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2,842 stories matching this filter · ← front page

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  • Anthropic’s Claude AI designs miniproteins from scratch in new study
    Anthropic announced that its AI system Claude was used to design and generate miniproteins from scratch in a recent research campaign. The study showed Claude could propose novel protein sequences…
    Endpoints · 2mo agoNeutral↗ source
  • Amgen ends partnership with TScan Therapeutics as Amylyx announces $350 million offering
    Amgen announced it is terminating its collaboration with TScan Therapeutics, a Waltham, Massachusetts company focused on T‑cell therapies. The decision ends a partnership that had been aimed at de…
    Endpoints · 2mo agoDealNegative↗ source
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  • AstraZeneca’s Tagrisso plus Orpathys improves survival in MET-mutated lung cancer
    A new combination therapy using AstraZeneca’s Tagrisso together with Hutchmed’s Orpathys has shown a survival benefit for patients with a specific form of non‑small cell lung cancer. The study focu…
    BioPharma Dive · 2mo agoPositive readoutPositive↗ source
  • Leo Pharma to acquire experimental rare-skin disease drug dersimelagon in up to $435 million deal
    Leo Pharma announced it will acquire the rights to dersimelagon, an experimental oral therapy currently under FDA review, in a transaction that could total up to $435 million in upfront and near‑te…
    BioPharma Dive · 2mo agoDealNeutral↗ source
  • Amylyx reports avexitide cuts severe hypoglycemia by 55% in bariatric surgery patients
    Amylyx Pharmaceuticals announced that its GLP-1 blocker avexitide achieved the primary endpoint in a late‑stage trial, reducing serious to severe hypoglycemic events by 55% compared with placebo in…
    BioPharma Dive · 2mo agoPositive readoutPositive↗ source
  • CSL Vifor warns Tavneos exit from Europe will cut revenue by about 25%
    CSL Vifor’s parent company CSL Limited said the withdrawal of the drug Tavneos from the European market creates a significant headwind for sales. The company expects its revenue to fall by roughly…
    Endpoints · 2mo agoRegulatoryNegative↗ source
  • BioMarin to buy Alesta Therapeutics for $275M, adding rare bone disease drug to pipeline
    BioMarin announced Tuesday that it will acquire privately held Alesta Therapeutics, paying $275 million upfront with potential additional payments tied to milestones. The deal, expected to close b…
    BioPharma Dive · 2mo agoDealPositive↗ source
  • Third patient dies in Chinese trial of RiboX Therapeutics' experimental genetic therapy
    A patient with an autoimmune disease died after receiving an experimental genetic medicine from RiboX Therapeutics, a Shanghai‑based biotech startup. The death marks the third fatality reported in…
    Endpoints · 2mo agoNegative↗ source
  • LEO Pharma spends $435 million to acquire rare-disease skin drug dersimelagon
    LEO Pharma announced it will pay $435 million to buy the rights to dersimelagon, an oral MC1R agonist originally developed by Tanabe Pharma. The drug has completed Phase 3 trials for two rare phot…
    BioSpace · 2mo agoDealPositive↗ source
  • Biotech funding rebound set to boost CDMO demand by early 2027
    Analysts note that demand for pharma services has historically lagged behind biotech funding, but a recent surge in venture capital is expected to drive activity for contract development and manufa…
    BioSpace · 2mo agoPositive↗ source
  • Regeneron halts Phase 1/2 uveitis antibody trial after safety concerns
    Regeneron announced termination of a Phase 1/2 study of its investigational anti-inflammatory antibody REGN7041, which was being evaluated for non-infectious uveitis. The company said the decision…
    BioSpace · 2mo agoNegative↗ source
  • Regeneron halts Phase 1/2 uveitis antibody trial over unfavorable risk-benefit profile
    Regeneron has stopped a Phase 1/2 study of its anti‑inflammatory antibody REGN7041 in non‑infectious uveitis, citing an unfavorable benefit‑risk assessment. The antibody targets CD3 on immune cell…
    BioSpace · 2mo agoNegative readoutNegative↗ source
