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2,468 stories matching this filter · ← front page

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  • Early-life gut microbiome may influence lifelong brain health, experts say
    The authors argue that the composition of a baby’s gut microbiome could play a pivotal role in shaping brain development and later cognitive health. They suggest that understanding this link may he…
    STAT · 7d agoNeutral↗ source
  • Gilead signs $1.9 billion deal with Vir Biotechnology to license dual-masked T-cell engagers for oncology
    Gilead Sciences announced a licensing agreement with Vir Biotechnology to access Vir's dual-masked PRO-XTEN T-cell engager platform for oncology. Under the deal, Vir will discover, design and opti…
    Fierce Biotech · 8d agoDealPositive↗ source
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  • BlackRock to acquire majority stake in Humana’s CenterWell clinics for $2.8 billion
    Humana announced that BlackRock will purchase Welsh Carson’s majority stake in the CenterWell Senior Primary Care network, a deal valued at $2.8 billion. The transaction covers roughly 150 Medicare…
    STAT · 8d agoDealPositive↗ source
  • Study finds nearly 40% of FDA advisory panels include reps linked to pharma-funded advocacy groups
    A new analysis published in Health Affairs Scholar examined FDA advisory committee meetings over the past 20 years and found that almost 40% featured a patient or consumer representative with activ…
    STAT · 8d agoRegulatoryNegative↗ source
  • iOnctura’s roginolisib shows encouraging phase 1 results in metastatic uveal melanoma
    iOnctura, a spinout of Merck KGaA, reported data from a two‑part phase 1 trial of its PI3K delta inhibitor roginolisib in patients with advanced solid and hematologic cancers, including a cohort of…
    Fierce Biotech · 8d agoPositive readoutPositive↗ source
  • Stryker invests $400 million in CMR Surgical, securing exclusive U.S. rights to Versius robotic platform
    Stryker announced a strategic investment of about $400 million in UK‑based CMR Surgical, a developer of modular, portable surgical robots. Under the agreement, Stryker will act as the exclusive U.…
    Fierce Biotech · 8d agoDealPositive↗ source
  • 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 · 8d 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 · 8d agoNegative readoutNegative↗ source
  • 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 · 8d agoDealPositive↗ source
  • Par Health initiates voluntary recall of Argatroban injection after detecting particulate contaminants
    Par Health USA announced a voluntary nationwide recall of its Argatroban Injection 250 mg/2.5 mL product, affecting 22 lots that have been distributed to hospitals and users. The recall was trigge…
    fda recalls · 8d agoRegulatoryNegative↗ 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 · 8d 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 · 8d 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 · 8d 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 · 8d 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 · 8d 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 · 8d 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 · 8d 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 · 8d 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 · 8d 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 · 8d 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 · 8d 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 · 8d 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 · 8d 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 · 8d 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 · 8d agoCRLNegative↗ source