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3,063 stories matching this filter · ← front page

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  • FDA outlines pathway for approval of personalized gene-editing therapies
    The U.S. Food and Drug Administration released a set of recommendations describing how developers can pursue regulatory approval for gene-editing treatments that are customized to a single patient’…
    Endpoints · 13d agoRegulatoryNeutral↗ source
  • AstraZeneca’s heart drug Wainua fails late-stage trial, raising 2027 outlook concerns
    AstraZeneca announced that its experimental heart disease therapy, Wainua, did not meet primary endpoints in a Phase III trial conducted in July. The failure is a setback for the company, whose pi…
    Endpoints · 13d agoNegative readoutNegative↗ source
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  • Biogen sees continued revenue growth and pipeline readouts, M&A not essential, CEO says
    Biogen reported third‑quarter earnings, marking a third straight quarter of revenue growth driven by its marketed products. The increase stemmed from higher sales of the Alzheimer’s therapy Leqemb…
    BioSpace · 13d agoEarningsPositive↗ source
  • Pfizer shuts India cancer drug plant for up to two years, worsening drug shortages
    Pfizer has temporarily closed a manufacturing site in India that produces several cancer medicines. The company says the facility will remain idle for as long as two years while it addresses the i…
    Endpoints · 13d agoRegulatoryNegative↗ source
  • Biogen posts third consecutive quarter of revenue growth, driven by Leqembi, Spinraza and Apellis products
    Biogen reported $2.8 billion in revenue for the third quarter, marking its third straight period of top‑line growth. The company credited its growth portfolio, led by the Alzheimer’s therapy Leqem…
    BioSpace · 13d agoEarningsPositive↗ source
  • Five newly approved drugs achieve strong launches by offering superior efficacy, pricing and access
    Over the past year several newly approved therapies have entered the market with sales and uptake that far exceed analyst expectations, driven by strong clinical data, reasonable pricing and easy p…
    BioSpace · 13d agoPositive↗ source
  • Biotech firms must adopt global regulatory strategies to commercialize drugs independently
    Biotech developers are increasingly able to fund the pursuit of regulatory approval and commercial launch on their own, rather than selling their assets early. This new option is driven by a reboun…
    BioSpace · 13d agoRegulatoryPositive↗ source
  • Formation Bio raises $600 million fund to expand AI-driven drug licensing and testing model
    Formation Bio, an AI-focused biotech that builds value by acquiring external drug assets, developing them and then transferring them to partners, announced a new financing round. The company secur…
    Endpoints · 13d agoDealPositive↗ source
  • Analysts Question Biogen's Lupus Drug Litifilimab Ahead of Key Phase 3 Readouts
    Analysts pressed Biogen CEO Chris Viehbacher during a recent call, focusing on the company's late‑stage pipeline. The discussion centered on litifilimab, Biogen’s experimental lupus therapy, with…
    Endpoints · 13d agoNeutral↗ source
  • FDA releases draft guidance to streamline approval of personalized gene therapies
    The FDA announced a draft guidance aimed at expanding access to gene therapies that target different mutations within the same disease. The proposal outlines an "individualized feature space" that…
    BioPharma Dive · 13d agoRegulatoryPositive↗ source
  • Chinese biotech BioGeometry secures over $100 million Series A for AI-driven protein design
    BioGeometry, a four-year-old biotech startup based in Beijing, announced it has closed a Series A financing round of more than $100 million. The capital will be used to expand its artificial-intel…
    Endpoints · 13d agoDealPositive↗ source
  • Eli Lilly to merge U.S. and international units after exec retirement; Novartis records $1.9B impairment on failed Avidity drug
    Eli Lilly announced that its U.S. and international divisions will be combined into a single unit called "Lilly Global Markets" after the retirement of long‑time executive Patrik Jonsson at the end…
