After its $247 million acquisition of Epizyme Inc., Ipsen SA will continue to shop for M&A prospects, said Ipsen CEO David Loew, noting that “the [company’s] firepower has not been absorbed in a significant fashion by this deal,” and the firm might undertake a larger transaction next time in oncology, rare diseases, or neurology. Read More
Armed with data but no crystal ball, the U.S. FDA’s Vaccines and Related Biologic Products Advisory Committee (VRBPAC) will be asked June 28 to predict the next-generation vaccines that will be needed to best respond to the COVID-19 futurescape. While Moderna Inc., Pfizer Inc. and Novavax Inc. will briefly present clinical data for their variant vaccines at the VRBPAC meeting, the discussion will be about the future of all COVID-19 vaccines being developed or authorized for the U.S. market. Read More
New data confirming that Gilead Sciences Inc.’s Hepcludex (bulevirtide) effectively cures hepatitis delta virus (hepatitis D), one of the most severe viral infections of the liver, and favorable phase III results from Madrigal Pharmaceuticals Inc.’s nonalcoholic steatohepatitis (NASH) contender were among the highest-profile scientific announcements at the International Liver Congress (ILC) 2022.
Japan’s Ministry of Health, Labour and Welfare has given Otsuka Holdings Co. Ltd. subsidiary Taiho Pharmaceutical Co. Ltd. the green light for its oral heat shock protein 90 (HSP90) inhibitor Jeselhy (pimitespib) to treat gastrointestinal stromal tumors (GIST) that have progressed after chemotherapy. The company will soon commercialize the drug in Japan. Read More
Italfarmaco SpA will seek meetings with the U.S. FDA and the European Medicines Agency to discuss filing requirements for givinostat in Duchenne muscular dystrophy (DMD) on the strength of data from a phase III trial in which those on the drug exhibited a slower decline in their ability to climb four stairs than those on placebo. Read More
The U.S. FDA has placed a clinical hold on Astellas Pharma Inc.’s Fortis phase I/II trial evaluating AT-845 following a serious adverse event of peripheral sensory neuropathy in one of the trial participants. AT-845 is an adeno-associated virus (AAV) gene replacement therapy being studied in adults with late-onset Pompe disease. Read More
Axsome Therapeutics Inc. and the U.S. FDA appear to be working out their differences. The company said it received the proposed labeling from the agency for AXS-05 (dextromethorphan + bupropion), an oral NMDA receptor antagonist with multimodal activity, for treating major depressive disorder. Read More
As a growing roster of nations moves to protect individual genomic and other health data in the name of privacy under the General Data Protection Regulation in the EU and similar laws elsewhere, chief aggregators of such data, drug developers, are struggling. Read More
New hires and promotions in the biopharma industry, including: Amberstone, Aptose, Bright Minds, Evommune, Humacyte, Inovio, Paraza, Sling, TCR2, Valo, Zymeworks. Read More
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Akston, Biolexis, Calithera, GSK, Intellia, Regeneron, Sanofi. Read More
Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Ainos, Antengene, Artelo, Basilea, Beigene, Defence, Degron, Kuria, Merck, Redx, Scohia. Read More
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Adverum, Amryt, Argenx, Basilea, Biomarin, Croma, Cytokinetics, Daewoong, Emergent, Gilead, Janssen, Kyowa Kirin, Merck, Novartis, Novavax, Oncopeptides, Sarepta. Read More
