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  • Key Biopharma Conferences to Watch in 2027 Highlight Industry Trends
    The article lists major medical meetings slated for 2027 that serve as platforms for companies to present clinical data and network. Highlights include the J.P. Morgan Healthcare Conference in ear…
    BioPharma Dive · 1mo agoNeutral↗ source
  • WHO releases updated draft guideline to strengthen quality risk management for manufacturers and regulators
    The World Health Organization has issued an updated draft guideline designed to help manufacturers establish effective quality risk management systems and to aid regulators in planning inspections.…
    raps · 1mo agoRegulatoryNeutral↗ source
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  • Season 2 of The Progress Profile podcast spotlights Alzheimer’s research and patient-centered trial design
    The Progress Profile: Alzheimer’s Research in Focus returns for a second season, offering conversations about Alzheimer’s disease and brain health. In the premiere episode, Dr. John Harrison, Dr.…
    BioPharma Dive · 1mo agoNeutral↗ source
  • Secretive new issue links diverse groups, raises concerns for pharma industry
    The article, dated October 6, 2026, was written by senior reporter Max Bayer and carries the title “In DC, a secretive new thorn has appeared in pharma’s side.” It notes that the Seattle Latino Ch…
    Endpoints · 1mo agoNegative↗ source
  • Vaxcyte's experimental pneumococcal vaccine VAX-31 meets Phase 3 endpoints, shares jump 35%
    Vaxcyte announced that its experimental pneumococcal vaccine VAX-31 achieved its primary objectives in a Phase 3 trial involving adult participants. The trial results showed that the vaccine met t…
    Endpoints · 1mo agoPositive readoutPositive↗ source
  • Vaxcyte's next-gen pneumococcal vaccine matches leading shots in Phase 3 trial
    Vaxcyte reported that its experimental pneumococcal vaccine, VAX-31, achieved its primary efficacy goals in the first of three Phase 3 studies. In adults aged 50 and older, the vaccine performed o…
    BioPharma Dive · 1mo agoPositive readoutPositive↗ source
  • Nobel Prize honors optogenetics pioneers; Roche licenses Alector’s Parkinson’s enzyme therapy
    The Nobel Committee awarded this year’s Physiology or Medicine prize to three scientists whose work created the field of optogenetics. Their discoveries of a light‑sensing protein in algae and its…
    BioPharma Dive · 1mo agoDealPositive↗ source
  • Shionogi to acquire Texas-based IntraBio for $2 billion, adding marketed rare-disease drug Aqneursa
    Shionogi announced Monday it will buy IntraBio, a Texas biotech, for $2 billion in cash, making IntraBio a wholly owned subsidiary of its U.S. division. The deal gives Shionogi ownership of Aqneur…
    BioPharma Dive · 1mo agoDealPositive↗ source
  • Shionogi agrees $2 billion upfront purchase of IntraBio, adding oral rare-disease drug Aqneursa to its portfolio
    Shionogi announced it will acquire Austin-based biotech IntraBio for $2 billion paid upfront. The deal brings IntraBio’s oral therapy Aqneursa into Shionogi’s rare‑disease pipeline, expanding its…
    Endpoints · 1mo agoDealPositive↗ source
  • AI drives faster drug development and reshapes biopharma manufacturing facilities
    AI is speeding up the identification of drug candidates, turning years of laboratory work into months by analyzing large biological datasets and accelerating early‑stage development. This accelera…
    BioPharma Dive · 1mo agoPositive↗ source
  • Leerink analyst downgrades Bristol Myers over pipeline concerns
    A Leerink analyst signaled new bearishness on Bristol Myers Squibb, downgrading the company's stock rating. Analyst David Risinger moved the rating from outperform to a lower stance, saying he is…
    Endpoints · 1mo agoNegative↗ source
  • Genmab reports 45.9% response rate for FRα‑directed ADC in platinum‑resistant ovarian cancer; Lilly expands Jaypirca label
    Genmab presented new data on its FRα‑targeted antibody‑drug conjugate Rina‑S in patients with platinum‑resistant ovarian cancer. In the trial, the ADC achieved an objective response rate of 45.9%,…
    Endpoints · 1mo agoPositive readoutPositive↗ source
