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1,198 stories matching this filter · ← front page

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  • FDA issues warning letters to Baxter and Olympus over GMP and QSR violations
    The U.S. Food and Drug Administration sent formal warning letters to Baxter International and Olympus Medical Systems. The letters allege that both companies failed to meet required good manufactu…
    raps · 19d agoRegulatoryNegative↗ source
  • Biopharma firms curb hiring as $100,000 H-1B visa fee limits foreign talent
    The U.S. Department of Homeland Security’s recent increase of the H-1B visa filing fee to $100,000 has made it much more expensive for biopharma employers to sponsor foreign-born scientists and eng…
    BioSpace · 19d agoRegulatoryNeutral↗ source
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  • Roche’s pipeline trim claims Poseida’s off-the-shelf CAR T asset
    Aside from RG6540, Roche also discontinued a host of other early-stage assets, including an antisense oligonucleotide for Alzheimer’s disease and a small-molecule candidate for geographic atrophy.
    BioSpace · 19d agoRegulatoryNeutral↗ source
  • Key career moves that propelled three BioSpace 40 Under 40 honorees to biotech leadership
    BioSpace highlighted three members of its 40 Under 40 list, asking them to describe pivotal moments that shaped their biotech careers. Lex Johnson, chief platform officer at Dispatch Bio, said the…
    BioSpace · 19d agoPositive↗ source
  • EMA opens consultation on platform trial methodology; MHRA to recognize CE-marked devices indefinitely
    The European Medicines Agency is launching a public consultation to gather feedback on the methodological aspects of confirmatory platform clinical trials. The agency seeks input from researchers,…
    raps · 19d agoRegulatoryNeutral↗ source
  • US patients skip half of new high-cost drugs as prices surge past $250K
    A new report from the Institute for Clinical and Economic Review and West Health finds that only about one-third of patients prescribed newly launched medicines actually fill them within 30 days, w…
    BioSpace · 20d agoNegative↗ source
  • FDA approves GSK‑Ionis hepatitis B functional cure, Hibsago, targeting undetectable virus after six months
    The FDA has approved bepirovirsen, an antisense oligonucleotide from GSK and Ionis, for chronic hepatitis B infection. It will be sold under the brand name Hibsago. The therapy is described as a f…
    BioSpace · 20d agoApprovalPositive↗ source
  • US biotech M&A surges as Chinese licensing deals dominate 2026 market
    Locust Walk reports that China now accounts for 58% of global licensing deal value in 2026, while the United States share has dropped to 26%. Despite the licensing shift, US biotech companies are…
    BioSpace · 20d agoDealPositive↗ source
  • Disc Medicine’s Phase 3 data revives rejected rare‑disease drug as China tightens biotech ownership rules
    Disc Medicine announced that its Phase 3 trial of a previously rejected rare‑disease therapy showed positive results, effectively rescuing the program and positioning it for another submission to t…
    BioSpace · 20d agoPositive readoutPositive↗ source
  • Novo reports 25% average weight loss in women using CagriSema, with greatest loss in premenopausal patients
    Novo's next-generation GLP-1 drug CagriSema showed substantial weight loss in women enrolled in the Phase 3 REDEFINE 1 trial. Women in the study lost about 25% of their body weight after 68 weeks,…
    BioSpace · 20d agoPositive readoutPositive↗ source
  • FDA cites Baxter’s inadequate oversight after repeated GMP violations at multiple plants
    The U.S. Food and Drug Administration has issued a warning letter to Baxter International, saying the company's leadership has failed to provide adequate oversight of its drug manufacturing operati…
    BioSpace · 19d agoRegulatoryNegative↗ source
  • Crossover fundraisings may hit $4.2 billion in 2026, with 2025 rounds still leading historic totals
    Crossover rounds are viewed as a bridge to public markets, with Jim Healy of Sofinnova Investments saying a large raise signals a company has reached a level of maturity and broader institutional i…
    BioSpace · 20d agoDealNeutral↗ source
  • FDA device officials prioritize hiring after layoffs, express optimism for upcoming MDUFA VI agreement
