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2,526 stories matching this filter · ← front page

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  • 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 · 6d 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 · 7d agoDealPositive↗ source
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  • Roche signs $1 billion deal with China’s Rona Therapeutics for RNAi obesity drug
    Roche announced a new agreement with Chinese biotech Rona Therapeutics to acquire an experimental RNA interference therapy targeting the protein ALK7 for obesity. Under the terms, Roche will pay $…
    BioPharma Dive · 7d agoDealPositive↗ 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 · 7d 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 · 7d 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 · 7d 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 · 7d 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 · 7d 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 · 7d agoDealPositive↗ source
  • Study urges regulators to adopt cloud platforms to speed drug approvals
    A new study led by Nina Cauchon of Amgen and co-authors, published in the Journal of Pharmaceutical Sciences, calls for broader use of cloud-based platforms by regulatory agencies. The authors arg…
    raps · 7d agoRegulatoryPositive↗ source
  • Connectivity in fluid management systems key to reducing process variability
    The sponsored article, authored by Chris McCoy of Cytiva, highlights the often‑overlooked role of fluid‑management components such as tubing, connectors, and sensors in bioprocesses. It argues tha…
    BioPharma Dive · 6d agoPositive↗ 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 · 7d 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 · 7d 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 · 7d agoPositive readoutNeutral↗ 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 · 7d 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 · 7d 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 · 7d 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 · 7d agoPositive↗ 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 · 7d agoPositive↗ source
  • Stakeholders urge FDA to adopt flexible approach for psychedelic drug regulation
    Various individuals and groups have submitted comments urging the U.S. Food and Drug Administration to be flexible in regulating psychedelic medicines that could treat major depressive disorder and…
    raps · 7d agoRegulatoryNeutral↗ source
  • Roche signs $1.2B partnership with China’s Rona for obesity drug as Stryker pours $400M into CMR Surgical
    Roche has entered a $1.2 billion agreement with Chinese firm Rona to advance an obesity treatment, targeting the growing market for weight‑loss therapies in China. The deal will combine Roche’s dr…
    raps · 7d agoDealPositive↗ source
  • Paragon spinout Velaris Therapeutics goes public via reverse merger with Alaunos, raising $350 million
    Paragon Labs, a biotechnology incubator, announced that its latest spinout, Velaris Therapeutics, became a public company through a reverse merger with Alaunos Therapeutics. The transaction places…
    BioPharma Dive · 7d agoDealPositive↗ source
  • Novartis secures supplemental FDA approval to market repurposed antibiotic Lamprene in the US
    Novartis has obtained a supplemental approval from the U.S. Food and Drug Administration for its drug Lamprene, allowing it to be sold as an antibiotic. Lamprene, originally developed decades ago…
    Endpoints · 7d agoApprovalPositive↗ source
  • BioNTech's mRNA cancer therapy fails to improve progression-free survival in head-neck cancer trial
    BioNTech reported that its experimental mRNA cancer immunotherapy, BNT 113, combined with Keytruda, did not meet the primary endpoint of progression-free survival in an interim analysis of a late-s…
    BioPharma Dive · 7d agoNegative readoutNegative↗ source
  • BioNTech's head and neck cancer vaccine fails to meet first primary endpoint in pivotal trial
    BioNTech reported that its experimental mRNA vaccine targeting head and neck cancer did not achieve one of the two primary goals in a pivotal study. The trial was designed to evaluate the vaccine’…
    Endpoints · 7d agoNegative readoutNegative↗ source