | NCT05205252 Comparator | Dec 2021 → Jul 2023 | refractory hematologic cancer | Epizyme, Inc. | Withdrawn | No outcome recorded Stop: Business |
| Phase 1/2 | NCT03837509 Background | Sep 2019 → Apr 2022 | refractory plasma cell neoplasm | Incyte Corporation | Terminated | No outcome recorded Stop: Enrollment |
| Phase 1/2 | NCT03656718 Background | Oct 2018 → Sep 2022 | neoplasm | Bristol-Myers Squibb | Completed | No outcome recorded |
| Phase 1/2 | NCT03446040 Background | Mar 2018 → Aug 2024 | cancer of unknown primary site | Bristol-Myers Squibb | Terminated | No outcome recorded Stop: Business |
| Phase 1/2 | NCT02754141 Background | Jun 2016 → Oct 2021 | cancer | Bristol-Myers Squibb | Completed | No outcome recorded |
| Phase 2 | NCT05730712 Background | Mar 2024 → Apr 2025 | castration-resistant prostate carcinoma | Mayo Clinic | Completed | No outcome recorded |
| Phase 2 | NCT05886036 Comparator | Jan 2024 → Oct 2026 expected | nodular lymphocyte predominant Hodgkin lymphoma | National Cancer Institute (NCI) | Recruiting | No outcome recorded |
| Phase 2 | NCT06101134 Background | Nov 2023 → Apr 2025 overdue | melanoma | Bristol-Myers Squibb | Active not recruiting | No outcome recorded |
| Phase 2 | NCT05996471 Background | Aug 2023 → May 2026 overdue | HIV infectious disease | ViiV Healthcare | Active not recruiting | No outcome recorded |
| Phase 2 | NCT04150692 Background | Jan 2021 → Mar 2026 | plasma cell myeloma | Washington University School of Medicine | Withdrawn | No outcome recorded |
| Phase 2 | NCT04070378 Background | Nov 2019 → Jun 2023 | Alzheimer disease | Marc L Gordon, MD | Completed | No outcome recorded |
| Phase 2 | NCT03467867 Background | Apr 2018 → Dec 2026 expected | chronic lymphocytic leukemia/small lymphocytic lymphoma | Georgetown University | Active not recruiting | No outcome recorded |
| Phase 2/3 | NCT05523167 Background | Oct 2022 → Jul 2026 | antisynthetase syndrome, dermatomyositis, immune-mediated necrotizing myopathy | argenx | Completed | Met primary |
| Phase 2/3 | NCT04799275 Background | May 2021 → Mar 2027 expected | T-cell/histiocyte rich large B cell lymphoma, diffuse large B-cell lymphoma activated B-cell type, diffuse large B-cell lymphoma germinal center B-cell type, diffuse large B-cell lymphoma with chronic inflammation +5 | National Cancer Institute (NCI) | Active not recruiting | No outcome recorded |
| Phase 3 | NCT06337318 Background | Oct 2024 → Mar 2032 expected | follicular lymphoma | National Cancer Institute (NCI) | Recruiting | No outcome recorded |
| Phase 3 | NCT05625399 Background | Mar 2023 → Aug 2025 overdue | melanoma | Bristol-Myers Squibb | Active not recruiting | No outcome recorded |
| Phase 3 | NCT05256225 Background | Nov 2022 → Oct 2027 expected | carcinosarcoma of the corpus uteri, endometrial clear cell adenocarcinoma, endometrial endometrioid adenocarcinoma, endometrial mixed adenocarcinoma +2 | National Cancer Institute (NCI) | Active not recruiting | No outcome recorded |
| Phase 3 | NCT05297565 Background | Aug 2022 → Feb 2024 | melanoma | Bristol-Myers Squibb | Completed | No outcome recorded |
| Phase 3 | NCT05415215 Background | Jul 2022 → Nov 2024 | female breast carcinoma, inflammatory breast carcinoma | Hoffmann-La Roche | Completed | No outcome recorded |
| Phase 3 | NCT04810078 Background | May 2021 → Jul 2025 overdue | clear cell renal carcinoma | Bristol-Myers Squibb | Active not recruiting | No outcome recorded |
| Phase 3 | NCT03735121 Background | Dec 2018 → Apr 2022 | non-small cell lung carcinoma | Hoffmann-La Roche | Completed | Met primary |
| Phase 3 | NCT01175213 Background | Jul 2010 → Aug 2013 | immunodeficiency disease | Baxalta now part of Shire | Completed | No outcome recorded |
News releases announcing trial results or a regulatory action · 185
| Date | Issuer | Release |
|---|---|---|
| 2026-10-08 | argenx | Results argenx Provides Update on Phase 3 UNITY Study of Efgartigimod SC in Sjögren's Disease argenx.com ↗
The decision is based on the recommendation from an Independent Data Monitoring Committee (IDMC) to stop the study for futility following an interim analysis. |
| 2026-09-23 | Janssen Research & Development, LLC | Results New model-based analysis further supports the potential of TECVAYLI® (teclistamab-cqyv) plus DARZALEX FASPRO® (daratumumab and hyaluronidase-fihj) to redefine long-term survival expectations in early line relapsed/refractory multiple myeloma jnj.com ↗
In the MajesTEC-3 study, TECVAYLI®plus DARZALEXFASPRO®significantly improved overall survival versus standard of care (SOC), with an estimated 83% of patients alive at 3 years. |
| 2026-09-14 | Janssen Research & Development, LLC | Results RYBREVANT FASPRO™ (amivantamab and hyaluronidase-lpuj) plus LAZCLUZE® (lazertinib) with prophylactic strategies shows low rates of treatment-related events at WCLC 2026 jnj.com ↗
Early results show consistently low rates across key treatment-related events and treatment discontinuation. |
| 2026-08-17 | Zai Lab (Shanghai) Co., Ltd. | Results Zai Lab and argenx Announce Positive Topline Results from Phase 3 ALKIVIA Trial of Efgartigimod in Autoimmune Myositis zailaboratory.com ↗
Zai Lab Limited (NASDAQ: ZLAB; HKEX: 9688) and argenx (Euronext & NASDAQ: ARGX), today announced positive topline results from the ALKIVIA Phase 3 study evaluating VYVGART® Hytrulo (efgartigimod alfa and hyaluronidase-qvfc) in adults with autoimmune myositis. |
| 2026-08-13 | Bristol-Myers Squibb | Regulatory U.S. FDA Grants Accelerated Approval to Bristol Myers Squibb's First CELMoD Therapy ZENBEXUS™, in Combination with Daratumumab and Hyaluronidase-fihj and Dexamethasone (ZDd) for Patients with Multiple Myeloma, as Early as First Relapse bms.com ↗ |
| 2026-07-30 | Janssen Research & Development, LLC | Regulatory Johnson & Johnson’s RYBREVANT FASPRO™ (amivantamab and hyaluronidase-lpuj) receives U.S. FDA Priority Review as potential first-in-class EGFR- and MET-targeted subcutaneous treatment for advanced head and neck cancer jnj.com ↗ |
| 2026-06-11 | Hoffmann-La Roche | Regulatory FDA grants Priority Review for Roche’s Tecentriq for a certain type of stage III colon cancer roche.com ↗
The FDA has granted Priority Review and is expected to make a decision on the approval by 9 October 2026. |
| 2026-05-31 | Janssen Research & Development, LLC | Results RYBREVANT FASPRO™ (amivantamab and hyaluronidase-lpuj) pivotal data show strong and durable responses in advanced head and neck cancer where options remain limited jnj.com ↗
Johnson & Johnson (NYSE: JNJ) today announced pivotal results from the Phase 1b/2 OrigAMI-4 study showing that subcutaneous amivantamab and hyaluronidase-lpuj delivered durable responses in patients with advanced head and neck squamous cell carcinoma previously treated with immunotherapy and chemotherapy. |
| 2026-05-15 | Genentech, Inc. | Regulatory FDA Approves Genentech’s Tecentriq for Adjuvant Muscle-Invasive Bladder Cancer With ctDNA-Guided Treatment gene.com ↗
FDA Approves Genentech’s Tecentriq for Adjuvant Muscle-Invasive Bladder Cancer With ctDNA-Guided Treatment |
| 2026-05-08 | argenx | Regulatory argenx Announces U.S. FDA Approval Expanding VYVGART and VYVGART Hytrulo for Use in All Adult Patients Living with gMG argenx.com ↗
The approved supplemental Biologics License Application (sBLA) expands VYVGART’s indication to include all serotypes of adult patients living with gMG – anti-AChR-Ab positive, anti-MuSK-Ab positive, anti-LRP4-Ab positive, and triple seronegative. |
| 2026-03-31 | Shanghai Henlius Biotech | Regulatory Henlius' Next-Generation rHuPH20 Approved for Clinical Trials, Accelerating Subcutaneous Delivery Platform Development henlius.com ↗ |
| 2026-03-06 | Halozyme Therapeutics | Regulatory U.S. FDA Approves TECVAYLI® in Combination with DARZALEX FASPRO® for Relapsed/Refractory Multiple Myeloma halozyme.com ↗
The newly approved TECVAYLI plus DARZALEX FASPRO treatment regimen, in which both drugs are administered subcutaneously, offers patients with relapsed or refractory multiple myeloma a new, effective treatment option that can be administered across all treatment settings. |
| 2026-03-05 | Janssen Research & Development, LLC | Regulatory Johnson & Johnson Announces U.S. FDA Approval of TECVAYLI® plus DARZALEX FASPRO® for Relapsed/Refractory Multiple Myeloma, Offering a Potential New Standard of Care as Early as Second Line jnj.com ↗ |
| 2026-02-19 | Janssen Research & Development, LLC | Results RYBREVANT FASPRO™ (amivantamab and hyaluronidase-lpuj) plus immunotherapy shows strong clinical benefit with 56 percent overall response rate in first-line recurrent or metastatic head and neck cancer jnj.com ↗ |
| 2026-02-19 | Janssen Research & Development, LLC | Results RYBREVANT FASPRO™ (amivantamab and hyaluronidase-lpuj) plus immunotherapy shows strong clinical benefit with 56 percent overall response rate in first-line recurrent or metastatic head and neck cancer jnj.com ↗ |
| 2026-02-18 | Janssen Research & Development, LLC | Regulatory RYBREVANT FASPRO™ (amivantamab and hyaluronidase-lpuj) receives U.S. FDA Breakthrough Therapy Designation for patients with advanced head and neck cancer jnj.com ↗ |
