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.
Japan’s Ministry of Health, Labor and Welfare (MHLW) approved a slew of new drugs in the last week of September, including Japan’s first sustained release GIP/GLP-1 receptor agonist for type 2 diabetes from Eli Lilly and Co. and Mitsubishi Tanabe Pharma Corp.; a self-administered injectable drug for rheumatoid arthritis from Eisai Co. Ltd. and Nippon Medac Co. Ltd.; a CAR T from Legend Biotech Corp. and Janssen Pharmaceutical KK; and two drugs from Astrazeneca plc, one in asthma and the other in pediatric plexiform neurofibromas in neurofibromatosis type 1.
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.
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.
Simcere Pharmaceutical Group has out-licensed its autoimmune drug candidate SIM-0278 for all indications to Almirall SA in a deal worth up to $507 million. Simcere granted exclusive global rights to the candidate to Almirall for development and commercialization excluding mainland China, Hong Kong, Macau, and Taiwan. In return, Almirall will pay Simcere $15 million up front.
Zai Lab Ltd. has agreed to pay $30 million up front to in-license from Seagen Inc. exclusive rights to the antibody-drug conjugate (ADC) Tivdak (tisotumab vedotin) in mainland China, Hong Kong, Macau and Taiwan.
The 2022 Albert Lasker Basic Medical Research Award has been awarded to Richard Hynes, of the Massachusetts Institute of Technology, Erkki Ruoslahti, of the Sanford Burnham Prebys Medical Discovery Institute, and Timothy Springer, of Harvard Medical School.
Cerecin Inc. has successfully closed the first tranche of a series IIB financing with investors from South Korea, with SK Securities Co. Ltd. and KNT Investment LLC leading the round.
Analysts were upbeat about positive results from Eisai Co Ltd. and Biogen Inc.’s phase III confirmatory Clarity Alzheimer’s disease (AD) trial of lecanemab that met both primary and secondary endpoints, and most agreed that the data should be enough to gain FDA approval for mild cognitive impairment due to AD.
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.
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