The SMART study supplements a growing body of evidence on the use of Zolgensma in a patient population older and heavier (1.5 – 9.1 years of age) than the children treated in previous clinical studies 1-6 Nearly all patients treated maintained or improved motor milestones after 52 weeks, with most switching to the one-time gene therapy from another chronically administered disease-modifying therapy 1-6 The SMART study is the first open-label clinical study of Zolgensma to include previously trea

Feb. 29, 2024 -- Achieve Life Sciences, Inc. (Nasdaq: ACHV), a late-stage pharmaceutical company committed to the global development and commercialization of cytisinicline for smoking cessation and nicotine dependence, today announced that it has reached agreement with the U.S. Food and Drug Administration (FDA) on the adequacy and timing of long-term cytisinicline exposure data requirements for a New Drug Application (NDA). During pre-NDA discussions held in the fourth quarter of 2023, the FDA

Feb. 26, 2024 -- Bitterroot Bio, a leader in innovative treatments for cardiovascular diseases, and Biotheus, a pioneer in monoclonal and multi-specific antibody design, today announced a multi-year research collaboration agreement. This partnership will explore innovative approaches to modulate the immune system and regulate inflammatory responses, which play key roles in the progression of a wide range of cardiovascular diseases. This collaboration combines Bitterroot Bio's expertise in card

Immunocore announces clinical trial collaboration and supply agreement with Bristol Myers Squibb to evaluate IMC-F106C (PRAME HLA-A02) in combination with nivolumab in its registrational Phase 3 first-line advanced cutaneous melanoma trial IMC-F106C is Immunocore’s first-in-class bispecific TCR ImmTAC candidate targeting PRAME HLA-A02; nivolumab is manufactured by Bristol Myers Squibb The clinical trial collaboration relates to Immunocore’s PRISM-MEL-301 registrational Phase 3 clinical trial in

Committee for Medicinal Products for Human Use (CHMP) recommends approval of the conditional marketing authorization (CMA) for sparsentan for the treatment of IgA nephropathy (IgAN) in Europe Positive CHMP opinion is based on pivotal Phase 3 PROTECT Study results European Commission decision is expected in Q2 2024 Feb. 23, 2024 -- Travere Therapeutics, Inc., (NASDAQ: TVTX) and CSL Vifor today announced that the European Medicines Agency’s (EMA) CHMP has recommended approval of sparsentan for th

Baxter to act as exclusive partner to Spectral for 10 years following PMX approval by U.S. FDA Feb. 21, 2024 -- Spectral Medical Inc. (“Spectral” or the “Company”) (TSX: EDT), a late-stage theranostic company advancing therapeutic options for sepsis and septic shock, is pleased to announce an extension to its supply and distribution agreement (the “Amended Agreement”) with Baxter Healthcare Corporation, a subsidiary of Baxter International Inc. (“Baxter”) (NYSE: BAX), originally entered into in

Feb. 20, 2024 -- Evaxion Biotech A/S (NASDAQ: EVAX) ("Evaxion" or the "Company"), a clinical-stage TechBio company specializing in developing AI-Immunology™ powered vaccines, announces the successful completion of the initial phases of its vaccine collaboration with MSD (tradename of Merck & Co., Inc., Rahway, NJ, USA). The vaccine development project combines both organizations' unique capabilities and know-how. Evaxion's Chief Executive Officer Christian Kanstrup expresses enthusiasm, "In Se

Feb. 13, 2024 -- Shattuck Labs, Inc. (Shattuck) (NASDAQ: STTK), a clinical-stage biotechnology company pioneering the development of bifunctional fusion proteins as a new class of biologic medicine for the treatment of patients with cancer and autoimmune disease, today announces a worldwide drug discovery collaboration with Ono Pharmaceutical Co., Ltd. (Ono), to generate novel bifunctional fusion proteins targeting certain pathways in autoimmune and inflammatory diseases. Under the terms of t

One of the largest pharmacy benefit management (PBM) companies in the United States has added VOQUEZNA (vonoprazan) tablets to its national formularies for commercial plans, effective immediately Feb. 13, 2024 -- Phathom Pharmaceuticals, Inc. (Nasdaq: PHAT), a biopharmaceutical company focused on developing and commercializing novel treatments for gastrointestinal diseases, today announced the placement of VOQUEZNA® (vonoprazan) tablets for the treatment of adults with Erosive Esophagitis, comm

Feb. 12, 2024 -- Freeline Therapeutics Holdings plc (Nasdaq: FRLN) (“Freeline”) and Syncona Ltd (“Syncona”) today announced that Freeline’s shareholders have approved the proposal for Bidco 1354 Limited (“Bidco”), a wholly owned subsidiary of Syncona Portfolio Limited (“Syncona Portfolio”), to acquire all shares of Freeline not currently owned by Syncona Portfolio for $6.50 per American Depositary Share (“ADS”) in cash (the “Acquisition”). As previously announced, Freeline and Bidco entered int