Abbvie Inc.’s encore to its $10.1 billion buyout of antibody-drug conjugate specialist Immunogen Inc. took the form of another takeover – this time of Cerevel Therapeutics Inc. for $45 per share in cash, which puts the total equity value at about $8.7 billion and provides Abbvie with “one of the most attractive growth portfolios in the industry,” CEO Richard Gonzalez said. Read More
After a nine-month review, the Biden administration is preparing to go where all other U.S. administrations have refused to trod. In releasing a draft framework to help federal agencies decide whether to exercise a federal march-in on patent rights protecting taxpayer-supported drugs and other inventions, including medical devices, the Department of Commerce’s National Institute of Standards and Technology included price as a factor in considering whether a product is “reasonably” available, as required under the 1980 Bayh-Dole Act. Read More
Three giants have produced new phase III study data for their already approved, big name therapies. Two were positive and the third was stopped for futility. Read More
The COVID-19 pandemic took a huge bite out of the U.S. FDA’s ability to conduct inspections in a timely manner, but the FDA’s Douglas Stearn said the agency has nonetheless ramped up these activities. Read More
The unique device identifier (UDI) might not be the most exciting U.S. FDA enforcement mandate for most of regulated industry, but the FDA’s Keisha Thomas indicated that compliance is less than adequate in the agency’s view. Thomas addressed an audience at the Food and Drug Law Institute’s annual enforcement conference here in the nation’s capital, acknowledging that the proposed alignment of the Quality System Regulation – also known as Part 820 – with ISO 13485 is no light lift. Read More
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New hires and promotions in the biopharma industry, including: Compass Pathways, In8bio, Nucleus Radiopharma, Rentschler, Santhera, Shorla, Tscan. Read More
Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Actelion, Amneal, BIAL, Concentra, Genevant, Hepion, Immutep, Innovent, J&J, Kintara, Korro, Lianbio, Marengo, Synaffix, Tilde, Treadwell, Vanda, Vyera. Read More
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Adaptimmune, Antengene, CG Oncology, Century, Zhejiang Jingxin, Mymd, Neurocrine, Novartis, Novavax, Optinose, Phathom, PTC, Ractigen, Systimmune. Read More
