The U.S. FDA’s green lighting of Omeros Corp.’s Yartemlea (narsoplimab) makes it the first approved treatment for hematopoietic stem cell transplant-associated thrombotic microangiopathy (TA-TMA), a life-threatening complication of hematopoietic stem cell (HSC) transplantation. The BLA for narsoplimab, a fully human monoclonal antibody that inhibits the enzyme mannan-binding lectin-associated serine protease-2, had a Dec. 26 PDUFA date. Read More
Reporting sales of its hepatitis B vaccine Heplisav-B pretty much in line with consensus and a phase I/II shingles prospect moving along, Dynavax Technologies Corp. scored a takeover deal with Sanofi SA, which is paying $15.50 per share in cash for a total equity value of about $2.2 billion. The amount is a 39% premium to Dynavax’s closing share price yesterday, Dec. 23. Read More
Hanx Biopharmaceuticals (Wuhan) Co., Ltd. raised HK$586 million (US$75.37 million) in its IPO on the Hong Kong Securities Exchange (HKEX:3378) on Dec. 23 to advance its clinical stage immuno-oncology pipeline. Read More
In a threshold event in the U.S., Medicare is planning to break through its obesity coverage barrier with a voluntary test of a model designed to enable Medicare Part D plans and state Medicaid programs to cover GLP-1 drugs prescribed for weight management. Read More
After an all-night negotiating session that concluded after 5 am on Dec. 12, political agreement was finally reached on the long-awaited EU pharmaceutical legislation. The aim of the new rules is to improve patient access and increase the competitiveness of the sector, but for the industry, it was too little too late in terms of the incentives, and potentially damaging in the measures to improve access. Read More
Gene therapy has had its commercial struggles in the past year. The cost to patients is in the millions and fewer are stepping forward for treatment than companies would like. While development continues in this game-changing field, some have struggled with regulatory authorities during development while others have just stepped away altogether. Read More
The year 2025 proved especially active with regard to deals that centered on the indication previously known as nonalcoholic steatohepatitis (NASH). Read More
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Biopharma happenings, including deals and partnerships, and other news in brief: Bioeq, Cassava, Dexcel, GSK, Orexo, Samsung Biologics, Seismic, Vaccinex, Windtree, Zydus. Read More
Regulatory snapshots, including global drug submissions and approvals, and other regulatory decisions and designations: Amneal, Formycon, Invivyd, Mannkind, Novo Nordisk, Reviva, Samsung Bioepis, Regeneron, Sanofi, Zai Lab. Read More