| 2026-02-17 | Janssen Research & Development, LLC | Regulatory FDA approves RYBREVANT FASPRO™ (amivantamab and hyaluronidase-lpuj) as the only EGFR-targeted therapy that can be administered once a month jnj.com ↗
Johnson & Johnson (NYSE: JNJ) today announced the U.S. Food and Drug Administration (FDA) has approved a new, simplified monthly dosing schedule* for RYBREVANTFASPRO™ (amivantamab and hyaluronidase-lpuj). |
| 2026-02-17 | Janssen Research & Development, LLC | Regulatory FDA approves RYBREVANT FASPRO™ (amivantamab and hyaluronidase-lpuj) as the only EGFR-targeted therapy that can be administered once a month jnj.com ↗ |
| 2026-02-11 | Huonslab Co., Ltd. | Regulatory Huonslab on Track for Recombinant Human Hyaluronidase ‘HYDIZYME™ Injection’ Development huonslab.com ↗
In December 2025, Huonslab submitted Biologics License Application (BLA) with the Ministry of Food and Drug Safety (MFDS) for its recombinant human hyaluronidase `HYDIZYME™ Injection (Development code: HLB3-002)’. |
| 2026-01-27 | Janssen Research & Development, LLC | Regulatory DARZALEX FASPRO®-based quadruplet regimen approved in the U.S. for newly diagnosed patients with multiple myeloma who are transplant ineligible jnj.com ↗ |
| 2025-12-22 | Huonslab Co., Ltd. | Regulatory Huonslab has submitted the Biologics License Application for Recombinant Human Hyaluronidase ‘HYDIZYME™ Injection’ - Applying HyDIFFUZE™ technology… Aiming for Approval in 2026 - huonslab.com ↗
Huonslab announced on the 22nd that it has filed for Biologics License Application with the Ministry of Food and Drug Safety (MFDS) for its recombinant human hyaluronidase 'HYDIZYME™’ (Development code: HLB3-002). |
| 2025-12-18 | Halozyme Therapeutics | Regulatory U.S. FDA Approves RYBREVANT FASPRO™ (amivantamab and hyaluronidase-lpuj) Co-Formulated with ENHANZE® for the Treatment of Advanced EGFR-mutated Non-Small Cell Lung Cancer halozyme.com ↗ |
| 2025-12-17 | Janssen Research & Development, LLC | Regulatory U.S. FDA Approval of RYBREVANT FASPRO™ (amivantamab and hyaluronidase-lpuj) Enables the Simplest, Shortest Administration Time for a First-Line Combination Regimen when combined with LAZCLUZE® (lazertinib) jnj.com ↗
RYBREVANTFASPRO™ is approved across all indications of RYBREVANT®(amivantamab-vmjw). |
| 2025-12-17 | Janssen Research & Development, LLC | Regulatory U.S. FDA Approval of RYBREVANT FASPRO™ (amivantamab and hyaluronidase-lpuj) Enables the Simplest, Shortest Administration Time for a First-Line Combination Regimen when Combined with LAZCLUZE® (lazertinib) jnj.com ↗
RYBREVANT FASPRO™ is approved across all indications of RYBREVANT (amivantamab-vmjw). |
| 2025-10-03 | Hoffmann-La Roche | Regulatory FDA approves Roche’s Tecentriq plus lurbinectedin as first-line maintenance therapy for extensive-stage small cell lung cancer roche.com ↗
This approval marks the first and only combination therapy for the first-line maintenance treatment of ES-SCLC, a highly aggressive disease for which treatment options have been limited. |
| 2025-10-02 | Genentech, Inc. | Regulatory FDA Approves Genentech’s Tecentriq Plus Lurbinectedin as First-Line Maintenance Therapy for Extensive-Stage Small Cell Lung Cancer gene.com ↗
This approval marks the first and only combination therapy for the first-line maintenance treatment of ES-SCLC, a highly aggressive disease for which treatment options have been limited. |
| 2025-06-20 | Halozyme Therapeutics | Regulatory Halozyme Announces argenx Received European Commission Approval for VYVGART® Subcutaneous Injection with ENHANZE® for Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) halozyme.com ↗
We are pleased to announce the European Commission approval of the subcutaneous injection of VYVGART, which is co-formulated with our ENHANZE drug delivery technology for use in CIDP patients. |
| 2025-06-03 | Janssen Research & Development, LLC | Results DARZALEX FASPRO® (daratumumab and hyaluronidase-fihj)-based regimen shows 95 percent progression-free survival at four years in transplant-eligible, newly diagnosed patients with multiple myeloma who achieved sustained MRD negativity jnj.com ↗
Data from Phase 3 CEPHEUS study show 60 percent overall MRD negativity (10) and improved PFS with DARZALEX FASPRO in transplant-ineligible newly diagnosed patients |
| 2025-05-28 | Bristol-Myers Squibb | Regulatory Bristol Myers Squibb Receives European Commission Approval for the Subcutaneous Formulation of Opdivo® (nivolumab) Across Multiple Solid Tumor Indications bms.com ↗
Opdivo is the first and only PD-1 inhibitor approved for subcutaneous (SC) use in the European Union |
| 2025-05-28 | Halozyme Therapeutics | Regulatory Halozyme Announces Bristol Myers Squibb Received European Commission Approval for Subcutaneous Opdivo® (nivolumab) Co-Formulated with ENHANZE® Across Multiple Solid Tumor Indications halozyme.com ↗
The approval by the EC is valid in all 27 member states of the European Union (EU), as well as Iceland, Liechtenstein and Norway. |
| 2025-05-20 | Janssen Research & Development, LLC | Regulatory U.S. FDA Oncologic Drugs Advisory Committee votes in favor of the benefit-risk profile of DARZALEX FASPRO® (daratumumab and hyaluronidase-fihj) for high-risk smoldering multiple myeloma jnj.com ↗ |
| 2025-04-29 | Huonslab Co., Ltd. | Results Huonslab Announced the Results of HLB3-002 Formulation Conversion Study in a Poster Presentation at 2025 AACR huonslab.com ↗
In Huonslab’s preclinical studies involving rats, the administration of a combination of HLB3-002 and infliximab significantly improved the bioavailability of infliximab compared to infliximab without HLB3-002. |
| 2025-04-28 | Halozyme Therapeutics | Regulatory Halozyme Announces argenx Received Positive CHMP Opinion for VYVGART® (efgartigimod alfa) Subcutaneous Injection with ENHANZE® for Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) halozyme.com ↗
We are delighted that the subcutaneous injection of VYVGART® co-formulated with our ENHANZE drug delivery technology, has been recommended for approval in the European Union. |
| 2025-04-10 | Halozyme Therapeutics | Regulatory Halozyme Announces FDA Approval of argenx's VYVGART® Hytrulo Prefilled Syringe Co-Formulated with ENHANZE® for Self-Injection for Generalized Myasthenia Gravis and Chronic Inflammatory Demyelinating Polyneuropathy halozyme.com ↗
VYVGART® Hytrulo prefilled syringe for self-injection is approved as a 20-to-30-second subcutaneous injection administered by a patient, caregiver, or healthcare professional. |
| 2025-04-10 | argenx | Regulatory argenx Announces FDA Approval of VYVGART Hytrulo Prefilled Syringe for Self-Injection in Generalized Myasthenia Gravis and Chronic Inflammatory Demyelinating Polyneuropathy argenx.com ↗ |
| 2025-03-31 | Halozyme Therapeutics | Regulatory Halozyme Announces Bristol Myers Squibb Received Positive CHMP Opinion for the Subcutaneous Formulation of Opdivo® (nivolumab) with ENHANZE® Across Multiple Solid Tumor Indications halozyme.com ↗ |
| 2025-03-28 | Bristol-Myers Squibb | Regulatory Bristol Myers Squibb Receives Positive CHMP Opinion for the Subcutaneous Formulation of Opdivo® (nivolumab) Across Multiple Solid Tumor Indications bms.com ↗
has recommended approval of a new Opdivo ® (nivolumab) formulation associated with a new route of administration (subcutaneous use), a new pharmaceutical form (solution for injection) and a new strength (600 mg/vial). |
| 2025-03-12 | GlaxoSmithKline | Results ViiV Healthcare’s investigational broadly neutralising antibody - N6LS - successfully maintains viral suppression in long-acting treatment of HIV gsk.com ↗
VH109 was generally well tolerated, though infusion site reactions were more frequent with SC administration, occurring in 14% compared to none with IV administration. |
| 2025-03-12 | ViiV Healthcare | Results ViiV HEALTHCARE’S INVESTIGATIONAL BROADLY NEUTRALISING ANTIBODY - N6LS - SUCCESSFULLY MAINTAINS VIRAL SUPPRESSION IN LONG-ACTING TREATMENT OF HIV viivhealthcare.com ↗
VH109 was generally well tolerated, though infusion site reactions were more frequent with SC administration, occurring in 14% compared to none with IV administration. |
| 2025-02-28 | Janssen Research & Development, LLC | Regulatory Johnson & Johnson’s DARZALEX® (daratumumab) subcutaneous-based regimen receives positive CHMP opinion for patients with newly diagnosed multiple myeloma, regardless of transplant eligibility jnj.com ↗
The recommendation is for daratumumab SC in combination with bortezomib, lenalidomide, and dexamethasone (daratumumab-VRd) for the treatment of adult patients with newly diagnosed multiple myeloma (NDMM). |
| 2024-12-30 | Halozyme Therapeutics | Regulatory Halozyme Announces argenx's VYDURA with ENHANZE® was Granted Regulatory Approval in Japan for Chronic Inflammatory Demyelinating Polyneuropathy halozyme.com ↗
VYVDURA was approved for CIDP as a once weekly 30-to-90 second subcutaneous injection, which can be self-administered at home, and is the first and only neonatal Fc receptor (FcRn) blocker approved for the treatment of CIDP. |
| 2024-12-30 | Halozyme Therapeutics | Regulatory Halozyme Announces Takeda Received Regulatory Approval for HYQVIA® 10% Subcutaneous Injection Set with ENHANZE® in Japan for Patients with Agammaglobulinemia or Hypogammaglobulinemia halozyme.com ↗