  • Roche signs $100 million upfront deal with Alector to advance Parkinson's research
    Roche announced a partnership with biotech Alector focused on neuroscience and Parkinson's disease, providing an upfront cash payment of $100 million. The agreement aims to combine Roche's resourc…
    Endpoints · 1mo agoDealPositive↗ source
  • Nobel prize honors scientists who pioneered light-activated gene therapy technology
    Three researchers received this year’s Nobel Prize in medicine for creating optogenetics, a technique that uses light to steer nerve activity. The award recognizes their foundational work that has…
    Endpoints · 1mo agoPositive↗ source
  • Sensible Bio raises $47 million Series A to build mRNA therapy manufacturing platform
    Sensible Biotechnologies announced it has closed a $47 million Series A financing round. The capital will be used to develop its proprietary manufacturing platform for mRNA based therapies. The fu…
    Endpoints · 1mo agoDealPositive↗ source
  • Epicrispr reports encouraging early data from EPI-321 in 12 patients with FSHD
    Epicrispr Biotechnologies released updated data on its epigenetic editing therapy EPI-321 aimed at treating facioscapulohumeral muscular dystrophy (FSHD). The company has now dosed twelve particip…
    Endpoints · 1mo agoPositive readoutPositive↗ source
  • CSL agrees $355M upfront deal to co-develop Alentis anti-fibrosis drug for kidney and liver
    CSL, an Australian drugmaker, announced a partnership with Alentis Therapeutics that includes a $355 million upfront payment. Under the agreement, CSL will co-develop Alentis's anti-fibrosis candi…
    Endpoints · 1mo agoDealNeutral↗ source
  • FDA delays review of Novo's hemophilia A drug denecimig over factory issues
    US regulators have extended the review of Novo's hemophilia A injection, denecimig, because of problems at an unnamed manufacturing facility. The FDA said ongoing remediation activities observed d…
    Endpoints · 1mo agoRegulatoryNegative↗ source
  • Diagnostic-driven therapies face patient loss due to workflow gaps, new commercialization model proposed
    The sponsored article from Diaceutics highlights that while diagnostic-driven therapies are being developed faster than ever, many patients who could benefit never receive them. The authors attribu…
    BioPharma Dive · 1mo agoNeutral↗ source
  • FDA warns Evolus over misleading Instagram claims about Jeuveau
    The FDA's Office of Prescription Drug Promotion sent an untitled warning letter to Evolus, the maker of the injectable cosmetic product Jeuveau. The letter says the company exaggerated the drug’s…
    raps · 1mo agoRegulatoryNegative↗ source
  • Bayer to invest $2.2B in new Ohio manufacturing complex as FDA CDER opens clinical trial modernization office
    Bayer announced plans to spend roughly $2.2 billion on a new manufacturing site in Ohio, aiming to broaden its production capabilities. The investment is projected to increase capacity and generat…
    raps · 1mo agoRegulatoryNeutral↗ source
  • FDA Requests Public Feedback on Designing Early-Phase Trials for Psychedelic Drug Ibogaine
    The U.S. Food and Drug Administration announced it is seeking comments from the public on how to structure early-phase clinical studies of ibogaine, a plant-derived psychoactive compound. The agen…
    raps · 1mo agoRegulatoryNeutral↗ source
  • Genentech parts ways with global AI head Richard Bonneau
    Genentech, the Roche biotech unit, announced that its global head of artificial intelligence for drug discovery, computational biologist Richard Bonneau, has left the company effective immediately.…
    Endpoints · 1mo agoNegative↗ source
  • FDA issues request for information on early-phase ibogaine trial design
    The FDA announced a request for information (RFI) to gather input on how to design early-phase clinical trials of ibogaine drug products. The agency is looking for comments on protocol elements su…
    fda press · 1mo agoRegulatoryNeutral↗ source
  • Australia's TGA begins five-year transition to new medicine labeling standards
    The Therapeutic Goods Administration has adopted two new labeling standards for medicines in Australia. The standards will become mandatory after a five-year transition period that starts now. Ph…
    raps · 1mo agoRegulatoryNeutral↗ source