Shares of Oyster Point Pharma Inc. (NASDAQ:OYST) soared to $11.57, or 38.6% on word of the buyout by Viatris Inc., which is also taking over privately held, development-stage Famy Life Sciences Ltd. to create an ophthalmology franchise that Viatris estimates could mean at least $1 billion in sales by 2028 as well as at least $500 million more in adjusted EBITDA. Read More
There are doubts about the future of GSK plc’s multiple myeloma drug Blenrep (belantamab mafodotin) after it failed to meet its goal of improving progression-free survival compared with standard chemotherapy in a confirmatory trial, placing its conditional approvals in the U.S. and Europe at risk.
Verve Therapeutics Inc.’s heart disease candidate, VERVE-101, is the latest gene editing-based therapy to hit a snag at the FDA, which issued a clinical hold, delaying the start of phase I testing in the U.S. News of the hold, which followed preclinical presentations over the weekend at the American Heart Association 2022 meeting, sent shares of Verve (NASDAQ:VERV) falling 30.5% to close Nov. 7 at $21.75. Read More
Radiopharmaceutical company Telix Pharmaceuticals Ltd’s TLX250-CDx (Zirconium (89Zr) TX250) met both primary and secondary endpoints in the phase III Zircon study in clear cell renal cell carcinoma, according to top-line data. Read More
Modern molecular techniques have progressed to the point where sequencing can seem almost quaint. At the Basic Science Symposium of The Liver Meeting 2022, new techniques were on full display, with sessions devoted to epigenetics, microbiome analysis and spatial transcriptomics. But the first session was still on genetic variants in all their forms – rare variants, common variants and non-germline mutations. Read More
It’s taken eight years of jury trials, court reversals and appeals for Amgen Inc. to get the nod to argue its case before the U.S. Supreme Court on what is needed to meet the enablement standard for functional patent claims that envelop a genus. Read More
Biocytogen Pharmaceuticals Co. Ltd.’s subsidiary Eucure Biopharma Co. Ltd. has granted Isu Abxis Co. Ltd. rights to use its humanized agonistic anti-CD40 antibody YH-003 to develop cancer drugs. Read More
New and updated preclinical and clinical data presented by biopharma firms at the AASLD Liver Meeting, including: Aligos, Asher, Assembly, Ocelot, Rivus, Terns. Read More
New and updated preclinical and clinical data presented by biopharma firms at the American Society of Nephrology Kidney Week including: Alpine Immune, Ionis, Kezar, Valenzabio, Xortx. Read More
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Akeso, Ascentage, Bioatla, Biomind, Biontech, Laurent, NGM, Pfizer, Rain, Redhill, Vicore. Read More
Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Akebia, Beam, DKSH, Eisai, Incyte, Mirati, Nkgen, Relief, Scancell, Vaccitech. Read More
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Apellis, Astrazeneca, Iveric, Medincell, Moderna, Sanofi, Teva. Read More