    BioPharma Dive · 13d agoNeutral↗ source
  • Merck and Moderna vaccine data leak ahead of ESMO, Merck's sac-TMT cuts endometrial cancer deaths, BMS reports CAR-T death
    A data leak of the highly anticipated personalized cancer vaccine being developed by Merck and Moderna surfaced online before the European Society for Medical Oncology (ESMO) meeting. The premature…
    BioSpace · 13d agoNeutral↗ source
  • Former Novo and Sanofi staff describe mixed layoff experiences, citing severance benefits and poor communication
    Three former employees of large pharmaceutical companies, including Novo and Sanofi, spoke to BioSpace about how they were let go. Their accounts form part of a broader survey that collects layoff…
    BioSpace · 13d agoLayoffsNegative↗ source
  • Zocdoc pushes AI personal agents into healthcare as other sectors restrict their use
    Zocdoc is positioning AI personal agents to take on patient‑focused tasks, signaling a new direction for health‑tech services. While Amazon, Delta Air Lines and several major U.S. banks have block…
    Endpoints · 13d agoPositive↗ source
  • Survey finds 78% of scientists expect AI to accelerate drug discovery this year
    Endpoints Signal surveyed roughly 1,500 biopharma insiders about AI's near-term impact on drug discovery. The respondents included a broad mix of industry roles. While scientists had been the most…
    Endpoints · 13d agoPositive↗ source
  • Astellas secures exclusive option on Audax Biosciences preclinical IL-12 cancer drug
    Astellas has taken an exclusive option to license a preclinical immuno-oncology asset from Audax Biosciences, an Australian biotech company. The asset is an IL-12 based cancer therapeutic that is…
    Endpoints · 13d agoDealNeutral↗ source
  • GSK vaccine sales miss expectations amid falling demand from adults
    With pressure on GSK’s vaccine business, analysts predict the U.K. pharma will face challenges as it prepares for the loss of exclusivity on a key product.
    BioSpace · 13d agoRegulatoryNeutral↗ source
  • FDA issues draft guidance for electronic IDE submissions via eSTAR
    The U.S. Food and Drug Administration released draft guidance outlining how sponsors can submit investigational device exemption (IDE) applications using the electronic Submission Template and Reso…
    raps · 13d agoRegulatoryNeutral↗ source
  • HHS pauses enforcement of ban on compounding wellness peptides as FDA drafts new rules
    HHS announced it will temporarily stop enforcing the existing prohibition on the compounding of certain peptides marketed for wellness. The agency said the move is intended to protect consumer saf…
    Endpoints · 13d agoRegulatoryNeutral↗ source
  • Biopharma leader urged to prioritize own job search after team layoffs
    A biopharma executive recently had to announce a downsizing of her team, and she described feeling guilt and grief for the impact on her direct reports. She said she would wait until every person…
    BioSpace · 13d agoLayoffsNeutral↗ source
  • Genmab’s cancer bispecific delivers early survival win in ‘exceedingly positive’ Phase 3 readout
    Analysts hailed the Phase 3 head and neck cancer results as a big victory for an asset central to Genmab’s growth plans.
    BioSpace · 13d ago↗ source
  • Lilly’s ‘triple-G’ drug tops Novo’s Ozempic in diabetes trial
    The highest dose of retatrutide beat Ozempic on measures of blood sugar and weight loss, but was also associated with higher side effect rates and treatment discontinuations.
    BioPharma Dive · 13d ago↗ source
  • Lilly’s retatrutide trounces Novo’s Ozempic in diabetes, weight loss
    Eli Lilly’s next-gen weight loss drug retatrutide soundly beat Novo’s approved medicine Ozempic in weight loss and blood sugar reduction, padding the case for a regulatory application that’s expect…
    BioSpace · 13d ago↗ source
  • Lilly's triple-G drug retatrutide outshines Novo's Ozempic in diabetes
    Eli Lilly’s retatrutide, the incretin shot that has already proven its effectiveness against other assets on a cross-trial basis, has cemented its utility in a head-to-head trial, albeit in diabete…
    Endpoints · 13d ago↗ source