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2,859 stories matching this filter · ← front page

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  • IQVIA and Veeva deepen partnership to accelerate clinical trial timelines
    IQVIA and Veeva Systems announced an expansion of their existing collaboration aimed at speeding up clinical trial execution and improving efficiency. The upgrade brings Veeva's trial management t…
    Fierce Biotech · 1mo agoDealPositive↗ source
  • BioNTech’s mRNA cancer vaccine misses key endpoint in head-and-neck trial, study to continue
    BioNTech reported that its mRNA cancer immunotherapy BNT113 did not improve progression‑free survival when added to Keytruda in patients with HPV16‑positive head and neck squamous cell carcinoma. T…
    Fierce Biotech · 1mo agoNegative readoutNegative↗ source
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  • Roche licenses Rona's ALK7 obesity candidate in $1.2 billion deal
    Roche has agreed to license an RNAi drug candidate targeting ALK7 from Chinese biotech Rona Therapeutics, with an upfront payment of $100 million and potential milestones up to $1.06 billion. The…
    Fierce Biotech · 1mo agoDealPositive↗ source
  • Patient advocates and experts raise alarm over safety of Neurocrine Biosciences rare disease drug
    Two months after an open letter highlighted possible safety issues, patient advocacy groups and several experts are publicly voicing growing alarm about a rare disease therapy marketed by Neurocrin…
    STAT · 1mo agoNegative↗ source
  • Trump administration proposes $70,000 fee to curb foreign student work authorizations
    The Department of Homeland Security announced a proposed $70,000 fee for a work authorization program that many foreign students and scholars use to gain professional experience in the United State…
    STAT · 1mo agoRegulatoryNegative↗ source
  • Saudi Arabia signs 46 biotech agreements at Riyadh summit, targeting $1.5 bn investment
    The fourth Riyadh Global Medical Biotechnology Summit wrapped up on September 16, with 46 agreements signed among local and international participants. The disclosed agreements represent about 5.5…
    Fierce Biotech · 1mo agoDealPositive↗ source
  • WCG launches AI-driven Activation Intelligence to speed clinical trial start-ups
    WCG, a provider of clinical trial solutions, announced a new AI-powered program called Activation Intelligence aimed at accelerating the start-up phase of studies. In early access, the tool report…
    Fierce Biotech · 1mo agoPositive↗ source
  • Safety concerns rise as Neurocrine's Prader-Willi drug linked to deaths and hospitalizations
    Patient advocates and several experts are voicing increasing alarm over the safety profile of Neurocrine Biosciences' therapy for Prader-Willi syndrome. The drug, Vykat XR, received approval 18 mo…
    STAT · 1mo agoRegulatoryNegative↗ source
  • Insulet launches full U.S. release of Omnipod Discover data platform for Omnipod 5 users
    Insulet announced that its Omnipod Discover platform is now fully available across the United States. The web-based service is built to work with the company’s Omnipod 5 automated insulin delivery…
    Fierce Biotech · 1mo agoPositive↗ source
  • Doctors donate heavily to fellow physicians running for office amid Medicare overhaul debate
    Doctors are contributing sizable amounts to political candidates who are also physicians, according to a STAT+ report. The donations come as Congress prepares its first major overhaul of Medicare…
    STAT · 1mo agoNeutral↗ source
  • Paragon Labs hires former Apogee leadership after AbbVie acquisition and spins out hypertension unit
    Paragon Labs announced it has brought several former Apogee Therapeutics executives onto its senior team following AbbVie's $10.9 billion purchase of Apogee. The incoming leaders include Michael H…
    Fierce Biotech · 1mo agoDealNeutral↗ source
  • North Carolina public worker health plan faces court challenge over provider restrictions
    The latest Health Care Inc. newsletter highlights a growing dispute over a health plan that covers North Carolina’s public employees and retirees. Employers often try to reduce health care costs b…
    STAT · 1mo agoRegulatoryNeutral↗ source