Halozyme Therapeutics, Inc. (NASDAQ: HALO) (Halozyme) today announced that Takeda received regulatory approval for HYQVIA® [Immune Globulin Infusion 10% (Human) with Halozyme's Recombinant Human Hyaluronidase] by the Japanese Ministry of Health, Labour and Welfare (MHLW) |
| 2024-12-30 | Halozyme Therapeutics | Regulatory Halozyme Announces FDA Approval of Bristol Myers Squibb's Opdivo Qvantig™ with ENHANZE® for Subcutaneous Use in Most Previously Approved Adult Solid Tumor Opdivo® (nivolumab) Indications halozyme.com ↗
We are pleased Opdivo Qvantig, which is co-formulated with our ENHANZE drug delivery technology, is now FDA-approved as the first and only subcutaneously administered PD-1 inhibitor in the U.S. |
| 2024-12-27 | Takeda | Regulatory Takeda Announces Approval of HYQVIA® 10% S.C. (Subcutaneous) Injection Set in Japan for Patients with Agammaglobulinemia or Hypogammaglobulinemia takeda.com ↗
The approval marks availability of the first and only facilitated subcutaneous immunoglobulin (fSCIG) therapy as a treatment option for appropriate patients in Japan. |
| 2024-12-27 | Bristol-Myers Squibb | Regulatory U.S. Food and Drug Administration Approves Opdivo Qvantig™ (nivolumab and hyaluronidase-nvhy) Injection, for Subcutaneous Use in Most Previously Approved Adult, Solid Tumor Opdivo® (nivolumab) Indications bms.com ↗ |
| 2024-12-27 | argenx | Regulatory argenx Announces Approval of VYVDURA (efgartigimod alfa and hyaluronidase-qvfc) in Japan for Adults with Chronic Inflammatory Demyelinating Polyneuropathy argenx.com ↗
argenx SE (Euronext & Nasdaq: ARGX), a global immunology company committed to improving the lives of people suffering from severe autoimmune diseases, today announced that Japan’s Ministry of Health, Labour and Welfare (MHLW) approved VYVDURA for adults with chronic inflammatory demyelinating polyneuropathy (CIDP). |
| 2024-12-16 | Janssen Research & Development, LLC | Regulatory Update on U.S. regulatory review of subcutaneous amivantamab jnj.com ↗
The CRL is related to observations as part of a standard pre-approval inspection at a manufacturing facility. |
| 2024-11-11 | Zai Lab (Shanghai) Co., Ltd. | Regulatory Zai Lab and argenx Announce Approval of VYVGART Hytrulo for Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) in China zailaboratory.com ↗
VYVGART Hytrulo is approved for CIDP as a once weekly 30-to-90 second subcutaneous injection. |
| 2024-11-11 | argenx | Regulatory argenx and Zai Lab Announce Approval of VYVGART Hytrulo for Chronic Inflammatory Demyelinating Polyneuropathy in China argenx.com ↗
VYVGART Hytrulo is approved for CIDP as a once weekly 30-to-90 second subcutaneous injection. |
| 2024-09-13 | Hoffmann-La Roche | Regulatory FDA approves Roche’s Tecentriq Hybreza, the first and only subcutaneous anti-PD-(L)1 cancer immunotherapy roche.com ↗
Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that the U.S. Food and Drug Administration (FDA) has approved Tecentriq HybrezaTM (atezolizumab and hyaluronidase-tqjs), the first and only PD-(L)1 inhibitor for subcutaneous (SC), under the skin injection for patients in the United States. |
| 2024-09-13 | Halozyme Therapeutics | Regulatory Halozyme Announces FDA Approval of Roche's Subcutaneous OCREVUS ZUNOVO™ with ENHANZE® for People with Relapsing and Primary Progressive Multiple Sclerosis halozyme.com ↗
today announced that Roche received U.S. Food and Drug Administration (FDA) approval for OCREVUS ZUNOVO™ |
| 2024-09-12 | Genentech, Inc. | Regulatory FDA Approves Genentech’s Tecentriq Hybreza, the First and Only Subcutaneous Anti-PD-(L)1 Cancer Immunotherapy gene.com ↗
FDA Approves Genentech’s Tecentriq Hybreza, the First and Only Subcutaneous Anti-PD-(L)1 Cancer Immunotherapy |
| 2024-09-12 | Halozyme Therapeutics | Regulatory Halozyme Announces FDA Approval of Roche's Tecentriq Hybreza™ With ENHANZE® for Multiple Types of Cancer halozyme.com ↗
Halozyme Therapeutics, Inc. (NASDAQ: HALO) ("Halozyme") today announced that Roche received U.S. Food and Drug Administration (FDA) approval for Tecentriq Hybreza™ (atezolizumab and hyaluronidase-tqjs) with Halozyme's ENHANZE® drug delivery technology. |
| 2024-09-04 | Huonslab Co., Ltd. | Results Huonslab Announces Positive Results from Non-Clinical PK Comparative Study of Trastuzumab Co-formulated with HyDIFFUZE™ huonslab.com ↗
The study results confirmed comparable PK profile and biological equivalence between the two groups. |
| 2024-07-30 | Janssen Research & Development, LLC | Regulatory DARZALEX FASPRO® (daratumumab and hyaluronidase-fihj)-based quadruplet regimen approved in the U.S. for patients with newly diagnosed multiple myeloma who are transplant-eligible jnj.com ↗ |
| 2024-07-16 | Zai Lab (Shanghai) Co., Ltd. | Regulatory Zai Lab and argenx Announce Approval of Efgartigimod Alfa Injection (Subcutaneous Injection) for Generalized Myasthenia Gravis in China zailaboratory.com ↗
Zai Lab Limited (NASDAQ: ZLAB; HKEX: 9688) and argenx (Euronext & Nasdaq: ARGX) today announced that China’s National Medical Products Administration (NMPA) approved the Biologics License Application (BLA) for efgartigimod alfa injection (subcutaneous injection) (efgartigimod SC), 1,000mg (5.6ml)/vial indicated as an add on to standard therapy for the treatment of adult patients with generalized myasthenia gravis (gMG) who are anti-acetylcholine receptor (AChR) antibody positive. |
| 2024-07-16 | argenx | Regulatory argenx and Zai Lab Announce Approval of Efgartigimod Alfa Injection (Subcutaneous Injection) for Generalized Myasthenia Gravis in China argenx.com ↗
argenx SE (Euronext & Nasdaq: ARGX) and Zai Lab Limited (Nasdaq: ZLAB; HKEX: 9688) today announced that China’s National Medical Products Administration (NMPA) approved the Biologics License Application (BLA) on July 16, 2024 for efgartigimod alfa injection (subcutaneous injection) (efgartigimod SC), 1,000mg (5.6ml)/vial indicated as an add on to standard therapy for the treatment of adult patients with generalized myasthenia gravis (gMG) who are anti-acetylcholine receptor (AChR) antibody positive. |
| 2024-06-25 | Halozyme Therapeutics | Regulatory Halozyme Announces Roche's OCREVUS® SC with ENHANZE® Receives European Commission Approval for Relapsing and Primary Progressive Multiple Sclerosis halozyme.com ↗ |
| 2024-06-21 | Halozyme Therapeutics | Regulatory Halozyme Announces argenx Receives FDA Approval for VYVGART® Hytrulo Co-Formulated with ENHANZE® for Chronic Inflammatory Demyelinating Polyneuropathy halozyme.com ↗
VYVGART® Hytrulo for CIDP is FDA-approved as a once weekly 30-to-90 second subcutaneous (SC) injection. |
| 2024-06-21 | argenx | Regulatory argenx Announces FDA Approval of VYVGART Hytrulo for Chronic Inflammatory Demyelinating Polyneuropathy argenx.com ↗
VYVGART Hytrulo is approved for CIDP as a once weekly 30-to-90 second subcutaneous injection. |
| 2024-06-18 | Takeda | Results Takeda Presents Long-Term Data from Phase 3 ADVANCE-CIDP 3 Clinical Trial of HYQVIA® in Patients with Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) at PNS Annual Meeting takeda.com ↗
Results showed favorable long-term safety and tolerability of HYQVIA, and a low relapse rate, supporting its use as maintenance treatment for CIDP. |
| 2024-06-17 | Janssen Research & Development, LLC | Regulatory Subcutaneous amivantamab Biologics License Application submitted to U.S. FDA for patients with EGFR-mutated non-small cell lung cancer jnj.com ↗
Johnson & Johnson (NYSE: JNJ) announced today the submission of a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for a fixed combination of amivantamab and recombinant human hyaluronidase for subcutaneous administration (SC amivantamab) for all currently approved or submitted indications of intravenous (IV) RYBREVANT®(amivantamab-vmjw) in certain patients with non-small cell lung cancer (NSCLC). |
| 2024-06-17 | Janssen Research & Development, LLC | Regulatory Subcutaneous amivantamab Biologics License Application submitted to U.S. FDA for patients with EGFR-mutated non-small cell lung cancer jnj.com ↗
Subcutaneous amivantamab Biologics License Application submitted to U.S. FDA for patients with EGFR-mutated non-small cell lung cancer |
| 2024-05-31 | Janssen Research & Development, LLC | Results First results from late-breaking Phase 3 PALOMA-3 study show five-fold reduction in infusion-related reactions with five-minute subcutaneous amivantamab administration jnj.com ↗
Administration time for SC amivantamab was reduced to approximately five minutes from five hours (across two days) and showed a five-fold reduction in infusion-related reactions (IRRs). |
| 2024-05-21 | Bristol-Myers Squibb | Regulatory Bristol Myers Squibb Announces Updated Action Date by the U.S. Food and Drug Administration for Subcutaneous Nivolumab (nivolumab and hyaluronidase) bms.com ↗
The updated goal date is December 29, 2024. |
| 2024-05-21 | Halozyme Therapeutics | Regulatory Halozyme Announces Bristol Myers Squibb Received Updated Action Date from the U.S. Food and Drug Administration for Subcutaneous Nivolumab Co-Formulated with ENHANZE® halozyme.com ↗
The updated goal date is December 29, 2024. |
| 2024-05-06 | Bristol-Myers Squibb | Regulatory U.S. Food and Drug Administration Accepts Bristol Myers Squibb’s Application for Subcutaneous Nivolumab (nivolumab and hyaluronidase) bms.com ↗
The FDA assigned a Prescription Drug User Fee Act (PDUFA) goal date of February 28, 2025. |
