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3,173 stories matching this filter · ← front page

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  • Sanofi sues Pfizer and Moderna over alleged infringement of mRNA delivery patents
    Sanofi has filed a lawsuit against Pfizer and Moderna, accusing the two companies of violating its patents covering lipid nanoparticle technology used to deliver mRNA in vaccines. The French drugm…
    Endpoints · 3mo agoRegulatoryNegative↗ source
  • Eli Lilly to acquire AtaiBeckley for $2.8 billion, signaling deeper bet on psychedelics
    Eli Lilly announced on Thursday that it will acquire psychedelic drug developer AtaiBeckley. The purchase price is set at $2.8 billion paid upfront. The sizable upfront payment highlights Lilly's…
    Endpoints · 3mo agoDealPositive↗ source
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  • Cue Biopharma appoints Dominic Borie as chief medical officer and head of R&D
    Cue Biopharma announced the hiring of Dr. Dominic Borie, MD, PhD, as its new chief medical officer and head of research and development. Borie joins from Kyverna Therapeutics, where he served as a…
    Fierce Biotech · 3mo agoPositive↗ source
  • Kelun-Biotech reports first-line success of Merck-partnered ADC sacituzumab tirumotecan in China
    Kelun-Biotech announced that its antibody‑drug conjugate sacituzumab tirumotecan, developed in partnership with Merck, achieved its primary efficacy endpoints when used as a first‑line therapy in a…
    Endpoints · 3mo agoPositive readoutNeutral↗ source
  • Khong Guan recalls glutinous rice balls with black sesame filling over possible undeclared peanuts
    Khong Guan Corporation announced a recall of certain lots of its Glutinous Rice Balls with Black Sesame Filling after discovering they may contain undeclared peanuts. The product, sold in 14.1‑oz…
    fda recalls · 3mo agoRegulatoryNegative↗ source
  • ‘Substantially better than before’: Why India has golden opportunity to build on innovative R&D wins
    A string of recent wins on the frontiers of novel drug development could mean that a homegrown innovation industry is within reach.
    Fierce Biotech · 3mo agoNeutral↗ source
  • Reporter attends AHA Leadership Summit in Denver to gauge hospital executives' priorities
    The author attended the American Hospital Association’s Leadership Summit in downtown Denver earlier this week. While there, the author handed out ice cream recommendations to attendees. The prim…
    Endpoints · 3mo agoNeutral↗ source
  • Merck-Kelun ADC sac-TMT shows progression-free survival benefit with Keytruda in late-stage NSCLC trial
    Kelun-Biotech announced that its antibody‑drug conjugate sac‑TMT, developed with Merck, achieved positive Phase 3 results when paired with Keytruda in a non‑small cell lung cancer trial. The data…
    BioSpace · 4mo agoPositive readoutPositive↗ source
  • J&J restructures pharma supply chain, offloading sites as part of $55 B U.S. manufacturing push
    Johnson & Johnson announced it is restructuring its pharmaceutical supply chain, offloading certain sites to streamline operations as part of its $55 billion U.S. manufacturing initiative. The cha…
    BioSpace · 4mo agoPositive↗ source
  • FDA acting chief says two journal articles by former commissioner do not represent agency policy
    Acting FDA Commissioner Kyle Diamantas announced that the agency is reversing its earlier position regarding two medical‑journal articles authored by former commissioner Marty Makary. The FDA now…
    Endpoints · 4mo agoRegulatoryNeutral↗ source
  • Johnson & Johnson to spend up to $750 million restructuring pharma manufacturing and closing plants
    Johnson & Johnson announced it will incur up to $750 million as it reshapes its pharmaceutical manufacturing network. The plan involves exiting certain factories and consolidating production, aimi…
    Endpoints · 4mo agoNeutral↗ source
  • Nobel laureate Jennifer Doudna unveils AI-driven platform to design novel gene‑editing enzymes
    Jennifer Doudna, the Nobel laureate who co‑invented CRISPR, announced a new AI‑powered platform for creating gene‑editing proteins in a paper published today in Science. The system uses computation…
    Fierce Biotech · 4mo agoPositive↗ source
  • Lonza urges biotech firms to prioritize early de-risking to streamline IND path
