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  • Eli Lilly’s Mounjaro and Merck’s oral PCSK9 inhibitor win FDA nod amid string of cardiovascular trial setbacks
    The cardiovascular drug development landscape entered the American Heart Association’s Scientific Sessions with a mix of optimism and disappointment. Recent months have seen several late‑stage tria…
    BioSpace · 3h agoRegulatoryNeutral↗ source
  • Neurosterix raises $105M Series B to advance oral M4 schizophrenia drug and adds former Karuna leaders
    Neurosterix, a spinout from Addex Therapeutics, announced a $105 million Series B financing. The round was led by RTW Investments with participation from GV, Janus Henderson Investors and others. A…
    BioSpace · 6h agoDealPositive↗ source
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  • FDA faces over 1,000 vacant positions as staffing shortage strains pharma oversight
    The FDA currently has more than a thousand open jobs, reflecting a deep staffing shortfall that began after a large wave of departures last year. The agency lost 1,343 employees at its CBER and CD…
    BioPharma Dive · 7h agoNegative↗ source
  • Pfizer secures up to $1.5 billion from Blackstone to fund berobenatide obesity drug development
    Pfizer announced a financing arrangement with Blackstone Life Sciences that could provide up to $1.5 billion to support the development of berobenatide, an obesity drug acquired from Metsera. The…
    BioSpace · 8h agoDealPositive↗ source
  • FDA’s fast-track voucher program appears to be discontinued, report finds
    A recent report indicates that the FDA’s expedited voucher program, launched to speed approval of certain drugs, has not issued any new vouchers in the six months since former commissioner Marty Ma…
    Endpoints · 2h agoRegulatoryNegative↗ source
  • Eros Apothecary recalls Candy Power For Man honey supplement after undisclosed tadalafil found
    Eros Apothecary of Indio, California announced a recall of its Candy Power For Man Organic Honey dietary supplement after FDA testing revealed the presence of undeclared tadalafil. Tadalafil is th…
    fda recalls · 5h agoCRLNegative↗ source
  • EnGene reports improved bladder cancer data after May setback
    EnGene, a biotech developing a bladder cancer therapy, released new data that appear more encouraging than the results disclosed in May. The May data had shown limited durability, causing a sharp…
    Endpoints · 6h agoPositive readoutPositive↗ source
  • BioNTech spends $205 million to buy Scholar Rock’s FDA priority-review voucher as J&J scales back in Norway
    BioNTech announced it has purchased an FDA priority review voucher from Scholar Rock for $205 million. The voucher, which can be used to accelerate the regulatory review of a future drug, was origi…
    Endpoints · 6h agoDealPositive↗ source
  • Merck KGaA records €366 million impairment on Lonza CDMO sale as PharmaLogic acquires Lantheus' manufacturing unit
    Merck KGaA disclosed a €366 million ($405.8 million) impairment loss tied to the sale of its contract development and manufacturing organization (CDMO) business to Lonza, according to its third‑qua…
    Endpoints · 7h agoDealNegative↗ source
  • Parker Institute chief urges renewed focus on cancer immunotherapy after mixed results from Revolution Medicines' drug
    Ira Mellman, who leads research at the Parker Institute for Cancer Immunotherapy, said on Sept. 16, 2026 that he felt disappointment and frustration as the industry celebrated Revolution Medicines'…
    Endpoints · 8h agoNegative↗ source
  • BMS to consolidate R&D under single leader as chief research officer exits
    Bristol Myers Squibb announced a reorganization of its research and development unit, merging early research and discovery with drug development under a single leader. Chief Research Officer Rober…
    BioSpace · 8h agoNeutral↗ source
  • Experts say predictive analytics and distributed manufacturing could curb drug shortages
    BioSpace Insights hosted a podcast episode featuring Christina Smolke, co-founder and CEO of Antheia, and Kyle Pudenz, senior vice president of data and AI product at Cencora. The conversation focu…
    BioSpace · 9h agoPositive↗ source
  • Blackstone pledges up to $1.5 billion to fund Pfizer's obesity drug berobenatide development
