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  • Takeda R&D chief Andy Plump to retire in 2027 as Novo Nordisk names Alex Hoffman global research head
    Takeda announced that its head of research and development, Andy Plump, will step down in June 2027. Plump, who joined Takeda from Sanofi in 2015 and has led R&D since December 2018, will retire af…
    Endpoints · 2mo agoNeutral↗ source
  • FDA leadership stabilizes under new CBER and CDER heads and appoints first AI deputy commissioner
    At the Food and Drug Administration, Karim Mikhail and Michael Davis have been confirmed as the permanent heads of the Center for Biologics Evaluation and Research and the Center for Drug Evaluatio…
    BioSpace · 2mo agoRegulatoryPositive↗ source
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  • Alzheon seeks up to $500M in new financing after Phase 3 setback for Alzheimer’s drug
    Alzheon, a biotech based in Framingham, Massachusetts, has been pursuing an Alzheimer’s therapy for more than a decade. Its lead candidate recently failed to achieve the primary goals in a Phase 3…
    Endpoints · 2mo agoDealNeutral↗ source
  • FDA plans study on barriers to women's enrollment in pregnancy exposure registries and announces PRV fee rates
    The Food and Drug Administration said it will conduct research into perceived barriers that limit women’s participation in pregnancy exposure registries. It also released the fee schedule for prio…
    raps · 2mo agoRegulatoryNeutral↗ source
  • FDA grants three-month review extension for Exelixis' metastatic colorectal cancer candidate
    Exelixis, a California drug developer, has provided the FDA with additional safety and efficacy data for its experimental therapy aimed at treating metastatic colorectal cancer. The agency respond…
    Endpoints · 2mo agoRegulatoryNeutral↗ source
  • BioSpace to Host Webinar on Using Podcasts, Webinars and Thought Leadership for Pharma Marketing
    BioSpace announced a webinar that will walk PR, communications and marketing teams through the use of podcasts, webinars and thought‑leadership programs to raise executive visibility in biotech and…
    BioSpace · 2mo agoNeutral↗ source
  • Whole Foods recalls Cabricharme cheese after undisclosed egg protein found
    Whole Foods Market announced a recall of its Fromagerie Coop de Mean Cabricharme cheese after testing revealed the presence of egg lysozyme, an egg-white protein that was not listed on the label.…
    fda recalls · 1mo agoRegulatoryNegative↗ source
  • Encoded Therapeutics secures $275M Series F to advance gene therapy for Dravet syndrome
    Encoded Therapeutics announced a $275 million Series F financing round aimed at moving its lead gene‑therapy candidate, ETX101, toward pivotal trials for Dravet syndrome. In the ongoing Phase 1/2…
    BioSpace · 2mo agoDealPositive↗ source
  • FDA signals openness to innovative trial designs for psychedelic therapies
    FDA regulators said they are willing to consider more flexible approaches for evaluating psychedelic medicines. The agency noted that studies could use active comparators instead of placebo, which…
    Endpoints · 2mo agoRegulatoryPositive↗ source
  • FDA pauses enrollment in Biohaven's epilepsy trials after earlier depression trial failure
    FDA placed a partial clinical hold on Biohaven's Kv7 potassium channel agonist, BHV-7000 (opakalim), halting enrollment of new patients in two late-stage focal epilepsy studies. The pause follows…
    BioSpace · 2mo agoRegulatoryNegative↗ source
  • Shionogi's mid-stage stroke drug redasemtide fails, while Bayer's Hyrnuo receives expanded NSCLC label
    Shionogi reported that its experimental stroke therapy redasemtide did not achieve the primary endpoint in a mid-stage clinical trial, marking a setback for the company’s neurology pipeline. The f…
    Endpoints · 2mo agoNegative readoutNeutral↗ source
  • ARPA-H launches ADVOCATE program to fund AI agents for health tech companies
    ARPA-H, the federal agency that funds breakthrough health technologies, announced the start of a new initiative called ADVOCATE. The program will award millions of dollars in grants to health-tech…
    Endpoints · 2mo agoPositive↗ source
  • FDA imposes partial clinical hold on Biohaven's experimental epilepsy drug BHV-7000
