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  • FDA advisory panel votes to expand use of four untested peptides despite safety concerns
    An FDA advisory committee narrowly voted to recommend adding four peptides to the agency's 503A Bulks List, a registry that would allow compounding pharmacies to use them in custom medications. The…
    BioPharma Dive · 1mo agoRegulatoryNegative↗ source
  • Sanofi stops development of eczema drug amlitelimab after mixed trial results
    Sanofi announced on Friday that it is halting further development of amlitelimab for atopic dermatitis, a drug it had once promoted as a potential successor to its blockbuster Dupixent. The compan…
    BioPharma Dive · 1mo agoNegative↗ source
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Infectious Disease457
  • Novo Nordisk seeks injunction to halt Eli Lilly's obesity drug ads
    Novo Nordisk filed a motion in a New Jersey federal court asking for a preliminary injunction that would stop Eli Lilly's advertisements for its obesity treatments. Novo claims the ads are mislead…
    BioPharma Dive · 1mo agoRegulatoryNegative↗ source
  • Summit Therapeutics faces under a year of cash runway as FDA decision on ivonescimab looms
    Summit Therapeutics reported that its cash and short-term investments total just over $690 million, which the company says is insufficient to fund operations for a full year. The biotech’s lead ca…
    BioSpace · 1mo agoRegulatoryNeutral↗ source
  • Roche drops Carmot’s acmopatide after Phase 2 success, shifts focus to enicepatide for weight loss and diabetes
    Roche announced it will stop developing acmopatide, an investigational obesity treatment acquired from Carmot Therapeutics. Acmopatide had met its primary endpoint in a Phase 2 trial in type 1 dia…
    BioSpace · 1mo agoNeutral↗ source
  • Baxter recalls cefazolin injection after cardboard particles detected
    Baxter International announced a voluntary nationwide recall of lot LD175708 of its cefazolin in dextrose injection, a single‑dose 100 ml infusion bag. The recall was prompted by a report that car…
    fda recalls · 1mo agoCRLNegative↗ source
  • Lilly’s $3.8B psychedelics bet won’t open the M&A floodgates
    Eli Lilly’s $3.8 billion play for AtaiBeckley has fueled speculation that Big Pharma is ready to embrace psychedelics. But while the acquisition does validate the drug class, analysts say it is unl…
    BioSpace · 1mo agoDealNeutral↗ source
  • Scribe Therapeutics raises $129 million in gene-editing IPO, debuting on Nasdaq
    Scribe Therapeutics completed an initial public offering that raised close to $129 million. The company sold 8.58 million shares at $15 each and will trade on Nasdaq under the ticker SCTX. The off…
    BioPharma Dive · 1mo agoDealPositive↗ source
  • Baxter voluntarily recalls Cefazolin in Dextrose injection after cardboard particles found
    Baxter International announced a voluntary nationwide recall of Lot LD175708 of its Cefazolin in Dextrose Injection, a single-dose infusion bag. The recall follows a report that cardboard particle…
    fda recalls · 1mo agoCRLNegative↗ source
  • Lidl US recalls Eridanous shortbread cookies over undeclared wheat, soy, milk, and egg allergens
    Lidl US announced a recall of its Eridanous Shortbread Cookies with Chocolate Truffle Coating & Apricot Filling, 11.6 oz boxes, after discovering that the packaging was in a foreign language and om…
    fda recalls · 1mo agoRegulatoryNegative↗ source
  • Eli Lilly to file FDA application for obesity drug retatrutide after Phase 3 trial results
    Eli Lilly announced that two additional Phase 3 trials of its experimental obesity medicine retatrutide met their primary goals, and the company plans to submit an FDA application for the drug next…
    BioPharma Dive · 1mo agoRegulatoryPositive↗ source
  • Eli Lilly to seek FDA approval for retatrutide in early 2027 after Phase 3 trials show over 20% weight loss
    Eli Lilly said its next‑generation obesity drug retatrutide produced substantial weight loss in two late‑stage Phase 3 studies. The data were presented from the TRIUMPH‑2 and TRIUMPH‑3 trials, whic…
    BioSpace · 1mo agoPositive readoutPositive↗ source
  • GSK receives FDA approval for ROS1 inhibitor Jideytro, marking its first lung cancer drug