    In a recent interview, Jaime Okray of Lonza highlighted that emerging biotech companies are shifting focus from pure speed to early identification of development risks as they aim for an IND filing…
    Fierce Biotech · 4mo agoPositive↗ source
  • AdvanCell secures $315M Series D to advance lead-based prostate cancer therapy
    AdvanCell announced a $315 million Series D financing round aimed at supporting development of its lead-based prostate cancer agent and expanding U.S. manufacturing capacity for the radioactive tre…
    Endpoints · 4mo agoDealPositive↗ source
  • Agentic AI poised to reshape clinical development by moving beyond tools to autonomous decision-making
    Earlier this year, a colleague argued that clinical leaders should stop asking whether they have an 'AI strategy', because the question often leads to the wrong conversation. Instead, leaders are…
    Fierce Biotech · 4mo agoPositive↗ source
  • J&J reports 18,000 new prescriptions for Icotyde in first full quarter
    Johnson & Johnson gave an update on the launch of its plaque-psoriasis drug Icotyde. The company said that in its first full quarter on the market, Icotyde generated about 18,000 new prescriptions…
    Endpoints · 4mo agoPositive readoutPositive↗ source
  • Nava Therapeutics raises $89 million to advance lipid nanoparticle platform targeting bone marrow, immune cells and kidney
    Nava Therapeutics, a stealth-mode biotech, announced it has secured $89 million in financing, according to a statement to Endpoints News. The capital will support development of a next generation…
    Endpoints · 4mo agoDealPositive↗ source
  • Braveheart Bio seeks Nasdaq listing to finance Phase 3 trial of Hengrui rival cardio drug
    Braveheart Bio announced it has filed for an initial public offering on the Nasdaq exchange. The company says the capital raised will be used to fund a Phase 3 study of its cardiovascular candidate…
    Endpoints · 4mo agoNeutral↗ source
  • Insilico Medicine and Bora Pharma launch AI-driven biologics manufacturing venture to challenge Chinese CDMOs
    Insilico Medicine, an AI drug discovery company, and Bora Pharmaceuticals, a Taiwan-based CDMO, announced the formation of a new joint venture. The new company will develop an AI-driven platform t…
    Endpoints · 4mo agoDealPositive↗ source
  • Senate HELP Committee probes CDC director nominee over potential political pressure on vaccine decisions
    Senate HELP Committee held a confirmation hearing for the Trump administration's CDC director nominee, Erica Schwartz, and pressed her on the possibility of political interference. Lawmakers asked…
    Endpoints · 4mo agoRegulatoryNegative↗ source
  • Eli Lilly invests in Oura to aid patients using GLP-1 medicines
    Eli Lilly announced an equity investment in Oura, a startup that makes a wearable health‑monitoring ring. The partnership is intended to support patients who are prescribed Lilly's GLP-1 medicines…
    Endpoints · 4mo agoDealPositive↗ source
  • Axiom's stem cell therapy shows zero mortality in phase-1 trial for newborn brain injuries
    Axiom Biosciences reported that its mesenchymal stem cell (MSC) therapy achieved a 0% mortality rate over two years in a phase‑1 study of newborns with severe brain injuries. The nine‑patient trial…
    Fierce Biotech · 4mo agoPositive readoutPositive↗ source
  • I&I startup Attovia Therapeutics files for IPO as biotech listing wave gains pace
    Attovia Therapeutics, an I&I startup that develops biologics, filed a registration statement to go public on Tuesday after the market closed. The filing brings the number of biotech companies expe…
    Endpoints · 4mo agoDealNeutral↗ source
  • FDA Grants Emergency Use Authorization for Ivermectin Liquid to Prevent New World Screwworm in Horses
    The U.S. Food and Drug Administration has issued an Emergency Use Authorization for an ivermectin oral solution intended for horses, aimed at preventing infestations by New World screwworm. The au…
    fda press · 4mo agoRegulatoryNeutral↗ source
  • Veradermics reports first positive efficacy data for oral minoxidil in women with pattern hair loss
    Veradermics announced that its oral formulation of minoxidil demonstrated positive efficacy in a mid‑stage trial involving women with pattern hair loss. The results mark the company's first effica…
    Endpoints · 4mo agoPositive readoutPositive↗ source