U.S. Food and Drug Administration approves CSL’s HEMGENIX® (etranacogene dezaparvovec-drlb), the first gene therapy for hemophilia B


KING OF PRUSSIA, PA, USA This historic approval provides a new treatment option that reduces the rate of annual bleeds, reduces or eliminates the need for prophylactic therapy and generates elevated and sustained factor IX levels for years after a one-time infusion. Excerpt from the Press Release: This historic approval provides a new treatment option…

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Varian Announces First Participant Treated in GENESIS II Clinical Trial of Genicular Artery Embolization for Knee Osteoarthritis


Excerpt from the Press Release: PALO ALTO, Calif., Nov. 17, 2022 /PRNewswire/ — Varian, a Siemens Healthineers company, announced today that the first trial participant has been treated as part of GENESIS II (Genicular artEry embolisatioN in patiEnts with oSteoarthrItiS of the knee), a study of Embozene® microspheres for genicular artery embolization (GAE) as treatment of…

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Merrimack Provides Ipsen Report That Onivyde® Regimen Demonstrated Statistically Significant Improvement in Overall Survival in Previously Untreated Metastatic Pancreatic Ductal Adenocarcinoma


Excerpt from the Press Release: CAMBRIDGE, Mass.–(BUSINESS WIRE)–Merrimack Pharmaceuticals, Inc. (Nasdaq: MACK) [(“Merrimack” or the “Company”)] announced that Ipsen, SA (“Ipsen”) issued a press release today reporting its primary analysis of the results of its Phase III NAPOLI 3 trial of Onivyde® (irinotecan liposome injection) plus 5 fluorouracil/leucovorin and oxaliplatin (NALIRIFOX regimen) as a treatment…

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Aulos Bioscience Presents Initial Data From First-in-Human Phase 1/2 Clinical Trial of Computationally Designed Antibody AU-007 at 37th Society for Immunotherapy of Cancer (SITC) Annual Meeting


Data show trend in decreasing Tregs, presenting unique profile among current IL-2 therapeutics Adding Phase 1/2 clinical trial sites in the U.S. following recent IND application clearance Excerpt from the Press Release: LARKSPUR, Calif.–(BUSINESS WIRE)–Aulos Bioscience, an immuno-oncology company working to revolutionize cancer care through the development of potentially best-in-class IL-2 therapeutics, today presented early…

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Inozyme Pharma Announces First Self-Administration of INZ-701 in Ongoing ENPP1 Deficiency Phase 1/2 Clinical Trial


Excerpt from the Press Release: BOSTON, Nov. 03, 2022 (GLOBE NEWSWIRE) — Inozyme Pharma, Inc. (Nasdaq: INZY), a clinical-stage rare disease biopharmaceutical company developing novel therapeutics for the treatment of pathologic mineralization and intimal proliferation, today announced the first self-administration of INZ-701 in the open-label Phase 2 extension portion of the ongoing Phase 1/2 clinical…

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Rain Therapeutics Provides Interim Analysis of Phase 2 Basket Trial of Milademetan for MDM2-Amplified Advanced Solid Tumors (MANTRA-2)


– Two patients exhibited an unconfirmed partial response at their first scan, and two additional patients saw promising tumor regression activity out of ten efficacy evaluable patients, demonstrating monotherapy activity of milademetan in MDM2-amplified patients – – Drug safety profile of milademetan preliminarily consistent with prior Phase 1 trial – – Protocol amendment planned to…

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Nevro Announces FDA Approval of HFX iQ™ Spinal Cord Stimulation System to Personalize the Treatment of Chronic Pain


Next Generation Senza® HFX iQ™ is the First and Only SCS System that Uses Artificial Intelligence to Optimize and Maintain Pain Relief Using Each Patient’s Response Excerpt from the Press Release: REDWOOD CITY, Calif., Oct. 12, 2022 /PRNewswire/ — Nevro Corp. (NYSE: NVRO), a global medical device company that is delivering comprehensive, life-changing solutions for the…

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BMF-219 Enters the Clinic for KRAS Solid Tumors


Biomea Fusion announces FDA clearance of Investigational New Drug (IND) application for covalent menin inhibitor BMF-219 in KRAS solid tumors. Biomea Fusion will now initiate a Phase I/Ib clinical trial (COVALENT-102) of BMF-219 as a monotherapy in patients who have unresectable, locally advanced, or metastatic non-small cell lung cancer (NSCLC), colorectal cancer (CRC) or pancreatic…

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Lyell Immunopharma Announces FDA Clearance of its IND for LYL845, a TIL Product Candidate Enhanced with its Novel Epigenetic Reprogramming Technology for Solid Tumors


Autologous TIL therapy enhanced with Lyell’s Epi-R™ reprogramming technology designed to create polyclonal T cell populations with properties of durable stemness and improved function Phase 1 trial to initially enroll patients with relapsed and/or refractory metastatic or locally advanced melanoma and subsequently expand into non-small cell lung cancer and colorectal cancer Initial data presentation expected…

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Annovis Bio Announces FDA Authorization to Proceed with Phase 2/3 Trial for Buntanetap in Alzheimer’s Disease


Excerpt from the Press Release: BERWYN, Pa., Oct. 6, 2022 /PRNewswire/ — Annovis Bio, Inc. (NYSE: ANVS) (“Annovis” or the “Company”), a late-stage clinical drug platform company addressing neurodegenerative diseases, announced today that the U.S. Food and Drug Administration (FDA) has authorized the Phase 2/3 clinical study of buntanetap in moderate Alzheimer’s Disease (AD). Following the…

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