    FDA announced a partial clinical hold on Biohaven's ion channel program, affecting the epilepsy trial of the experimental drug BHV-7000. The hold was issued after the agency requested additional p…
    Endpoints · 2mo agoRegulatoryNegative↗ source
  • Drugmakers Rethink Launch Strategies as MFN Pricing Rules Shake Market
    A new Numerof & Associates report says that the rollout of Most Favored Nation (MFN) pricing rules is forcing drugmakers to overhaul how they choose launch markets. Executives surveyed said the Un…
    BioSpace · 2mo agoRegulatoryNegative↗ source
  • BridgeBio Oncology shares tumble 24% as it narrows KRAS program focus
    BridgeBio Oncology Therapeutics saw its stock drop sharply after announcing a strategic shift. The company said it will scale back its broader pipeline to concentrate resources on its lead KRAS in…
    Endpoints · 2mo agoNegative↗ source
  • Pharma investment in UK rises as government increases drug pricing and engagement
    The UK trade group says pharmaceutical investment is picking up after a lull last year. The uptick follows recent government steps to raise reimbursement rates for medicines and to foster closer c…
    Endpoints · 2mo agoRegulatoryPositive↗ source
  • FDA proposes 50% fee cut for US early-stage trials, but industry says speed matters more
    The FDA announced a proposal to cut the application fee by half for drugs that run their early-stage trials in the United States. The reduction, about $2.3 million at current rates, is intended to…
    BioSpace · 2mo agoRegulatoryNegative↗ source
  • UK issues AI-in-medicine regulatory recommendations; FDA pauses new enrollment in Biohaven epilepsy trials
    The United Kingdom has released a set of recommendations aimed at governing the use of artificial intelligence in medical applications. The guidance outlines how AI tools should be evaluated and mo…
    raps · 2mo agoRegulatoryNeutral↗ source
  • Takeda R&D chief Andy Plump to retire in June 2027 after 12-year tenure
    Takeda announced that its longstanding head of research and development, Andy Plump, will step down and retire in June 2027. Plump has been with the Japanese drugmaker for about 12 years, leading…
    BioSpace · 2mo agoNeutral↗ source
  • Lonza announces new spray-drying plant in Bend, Oregon as Samsung Bio secures $262 million contract
    Lonza announced plans to construct a new commercial spray-drying facility in Bend, Oregon, expanding its manufacturing footprint in the United States. The plant will increase Lonza’s capacity to p…
    Endpoints · 2mo agoPositive↗ source
  • Tyra Biosciences shares tumble as bladder cancer pill shows lower-than-expected complete response
    Tyra Biosciences presented Phase 2 SURF302 data for its investigational oral drug dabogratinib in patients with low‑grade intermediate‑risk non‑muscle invasive bladder cancer. The trial reported th…
    BioSpace · 2mo agoNegative readoutNegative↗ source
  • August 2026 biopharma layoffs affect just over 500 workers, a 90% drop from a year earlier
    In August 2026, twelve biotech and pharmaceutical firms announced workforce reductions, impacting a total of about 526 employees. This represents a sharp 90% decline in the number of people affecte…
    BioSpace · 2mo agoLayoffsNegative↗ source
  • FDA signals openness to innovative approaches for psychedelic drug development
    FDA officials said the agency is open to novel, innovative approaches to the clinical development of psychedelic drugs, citing the worsening mental health crisis in the United States. The agency’s…
    raps · 2mo agoRegulatoryNeutral↗ source
  • Biotech industry rebounds as Endpoints 11 awards return in Boston
    The article notes that the Endpoints 11 awards will be unveiled in Boston on the night of September 24, marking the event’s return after a period of industry slowdown. It reflects on how the biote…
    Endpoints · 2mo agoNeutral↗ source
  • EMA revises GVP inspection guideline to incorporate new subcontractor rules
    The European Medicines Agency has issued an update to its guideline on good pharmacovigilance practice inspections. The revision aligns the guidance with recent changes to the rules governing subco…
    raps · 2mo agoRegulatoryNeutral↗ source