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3,988 stories matching this filter · ← front page

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  • Verdiva Bio halts phase 2 oral GLP-1 trial after enrolling only eight participants
    Verdiva Bio announced it is ending its phase 2 study of VRB-101, a once‑weekly oral GLP‑1 candidate, after the trial fell far short of its enrollment target. The study was intended to evaluate swi…
    Fierce Biotech · 7d agoNegative readoutNegative↗ source
  • FTC seeks contempt ruling against Martin Shkreli for breaching lifetime pharma ban
    The Federal Trade Commission has asked a judge to hold Martin Shkreli in contempt for allegedly breaching the lifetime ban that was imposed after his 2022 release from prison. The agency alleges t…
    BioSpace · 7d agoRegulatoryNegative↗ source
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  • Radical Numerics aims to develop general biological intelligence, says CEO Eric Nguyen
    STAT’s AI Prognosis newsletter features an interview with Eric Nguyen, chief executive of Radical Numerics. The Boston-based startup says it is working toward what it calls “general biological inte…
    STAT · 7d agoPositive↗ source
  • Verastem makes its stand as a RevMed competitor in pancreatic cancer
    Verastem Oncology had a big Wednesday morning: It announced new data amid a tense competition for the next-wave KRAS agents, as well as a $250 million raise and the departure of its CEO. The Massac…
    Endpoints · 7d agoNeutral↗ source
  • 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
  • Verdiva ends mid-stage study of oral GLP-1 amid ‘market evolution’
    The candidate is an oral version of ecnoglutide, a subcutaneous formulation of which is approved in China for type 2 diabetes and weight management. Pfizer owns commercialization rights for ecnoglu…
    BioSpace · 7d ago↗ 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 · 7d agoDealPositive↗ source
  • 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 · 7d 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
  • Roche signs $1.2 bn obesity partnership with China's Rona Therapeutics, paying up to $100 m upfront
    Roche announced its seventh China deal this year, partnering with RNA‑interference specialist Rona Therapeutics to target obesity. The collaboration licenses an ALK7 inhibition asset and includes…
    Endpoints · 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
  • Verdiva Bio halts mid-stage obesity trial of its GLP-1 pill, citing market evolution
    Verdiva Bio, a well-funded private biotech, announced it has terminated one of its Phase 2 trials for its lead oral GLP-1 obesity candidate. The company said the decision reflects a shift in the m…
    Endpoints · 8d agoNegative↗ source
  • Soufflé Therapeutics raises $135 million to develop three RNA medicines
    Soufflé Therapeutics, a biotech with ties to MIT professor Bob Langer, announced a new financing round. The round raised $135 million from venture capital investors. The capital will be used to a…
    Endpoints · 8d agoDealPositive↗ source
  • Beam Therapeutics reports early Phase 1/2 data for base editing therapy in GSD Ia, partners with Pfizer and Enodia
    Beam Therapeutics disclosed early results from a Phase 1/2 study evaluating a base editing approach aimed at correcting the genetic defect that causes glycogen storage disease type Ia, a rare metab…
    Endpoints · 8d agoPositive readoutNeutral↗ source
  • BioNTech's head and neck cancer mRNA vaccine fails to extend progression-free survival in Phase 3 trial
    BioNTech reported that its experimental mRNA immunotherapy BNT113 did not meet its primary endpoint in a Phase 3 trial for a specific head and neck cancer, failing to improve progression-free survi…
    BioSpace · 8d agoNegative readoutNegative↗ 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
  • Syndax halts Niktimvo trial for idiopathic pulmonary fibrosis after mid-stage failure
    Syndax announced it will stop testing Niktimvo (axatilimab) in idiopathic pulmonary fibrosis after the Phase 2 MAXPIRe trial failed to meet its primary endpoint. The study enrolled 145 patients an…
    BioSpace · 8d agoNegative readoutNegative↗ source
  • Pfizer strikes over $500M partnership with Enodia to develop Sec61-targeting small-molecule drugs
    Pfizer's venture arm helped fund Enodia Therapeutics with a $25 million seed round earlier this year. The two companies have now announced a collaboration that could be worth more than $500 millio…
    BioSpace · 8d agoDealPositive↗ 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
  • Paragon Labs launches ninth biotech, Velaris Therapeutics, via reverse merger to bring cardiopulmonary drugs to Alaunos
    Paragon Labs announced the creation of its ninth biotech company, Velaris Therapeutics, using a reverse‑merger approach it has refined over the past four years. The transaction was completed on Tu…
    Endpoints · 8d agoDealPositive↗ source