    GSK's FDA approval of Jideytro, a ROS1 inhibitor for advanced non-small cell lung cancer patients with ROS1 gene fusions who have already received ROS1-directed therapy, was announced on Wednesday.…
    BioSpace · 1mo agoApprovalPositive↗ source
  • BeOne invests $300 million in New Jersey plant, adding small-molecule capacity and 120 jobs
    BeOne Medicines announced a $300 million investment to expand its manufacturing campus in Hopewell, New Jersey. The expansion will include a three‑story, 145,000‑square‑foot building for small‑mol…
    BioSpace · 1mo agoDealPositive↗ source
  • Roche says its late-stage pipeline is full, sees growth through 2030
    Roche's CEO Thomas Schinecker told analysts that the company has 19 investigational medicines that could launch by 2030, indicating a robust late-stage pipeline. He added that the depth of the pip…
    BioSpace · 1mo agoEarningsPositive↗ source
  • Biopharma firms must prioritize hiring and retaining commercial talent for successful drug launches
    A BioSpace webinar brought together commercial leaders and a recruiting specialist to discuss how biopharma companies can better hire and keep commercial staff as they prepare for new product launc…
    BioSpace · 1mo agoNeutral↗ source
  • Biopharma layoffs must double in second half of 2026 to match 2025 cuts
    The first half of 2026 saw biopharma companies cut slightly fewer jobs than the same period a year earlier, with layoffs affecting about 2% fewer employees overall. To reach the total workforce re…
    BioSpace · 1mo agoLayoffsNegative↗ source
  • FDA says it has not paused CRL releases amid transparency push
    An unnamed pharmaceutical company filed a citizen petition in April asking the FDA to change how it publicly releases Complete Response Letters, arguing the new policy conflicts with long‑standing…
    BioSpace · 1mo agoRegulatoryNeutral↗ source
  • Nordic biotech must unite to become a global force, say venture investors
    The latest episode of BioSpace's podcast Denatured features Ester Sklarsky of Sound Bioventures and João Ribas of Novo Holdings Seed Investments discussing the future of Nordic biotech. The guests…
    BioSpace · 1mo agoNeutral↗ source
  • Midwest Poultry Services recalls over 1.5 million dozen eggs over possible Salmonella Enteritidis contamination
    Midwest Poultry Services, L.P. announced a voluntary recall of 1,589,577 dozen white and brown cage-free shell eggs produced in Texas. The recall was triggered by a potential contamination with Sa…
    fda recalls · 1mo agoCRLNegative↗ source
  • GSK secures FDA approval for lung-cancer drug Jideytro after $10.6 billion Nuvalent acquisition
    GSK received FDA clearance for Jideytro, a therapy for patients with metastatic non‑small cell lung cancer that have ROS1 gene alterations and have already been treated with another targeted drug.…
    BioPharma Dive · 1mo agoApprovalPositive↗ source
  • Arrowhead’s plozasiran cuts triglycerides up to 81% in late-stage trials, shows promise for severe hypertriglyceridemia
    Arrowhead Pharmaceuticals reported positive data from two late-stage studies of its RNA-based drug plozasiran in adults with severe hypertriglyceridemia. The trials used a subcutaneous injection e…
    BioPharma Dive · 1mo agoPositive readoutPositive↗ source
  • AstraZeneca’s rare disease drug Wainua fails Phase 3, narrowing path to $80 billion sales goal
    AstraZeneca announced that its rare disease therapy Wainua did not meet its primary endpoints in a Phase 3 trial, ending plans to broaden the drug’s label for transthyretin amyloidosis cardiomyopat…
    BioSpace · 1mo agoNegative readoutNegative↗ source
  • Repligen to acquire BioLife Solutions for $1.5 billion, boosting its role in cell therapy preservation
    Repligen announced a $1.5 billion acquisition of BioLife Solutions, a company whose CryoStor media is used to preserve cell therapies during storage and transport. BioLife’s products are employed…
    BioSpace · 1mo agoDealPositive↗ source
  • Crystalys Therapeutics raises $130M Series B to advance gout drug dotinurad toward global launch
    Crystalys Therapeutics announced a $130 million Series B financing to move its gout drug dotinurad through late-stage trials and prepare for commercial launch. The round was led by Frazier Life Sc…
    BioPharma Dive · 1mo agoDealPositive↗ source