What the results might mean for the future of other developers in the cannabinoid receptor 1 (CB1) weight-loss arena came into question after Novo Nordisk A/S unveiled phase IIa findings with monlunabant, a small-molecule oral inverse agonist, formerly INV-202. Read More
A little more than a year after the U.S. FDA refused to review the NDA for Biohaven Ltd.’s ultra rare disease treatment, new and positive phase III data have changed the treatment’s momentum. The upbeat results came as a surprise to analysts and investors, with the stock having a strong day and the company prepping an NDA for a fourth quarter submission. Read More
Chimeric antigen receptor (CAR) T-cell therapy moved the needle at the 2024 ECTRIMS (European Committee for Treatment and Research in Multiple Sclerosis) congress and will continue to do so – not just in multiple sclerosis (MS), but in other autoimmune diseases as well. Read More
For once, the EMA appears to have pipped the U.S. FDA to the post, with Pfizer Inc.’s hemophilia A and B therapy Hympavzi (marstacimab) recommended for approval in Europe on Sept. 20, while the U.S. PDUFA date is set for the fourth quarter of the year. Read More
The U.S. Court of Appeals for the Fifth Circuit revived the Pharmaceutical Research and Manufacturers of America’s (PhRMA) constitutional challenge to the Medicare price negotiations, sending it back to a federal court in Texas for a do-over. Read More
Both the biotech industry and Hong Kong have become strategic points for China as the People’s Republic of China works to lay a biotech “belt and road” through Asia to expand global influence. Read More
Vicebio Ltd. is funded to take two of its molecular clamp respiratory infection vaccines through phase II development, after raising $100 million in a series B. Read More
When the U.S. FTC filed suit Sept. 20 against the country’s three largest pharmacy benefit managers over their alleged use of rebates to artificially inflate U.S. insulin prices, it also put the three big insulin makers, and other drug manufacturers, on notice that they could be next. Read More
August saw the U.S. FDA approve 22 drugs, an increase from July's 17 but fewer than the 28 approved in June. This brings the 2024 monthly average to just over 19 approvals, outpacing last year's average of 16 per month, as well as the 12.5 per month seen in 2022 and 17 per month in both 2021 and 2020. Read More
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Innovative, Neuraptive, Novo Nordisk, Passage, Quralis, Sanofi, Sensorion, Tectonic. Read More
Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Acadia, Axcelead, Biosyent, Centenara, Mithra, Novalon, Rejuveron. Read More
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Amplia, Apellis, Biocon, Biotech, Ipsen, Janssen, Johnson & Johnson, Merck, Novo Nordisk, Pfizer, Samsung Bioepis, Sanofi. Read More