| 2024-04-16 | argenx | Results argenx Data Highlight Evidence that VYVGART and VYVGART Hytrulo Drive Transformative Outcomes for Patients with Debilitating Autoimmune Disease argenx.com ↗
The results of the ADHERE trial show that VYVGART Hytrulo reduces the risk of clinical deterioration in patients with CIDP while minimizing side effects and reducing the treatment burden. |
| 2024-03-04 | GlaxoSmithKline | Results ViiV Healthcare presents phase I clinical trial findings of a cabotegravir long-acting injectable investigational formulation allowing at least four months between doses gsk.com ↗
Following co-administration of CAB200 + rHuPH20, the observed CAB plasma concentration increased proportionally with dose |
| 2024-02-19 | argenx | Regulatory argenx Announces FDA Acceptance of Supplemental Biologics License Application with Priority Review for VYVGART Hytrulo in Chronic Inflammatory Demyelinating Polyneuropathy argenx.com ↗
FDA’s acceptance of the sBLA represents an important milestone in our continued drive to bring novel treatments for rare, autoimmune diseases, and a significant step forward for people whose lives have been profoundly impacted by this devastating disease. |
| 2024-01-30 | Janssen Research & Development, LLC | Regulatory Johnson & Johnson submits supplemental Biologics License Application to U.S. FDA seeking approval of DARZALEX FASPRO® (daratumumab and hyaluronidase-fihj)-based regimen for the treatment of patients with transplant-eligible, newly diagnosed multiple myeloma jnj.com ↗
Johnson & Johnson announced today the submission of a supplemental Biologics License Application (sBLA) to the U.S. Food and Drug Administration (FDA) seeking approval of a new indication for DARZALEXFASPRO® |
| 2024-01-29 | Takeda | Regulatory Takeda’s HYQVIA® Approved by European Commission as Maintenance Therapy in Patients with Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) takeda.com ↗ |
| 2024-01-29 | Halozyme Therapeutics | Regulatory Halozyme Announces Takeda Received European Commission Approval for HYQVIA® Co-formulated with ENHANZE® as Maintenance Therapy for Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) halozyme.com ↗
HYQVIA® is the only FDA and now EC-approved combination of immunoglobulin (IG) and hyaluronidase for CIDP and is administered by facilitated subcutaneous infusion. |
| 2024-01-27 | Bristol-Myers Squibb | Results Subcutaneous Nivolumab (nivolumab and hyaluronidase) Shows Noninferiority Compared to Intravenous Opdivo (nivolumab) in Advanced or Metastatic Clear Cell Renal Cell Carcinoma in CheckMate -67T Trial bms.com ↗
Subcutaneous nivolumab demonstrated noninferior pharmacokinetics (co-primary endpoints) and objective response rate (key powered secondary endpoint) compared to intravenous Opdivo |
| 2024-01-18 | Halozyme Therapeutics | Regulatory Halozyme Announces argenx Received Approval in Japan for VYVDURA® (efgartigimod alfa and hyaluronidase-qvfc) Co-Formulated with ENHANZE® for Generalized Myasthenia Gravis halozyme.com ↗
Today's approval includes the opportunity for patient self-administration of SC VYVGART with ENHANZE at home, adding an additional treatment option for patients. |
| 2024-01-17 | argenx | Regulatory argenx Announces Approval of VYVDURA® (efgartigimod alfa and hyaluronidase-qvfc) Injection for Subcutaneous Use in Japan for Generalized Myasthenia Gravis argenx.com ↗ |
| 2024-01-16 | Takeda | Regulatory U.S. FDA Approves Takeda’s HYQVIA ® as Maintenance Therapy in Adults with Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) takeda.com ↗
Takeda ( TSE:4502/NYSE:TAK ) today announced that the U.S. Food and Drug Administration (FDA) has approved HYQVIA ® [Immune Globulin Infusion 10% (Human) with Recombinant Human Hyaluronidase] for the treatment of chronic inflammatory demyelinating polyneuropathy (CIDP) as maintenance therapy to prevent the relapse of neuromuscular disability and impairment in adults. |
| 2024-01-16 | Halozyme Therapeutics | Regulatory Halozyme Announces Takeda Receives FDA Approval for HYQVIA® Co-formulated with ENHANZE® as Maintenance Therapy in Adults with Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) halozyme.com ↗ |
| 2024-01-16 | Halozyme Therapeutics | Regulatory Halozyme Announces Roche Receives European Commission Approval of Tecentriq® SC with ENHANZE® Representing the EU's First Subcutaneous PD-(L)1 Cancer Immunotherapy for Multiple Cancer Types halozyme.com ↗
Halozyme Therapeutics, Inc. (NASDAQ: HALO) ("Halozyme") today announced that Roche received European Commission (EC) marketing authorization of Tecentriq® SC (atezolizumab) co-formulated with ENHANZE®, Halozyme's proprietary recombinant human hyaluronidase enzyme, rHuPH20. |
| 2023-11-28 | argenx | Results argenx Reports Topline Results from ADVANCE-SC Study of VYVGART Hytrulo in Primary Immune Thrombocytopenia argenx.com ↗
The study did not meet the primary endpoint of a sustained platelet count response in chronic ITP patients. |
| 2023-11-16 | Halozyme Therapeutics | Regulatory Halozyme Announces argenx Receives European Commission Approval of VYVGART® SC with ENHANZE® for Generalized Myasthenia Gravis halozyme.com ↗
Halozyme Therapeutics, Inc. (NASDAQ: HALO) ("Halozyme") today announced that argenx received European Commission (EC) approval of VYVGART® SC (efgartigimod alfa and hyaluronidase-qvfc) co-formulated with ENHANZE® for the treatment of generalized myasthenia gravis (gMG) in adult patients who are anti-acetylcholine receptor (AChR) antibody positive. |
| 2023-10-19 | Bristol-Myers Squibb | Results Phase 3 CheckMate -67T Trial of Subcutaneous Nivolumab (nivolumab and hyaluronidase) Meets Co-Primary Endpoints in Advanced or Metastatic Clear Cell Renal Cell Carcinoma bms.com ↗ |
| 2023-10-19 | Halozyme Therapeutics | Results Positive Topline Results Reported from Bristol Myers Squibb's Phase 3 CheckMate-67T Trial of Subcutaneous Nivolumab with Halozyme's ENHANZE® Drug Delivery Technology for Advanced or Metastatic Clear Cell Renal Cell Carcinoma halozyme.com ↗
The study met its co-primary pharmacokinetics endpoints and key secondary endpoint. |
| 2023-10-16 | Halozyme Therapeutics | Results Update: Halozyme Announces Presentation of Positive Clinical Data of its High-Volume Auto-Injector Demonstrating Successful Rapid Subcutaneous Drug Delivery at 13th Annual PODD: Partnership Opportunities in Drug Delivery Conference halozyme.com ↗
The primary endpoint of the study was achieved with all subjects receiving the completed dose with HVAI, demonstrating that 10 mL of a representative biologic product can be rapidly delivered using Halozyme's ENHANZE® and HVAI technologies. |
| 2023-10-16 | Halozyme Therapeutics | Results Halozyme Announces Positive Clinical Data of its High-Volume Auto-Injector Demonstrating Successful Rapid Subcutaneous Drug Delivery halozyme.com ↗
Halozyme Therapeutics, Inc. (NASDAQ: HALO) ("Halozyme") today announced positive results of a clinical study demonstrating subcutaneous administration of 10 mL of a representative biologic product co-formulated with its ENHANZE® drug delivery technology, in approximately 30 seconds. |
| 2023-10-10 | Genentech, Inc. | Results Genentech’s Ocrevus Twice-Yearly, 10-Minute Subcutaneous Injection Was Non-Inferior to Intravenous Infusion and Provided Near-Complete Suppression of Brain Lesions gene.com ↗
Study results demonstrate the effect of Ocrevus® (ocrelizumab) as an investigational twice-yearly, 10-minute subcutaneous injection on pharmacokinetic, biomarker, and MRI measures in patients with relapsing or primary progressive multiple sclerosis (RMS or PPMS). |
| 2023-09-25 | Chugai Pharmaceutical | Regulatory Chugai Obtains Regulatory Approval for Phesgo, the Fixed-Dose Subcutaneous Combination of Perjeta and Herceptin for HER2-Positive Breast and Colorectal Cancer chugai-pharm.co.jp ↗ |
| 2023-07-17 | Zai Lab (Shanghai) Co., Ltd. | Results Zai Lab and argenx Report Positive Topline Data from ADHERE Study of VYVGART Hytrulo in Patients with Chronic Inflammatory Demyelinating Polyneuropathy zailaboratory.com ↗
The study met its primary endpoint (p=0.000039), demonstrating a significantly lower risk of relapse with VYVGART Hytrulo compared to placebo. |
| 2023-07-17 | Halozyme Therapeutics | Results Positive Topline Data Reported from argenx's ADHERE Study of VYVGART® Hytrulo with Halozyme's ENHANZE® Drug Delivery Technology in Patients with Chronic Inflammatory Demyelinating Polyneuropathy halozyme.com ↗
Halozyme Therapeutics, Inc. (NASDAQ: HALO) ("Halozyme") today announced that argenx reported positive topline data from the ADHERE study evaluating VYVGART® Hytrulo (efgartigimod alfa and hyaluronidase-qvfc) with ENHANZE® in adults with chronic inflammatory demyelinating polyneuropathy (CIDP). |
| 2023-07-16 | argenx | Results argenx Reports Positive Topline Data from ADHERE Study of VYVGART Hytrulo in Patients with Chronic Inflammatory Demyelinating Polyneuropathy argenx.com ↗
The study met its primary endpoint (p=0.000039), demonstrating a significantly lower risk of relapse with VYVGART Hytrulo compared to placebo. |
| 2023-07-13 | Halozyme Therapeutics | Results Positive Results Announced from Phase 3 OCARINA II Trial Evaluating Roche's OCREVUS® (ocrelizumab) with Halozyme's ENHANZE® Drug Delivery Technology in Patients with Multiple Sclerosis halozyme.com ↗
