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  • Trump nominates Heidi Overton as FDA commissioner, known for criticism of vaccine mandates and abortion pills
    President Donald Trump announced Heidi Overton as his nominee for FDA commissioner, marking the start of a new chapter for the agency. Overton has previously voiced criticism of vaccine requiremen…
    Endpoints · 2mo agoRegulatoryNeutral↗ source
  • Trump administration eyes Heidi Overton as next FDA commissioner
    President Donald Trump is reported to be preparing a nomination for Heidi Overton to become the next commissioner of the Food and Drug Administration, according to multiple news outlets. Overton i…
    BioPharma Dive · 2mo agoRegulatoryNeutral↗ source
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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 · 2mo agoPositive readoutPositive↗ source
  • Trump nominates White House aide Heidi Overton as FDA commissioner
    President Donald Trump announced his intent to nominate Heidi Overton, M.D., Ph.D., a current White House aide, to lead the Food and Drug Administration. Overton earned her medical degree from the…
    Fierce Biotech · 2mo agoRegulatoryNeutral↗ source
  • Tolerance Bio secures up to $260 M for thymus‑targeting fusion protein, moves into Phase 2 trials
    Tolerance Bio, a Philadelphia biotech founded in October 2024, has signed a licensing agreement to acquire rights to NeoImmuneTech’s long‑acting IL‑7 fusion protein, efineptakin alfa, for up to $26…
    Fierce Biotech · 2mo agoDealPositive↗ 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 · 2mo agoRegulatoryNeutral↗ source
  • 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 · 2mo 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 · 2mo agoNeutral↗ source
  • Merck partners with Sarah Cannon to accelerate community oncology trials
    Merck & Co. has entered a collaboration with the Sarah Cannon Research Institute to expand patient access to oncology trials at community sites across the United States. The partnership will use S…
    Fierce Biotech · 2mo agoDealPositive↗ source
  • Biotech and Academia Explore New Partnership Models to Boost Drug Development
    The article notes that declining alternative funding and a drop in research grants are forcing biotech companies and universities to rethink how they collaborate. At the 2026 Chief Medical Officer…
    Fierce Biotech · 2mo agoPositive↗ source
  • Emerging Biotechs Can Speed Development with Tailored Global Trial Strategies, Panel Says
    A panel of biotech chief medical officers and CRO executives discussed how small biotechs can accelerate clinical development by using fit-for-purpose global trial designs. They highlighted both t…
    Fierce Biotech · 2mo agoNeutral↗ source
  • Pharma execs discuss how to evaluate biotech partners and acquisition targets
    A recent CMO Summit 360° webcast brought together biotech chief medical officers and pharma representatives to talk about how pharma teams assess biotech companies for partnerships or acquisitions.…
    Fierce Biotech · 2mo agoNeutral↗ source
  • Amgen ends $500M Crohn’s disease collaboration with TScan, but TScan says pipeline strategy stays on track
    Amgen has terminated its collaboration with TScan Therapeutics that was aimed at Crohn’s disease, ending a deal that could have delivered up to $500 million in milestones. The partnership began in…
    Fierce Biotech · 2mo agoDealNeutral↗ 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 · 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
  • 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
  • Merck and Moderna’s personalized mRNA vaccine shows longer recurrence-free survival in phase 3 melanoma trial
    Merck and Moderna reported that their individualized mRNA cancer vaccine, given together with Keytruda, extended the time patients remained free of melanoma recurrence in a late-stage study. The p…
    Fierce Biotech · 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
  • Merck partners with Sarah Cannon to accelerate community oncology trials
    Merck and Sarah Cannon Research Institute announced a collaboration to improve patient access to oncology trials at community sites across the United States. The partnership will use SCRI’s Accele…
    Fierce Biotech · 2mo agoDealPositive↗ 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
  • BioMarin to acquire Alesta Therapeutics for $275 million to expand bone disease pipeline
    BioMarin Pharmaceutical announced it will purchase Alesta Therapeutics for an upfront payment of $275 million. Alesta is developing an oral small-molecule drug, ALE1, aimed at treating hypophospha…
    Fierce Biotech · 2mo agoDealPositive↗ source
  • Craif raises $33M to expand its urine-based pancreatic cancer test
    AI biopharma Craif announced a $33 million Series D financing, bringing its total capital raised to $88 million. The funding will be used to scale research on its urine-based microRNA test, miSign…
    Fierce Biotech · 2mo agoDealNeutral↗ source
  • J&J MedTech secures FDA 510(k) clearance for Monarch Quest 3 bronchoscopy software update
    Johnson & Johnson MedTech announced that its Monarch bronchoscopy robot has received FDA 510(k) clearance for the latest software version, Monarch Quest 3. This marks the fourth major software laun…
    Fierce Biotech · 2mo agoRegulatoryPositive↗ 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