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1,611 stories matching this filter · ← front page

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  • Sanofi R&D chief urges Western pharma to factor China’s growing innovation into pipelines
    Sanofi’s newly appointed head of research and development said on Wednesday that Western pharmaceutical companies can no longer overlook China’s rapid progress in biopharma innovation. He noted th…
    Endpoints · 6d agoNeutral↗ source
  • FDA proposes new framework prioritizing consistency over flexibility for rare disease drug reviews
    The FDA announced a shift in its approach to evaluating rare disease therapies, emphasizing a more uniform assessment process. Agency officials explained that the flexibility shown over the summer…
    Endpoints · 6d agoRegulatoryNeutral↗ source
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  • FDA launches Rare Disease Framework Initiative to reshape drug development for small patient populations
    The FDA announced a new Rare Disease Framework Initiative aimed at overhauling how drugs and biologics for rare conditions are developed. The initiative will produce a tailored framework that refl…
    fda press · 6d agoRegulatoryPositive↗ source
  • Ultragenyx sells second priority review voucher as Biomea shares tumble after oral GLP-1 data
    Ultragenyx Pharmaceutical, a commercial-stage rare disease company, completed its second sale of a priority review voucher this month. The voucher sale reflects the company's strategy of monetizin…
    Endpoints · 6d agoDealNeutral↗ source
  • Vir Biotechnology signs $65M upfront deal with Gilead for solid tumor T-cell engager
    Vir Biotechnology announced a new collaboration with Gilead Sciences focused on a solid tumor T-cell engager. Under the agreement, Gilead will provide an upfront payment of $65 million and up to $…
    Endpoints · 6d agoDealPositive↗ source
  • Arrowhead’s RNA drug cuts Alzheimer’s tau protein in early human study
    Arrowhead Pharmaceuticals reported early-stage data showing its subcutaneous RNA therapeutic can reach the brain and lower tau protein, a hallmark of Alzheimer’s disease. In a first-in-human trial…
    Endpoints · 6d agoPositive readoutPositive↗ source
  • Zealand Pharma signs up to $1.3 billion AI partnership with Generate Biomedicines for protein-based obesity drugs
    Zealand Pharma announced a partnership with Generate Biomedicines to develop new protein-based treatments targeting obesity and related metabolic conditions. The collaboration will use Generate's…
    Endpoints · 6d agoDealPositive↗ source
  • GSK to cut up to 1,200 jobs in Belgium as part of cost-cutting plan
    GSK said it will make up to 1,217 workers redundant from its facilities in Belgium. The job reductions are part of a cost-cutting programme that CEO Luke Miels first outlined in July. The announc…
    Endpoints · 6d agoLayoffsNegative↗ 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 · 6d agoNeutral↗ 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
  • 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
  • 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
  • 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 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
  • 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 · 7d 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 · 7d 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 · 7d agoPositive↗ 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 · 7d 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 · 7d 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 · 7d agoNegative readoutNegative↗ 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 · 7d 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 · 7d agoCRLNegative↗ source