OCREVUS subcutaneous injection co-formulated with ENHANZE®, Halozyme's proprietary recombinant human hyaluronidase enzyme, rHuPH20, was shown to be non-inferior to OCREVUS given by intravenous infusion (IV) as measured by pharmacokinetics (levels in the blood) at 12 weeks. |
| 2023-06-20 | Halozyme Therapeutics | Regulatory Halozyme Announces argenx Receives FDA Approval for VYVGART® Hytrulo With ENHANZE® for Subcutaneous Use in Generalized Myasthenia Gravis halozyme.com ↗ |
| 2023-06-20 | argenx | Regulatory argenx Announces U.S. Food and Drug Administration Approval of VYVGART Hytrulo (efgartigimod alfa and hyaluronidase-qvfc) Injection for Subcutaneous Use in Generalized Myasthenia Gravis argenx.com ↗
argenx SE (Euronext & Nasdaq: ARGX), a global immunology company committed to improving the lives of people suffering from severe autoimmune diseases, today announced that the U.S. Food and Drug Administration (FDA) approved VYVGART® Hytrulo (efgartigimod alfa and hyaluronidase-qvfc). |
| 2022-11-22 | argenx | Regulatory argenx Announces U.S. FDA Acceptance of Biologics License Application for Subcutaneous Efgartigimod in Generalized Myasthenia Gravis with Priority Review argenx.com ↗
The application has been granted a Prescription Drug User Fee Act (PDUFA) target action date of March 20, 2023. |
| 2022-08-02 | Hoffmann-La Roche | Results Roche’s subcutaneous formulation of Tecentriq demonstrates positive Phase III results roche.com ↗
The study showed non-inferior levels of Tecentriq in the blood (pharmacokinetics), when injected subcutaneously, compared with intravenous (IV) infusion, in cancer immunotherapy-naïve patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) for whom prior platinum therapy has failed. |
| 2022-08-02 | Halozyme Therapeutics | Results Positive Results Announced from Phase III IMscin001 Study Evaluating Subcutaneous Formulation of Tecentriq® with ENHANZE® in Advanced Non-Small Cell Lung Cancer halozyme.com ↗
Halozyme Therapeutics, Inc. (NASDAQ: HALO) ("Halozyme") today announced that Roche's Phase III IMscin001 study evaluating a subcutaneous (SC) formulation of Tecentriq® (atezolizumab) with Halozyme's ENHANZE® technology met its co-primary endpoints. |
| 2022-07-21 | Takeda | Results Takeda Announces Positive Topline Results from Pivotal Phase 3 Clinical Trial Evaluating HYQVIA ® for Maintenance Treatment of Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP) takeda.com ↗
Topline data show that HYQVIA reduced relapse of neuromuscular disability and impairment when used as a maintenance therapy for CIDP, supporting its potential as a facilitated subcutaneous immunoglobulin (fSCIG) solution that could allow for monthly infusion for many CIDP patients. |
| 2022-03-22 | Halozyme Therapeutics | Results Positive Topline Results Announced from ADAPT-SC Study Evaluating Subcutaneous Efgartigimod Using ENHANZE® Drug Delivery Technology for Generalized Myasthenia Gravis halozyme.com ↗
Study met primary endpoint, demonstrating noninferior total IgG reduction at day 29 with subcutaneously administered efgartigimod compared to intravenous (IV) administration |
| 2021-12-01 | Halozyme Therapeutics | Regulatory Halozyme Announces Janssen Receives U.S. FDA Approval of DARZALEX FASPRO® (daratumumab and hyaluronidase-fihj) in Combination with Carfilzomib and Dexamethasone for Patients with Multiple Myeloma After First or Subsequent Relapse halozyme.com ↗ |
| 2021-07-12 | Janssen Research & Development, LLC | Regulatory Janssen Announces U.S. FDA Approval of DARZALEX FASPRO® (daratumumab and hyaluronidase-fihj) in Combination with Pomalidomide and Dexamethasone for Patients with Multiple Myeloma After First or Subsequent Relapse jnj.com ↗
The approval follows the regulatory submission to the FDA in November 2020 and marks the sixth indication for DARZALEX FASPRO® in the treatment of multiple myeloma. |
| 2021-07-12 | Halozyme Therapeutics | Regulatory Halozyme Announces Janssen Receives U.S. FDA Approval of DARZALEX FASPRO® (daratumumab and hyaluronidase-fihj) in Combination with Pomalidomide and Dexamethasone for Patients with Multiple Myeloma After First or Subsequent Relapse halozyme.com ↗ |
| 2021-01-15 | Janssen Research & Development, LLC | Regulatory DARZALEX FASPRO® (daratumumab and hyaluronidase-fihj) Becomes the First FDA-Approved Treatment for Patients with Newly Diagnosed Light Chain (AL) Amyloidosis jnj.com ↗
This indication is approved under accelerated approval and is based on the hematologic complete response rate (hemCR) measure. |
| 2021-01-15 | Halozyme Therapeutics | Regulatory Halozyme Announces Janssen Receives FDA Approval Of DARZALEX FASPRO® (Daratumumab And Hyaluronidase-fihj) As Treatment For Newly Diagnosed Patients With Light Chain (AL) Amyloidosis halozyme.com ↗
Janssen Biotech, Inc. (Janssen) has received U.S. Food and Drug Administration (FDA) approval of DARZALEX FASPRO® (daratumumab and hyaluronidase-fihj) in combination with bortezomib, cyclophosphamide and dexamethasone (D-VCd) for the treatment of adult patients with newly diagnosed light chain (AL) amyloidosis. |
| 2021-01-15 | Genmab | Regulatory Genmab Announces that Janssen has been Granted U.S. FDA Approval for DARZALEX FASPRO® (daratumumab and hyaluronidase-fihj) for Patients with Newly Diagnosed Light-chain (AL) Amyloidosis genmab.com ↗
DARZALEX FASPRO® (daratumumab and hyaluronidase-fihj) approved by U.S. FDA as the first and only therapy for newly diagnosed Light-chain (AL) amyloidosis |
| 2020-12-23 | Halozyme Therapeutics | Regulatory Halozyme Announces Roche Receives European Commission Approval For Phesgo® (Fixed-Dose Combination Of Perjeta® And Herceptin® For Subcutaneous Injection) Utilizing Halozyme's ENHANZE® Technology For The Treatment Of Patients With HER2-Positive Breast Cancer halozyme.com ↗
Halozyme Therapeutics, Inc. (NASDAQ: HALO) today announced that the European Commission has approved Roche's Phesgo®, a fixed-dose combination of Perjeta® (pertuzumab) and Herceptin® (trastuzumab) with Halozyme's ENHANZE® technology, administered by subcutaneous injection for the treatment of patients with early and metastatic HER2-positive breast cancer. |
| 2020-12-07 | Janssen Research & Development, LLC | Results Data from the ANDROMEDA Study Show Hematologic Response for DARZALEX FASPRO® (daratumumab and hyaluronidase-fihj) in Newly Diagnosed Light Chain (AL) Amyloidosis jnj.com ↗
Data from the ANDROMEDA Study Show Hematologic Response for DARZALEX FASPRO® (daratumumab and hyaluronidase-fihj) in Newly Diagnosed Light Chain (AL) Amyloidosis |
| 2020-12-04 | Janssen Research & Development, LLC | Results Data from the APOLLO Study Show Clinically Meaningful Response with DARZALEX FASPRO® (daratumumab and hyaluronidase-fihj) Regimen After First or Subsequent Relapse in Multiple Myeloma jnj.com ↗
The APOLLO study represents the ninth positive Phase 3 study for daratumumab. |
| 2020-11-13 | Halozyme Therapeutics | Regulatory Halozyme Announces CHMP Recommends EU Approval Of Roche's Phesgo® (Fixed-Dose Combination Of Perjeta® And Herceptin® For Subcutaneous Injection) Utilizing Halozyme's ENHANZE® Technology For HER2-Positive Breast Cancer halozyme.com ↗
Based on this recommendation, a final decision regarding the approval of Phesgo is expected from the European Commission in the near future. |
| 2020-11-12 | Halozyme Therapeutics | Regulatory Halozyme Announces Janssen Submission Of Applications In US And EU Seeking Approval Of DARZALEX FASPRO™/ DARZALEX® Subcutaneous (SC) Formulation Utilizing ENHANZE® Technology, Combination With Pomalidomide And Dexamethasone For Patients With Relapsed Or Refractory Multiple Myeloma halozyme.com ↗
The applications seek approval of the combination of DARZALEX FASPRO™/ DARZALEX® SC with pomalidomide and dexamethasone (D-Pd) for the treatment of patients with relapsed or refractory multiple myeloma who have received at least one prior line of therapy. |
| 2020-09-17 | Halozyme Therapeutics | Results Halozyme Announces Poster Presentation Of Data From Roche's Phase 1b Study Evaluating Atezolizumab For Subcutaneous Administration Utilizing Enhanze® In Non-Small Cell Lung Cancer halozyme.com ↗
The poster concluded that atezolizumab utilizing ENHANZE® was well tolerated, provided similar exposure as atezolizumab IV and that results support further development of subcutaneous atezolizumab in IMscin001 Part 2, a confirmatory phase III study. |
| 2020-09-10 | Halozyme Therapeutics | Regulatory Halozyme Announces Janssen Submission For FDA Approval Of DARZALEX FASPRO™ (daratumumab and hyaluronidase-fihj) For The Treatment Of Patients With Light Chain (AL) Amyloidosis halozyme.com ↗ |
| 2020-06-29 | Halozyme Therapeutics | Regulatory Halozyme Announces Roche Receives FDA Approval For Phesgo™ (Fixed-Dose Combination Of Perjeta® And Herceptin® For Subcutaneous Injection) Utilizing Halozyme's ENHANZE® Technology For The Treatment Of Patients With HER2-Positive Breast Cancer halozyme.com ↗
This is the first time a product has been approved combining two monoclonal antibodies that can be administered by a single subcutaneous injection utilizing Halozyme's ENHANZE® technology. |