  • FTC and seven states seek contempt order against Martin Shkreli for breaching pharma work ban
    The FTC, joined by seven states, filed a petition with a federal court asking that Martin Shkreli be held in contempt for allegedly violating a court order that bars him from any involvement in the…
    STAT · 1mo agoRegulatoryNegative↗ source
  • Lancet study assesses performance of Google’s diagnostic chatbot AMIE
    STAT’s Health Tech newsletter highlighted a recent evaluation of Google’s diagnostic chatbot AMIE that was published in The Lancet. The article notes that the study examined how well the chatbot c…
    STAT · 1mo agoNeutral↗ source
  • Nurix halts development of BTK degrader zelebrudomide after phase 1 review
    Nurix announced it will discontinue clinical development of its BTK degrader zelebrudomide, also known as NX-2127, following completion of enrollment in a phase 1 trial for aggressive non‑Hodgkin l…
    Fierce Biotech · 1mo agoNegative↗ source
  • Veteran infectious disease journalist Helen Branswell dies at 69
    Helen Branswell, a veteran reporter covering infectious diseases, died on Tuesday at age 69. Her sister said the cause was complications from cancer. Branswell was known for clear, nuanced coverag…
    STAT · 1mo agoNeutral↗ source
  • Pan Pepín recalls Para Bien Al Grano cereal batches over undeclared sesame allergen
    Pan Pepín Inc., based in Bayamón, Puerto Rico, issued a voluntary recall of certain lots of its Para Bien Al Grano product after discovering that sesame, an undeclared allergen, is present. The co…
    fda recalls · 1mo agoCRLNegative↗ source
  • Pan Pepin recalls Para Bien Al Grano boxes after discovering undeclared sesame
    Pan Pepin Inc., based in Bayamón, Puerto Rico, announced a recall of certain lots of its 24‑oz Para Bien Al Grano product because sesame was present but not listed on the label. The undeclared ses…
    fda recalls · 1mo agoCRLNegative↗ source
  • Physicians Face Learned Helplessness From Training Culture, Says STAT+ Columnist
    Frances Mei Hardin, a former ENT surgeon, launches a new STAT+ column called Chief Complaint, where she examines challenges confronting doctors today. She highlights a striking example: some resid…
    STAT · 1mo agoNegative↗ source
  • Botched lethal injection of Christa Pike raises questions about execution protocols
    An execution attempt on death-row inmate Christa Pike failed, leaving her alive after the lethal injection protocol was administered. The incident has been described as the most severe botched exec…
    STAT · 1mo agoNegative↗ source
  • BMS reports phase 3 successes in IPF drug and neuroendocrine tumor radiotherapy
    Bristol Myers Squibb announced that two of its phase 3 trials have met primary endpoints, marking important milestones as the company seeks growth beyond its patent expirations. The Aloft-IPF stud…
    Fierce Biotech · 1mo agoPositive readoutPositive↗ source
  • Roche reports updated eye drug data and FDA filing acceptance, targets July 2027 decision
    Roche Genentech has presented new data from its eye disease trials, a year after a mixed Phase 3 readout, and noted that the FDA has accepted its filing for vamikibart with a decision slated for Ju…
    Fierce Biotech · 1mo agoRegulatoryPositive↗ source
  • Tortugas Neuroscience's obuprazine shows significant improvement in phase 2b schizophrenia trial in China
    Tortugas Neuroscience, a biotech founded by former Sage Therapeutics staff with $106 million in funding, reported positive data from a phase 2b study of its schizophrenia candidate obuprazine, lice…
    Fierce Biotech · 1mo agoPositive readoutPositive↗ source
  • Merck’s deeper dive into efficacy, safety of $1.3B eye disease drug raises fears of ‘limited’ potential
    Merck & Co. has poured out its Brunello data, revealing a mix of undifferentiated efficacy and concerning safety that led analysts to predict “limited competitive potential” in diabetic macular ede…
    Fierce Biotech · 1mo agoRegulatoryNeutral↗ source
  • Biotech closures drop to ten in 2026, marking improvement after years of high layoffs
    Fierce's annual "biotech graveyard" list shows ten company closures reported so far in 2026, a sharp decline from sixteen last year and twenty‑seven in 2023. The drop reflects broader easing of bi…
    Fierce Biotech · 1mo agoLayoffsPositive↗ source