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2,344 stories matching this filter · ← front page

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  • Ono Pharma’s endocannabinoid drug ONO-1110 fails five Phase 2 trials, prompting broader concerns
    Ono Pharma reported that its experimental endocannabinoid modulator ONO-1110 did not achieve the primary efficacy endpoint in five separate Phase 2 clinical trials. The failures span multiple indi…
    Endpoints · 11d agoNegative readoutNegative↗ source
  • Genmab shares climb after head-and-neck cancer data as Iovance and Coherus stocks fall
    Genmab's shares moved higher after the company released data from a head‑and‑neck cancer trial, which investors interpreted as a positive signal for the drug's potential. In contrast, Iovance and…
    Endpoints · 11d agoPositive readoutNeutral↗ source
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  • Big tech and startups are building personal AI agents to analyze patients’ medical records
    In a recent column the author notes that personal artificial-intelligence agents are poised to enter the healthcare arena. Large technology firms and emerging startups are creating platforms that…
    Endpoints · 11d agoNeutral↗ source
  • Anthropic outlines biopharma strategy ahead of potential record-size IPO
    Anthropic, the AI startup that recently filed paperwork for what could become the largest initial public offering in business history, used its AI Day event to detail its biopharma ambitions. The…
    Endpoints · 11d agoNeutral↗ source
  • Flagship Pioneering merges three portfolio companies to boost AI drug discovery
    Flagship Pioneering, a biotech incubator based in Cambridge, Massachusetts, announced it is merging three of its portfolio companies into a single organization. The consolidation includes a compan…
    Endpoints · 11d agoDealPositive↗ source
  • Flagship Pioneering merges three biotech startups to launch AI-driven drugmaker Etcelera
    Flagship Pioneering announced the creation of Etcelera Therapeutics by merging three of its portfolio companies - Etiome, Cellarity and Empress Therapeutics. The new venture will combine artificia…
    BioPharma Dive · 11d agoDealPositive↗ source
  • FDA approves Stada's Lucentis biosimilar; Lilly claims its triple-G candidate outperforms Ozempic in diabetes
    The U.S. Food and Drug Administration has granted approval for Stada's biosimilar version of Lucentis, expanding treatment options for eye diseases. Lilly announced that its experimental "triple‑G…
    raps · 11d agoApprovalPositive↗ source
  • EMA and African regulator issue joint guidance to accelerate Ebola vaccine trials
    The European Medicines Agency and its African counterpart have released a joint position paper aimed at facilitating Ebola vaccine research. The guidance is intended to help launch clinical trials…
    raps · 11d agoRegulatoryPositive↗ source
  • Eli Lilly leans on cash-pay model to grow obesity drug sales in US and overseas
    Eli Lilly has observed that patients in the United States are prepared to pay several hundred dollars each month for treatments targeting obesity. The company has focused on a cash-pay approach, s…
    Endpoints · 11d agoNeutral↗ source
  • Dren Bio secures $350 million to advance blood-cancer therapy toward 2027 launch
    Dren Bio, a California biotech firm, announced it has closed a financing round that raised $350 million. The funding will be directed toward developing its lead blood‑cancer drug, with the company…
    Endpoints · 11d agoDealPositive↗ source
  • HHS issues interim policy allowing compounding of six unapproved peptides under set conditions
    HHS announced an interim policy that will not take enforcement action against state-licensed pharmacies, federal facilities, or licensed physicians that compound six unapproved peptide bulk drug su…
    raps · 11d agoRegulatoryNeutral↗ source
  • FDA issues revised draft guidance for drug-device combination product performance
    The U.S. Food and Drug Administration has released a revised draft guidance aimed at helping sponsors of drug-device combination products develop essential drug delivery device performance characte…
    raps · 11d agoRegulatoryNeutral↗ source
  • HHS to allow compounders to make 6 unapproved peptides
    RFK Jr. has given notice that the agency won’t take enforcement action on six peptides that controversially won a contested recommendation from outside advisers to the FDA in July.
    BioPharma Dive · 11d ago↗ source
  • 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 · 12d 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 · 12d agoNegative readoutNegative↗ 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 · 12d agoRegulatoryNegative↗ 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 · 12d 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 · 12d 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 · 12d 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 · 12d 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 · 12d agoNeutral↗ 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 · 12d 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 · 12d 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 · 12d agoDealNeutral↗ 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 · 12d agoRegulatoryNeutral↗ source