| 2020-06-13 | Halozyme Therapeutics | Results Halozyme Announces Findings From Janssen's Phase 3 Andromeda Study Evaluating Subcutaneous Daratumumab Utilizing ENHANZE® In Light-Chain Amyloidosis Presented At European Hematology Association 25th Annual Congress halozyme.com ↗
Janssen reported that the study met the primary endpoint of percentage of patients with hematologic complete response. |
| 2020-05-01 | Janssen Research & Development, LLC | Regulatory U.S. Food and Drug Administration Approves DARZALEX FASPRO™ (daratumumab and hyaluronidase-fihj), a New Subcutaneous Formulation of Daratumumab in the Treatment of Patients with Multiple Myeloma jnj.com ↗ |
| 2020-05-01 | Halozyme Therapeutics | Regulatory Halozyme Announces Janssen Receives FDA Approval Of DARZALEX FASPRO™ Utilizing Halozyme's ENHANZE® Technology For The Treatment Of Patients With Multiple Myeloma halozyme.com ↗
Halozyme Therapeutics, Inc. (NASDAQ: HALO) today announced that its collaborator Janssen Biotech, Inc. (Janssen) has received approval from the U.S. Food and Drug Administration (FDA) for DARZALEX FASPRO™ (daratumumab hyaluronidase human- fihj). |
| 2020-02-25 | Hoffmann-La Roche | Regulatory FDA accepts Roche’s Biologics License Application for fixed-dose subcutaneous combination of Perjeta and Herceptin for HER2-positive breast cancer roche.com ↗ |
| 2020-02-25 | Halozyme Therapeutics | Regulatory Halozyme Announces FDA Has Accepted Biologics License Application For Fixed-Dose Subcutaneous Combination Of Perjeta® And Herceptin® Using Enhanze® Technology halozyme.com ↗
Halozyme Therapeutics, Inc. (NASDAQ: HALO) today announced that the U.S. Food and Drug Administration has accepted a Biologics License Application (BLA) from Genentech, a member of the Roche Group, for the fixed-dose combination of pertuzumab (Perjeta®) and trastuzumab (Herceptin®) for subcutaneous administration using Halozyme's ENHANZE® drug delivery technology in combination with intravenous (IV) chemotherapy for the treatment of eligible patients with HER2-positive breast cancer. |
| 2020-02-24 | Genentech, Inc. | Regulatory FDA Accepts Genentech’s Biologics License Application for Fixed-Dose Subcutaneous Combination of Perjeta And Herceptin For HER2-Positive Breast Cancer gene.com ↗
FDA Accepts Genentech’s Biologics License Application for Fixed-Dose Subcutaneous Combination of Perjeta And Herceptin For HER2-Positive Breast Cancer |
| 2019-12-12 | Halozyme Therapeutics | Results Data From Phase 3 Trial Evaluating Fixed-Dose Subcutaneous Combination Of Perjeta® And Herceptin® Using Halozyme's ENHANZE® Drug Delivery Technology To Be Presented At San Antonio Breast Cancer Symposium halozyme.com ↗
The FeDeriCa study met its primary endpoint, with subcutaneous administration of the FDC showing non-inferior levels of Perjeta® in the blood during a given dosing interval (Ctrough) when compared to IV administration of Perjeta®. |
| 2019-12-11 | Genentech, Inc. | Results Genentech’s Fixed-dose Subcutaneous Combination of Perjeta and Herceptin Comparable to Intravenous Formulations in People With HER2-Positive Breast Cancer gene.com ↗
Phase III FeDeriCa study showed non-inferior pharmacokinetics and comparable efficacy and safety with new fixed-dose combination when compared to intravenous formulations |
| 2019-09-13 | Halozyme Therapeutics | Results Positive Results Announced From Phase 3 Trial Evaluating Fixed-Dose Subcutaneous Combination Of Perjeta® And Herceptin® Using Halozyme's Enhanze® Drug Delivery Technology halozyme.com ↗
The study results demonstrated non-inferior levels of Perjeta® in the blood (pharmacokinetics) compared to standard intravenous (IV) infusion of Perjeta® plus Herceptin® and chemotherapy in patients with HER2-positive early breast cancer. |
| 2019-09-12 | Genentech, Inc. | Results Genentech’s Fixed Dose Subcutaneous Combination of Perjeta And Herceptin Showed Non-Inferiority When Compared to Intravenous Formulations for People With HER2-Positive Breast Cancer gene.com ↗
Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), today announced the Phase III FeDeriCa study met its primary endpoint. |
| 2019-07-12 | Janssen Research & Development, LLC | Regulatory Janssen Submits Application to U.S. FDA Seeking Approval of New DARZALEX® (daratumumab) Subcutaneous Formulation jnj.com ↗ |
| 2019-06-03 | Janssen Research & Development, LLC | Results Phase 3 COLUMBA Study Investigating a Subcutaneous Formulation of DARZALEX® (daratumumab) Showed Non-Inferiority to Intravenous Administration in Patients with Relapsed/Refractory Multiple Myeloma jnj.com ↗
The results showed non-inferior efficacy and pharmacokinetics for the SC administered formulation of DARZALEX compared to intravenous (IV) administration, the only currently approved formulation of DARZALEX (abstract #8005). |
| 2019-06-02 | Janssen Research & Development, LLC | Results Phase 3 COLUMBA Study Investigating a Subcutaneous Formulation of DARZALEX® (daratumumab) Showed Non-Inferiority to Intravenous Administration in Patients with Relapsed/Refractory Multiple Myeloma jnj.com ↗
The results showed non-inferior efficacy and pharmacokinetics for the SC administered formulation of DARZALEX compared to intravenous (IV) administration, the only currently approved formulation of DARZALEX (abstract #8005). |
| 2019-02-28 | Hoffmann-La Roche | Regulatory FDA approves Herceptin Hylecta for subcutaneous injection in certain HER2-positive breast cancers roche.com ↗
The approval of Herceptin Hylecta gives physicians and patients in the United States a new option to select treatment based on individual needs and preferences. |
| 2019-02-28 | Genentech, Inc. | Regulatory FDA Approves Herceptin Hylecta for Subcutaneous Injection in Certain HER2-Positive Breast Cancers gene.com ↗
FDA Approves Herceptin Hylecta for Subcutaneous Injection in Certain HER2-Positive Breast Cancers |
| 2019-02-28 | Halozyme Therapeutics | Regulatory Halozyme Announces FDA Approval Of Herceptin Hylecta™ halozyme.com ↗
Halozyme Therapeutics, Inc. (NASDAQ: HALO), a biotechnology company developing novel oncology and drug-delivery therapies, today announced that Genentech, a member of the Roche Group, has received approval from the U.S. Food and Drug Administration (FDA) for Herceptin Hylecta™, a subcutaneous fixed-dose combination of trastuzumab and hyaluronidase-oysk. |
| 2018-09-17 | Halozyme Therapeutics | Regulatory Halozyme Announces Approval Of Subcutaneous Formulation Of Trastuzumab (Herceptin®) In Canada halozyme.com ↗
Halozyme Therapeutics, Inc. (NASDAQ: HALO) today announced that Roche has received approval from Health Canada for a subcutaneous (SC) formulation of trastuzumab (Herceptin SC) for the treatment of patients with HER2-positive breast cancer. |
| 2018-07-11 | Halozyme Therapeutics | Regulatory FDA Accepts Biologics License Application For Subcutaneous Formulation Of Herceptin halozyme.com ↗ |
| 2017-06-23 | Hoffmann-La Roche | Regulatory FDA approves Rituxan Hycela (rituximab and hyaluronidase human) for subcutaneous injection in certain blood cancers roche.com ↗ |
| 2017-06-22 | Halozyme Therapeutics | Regulatory FDA Approves Genentech's RITUXAN HYCELA, A Subcutaneous Rituximab Coformulated With Halozyme ENHANZE Technology halozyme.com ↗
RITUXAN HYCELA has been approved for patients with follicular lymphoma, diffuse large B-cell lymphoma and chronic lymphocytic leukemia, and is expected to be available within one to two weeks. |
| 2017-03-29 | Genentech, Inc. | Regulatory FDA Advisory Committee Unanimously Recommends Approval of Genentech’s Subcutaneous Rituximab for Certain Blood Cancers gene.com ↗
FDA Advisory Committee Unanimously Recommends Approval of Genentech’s Subcutaneous Rituximab for Certain Blood Cancers |
| 2017-03-29 | Halozyme Therapeutics | Regulatory FDA Advisory Committee Provides Unanimous Recommendation For Subcutaneous Rituximab Coformulated With Halozyme Enhanze Technology halozyme.com ↗
an Oncologic Drug Advisory Committee of the U.S. Food and Drug Administration voted 11 to 0 that the benefit/risk of rituximab/hyaluronidase for subcutaneous (under the skin) injection was favorable |
| 2016-11-21 | Halozyme Therapeutics | Results Halozyme Provides Update On AbbVie Collaboration halozyme.com ↗
Halozyme Therapeutics, Inc. (NASDAQ: HALO) today announced that AbbVie has discontinued a development program using the Halozyme ENHANZE™ platform technology and the tumor necrosis factor alpha (TNF-alpha) target following completion of a phase 1 study in which the target results were not achieved. |
| 2016-11-03 | Hoffmann-La Roche | Regulatory Roche showcases new clinical data across a variety of blood diseases at American Society of Hematology 2016 Annual Meeting roche.com ↗
US FDA has accepted the Biologics License Application for a subcutaneous formulation of Rituxan®(rituximab/hyaluronidase) |
| 2016-11-03 | Genentech, Inc. | Regulatory Genentech Showcases New Clinical Data Across a Variety of Blood Diseases at American Society of Hematology 2016 Annual Meeting gene.com ↗
FDA has accepted the Biologics License Application for a subcutaneous formulation of Rituxan® (rituximab/hyaluronidase) |
| 2016-11-03 | Halozyme Therapeutics | Regulatory FDA Accepts Genentech's Biologics License Application For Subcutaneous Formulation Of Rituximab halozyme.com ↗
