Bristol Myers Squibb Co. (BMS) dodged a black-box warning on the label of just-approved Sotyktu (deucravacitinib), but hurdles lie ahead for the first-in-class, oral, allosteric tyrosine kinase 2 inhibitor. Designed to treat adults with moderate to severe plaque psoriasis who are candidates for systemic therapy or phototherapy, Sotyktu is priced as $75,000 per year, and will become available during September, BMS said. Read More
Spectrum Pharmaceuticals Inc. celebrated a long-awaited win with the U.S. FDA’s approval late Sept. 9 of novel G-CSF drug eflapegrastim, cleared for use in chemotherapy-induced neutropenia nearly four years after the company first filed for regulatory approval. Despite moves this year to reduce its cash burn, Spectrum has ready to go a commercial team expected to sell eflapegrastim as well as cancer drug poziotinib, which is under FDA review with a PDUFA date of Nov. 24, 2022. Read More
Scientifically at least, the biggest story coming out of the European Society for Medical Oncology (ESMO) 2022 Congress is the success of cell therapy in solid tumors. “During this ESMO, there is a lot of novelty coming from T-cell therapies,” John Haanen told the audience at his joint keynote speech with Ton Schumacher – so much so that Haanen and Schumacher, both group leaders at the Netherlands Cancer Institute, left antibodies out of their keynote session in order to do justice to the advances in cell therapies. Read More
Data presented Sept. 9 at the European Society of Medical Oncology 2022 Congress showed impressive effects for KRAS inhibitors. But they also illustrated their limitations. Earlier-stage trials and researcher presentations, meanwhile, suggested ways those limitations might be addressed. Results from the Codebreak 200 study, presented in the day’s Presidential Symposium, were typical of the best that targeted therapies have to offer: large effects for brief time periods. Read More
The gamma secretase inhibitor nirogacestat (Springworks Therapeutics Inc.) reduced the risk of disease progression by roughly 70% in a randomized placebo-controlled phase III trial in patients with desmoid tumors. Read More
Catalym GmbH reported in an oral session at the European Society for Medical Oncology meeting in Paris that its first-in-class growth differentiation factor 15 inhibitor, visugromab, demonstrated preliminary signs of efficacy in a heavily pretreated group of cancer patients who were resistant or refractory to checkpoint inhibitors. Read More
With a goal of manufacturing biotechnology in the U.S. that’s invented in the U.S., President Joe Biden signed an executive order Sept. 12 launching a National Biotechnology and Biomanufacturing Initiative that’s intended to strengthen the country’s bioeconomy, build stronger supply chains, and better utilize and secure biological data. Read More
Nodus Oncology Ltd. is set to explore new avenues of DNA damage response by targeting the chromosome next-door neighbors of tumor suppressor genes that are damaged when tumor suppressor genes are inactivated via homozygous deletion. These collaterally deleted ‘passenger genes’ play diverse functions in cell homeostasis and so present a number of molecularly targeted vulnerabilities that can provide a route to destroying cells which carry a tumor suppressor gene. Read More
New and updated preclinical and clinical data presented by biopharma firms at the European Society for Medical Oncology Congress 2022, including: Adaptimmune, Curelab, Novartis. Read More
Clinical updates, including trial initiations, enrollment status and data readouts and publications: ABVC, Allakos, Arcutis, Astrazeneca, Innocare, Merck, Regeneron, Sanofi, Sparrow.
Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Adagio, Adial, Alume, Aptose, Attralus, Azura, Bavarian Nordic, Celgren, Cellusion, Epivax, Fosun, Infexious, Intravacc, Invivyd, Purnovate. Read More
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Pfizer. Read More
