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2,474 stories matching this filter · ← front page

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  • 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 · 28d 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 · 28d 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 · 28d 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 · 28d agoRegulatoryPositive↗ 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 · 27d 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 · 27d 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 · 27d 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 · 27d 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 · 28d 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 · 28d 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 · 28d 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 · 28d 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 · 28d 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 · 28d 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 · 27d agoApprovalPositive↗ 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 · 27d agoNegative readoutNegative↗ source
  • Readily secures $11 million to expand AI compliance platform for insurers
    Readily, a San Francisco‑based startup, uses artificial intelligence to monitor and flag changes in government regulations that affect insurance companies. The company announced it has closed an $…
    Endpoints · 27d agoDealPositive↗ source
  • Rudy Tanzi says he may be nearing a cheap, safe Alzheimer’s prevention pill
    Rudolph Tanzi has spent decades pursuing a way to stop Alzheimer’s disease before it starts. As a leading researcher, he has long spoken about the need for a simple, widely accessible solution. T…
    Endpoints · 27d agoPositive↗ source
  • Former Apogee Therapeutics leaders join Paragon Labs to expand R&D and company creation platform
    Michael Henderson, who previously led Apogee Therapeutics, is now serving as chief executive officer of Paragon Labs. He is accompanied by five other former Apogee executives who have moved to Par…
    Endpoints · 28d agoPositive↗ 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 · 28d agoDealNeutral↗ source
  • FTC and seven states seek contempt order against Martin Shkreli for breaching lifetime pharma ban
    Martin Shkreli is again under investigation by the Federal Trade Commission. The FTC, together with seven states, filed a petition in a New York federal court asking that Shkreli be held in contem…
    Endpoints · 27d agoRegulatoryNegative↗ source
  • Health tech firms expand AI scribing tools toward prescribing and billing functions
    Health technology companies are accelerating development of artificial‑intelligence driven scribing solutions that can be deployed across health systems. While early versions focused on documentin…
    Endpoints · 27d agoNeutral↗ source
  • Syndax halts development of Niktimvo after Phase 2 failure in IPF trial
    Syndax announced it is stopping work on its experimental drug Niktimvo for idiopathic pulmonary fibrosis (IPF) after the compound did not meet its primary endpoints in a placebo-controlled Phase 2…
    Endpoints · 28d agoNegative readoutNegative↗ 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 · 28d agoNegative↗ 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 · 27d agoCRLNegative↗ source