After two decades of work with Translarna (ataluren) for nonsense mutation Duchenne muscular dystrophy, PTC Therapeutics Inc. withdrew its bid for approval of the compound upon hearing from the U.S. FDA. Regulators told Warren, N.J.-based PTC that the data package for Translarna is “unlikely to meet the agency's threshold of substantial evidence of effectiveness.”
Biopharma dealmaking continued its momentum into 2026, with January logging $31.16 billion in total value. That figure outpaced January 2025’s $28.63 billion and exceeded the 2025 monthly average of $24.38 billion. In addition, January 2026 ranks as the highest first month in the past eight years.
A circuit formed by tumor, immune and nervous systems triggers cancer cachexia and anorexia, the excessive loss of weight, muscle and fat experienced in some cancer types. A new study is the first showing these three actors of a triangle interaction that initiates and feeds the process.
Undeterred by all the unsuccessful biopharma suits challenging the U.S. Medicare price negotiations, Abbvie Inc. filed its own complaint Feb. 11 in the U.S. District Court for the District of Columbia, seeking to undo CMS’ selection of Botox in the third round of the negotiations.
Regulatory snapshots for biopharma and med tech, including global submissions and approvals, and other regulatory decisions and designations: Agilent, Biocardia, Biofrontera, Biorestorative, GSK, Immune, Moderna, Outlook, Regenxbio, Takeda, Zoll.
Biopharma and med-tech happenings, including deals and partnerships, and other news in brief: Biocodex, Calbiotech, Formycon, Helsinn, Liquid, Lotus, Magnapharm, Owlet, Theranexus.
Clinical updates for biopharma and med tech, including data readouts and publications: Bioxytran, Eccogene, Heparegenix, Intrabio, Heparegenix, Upstream.
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