Halozyme Therapeutics, Inc. (NASDAQ: HALO) today announced that the U.S. Food and Drug Administration (FDA) has accepted Genentech's Biologics License Application for a subcutaneous formulation of rituximab in multiple blood cancer indications. |
| 2015-06-22 | Amphastar Pharmaceuticals, Inc. | Regulatory Amphastar Pharmaceuticals Receives Approval for AMPHADASE(R) Supplement, Marking the First Product From Its China Facility amphastar.com ↗
Amphastar Pharmaceuticals, Inc. (Nasdaq:AMPH) ("Amphastar" or the "Company") announced today that the U.S. Food and Drug Administration ("FDA") granted approval of the Company's New Drug Application ("NDA") supplement for Amphadase ® (hyaluronidase injection). |
| 2014-10-20 | Halozyme Therapeutics | Regulatory Halozyme Receives FDA Approval For Additional Manufacturing Facilities For Hylenex® Recombinant halozyme.com ↗
The FDA approved the use of the Cook Pharmica manufacturing facility in Bloomington, Indiana for the production of bulk rHuPH20, the active ingredient used in Hylenex, and the Patheon® facility in Greenville, North Carolina, for production of finished Hylenex product. |
| 2014-09-12 | Halozyme Therapeutics | Regulatory FDA Approves Baxter’s HYQVIA for Treatment of Adults with Primary Immunodeficiency halozyme.com ↗ |
| 2014-07-31 | Halozyme Therapeutics | Regulatory FDA Advisory Committee Panel Provides Favorable Recommendation on Baxter’s HyQvia for Primary Immunodeficiency halozyme.com ↗
Baxter International Inc. (NYSE:BAX) and Halozyme Therapeutics, Inc., (NASDAQ:HALO) today announced that the Blood Products Advisory Committee (BPAC) of the U.S. Food and Drug Administration (FDA) voted 15-1 that HyQvia [Immune Globulin Infusion 10% (Human) with Recombinant Human Hyaluronidase], Baxter’s investigational subcutaneous treatment for patients with primary immunodeficiency (PI), has a favorable risk/benefit profile. |
| 2014-06-15 | Halozyme Therapeutics | Results Halozyme Announces Presentation Of Clinical Data At The American Diabetes Association 74th Scientific Sessions halozyme.com ↗
Data reported in the presentation show that the study's primary endpoint of non-inferiority for A1C at six months between the use of Hylenex and the new formulation of Hylenex in comparison to no pre-treatment was met. |
| 2014-05-21 | Halozyme Therapeutics | Regulatory Baxter Provides U.S. Regulatory Update on HyQvia, Its Investigational Subcutaneous Treatment for Primary Immunodeficiency halozyme.com ↗
The PDUFA date has been extended by three months, which is the standard extension period. |
| 2014-03-31 | Halozyme Therapeutics | Results Halozyme Announces that Consistent 1 Trial Of Hylenex® Recombinant Met Primary Endpoint halozyme.com ↗
Halozyme Therapeutics, Inc. (NASDAQ: HALO) today announced that the primary endpoint of non-inferiority of A1C levels at six months was met for the CONSISTENT 1 trial. |
| 2014-01-24 | Halozyme Therapeutics | Regulatory Halozyme Announces Positive Opinion From CHMP For European Approval Of Roche's MabThera SC halozyme.com ↗ |
| 2013-12-02 | Halozyme Therapeutics | Regulatory Baxter Submits Amended BLA to U.S. FDA for HyQvia for Primary Immunodeficiency halozyme.com ↗ |
| 2013-09-02 | Halozyme Therapeutics | Regulatory Halozyme Announces Roche Receives Marketing Authorization for Herceptin SC in European Union halozyme.com ↗
Halozyme Therapeutics, Inc. (NASDAQ: HALO) announced today that the European Commission has granted Roche European Union (EU) marketing authorization for the use of a time-saving subcutaneous (SC) formulation of Herceptin® (trastuzumab) for the treatment of HER2-positive breast cancer. |
| 2013-08-01 | Halozyme Therapeutics | Results Halozyme Provides Update on ViroPharma Phase 2 Trial of Subcutaneous Cinryze (C1 Esterase Inhibitor [Human]) Formulation with rHuPH20 halozyme.com ↗
The discontinuation of the study is a precaution related to the emergence of an unexpected incidence and titer of non-neutralizing anti-rHuPH20 antibodies in a number of patients with the formulation being used in this study. |
| 2013-06-28 | Halozyme Therapeutics | Regulatory Halozyme Announces Positive Opinion from CHMP On Roche's Herceptin SC for European Approval halozyme.com ↗ |
| 2013-05-21 | Halozyme Therapeutics | Regulatory Baxter Receives Marketing Authorization for HyQvia in European Union halozyme.com ↗ |
| 2013-03-22 | Halozyme Therapeutics | Regulatory Baxter And Halozyme Announce Positive Opinion For HyQvia For Treatment Of Primary And Secondary Immunodeficiencies In The European Union halozyme.com ↗ |
| 2012-12-08 | Halozyme Therapeutics | Regulatory Halozyme Announced Roche Filed A Marketing Authorization Application For Subcutaneous MabThera halozyme.com ↗
Halozyme Therapeutics, Inc. (NASDAQ: HALO) today announced that Roche has submitted a line extension application to the European Medicines Agency for a subcutaneous (SC) formulation of MabThera® (rituxumab). |
| 2012-09-21 | Halozyme Therapeutics | Regulatory ViroPharma And Halozyme Provide Update On Clinical Development Of Subcutaneous Cinryze® (C1 Esterase Inhibitor [Human]) With Recombinant Human Hyaluronidase (rHuPH20) halozyme.com ↗
ViroPharma Incorporated (Nasdaq: VPHM) and Halozyme Therapeutics, Inc. (Nasdaq: HALO) announced today that the U.S. Food & Drug Administration (FDA) has provided guidance enabling ViroPharma to resume clinical studies of the subcutaneous administration of Cinryze in combination with rHuPH20. |
| 2012-08-01 | Halozyme Therapeutics | Regulatory Halozyme Confirms Baxter Has Received A Complete Response Letter For HyQ BLA halozyme.com ↗
Halozyme Therapeutics, Inc. (NASDAQ: HALO) today announced that the Center for Biologics Evaluation and Research (CBER) of the U.S. Food and Drug Administration (FDA) has issued a complete response letter (CRL) for Baxter's HyQ Biologics License Application (BLA). |
| 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 ↗
Further, data from the study indicated that rHuPH20 reduced postprandial glycemic excursions, as well as significantly reduced hypoglycemic events. |
| 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 ↗
Halozyme Therapeutics, Inc. (NASDAQ: HALO) today presented results from a Phase 4 study of Hylenex® recombinant (hyaluronidase human injection) in sensor augmented insulin analog pump (SAP) therapy in patients living with Type 1 diabetes. |
| 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). |
| 2012-04-16 | Halozyme Therapeutics | Regulatory Baxter and Halozyme Provide Update on HyQ Biologics License Application halozyme.com ↗
Baxter International Inc. (NYSE: BAX) and Halozyme Therapeutics, Inc. (NASDAQ: HALO) today announced that the U.S. Food and Drug Administration (FDA) is requesting additional information to complete its review of the HyQ Biologics License Application (BLA). |
| 2012-03-06 | Halozyme Therapeutics | Results ViroPharma and Halozyme Announce Positive Data of Subcutaneous Cinryze® (C1 esterase inhibitor [human]) with Recombinant Human Hyaluronidase (rHuPH20) halozyme.com ↗
According to the presenters, these data demonstrate that subcutaneous co-administration of Cinryze with rHuPH20 was easy to administer, well tolerated and resulted in sustained physiologically relevant C1 INH functional concentrations. |
| 2011-12-06 | Halozyme Therapeutics | Results ViroPharma and Halozyme Therapeutics Announce Positive Data From Initial Phase 2 Assessment of Subcutaneous Cinryze® (C1 esterase inhibitor [human]) with Hyaluronidase (rHuPH20) halozyme.com ↗
In this study, the addition of rHuPH20 led to higher maximum levels and greater systemic exposure of functional and antigenic C1 inhibitor (C1 INH) for both Cinryze doses evaluated (1000 and 2000 units) as compared to subcutaneous administration of Cinryze alone. |
| 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. |
| 2011-10-18 | Halozyme Therapeutics | Results Halozyme Announces Positive Results from Roche's Subcutaneous Herceptin Phase 3 Trial halozyme.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). |
| 2011-04-14 | 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. |
| 2010-11-12 | 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. |
| 2010-10-06 | Halozyme Therapeutics | Results Baxter Presents Data from Interim Analyses of Phase III Clinical Trial of HyQ at European Society for Immunodeficiencies Meeting halozyme.com ↗
The interim data showed that 28 out of 29 HyQ treated study participants were able to infuse IG under the skin at infusion volumes, intervals and rates equivalent to their previous intravenous administration of IG. |
| 2010-06-28 | Halozyme Therapeutics | Results Coinjection of Halozyme's rHuPH20 Enzyme Accelerates the Absorption and Action of Mealtime Insulin Analogs halozyme.com ↗ |
| 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 ↗
today announced Phase 2 results demonstrating that the subcutaneous coinjection of rHuPH20 (recombinant human hyaluronidase, PH20) with lispro significantly improves postprandial hyperglycemia, reduces hypoglycemia, and accelerates the absorption of mealtime insulin in patients with type 2 diabetes. |
| 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. |
| 2009-10-05 | Halozyme Therapeutics | Results Baxter Announces the Commercial Launch of HYLENEX at ACEP for Use in Pediatric Rehydration halozyme.com ↗
