The pivotal phase III study of brilaroxazine from Reviva Pharmaceuticals Holdings Inc. for adults with schizophrenia hit its primary endpoint and two key secondary endpoints, following positive phase II data in 2021. The serotonin-dopamine signaling modulator, the company’s lead candidate, is a once-daily treatment. Results from the study showed brilaroxazine demonstrated reductions in all major symptom domains for the patients and the secondary endpoints at week 4 when comparing the 50-mg dose with placebo. Read More
With Deciphera Pharmaceuticals Inc.’s positive top-line data in hand from the pivotal phase III study called Motion, Wall Street speculation turned to the comparative safety and regulatory odds for vimseltinib (which analysts often refer to as “vim”) in patients with tenosynovial giant cell tumor (TGCT) not amenable to surgery. Read More
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.
Patients living with aggressive nasopharyngeal carcinoma (NPC) now have a new treatment option with the U.S. FDA approval of Junshi Biosciences Co. Ltd./Coherus Biosciences Inc.’s PD-1 inhibitor antibody Loqtorzi (toripalimab), which will likely become the new standard of care for NPC. Read More
Drawn to the potential for improved selectivity and safety profiles of PARP-1-specific inhibitors over their first-generation counterparts, Merck KGaA signed an exclusive, worldwide license deal with Jiangsu Hengrui Pharmaceuticals Co. Ltd. worth up to €1.4 billion (US$1.5 billion) to gain access to the latter’s next-generation poly (ADP-ribose) polymerase (PARP)-1 inhibitor, HRS-1167. Read More
Shanghai-based Henlius Biotech Inc. and India’s Intas Pharmaceuticals Ltd. agreed upon a potential €185 million (US$195.38 million) licensing deal for Intas to develop and sell Henlius’ China NMPA-approved lung cancer drug, serplulimab, across Europe and India. Serplulimab (HLX-02) is a recombinant humanized PD-1 monoclonal antibody (MAb) injection that first gained approval as Hansizhuang in March 2022. Read More
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Acumen, Alector, Atamyo, Corcept, Decibel, Essa, Innocare, Kymera, Medicinova, Otsuka, Regeneron, Sernova and SN Bioscience. Read More
Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: 23andme, Anheart, Bluebird Bio, Boehringer, Bristol Myers, Burning Rock, Enterome, GSK, Karyopharm, Moderna, Nippon Kayaku, Obseva, Organon and Xoma. Read More
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Calliditas, Eli Lilly, Everest, Genentech, Immunogen, Novartis, Roche and Santhera. Read More