    Blackstone Life Sciences has agreed to provide up to $1.5 billion to support the research and development of Pfizer's obesity candidate, berobenatide, which originated from the former Metsera progr…
    Endpoints · 11h agoDealPositive↗ source
  • BMS consolidates R&D under chief medical officer Cristian Massacesi as chief research officer Robert Plenge exits
    Bristol Myers Squibb announced that starting Jan. 1, its chief medical officer and head of development, Cristian Massacesi, will lead a newly combined research and development unit, merging previou…
    Fierce Biotech · 14h agoNeutral↗ source
  • Biopharma layoffs rise YoY in October but overall trend points down for 2026
    October marked the first time this year that both the number of biotech and pharma firms announcing workforce cuts and the total employees affected rose compared with 2025. Three additional employ…
    BioSpace · 16h agoLayoffsNegative↗ source
  • Neurosterix secures $105M Series B to launch phase 2 schizophrenia trial
    Addex Therapeutics' spinout Neurosterix announced a $105 million Series B financing to fund its upcoming phase 2 trial of NTX-253 for schizophrenia. The round was led by a syndicate of leading lif…
    Fierce Biotech · 18h agoDealPositive↗ source
  • Google launches Gemini AI platform for healthcare
    Google has introduced Gemini, a new artificial‑intelligence platform aimed at the healthcare sector. The rollout marks the company's latest move into health‑focused technology. The firm already su…
    Endpoints · 2h agoPositive↗ source
  • HHS rolls out new funding and research programs for psychedelics, with a focus on ibogaine
    HHS announced Thursday a series of new funding allocations and research initiatives aimed at advancing the study of psychedelic compounds. The effort follows President Donald Trump's spring execut…
    Endpoints · 2h agoRegulatoryPositive↗ source
  • Rezera delays $200M IPO amid weak market conditions
    Rezera, a biotech developing drugs for cardiovascular and inflammatory diseases, announced that it will not proceed with its planned initial public offering that had been scheduled for Friday. The…
    Endpoints · 2h agoDealNegative↗ source
  • Game Changer Products recalls 10 Day Forecast capsules after FDA finds undeclared sildenafil and acetaminophen
    Game Changer Products LLC announced a voluntary nationwide recall of its 10 Day Forecast capsules, a dietary supplement marketed at 3200 mg. The FDA’s analysis detected the presence of undeclared…
    fda recalls · 5h agoCRLNegative↗ source
  • Bristol Myers appoints Cristian Massacesi as head of R&D as Robert Plenge exits
    Bristol Myers Squibb announced a reorganization of its research and development organization, merging the research and development units under a single leader. Cristian Massacesi, currently chief…
    BioPharma Dive · 6h agoNeutral↗ source
  • FDA shelves Commissioner’s National Priority Voucher program ahead of Heidi Overton confirmation vote
    The Food and Drug Administration has halted the Commissioner’s National Priority Voucher (CNPV) program as the Senate prepares to vote on Heidi Overton’s nomination as the agency’s next commissione…
    BioSpace · 6h agoRegulatoryNeutral↗ source
  • Bristol Myers shifts R&D leadership to chief medical officer Cristian Massacesi as research head Robert Plenge departs
    Bristol Myers Squibb announced a reorganization of its research and development structure. The company said chief medical officer and head of development Cristian Massacesi will assume the duties…
    Endpoints · 9h agoNeutral↗ source
  • FDA suspends National Priority Voucher pilot and pauses release of complete response letters
    The Food and Drug Administration has quietly ended the National Priority Voucher pilot, a program that was designed to speed the review of certain drug candidates. In addition, the agency appears…
    Fierce Biotech · 11h agoRegulatoryNeutral↗ source
  • Vor Bio pays RemeGen $10 million for rights to long-acting autoimmune drug candidate RC298
    Vor Bio announced a licensing agreement with RemeGen, paying $10 million upfront in cash and issuing warrants valued at about $46 million for rights to RC298 outside Greater China. RC298 is a long…
    Fierce Biotech · 12h agoDealPositive↗ source