This approach was found to be effective, easy to use and well-tolerated. |
| 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 ↗
Halozyme Therapeutics, Inc. (Nasdaq: HALO) today announced additional Phase 2 results that demonstrated faster insulin absorption and increased peak insulin concentrations in type 1 diabetic patients after co-administration of its recombinant hyaluronidase enzyme (rHuPH20 or PH20) with Humulin® R (regular human insulin), a mealtime insulin. |
| 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 ↗
Halozyme Therapeutics, Inc. (Nasdaq: HALO) today announced Phase 2 results that demonstrated faster insulin absorption and increased peak insulin concentrations in type 1 diabetic patients after co-administration of its recombinant hyaluronidase enzyme (PH20) with Humalog® (insulin lispro), a mealtime insulin analog. |
| 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. |
| 2008-07-22 | Halozyme Therapeutics | Results Halozyme Therapeutics Announces Positive Findings With Pegylated Enzyme in Prostate Cancer Models halozyme.com ↗
The study showed that treatment of hormone resistant human prostate cancer in tumor bearing mouse models with intravenous PEGPH20 in combination with the chemotherapeutic drugs, docetaxel (Taxotere(R)) or liposomal doxorubicin (Doxil(R)) resulted in a substantial increase in anti-tumor activity. |
| 2008-06-30 | Halozyme Therapeutics | Results Halozyme Therapeutics Announces That Chemophase Meets Primary Endpoint in Phase I/IIa Clinical Trial halozyme.com ↗
The study reported no dose-limiting toxicities and no observed side effects attributable to the enzyme, and established the dose for subsequent clinical trials, therefore achieving the pre-defined primary objective of the study. |
| 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 |
| 2008-04-16 | Halozyme Therapeutics | Results Halozyme Therapeutics Presents Findings on Combinations of rHuPH20 Enzyme With Bisphosphonates at the American Association for Cancer Research Conference halozyme.com ↗
In rodent intradermal models, the maximal concentration of bisphosphonates that could be administered without producing ISRs was increased 3- to 5-fold when co-administered in combination with rHuPH20. |
| 2008-04-15 | Halozyme Therapeutics | Results Halozyme Therapeutics Presents Pre-Clinical Studies of Systemic Delivery of Pegylated rHuPH20 Enyzme in Prostate Cancer Models at American Association for Cancer Research Conference halozyme.com ↗
PEGrHuPH20 significantly reduced tumor IFP in a dose dependent fashion, achieving more than 85% reduction in IFP following IV administration. |
| 2008-03-10 | Halozyme Therapeutics | Results Halozyme Therapeutics Presents Favorable New Safety and Pharmacokinetic Data on rHuPH20 Enzyme Produced Via New Manufacturing Process at European Federation for Pharmaceutical Sciences halozyme.com ↗
Halozyme Therapeutics, Inc. (Nasdaq: HALO), a biopharmaceutical company developing and commercializing products based on the extracellular matrix, today announced new safety and pharmacokinetic data from a second generation manufacturing process for its recombinant human PH20 enzyme (rHuPH20). |
| 2008-01-08 | Halozyme Therapeutics | Results Halozyme Therapeutics Announces Peer-Reviewed Publications of the INFUSE-LR Clinical Trial Results and Clinical Practice Experience With Hylenex halozyme.com ↗
The authors of this publication concluded from this volunteer subject study that clinically relevant fluid volumes can be rapidly delivered subcutaneously (Sub-Q) with HYLENEX in a well-tolerated manner without the need for an infusion pump. |
| 2007-07-09 | Halozyme Therapeutics | Results Halozyme Therapeutics' Enhanze Technology Large Protein Molecule Therapeutic Clinical Trial Results Presented at the 34th Annual Meeting of the Controlled Release Society halozyme.com ↗
Co-Injection of rHuPH20 with HUMIRA(R) Estimated to Increase the Maximal Steady State Subcutaneous Bioavailability from 64% to 100% |
| 2007-01-22 | Halozyme Therapeutics | Results Halozyme Therapeutics Releases Results of Enhanze Technology Clinical Trial to Improve the Subcutaneous Absorption of a Large Protein Molecule Therapeutic halozyme.com ↗
The data from this clinical trial support the study hypothesis that rHuPH20 increases the relative bioavailability of the LPMT: |
All press releases naming this drug 272 releases
| Date | Issuer | Release |
|---|---|---|
| Show all 272 releases opens the full record — a long page | ||
Evidence & citations 17 cited values
Every value below carries the sentence it was read from. 72 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | rhuph20 | “Daratumumab 1800 mg co-formulated with rHuPH20 (2000 U/mL) and administered subcutaneously once weekly for Cycles 1 and 2, once every 2 weeks for Cycles 3 to 6, and then once...” NCT03837509 ↗46“Participants in cohort 1a will receive amivantamab admixed with rHuPH20 (Ami-LC-MD) subcutaneous (SC) infusion and participants in cohort 1b will receive amivantamab (Ami-LC)...” NCT04606381 ↗ “Study Medications Hylenex recombinant (hyaluronidase human injection); rHuPH20 (Hylenex is a registered trademark of Baxter International, Inc. or its subsidiaries)” NCT00311519 ↗ “Participants will receive 1800 mg daratumumab with 30,000 U (2000 U/mL) rHuPH20 SC injection once weekly for the first 8 weeks” NCT03242889 ↗ “The investigational medication to be studied is an enzyme called ChemophaseTM (recombinant human hyaluronidase, rHuPH20).” NCT00318643 ↗ “Rivipansel administered as a single dose subcutaneously with rHuPH20 in cross-over fashion.” NCT02217917 ↗ “Subcutaneous injection of efgartigimod coformulated with rHuPH20, a permeation enhancer” NCT05523167 ↗ “recombinant human hyaluronidase (rhuph20, Pf 06744547)” NCT02667223 ↗ “daratumumab 1800 mg with rHuPH20 30,000 units” NCT04070378 ↗ “Drug: ENHANZE (rHuPH20)” NCT04311710 ↗ “Drug: rHuPH20” NCT03972306 ↗ |
| Known as | Chemophase | ClinicalTrials.gov intervention name — accepted as the source's own label NCT00318643 ↗ |
| Known as | ChemophaseTM | “The investigational medication to be studied is an enzyme called ChemophaseTM (recombinant human hyaluronidase, rHuPH20).” NCT00318643 ↗ |
| Known as | ENHANZE | ClinicalTrials.gov intervention name — accepted as the source's own label NCT04311710 ↗ |
| Known as | human recombinant hyaluronidase | “morphine administered subcutaneously (SC) with and without human recombinant hyaluronidase (HYLENEX) and intravenously” NCT00593281 ↗ |
| Known as | Hyaluronidase Human | ClinicalTrials.gov intervention name — accepted as the source's own label NCT05886036 ↗ |
| Known as | hyaluronidase human injection | “Study Medications Hylenex recombinant (hyaluronidase human injection); rHuPH20 (Hylenex is a registered trademark of Baxter International, Inc. or its subsidiaries)” NCT00311519 ↗ |
| Known as | Hyaluronidase-Fihj | “-Subcutaneous daratumumab and hyaluronidase-fihj” NCT04150692 ↗ |
| Known as | Hyaluronidase-zzxf | “Pertuzumab, Trastuzumab, and Hyaluronidase-zzxf” NCT05415215 ↗ |
| Known as | HYLENEX | “morphine administered subcutaneously (SC) with and without human recombinant hyaluronidase (HYLENEX) and intravenously” NCT00593281 ↗ |
| Known as | Hylenex recombinant | “Study Medications Hylenex recombinant (hyaluronidase human injection); rHuPH20 (Hylenex is a registered trademark of Baxter International, Inc. or its subsidiaries)” NCT00311519 ↗3“Ondansetron solution (4 mg) single administration + Hylenex recombinant (150 U) single administration” NCT01572012 ↗ “Hylenex recombinant (for short, Hylenex) in subcutaneous (SC) injection” NCT00547664 ↗ “Recombinant DNA-based hyaluronidase (RDNAH/Hylenex recombinant)” NCT02654522 ↗ |
| Known as | Pf 06744547 | “A Phase 1, Randomized, Double Blind, Sponsor Open, Placebo Controlled, Single And Multiple Ascending Dose Study To Evaluate The Safety, Tolerability, And Pharmacokinetics Of...” NCT02217917 ↗1“recombinant human hyaluronidase (rhuph20, Pf 06744547)” NCT02667223 ↗ |
| Known as | RDNAH | “Recombinant DNA-based hyaluronidase (RDNAH/Hylenex recombinant)” NCT02654522 ↗ |
| Known as | recombinant human hyaluronidase | “The investigational medication to be studied is an enzyme called ChemophaseTM (recombinant human hyaluronidase, rHuPH20).” NCT00318643 ↗3“with Recombinant Human Hyaluronidase \[rHuPH20\] 30,000 units \[U\]” NCT03242889 ↗ “recombinant human hyaluronidase (rhuph20, Pf 06744547)” NCT02667223 ↗ “recombinant human hyaluronidase (rHuPH20)” NCT03662334 ↗ |
| Known as | recombinant human hyaluronidase PH20 | “part 1, 20 mg/kg SC + recombinant human hyaluronidase PH20 [rHuPH20] 2,000 U/mL; part 2, 60 mg/kg IV; part 3, 3,000 mg SC + rHuPH20 2,000 U/mL” PMID 40698814 ↗ Jul 20254“Recombinant human hyaluronidase PH20 (rHuPH20) is the active ingredient of the investigational ENHANZE™ Drug Product (EDP).” NCT03538626 ↗ “daratumumab co-formulated with recombinant human hyaluronidase PH20” PMID 32915384 ↗ Sep 2020 “Recombinant Human Hyaluronidase PH20 (rHuPH20)” NCT05418868 ↗ “recombinant human hyaluronidase PH20 (rHuPH20)” NCT04073589 ↗ |
| Modality | Protein / enzyme biologic | “an enzyme called hyaluronidase, and is a human recombinant form of the enzyme” NCT00311519 ↗ |
| Route | Subcutaneous | “Each subject will receive a SC infusion” NCT00311519 ↗ |