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  • Biokin's EGFR-HER3 bispecific ADC succeeds in late-stage Chinese lung cancer trial
    Chinese biotech Biokin announced that its EGFRxHER3 bispecific antibody-drug conjugate met its primary endpoint in a late-stage trial in a genetically defined subset of non-small cell lung cancer (…
    Endpoints · 26d agoPositive readoutPositive↗ source
  • Federal appeals court revives portion of Teva's Medicare price-negotiation lawsuit amid Austedo discount plans
    Federal appeals court in the D.C. Circuit issued a decision Tuesday that partially overturns a lower‑court ruling that had dismissed Teva's challenge to Medicare's drug pricing negotiations. The r…
    Endpoints · 26d agoRegulatoryNeutral↗ source
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  • Trump expected to nominate Heidi Overton as new FDA commissioner
    President Donald Trump is expected to nominate Heidi Overton as the next commissioner of the U.S. Food and Drug Administration, according to a source familiar with the decision. Overton's selectio…
    Endpoints · 26d agoRegulatoryNeutral↗ source
  • Lilly's mid‑stage weight‑loss trial looms as amylin design becomes a key differentiator
    The pharmaceutical community is watching a growing debate over how best to design amylin‑based medicines. Analysts say that the structural choices made by companies could determine which candidates…
    Endpoints · 26d agoNeutral↗ source
  • Biopharma hiring surges in New Jersey, 11 companies post dozens of new roles
    BioSpace data shows job postings for biopharma positions in New Jersey have risen year over year, with a notable 73% jump in July compared with the same month last year. The upward trend has persi…
    BioSpace · 26d agoPositive↗ source
  • Amylyx reports promising GLP-1 blocker results while Summit faces survival setbacks and Definium shows anxiety therapy benefit
    Amylyx said its investigational GLP-1 blocker avexitide cut the combined rate of level 2 and level 3 hypoglycemic events by about 55% in patients with post‑bariatric hypoglycemia, beating analyst e…
    BioSpace · 26d agoNeutral↗ source
  • LabCentral partners with Hong Kong Science and Technology Parks to link biotech founders across US and China
    LabCentral, a Massachusetts biotech accelerator, signed a memorandum of understanding with Hong Kong Science and Technology Parks Corporation (HKSTP) in June at the BIO International Convention. T…
    BioSpace · 26d agoDealPositive↗ source
  • Why Biopharma Executives Should Hire an ‘Implementer’ to Turn Ideas into Action
    Leadership Lab is a new column aimed at biopharma leaders facing real‑world pressures. In the opening piece, Michael Pietrack of Kaye/Bassman International argues that the most valuable hire for an…
    BioSpace · 26d agoPositive↗ source
  • 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 · 26d 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 · 26d agoDealNegative↗ 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 · 27d agoRegulatoryNegative↗ 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 · 27d agoNegative↗ source
  • FDA releases discussion paper seeking input on regulation of generative AI medical devices
    The U.S. Food and Drug Administration issued a discussion paper outlining considerations for regulating generative AI-enabled medical devices and asked stakeholders to provide feedback. The paper…
    fda press · 27d agoRegulatoryNeutral↗ 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 · 27d 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 · 27d 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 · 27d 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 · 27d 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 · 27d 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 · 27d 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 · 27d agoDealNeutral↗ 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 · 27d 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 · 27d 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 · 27d 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 · 27d 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 · 27d agoNegative↗ source