  • Amylyx reports Phase 3 success for avexitide in post-bariatric hypoglycemia
    Amylyx announced a late-stage success for avexitide, a GLP-1 receptor antagonist, in a Phase 3 trial targeting post-bariatric hypoglycemia. The trial results showed the drug achieved its primary e…
    Endpoints · 2mo agoPositive readoutPositive↗ source
  • Amylyx to seek FDA approval for avexitide after Phase 3 success in post-bariatric hypoglycemia
    Amylyx announced plans to file a new drug application for avexitide, a GLP-1 receptor antagonist, after a Phase 3 trial showed reduction in serious hypoglycemia in patients who had gastric bypass s…
    BioSpace · 2mo agoRegulatoryPositive↗ source
  • Leo Pharma to license Tanabe’s oral drug for rare light-sensitive skin disease, paying up to $435 million
    Leo Pharma announced a licensing agreement with Japan's Tanabe Pharma for an oral treatment targeting two genetic skin disorders that cause pain when exposed to sunlight. Under the deal, Leo Pharm…
    Endpoints · 2mo agoDealNeutral↗ source
  • FDA issues draft guidance for generative AI medical devices as industry calls for German drug pricing reform
    The U.S. Food and Drug Administration has published a draft guidance document that outlines the agency's expectations for medical devices that incorporate generative artificial intelligence. The dr…
    raps · 2mo agoRegulatoryNeutral↗ source
  • BioMarin signs new deal for early-stage bone disease asset
    BioMarin recently halted development of a rare disease drug that it had acquired in a $270 million transaction. Within a week, the company announced another deal to acquire an early‑stage asset aim…
    Endpoints · 2mo agoDealNeutral↗ source
  • Sandoz inks $322M Henlius deal for rights to as many as 10 biosimilars
    The initial batch of biosimilars includes copies of Amgen, Eli Lilly and GSK drugs that collectively generate billions of dollars in annual revenues.
    BioSpace · 2mo agoDealNeutral↗ source
  • AI and data sharing essential for safer cell and gene therapies, says industry leader
    The author argues that keeping data secret in cell and gene therapy harms patients, and that a commitment to transparency and artificial intelligence is needed to make these treatments safer and mo…
    BioSpace · 2mo agoPositive↗ source
  • Biden-era law, not Trump, drives 2026 drop in brand-drug list prices
    List prices for brand-name drugs fell sharply in 2026, marking a notable decline from previous years. Industry experts attribute the reduction primarily to a law enacted during the Biden administr…
    Endpoints · 2mo agoRegulatoryNeutral↗ source
  • FDA updates guidance to clarify ANDA and 505(b)(2) approval pathways
    The FDA released a draft guidance that updates a seven-year-old document on abbreviated drug approval pathways. The guidance clarifies the distinction between traditional Abbreviated New Drug Appl…
    raps · 2mo agoRegulatoryNeutral↗ source
  • Study highlights limits of premarket evaluation for identifying recalls of high-risk medical devices
    More than one-third of high-risk therapeutic medical devices approved over the last decade were subject to serious recalls, but the lack of consistent characteristics of these recalled devices sugg…
    raps · 2mo agoRegulatoryNeutral↗ source
  • Epic faces mounting pressure ahead of annual customer meeting
    Reporter Ngai Yeung spent Monday night in downtown Madison, Wisconsin, sampling cheese curds and chatting with attendees before the keynote of Epic's annual customer meeting. The atmosphere at the…
    Endpoints · 2mo agoNegative↗ source
  • Study finds measuring non-clinical influences on FDA approvals is complex
    A new study examined how non-clinical factors might affect the U.S. Food and Drug Administration's drug approval decisions. Researchers concluded that quantifying such influences is challenging be…
    raps · 2mo agoRegulatoryNeutral↗ source
  • Drug makers and animal testing groups urge FDA to keep flexible guidance on animal studies for cancer drugs
    A coalition of drug developers, regulators and laboratory animal-testing organizations has asked the U.S. Food and Drug Administration to keep its guidance on cancer-drug safety studies flexible.…
    raps · 2mo agoRegulatoryNeutral↗ source