Bayer AG’s asundexian, considered one of the next generation class of anticoagulants and a potential blockbuster, has failed a phase III clinical trial in atrial fibrillation. The factor XIa inhibitor is one of three with a similar mechanism of action in late stage development by big companies.
Bristol Myers Squibb Co. has identified triazole N-linked carbamoyl cyclohexyl acids acting as lysophosphatidic acid LPA1 receptor (LPAR1; EDG2) antagonists reported to be useful for the treatment of fibrosis, cancer, transplant rejection, osteoporosis, inflammatory disorders, neuropathic pain, atherosclerosis and chronic obstructive pulmonary disease, among others.
From the start of the Nov. 16 Oncologic Drugs Advisory Committee meeting, the U.S. FDA made it clear that withdrawing Acrotech Biopharma Inc.’s peripheral T-cell lymphoma drugs, Folotyn (pralatrexate) and Beleodaq (belinostat), from the market until a long-overdue confirmatory trial is completed is not an option given the current treatment landscape.
More than a week earlier than its PDUFA date, Bristol Myers Squibb Co. received U.S. FDA approval of its next-generation ROS1 tyrosine kinase inhibitor repotrectinib for adults with ROS1-positive locally advanced or metastatic non-small-cell lung cancer.
If everything goes according to the current plan, the U.S. FDA would get the final report of a confirmatory trial for Acrotech Biopharma Inc.’s Folotyn (pralatrexate) and Beleodaq (belinostat) in 2030 – more than two decades after Folotyn received accelerated approval to treat relapsed or refractory peripheral T-cell lymphoma and 16 years after Beleodaq was granted accelerated approval for the same indication.
Eukaryotic peptide chain release factor GTP-binding subunit ERF3A (GSPT1) degradation inducers have been reported in a Bristol Myers Squibb Co. patent as potentially useful for the treatment of cancer.
Hitching onto the emerging drug class of degrader-antibody conjugates (DAC), U.S. pharma giant Bristol Myers Squibb Co. (BMS) is picking up rights to the U.S. and Korean biotech Orum Therapeutics Inc.’s blood cancer candidate, ORM-6151, in a potential $180 million deal.
American pharma giant Bristol Myers Squibb Co. (BMS) will pick up the rights to Lianbio Co. Ltd.’s FDA-approved drug for obstructive hypertrophic cardiomyopath, Camzyos (mavacamten), in six Asian countries by paying $350 million up front and waiving some outstanding payments.
Most of the patients and advocacy groups speaking at the first of 10 public listening sessions questioned the Biden administration’s talking points that U.S. Medicare’s prescription drug price negotiation will be good for beneficiaries because it will improve access to costly drugs by lowering prices.
