Indivior selected GABA B PAM drug candidate for development in substance use disorders (SUD) and starts IND enabling studies Ad Hoc Announcement Pursuant to Art. 53 LR Geneva, Switzerland, November 22, 2024 - Addex Therapeutics (SIX/NASDAQ: ADXN), a clinical-stage biopharmaceutical company focused on developing a portfolio of novel small molecule allosteric modulators for neurological disorders, today reported its third quarter financial results for the periods ended September 30, 2024, and pr

AstraZeneca's bid to convert its anticoagulant reversal drug Andexxa (andexanet alfa) from accelerated to full approval faces headwinds after an FDA advisory committee raised safety and efficacy concerns during a meeting Thursday.The panel discussed data from ANNEXA-I, AstraZeneca's confirmatory trial that was stopped early last year after achieving superior haemostatic efficacy, the ability to limit the expansion of a potentially life-threatening bleed in the brain, versus usual care.However, F

Neurogene disclosed in a filing with the US Securities and Exchange Commission that a patient who suffered a serious adverse event (AE) in an ongoing Phase I/II study of its gene therapy for Rett syndrome has now died. The company first said last week that a participant given the higher 3E15 vg dose of NGN-401 had experienced a treatment-related serious AE described as "consistent with known risks of AAV gene therapy." The issue clouded promising efficacy seen in the low-dose group (for related

Fresh off its recent FDA nod of Tremfya (guselkumab) for ulcerative colitis using an intravenous induction regimen, Johnson & Johnson has now filed for approval of a subcutaneous (SC) induction option, which could make it the first IL-23 inhibitor to offer both administration methods.The submission is supported by the Phase III ASTRO study, which demonstrated statistically significant clinical remission at week 12 using a 400-mg SC induction dose administered at weeks 0, 4, and 8. The trial also

The floodgates for AI-enabled protein design burst open in 2024, with the Institute for Protein Design's David Baker claiming a Nobel Prize in chemistry for his foundational work, and DeepMind's unveiling of AlphaFold 3 to predict protein structures and interactions with  "unprecedented accuracy" (see – ViewPoints: Madrona's Chris Picardo on the AI-biotech convergence and ViewPoints: Expert expounds on potential for AlphaFold 3 to revolutionise research, democratise drug discovery).The year has

Halozyme Therapeutics has pulled its €2-billion ($2.1 billion) acquisition proposal for Evotec after multiple failed attempts to engage the German company's leadership in meaningful discussions about a potential merger. The withdrawal comes a week after Halozyme's unsolicited €11-per-share cash offer, which initially drove Evotec's stock price up by 23%.CEO Helen Torley cited Evotec's consistent unwillingness to explore the proposed combination. Despite initial informal discussions with a superv

Lexicon Pharmaceuticals' diabetes hopeful Zynquista (sotagliflozin) has once again been shot down by the FDA — and this time, the drug developer is waving the white flag. The firm disclosed Friday that it has received a "deficiencies preclude discussion" letter from the FDA pointing out issues with its regulatory application that prevent any conversations regarding labelling for the drug, and/or post-marketing requirements.In light of the setback, Lexicon is closing down all commercialisation ac

— Launch follows approval by Japanese Ministry of Health, Labour and Welfare in September 2024 — — Milestone payment to be made to HUTCHMED from Takeda — — Fruquintinib already launched in several regions including the United States, Europe and China — HONG KONG, SHANGHAI & FLORHAM PARK, N.J., Nov. 21, 2024 (GLOBE NEWSWIRE) -- HUTCHMED (China) Limited (“HUTCHMED”) (Nasdaq/AIM:HCM; HKEX:13) today announces that it will receive a milestone payment following the pricing approval and laun

ROCKVILLE, Md. and SUZHOU, China, Nov. 21, 2024 /PRNewswire/ -- Ascentage Pharma (6855.HK), a global biopharmaceutical company engaged in discovering, developing and commercializing therapies to address global unmet medical needs primarily for malignancies, announced today that findings from a phase Ib multicenter clinical trial (NCT04260022) of its third-generation BCR-ABL1 tyrosine kinase inhibitor (TKI) have been published in the November 2024 issue of JAMA Oncology, marking a milestone in gl

Halozyme Therapeutics announced today that it has withdrawn its non-binding proposal to acquire Evotec. The $11.45 (€11.00) per share cash offer, which valued Evotec at approximately $2.8 billion (€2 billion), was rescinded after Evotec's management and supervisory boards declined to engage in discussions regarding the potential transaction. Helen Torley, Halozyme's president and CEO, expressed disappointment in a statement, emphasizing the strategic benefits of a merger. "We continue to believe