In what may just be the takeover effort’s first volley, Sumitovant Biopharma Ltd., a subsidiary of Sumitomo Pharma Co. Ltd., made a hefty offer for Myovant Sciences Ltd. – which said no. Shares of Myovant (NASDAQ:MYOV) closed at $24.44, up $6.48, or 36.1% on word of the unsolicited buyout proposal. Read More
The Nobel Prize in Physiology or Medicine 2022 was awarded to Svante Pääbo today "for his discoveries concerning the genomes of extinct hominins and human evolution." Pääbo, who is currently the director of the Max Planck Institute for Evolutionary Anthropology in Leipzig, Germany, and his colleagues overcame extreme technical challenges to sequence the DNA of ancient hominids – because after tens of thousands of years, there is no such thing as aging well for DNA. Read More
The U.S. Congress has finally managed to pass legislation that reauthorizes several FDA user fee programs, but the final vote came on the last day of the federal fiscal year and addressed a stripped-down version of previous user fee bills. While several key considerations survived the shift to a lean bill, the FDA will have to wait for another day to be authorized to regulate lab-developed tests and to revise the accelerated approval program for pharmaceuticals, measures that may be revisited before the end of the current calendar year. Read More
Incyte Corp. has agreed to acquire Villaris Therapeutics Inc., the developer of a monoclonal antibody for vitiligo that aims to treat a larger proportion of the skin than an available topical cream, for $70 million up front, plus up to $310 million in potential development and regulatory milestone payments. The deal includes up to $1.05 billion in commercial milestones on net sales of auremolimab, a preclinical MAb that works against IL-15Rβ and is expected to reach the clinic in 2023. Read More
The U.S. FDA has approved Taiho Oncology Inc.’s Lytgobi (futibatinib) for adults with previously treated, unresectable, locally advanced or metastatic intrahepatic cholangiocarcinoma harboring fibroblast growth factor receptor 2 (FGFR-2) gene fusions or other rearrangements. The approval arrived on its Sept. 30 PDUFA date. Read More
Companies across biotech and pharma are scrambling to find ways of reducing their energy consumption and overall dependence on fossil fuels, following the sudden and stark increase in prices sparked by Russia’s invasion of Ukraine. Read More
Three months after agreeing to an intellectual property waiver for COVID-19 vaccines, World Trade Organization (WTO) members are discussing expanding it to therapies, diagnostics and devices used in preventing, diagnosing and treating COVID-19 infections. Read More
The U.S. Department of Health and Human Services (HHS) needs to do more and act faster to crack down on drug manufacturers that restrict 340B prescription drug discounts to contract pharmacies, two senators said in a letter to HHS Secretary Xavier Becerra. Read More
New hires and promotions in the biopharma industry, including: Abcuro, Arvinas, Celularity, Century, Cerevance, Codexis, Crinetics, Evommune, Kuros, Macomics, Optibrium, Paxmedica, Roche, Urica, Vico. Read More
Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Amplifybio, Astrazeneca, Avista Public Acquisition, Bavarian Nordic, Chromadex, Genmab, Ligand, Logicbio, Omeros, Omniab, Oxford Biotherapeutics, Pact and Venatorx. Read More
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Citius, Immuneering, Immupharma, Inflammx, Lepu, Regeneron, Sanofi. Read More
