Positive data from Novo Nordisk A/S’s pivotal phase IIIa study of once-weekly and once-monthly doses of its hemophilia treatment, Mim8, are prompting the company to say it will submit the first regulatory approval request toward the end of this year. It could challenge Roche Holding AG’s Hemlibra (emicizumab), a bispecific factor IXa- and factor X-directed antibody for hemophilia A, that was approved in 2017 by the U.S. FDA.
In a research collaboration that could bring in up to $600 million, Metaphore Biotechnologies Inc. has become the third Flagship Pioneering company this year to cut a development deal with mighty obesity space player Novo Nordisk A/S.
Homerun success of Novo Nordisk A/S’ semaglutide, which recently became the U.S.’s biggest blockbuster drug, is serving as an “inflection point” for obesity therapeutics and fueling the drive for new and improved therapies, speakers said at Bio Korea 2024 on May 8.
With round 1 not yet completed, the U.S. Centers for Medicare & Medicaid Services (CMS) already is prepping for round 2 of the Medicare negotiations mandated by the 2022 Inflation Reduction Act. While the negotiation process will expand to Part B drugs in the future, round 2, like the first cycle, will be limited to single-source Part D drugs that account for some of the highest Medicare expenditures. However, the number of drugs selected for the next cycle could grow from the current 10 to up to 15
In the wake of Novo Nordisk’s semaglutide nabbing the title of the U.S.’s biggest blockbuster drug, it’s little surprise that Amgen Inc.’s obesity candidate, Maritide (maridebart cafraglutide), hogged the stage during the firm’s first-quarter earnings call after market close May 2, with company executives touting promising phase II data and a differentiated profile, sending shares of Thousand Oaks, Calif.-based Amgen (NASDAQ:AMGN) up nearly 12% to close May 3 at $311.29.
Just a few days after the U.S. Congressional Research Service issued a report suggesting ways Congress could resolve the unanswered questions about patent listings in the FDA’s Orange Book, the FTC sent a second round of warning letters to eight biopharma companies and their subsidiaries, citing the listing of device patents for combination products.
The U.S. government chalked up another win April 29 against the constitutional challenges to the Inflation Reduction Act’s provision mandating direct Medicare price negotiations for selected prescription drugs.
Big pharma continues to seek innovation in China despite rising geopolitical tension, speakers said at the Asia Bio Partnering Forum in Singapore April 24.
There was a time not that long ago when Merck & Co. Inc.’s Keytruda (pembrolizumab), with its multiple cancer indications, was seen as the heir apparent to Humira’s title of the biggest blockbuster drug. Not anymore. That title now belongs to Novo Nordisk A/S’ semaglutide, approved as Ozempic in 2017 to treat diabetes and as Wegovy in 2021 to help with weight loss.
Big pharma continues to seek innovation in China despite rising geopolitical tension, speakers said at the Asia Bio Partnering Forum in Singapore April 24.