    Top officials from the FDA's Center for Devices and Radiological Health spoke at a town‑hall session during The MedTech Conference. They said the agency is concentrating on rebuilding staff after a…
    raps · 20d agoRegulatoryPositive↗ source
  • Pharma companies push FDA for risk-based flexibility in container-closure testing guidance
    Major pharma firms have written to the FDA urging a shift in its current guidance on testing container-closure systems for drug and biologic products. They argue that a risk-based, flexible approa…
    raps · 20d agoRegulatoryNeutral↗ source
  • Eight biopharma companies posting dozens of remote job openings
    BioSpace compiled a list of eight biopharma firms currently advertising remote positions for life‑science professionals. The companies together have roughly 300 openings, ranging from strategic ac…
    BioSpace · 20d agoNeutral↗ source
  • Companies price the role, not the employee, says executive coach on compensation expectations
    Executive coach Angela Justice argues that firms usually set pay based on the value of the job itself rather than the individual who fills it. She says this distinction is often clear in theory but…
    BioSpace · 20d agoNegative↗ source
  • Genmab faces steep revenue cliff as Darzalex patents expire, eyes pivotal Epkinly readout
    Genmab relies heavily on Darzalex, a cancer drug co‑developed with Johnson & Johnson, which currently provides about 90% of the company’s sales. U.S. patents for Darzalex are set to expire in 2029,…
    BioSpace · 21d agoNegative↗ source
  • Rapport Therapeutics reports Phase 2 success for RAP-219 in bipolar mania trial
    Rapport Therapeutics announced that its lead candidate RAP-219 met the primary endpoint in a Phase 2 study of adults with acute bipolar mania. The double-blind trial enrolled 253 patients and meas…
    BioSpace · 21d agoPositive readoutPositive↗ source
  • Lilly commits up to $1.1 billion to Hong Kong biotech METiS TechBio's AI-driven lipid nanoparticle platform
    Lilly announced a partnership with Hong Kong‑listed METiS TechBio, providing an upfront payment in the low double‑digit‑million‑dollar range and making the company eligible for up to $1.1 billion i…
    BioSpace · 21d agoDealPositive↗ source
  • Alnylam shares tumble to $250 after cutting full-year revenue guidance for its TTR franchise
    Alnylam Pharmaceuticals saw its share price slide to about $250 after the company lowered its full-year revenue outlook for its transthyretin (TTR) franchise. The guidance cut, announced in July, f…
    BioSpace · 21d agoEarningsNegative↗ source
  • AstraZeneca teams with Oracle on AI-driven clinical trials as FDA clears Haemonetics vascular closure system
    AstraZeneca announced a collaboration with technology firm Oracle to incorporate artificial intelligence into its clinical trial processes. The partnership aims to use Oracle's cloud and data analy…
    raps · 21d agoApprovalPositive↗ source
  • Gilead’s emvistegrast shows superior response to placebo in Phase 2 ulcerative colitis trial
    Gilead Sciences reported that its investigational oral drug emvistegrast achieved a higher clinical response rate than placebo in a Phase 2 study of ulcerative colitis. The trial enrolled 238 patie…
    BioSpace · 21d agoPositive readoutPositive↗ source
  • FDA issues import alert on Olympus endoscopic devices over quality violations
    The U.S. Food and Drug Administration has issued an import alert for certain medical devices manufactured in Japan by Olympus Medical Systems Corporation and its subsidiaries. The alert applies to…
    fda medwatch · 21d agoRegulatoryNegative↗ source
  • Cardinal Health issues updated instructions for Presource kits containing recalled BD Alaris infusion sets
    The FDA CDRH issued an Early Alert to inform the public of a potentially high‑risk device issue involving Cardinal Health Presource kits that may contain BD Alaris Pump Infusion Sets linked to a re…
    fda medwatch · 21d agoRegulatoryNegative↗ source
  • Nova Biomedical pulls Gen 2.0 StatStrip hospital glucose meters over patient ID software flaw
    Nova Biomedical has issued a recall of its StatStrip Glucose Hospital Meter System Gen 2.0 model after discovering a software issue that could assign glucose results to the wrong patient. The FDA…
    fda medwatch · 21d agoCRLNegative↗ source