NDA
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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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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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…
Read More 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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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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– 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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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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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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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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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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