Only two days after Bridgebio Pharma Inc. impressed investors with data from BBP-418 in limb-girdle muscular dystrophy type 2I/R9, the company was back at it again, this time reporting positive top-line results from its global phase III study of encaleret in autosomal dominant hypocalcemia type 1, a genetic form of hypoparathyroidism. Read More
Ten years after the first biosimilar launched on the U.S. market, the FDA is taking steps to make biosimilar development and pharmacy substitution more like that of generics, reducing the cost of the drugs in the process. “We want to see more biosimilars. We want to see more competition,” FDA Commissioner Marty Makary said at an Oct. 29 media briefing in which he announced new guidance to streamline biosimilar development, cut through the red tape and shorten the timeline. Read More
Qyuns Therapeutics Co. Ltd. signed a potential $1.07 billion license deal with Roche Holding AG, granting the latter exclusive rights to QX-031N – a human thymic stromal lymphopoietin and interleukin-33)-targeting bispecific antibody. Read More
Shooting for further proof of durable, drug-free, disease-free remission with a single dose of KYV-101 in generalized myasthenia gravis, Kyverna Therapeutics Inc. plans to start phase III work by the end of this year. The Emeryville, Calif.-based firm rolled out positive interim results from the phase II portion of the registrational Kysa-6 clinical trial testing the drug, a fully human, autologous, CD19 CAR T-cell therapy with CD28 costimulation. Read More
With a modest $7 million up front but an ultimate payout potentially topping $1 billion on the line, Modex Therapeutics Inc. will collaborate with Regeneron Pharmaceuticals Inc. to find and develop multispecific antibodies for treating multiple indications. Read More
What trends in life sciences have defined the last three decades? BioWorld Editor Nuala Moran picks monoclonal antibodies as the most significant. “They are the cornerstone around which medical biotechnology as a sector has been built.” Read More
Biopharma happenings, including deals and partnerships, and other news in brief: Empirico, GSK, Locus, Milliporesigma, Novartis, Pacira, Promega, Qilu, Tourmaline, Viatris. Read More
Regulatory snapshots, including global drug submissions and approvals, and other regulatory decisions and designations: Astrazeneca, Eli Lilly, Enigma, GSK, Kyowa, Neurenati, Nora, Orchard, Regeneron, Sunshine, Unicycive. Read More
