New five-year breast cancer survival data from Greenwich Lifesciences Inc. ignited its stock for a wild ride that climbed nearly 1,000% upward Dec. 9, marking one of the biotech sector’s biggest single-day gains in 2020. Read More
Data presented at the 2020 San Antonio Breast Cancer Symposium (SABCS) – held, of course, in cyberspace and not San Antonio this year – added to the evidence that adding Verzenio (abemaciclib, Eli Lilly and Co.) to endocrine therapy for up to two years benefited women with high-risk, early stage hormone receptor-driven and HER2-negative breast cancer. Read More
DUBLIN – Shares in Pluristem Therapeutics Inc. were down 40% by midday Dec. 9 on news that it was terminating a pivotal phase III trial of its allogeneic, placenta-derived cell therapy, PLX-PAD, in critical limb ischemia (CLI), following a futility analysis, which concluded that the study would be unlikely to meet its primary endpoint. Read More
Fresh off hitting key regulatory milestones in Europe and the U.S. for its investigational cholestatic liver disease therapy, maralixibat, Mirum Pharmaceuticals Inc. has secured a $210 million deal with Oberland Capital Management LLC supporting the drug's potential commercialization and the company's pipeline development plans. Read More
Wall Street is liking the prospects of Neurocrine Biosciences Inc.’s NBI-827104, in the rare pediatric indication called epileptic encephalopathy with continuous spikes and waves during sleep. San Diego-based Neurocrine is moving the orally active, brain-penetrating T-type calcium channel blocker, licensed from Idorsia Ltd., of Allschwil, Switzerland, into phase II trials. Read More
HONG KONG – Taipei, Taiwan-based Pharmaengine Inc. has signed a collaboration and licensing deal with Cambridge, U.K.-based Sentinel Oncology Ltd. for the latter’s checkpoint kinase 1 inhibitor, SOL-578. Through the agreement, Sentinel will receive an exclusivity payment and Pharmaengine will fund the IND-enabling studies. Read More
HONG KONG – New approaches to trials, digitalization and the effective use of advance technologies like artificial intelligence are reshaping how clinical trials are conducted, drugs are discovered, and new devices are developed, said participants at the Asia-focused Phar-East 2020 conference on Dec. 8. Read More
The latest global regulatory news, changes and updates affecting biopharma, including: Sacklers threatened with House subpoena; DEA proposes de-scheduling Alkermes drug; Marburg MCMs protected under PREP; OPDP: Don’t make risks a P.S.; U.S. Senators sound off on E&M offsets. Read More
New and updated preclinical and clinical data presented by biopharma firms at the American Society of Hematology’s annual meeting, Dec. 5-8, including: Company List: Gamida, Glycomimetics, Janssen, Jasper, Kadmon, Keros, Kiadis, Kleo, Maat, Macrogenics, Medigene, Mesoblast, Mustang, Novartis, Oncopeptides, Oncternal, Oryzon, Pfizer, Pharmaessentia, Protagonist, Sangamo, Roche, Rocket, Schrodinger, Seagen, Sierra Oncology, Sumitomo, Sutro, Synthekine, Teneobio, TG, Treadwell, Uniqure, Xencor. Read More
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: 9 Meters, Albireo, Amryt, Bebig, Beigene, Citius, Chugai, Lipocine, Pfizer, Rafarma, Sinovac, Sorrento, Tricida, Tvax, United, Valeo. Read More
