DUBLIN – The EMA has rejected Biogen Inc.’s application for European Union approval of Aduhelm (aducanumab), its controversial Alzheimer’s disease drug. Its human medicines committee (CHMP) issued a negative opinion on Biogen’s dossier during its December meeting this week, stating that the data from the key studies submitted in support of the application “were conflicting and did not show overall that Aduhelm was effective at treating adults with early stage Alzheimer’s disease.” Read More
Genfit SA’s global development and commercialization deal with Ipsen Pharma SA for phase III-stage elafibranor in primary biliary cholangitis (PBC) – plus a separate arrangement for rights to an asset earlier in development from Genoscience Pharma SA – represent “the logical next steps in the implementation of a strategy that we outlined to you about 18 months ago,” Genfit CEO Pascal Prigent said during a conference call with investors. Read More
LONDON – Metabolic diseases specialist Northsea Therapeutics BV closed a $80 million series C to fund phase II development in two further indications, as it awaits the final results from the phase IIb trial of its lead product, icosabutate, in the treatment of nonalcoholic steatohepatitis (NASH), which are due at the start of 2023. Read More
Top-line data from Bellerophon Therapeutics Inc.’s phase II study of its pulsed inhaled nitric oxide technology, Inopulse, showed decreases in mean pulmonary arterial pressure and pulmonary vascular resistance (PVR) in treating pulmonary hypertension associated with sarcoidosis. Read More
Qilu Pharmaceutical Co. Ltd. licensed rights to AB-729, an RNA interference (RNAi) therapeutic from Arbutus Biopharma Corp., in a deal worth up to $300 million. Qilu obtained rights to develop and commercialize the phase II asset for the treatment of hepatitis B (HBV) in mainland China, Hong Kong, Macau, and Taiwan. Under terms of the agreement, Qilu will pay Arbutus $40 million up front, as well as up to $245 million in development, regulatory and sales milestones. In addition, Qilu will make a $15 million equity investment in Arbutus at a price of $4.19 per share. Read More
With a few weeks left in the year, the biopharma industry has raised a total of $116.18 billion through 1,506 transactions, both of which are second only to 2020. Read More
New hires and promotions in the biopharma industry, including: Chemomab, Cohbar, Coherus, Exelixis, Gritstone, Norgine, Onconano, Oncosec, Synerkine, Transcenta. Read More
New and updated preclinical and clinical data presented by biopharma firms at the American Society of Hematology annual meeting, including: Century, Forma. Read More
Biopharmas raising money in public or private financings, including: 20n Bio, Abeona, Addex, Amylyx, Bellus, Eqrx, Omega Funds, Specific Biologics. Read More
Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Advaxis, Amplyx, Biomarin, Cadila, Cassiopea, Cava, Cosmo, Hyloris, Iktos, Kineta, Lipidor, Mynd, Pfizer, Providence, Purdue, Skyline, Vaneltix, Vera. Read More
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Alvotech, BMS, Braeburn, Calliditas, Camurus, Daiichi, Innoskel, Mesoblast, Mitotech, Neuvivo, Nkarta, Novavax, Pfizer, Rakuten, Sobi, Verrica, Zai Lab. Read More
