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While the FDA did not announce the recipient names of the Commissioner’s National Priority Vouchers, the agency’s descriptions of the awarded products match those in development at Compass Pathways, Transcend Therapeutics and Usona Institute.
Original title: “FDA awards priority vouchers to 3 undisclosed companies for investigational psychedelics”
Lilly shares dipped, and Novo’s climbed, as Foundayo’s early trajectory diverged from that of oral Wegovy. Elsewhere, Regeneron inked a drug price deal and two companies announced leadership changes.
Original title: “Lilly tumbles on Foundayo’s shaky week; FDA to issue vouchers for psychedelics”
Neal and Azbee awards have validated our approach to reporting on the industry at a time of unprecedented shifts at the FDA and other federal agencies.
Original title: “BioSpace elevates journalism as biopharma evolves in the Trump era”
Daiichi Sankyo’s full-year report was originally scheduled for April 27 but has now been pushed back to May 11. That same day, the pharma expects to release its five-year business plan.
Original title: “Daiichi Sankyo shares slip after delaying annual earnings report”
Pfizer’s decision to cut its early-stage cancer asset was due to “strategic business reasons” and not driven by safety or efficacy concerns.
Original title: “Pfizer culls early PD-L1 asset after series of clinical wins, deals in cancer”
3Billion, an AI-based rare disease diagnostics firm, saw shares rise 10% after securing 30 billion won in its first major funding since listing, backed by major Korean institutions. Shares of 3Billion (394800.KQ), an artificial intelligence-based rare disease diagnostics company, rose sharply in early trading. #3Billion#Biotech#AIHealthcare#KoreaStartup#RareDisease#GeneticDiagnostics#KOSDAQ
Original title: “3Billion Shares Jump 10% on 30 Billion Won Funding Deal - Seoul Economic Daily”
The 185-acre site will be the company’s largest single investment to date, with a focus on small-volume parenteral products like vials and prefilled syringes.
Original title: “Drugmaker AbbVie chooses North Carolina for $1.4B manufacturing campus”
The takeover will give Amneal control of four facilities to manufacture biosimilars for a planned wave of launches in the coming years.
Original title: “Amneal inks $1.1B Kashiv buyout to pursue biosimilar market leadership”
A string of research setbacks have left the pharmaceutical giant at a crossroads just as a new CEO is set to take over. But positive first-quarter earnings provided the company with a needed boost.
Original title: “Sanofi posts upbeat sales as R&D pressure builds”
Chief Scientific Officer Pedro Beltran will succeed Eli Wallace as CEO of BridgeBio Oncology Therapeutics, as the board eyes a busy period of clinical advancement in the RAS oncology space.
Original title: “BBOT shakes up leadership as RAS competitors get more visibility”