The multibillion-dollar market potential for obesity medications that analysts expect in the next decade signifies change is afoot for a patient population historically plagued with unsafe options and generally dismissed by investors and insurers. While glucagon-like peptide 1 receptor agonists have paved the way – offering hope-filled patients the first significant non-surgical weight loss benefit upwards of 15% – only a small portion of the obesity population and certain overweight patients are treated with medication, and even a smaller percentage receive insurance reimbursement. Read More
With Tofidence (tocilizumab-bavi), a monoclonal antibody from Biogen Inc., the U.S. FDA has approved the first biosimilar to the Roche Group AG’s Actemra (tocilizumab), a blockbuster with declining numbers. Tofidence was greenlighted Sept. 29 for treating rheumatoid arthritis in adults, and for treating polyarticular and systemic juvenile idiopathic arthritis in those ages 2 and older. It’s also the first biosimilar approved to treat systemic juvenile idiopathic arthritis. Read More
Syndax Pharmaceuticals Inc. is gearing up for a U.S. FDA filing by the end of 2023 on the back of positive data from a pivotal phase I/II study testing menin inhibitor revumenib in adult and pediatric patients with relapsed/refractory KMT2A-rearranged acute myeloid leukemia and acute lymphoid leukemia. Read More
Three years after Alnylam Pharmaceuticals Inc. gained U.S. FDA approval of the first treatment for rare disease primary hyperoxaluria type 1 (PH1), Novo Nordisk A/S solidified its own marketing clearance for RNAi therapy Rivfloza (nedosiran). Read More
Even as the court challenges continue, the first round of U.S. government price negotiations for selected Medicare Part D drugs officially began Oct. 1 with manufacturers of those drugs having to sign agreements to participate in the process. While the Centers for Medicare & Medicaid Services had yet to disclose, as of press time, how many manufacturers signed the negotiation agreements, all the companies with selected drugs reportedly had indicated they would sign by the deadline even as they pursue litigation. Read More
Researchers who follow their instincts and achieve slow results while trying to break barriers have little support. They replace it with persistence. This is the story of Katalin Karikó and Drew Weissman. What was once a dream in their minds was later a success. Their work together for decades was essential to achieving mRNA vaccines, and their perseverance was rewarded today with the 2023 Nobel Prize in Medicine. Read More
After a long and bumpy path to approval, the U.S. FDA has finally given the green light to Cyclopharm Ltd’s Technegas combination product a day after the Sept. 29 PDUFA date.
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Abbvie, Ascletis, Astrazeneca, Callidtas, Immunogenesis, Ionis, JCR, Nanobiotix, Scisparc, Structure, Verastem, Vericel. Read More
Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Bausch + Lomb, Clade, Gadeta, Infinity, Mei, Moderna, Nkgen, Novartis. Read More
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Amicus, Biontech, Capricor, Erydel, Geron, Hutchmed, Outlook, Pfizer, Quince, Regeneron, Takeda. Read More
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