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2,112 stories matching this filter · ← front page

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  • Rudy Tanzi says he may be nearing a cheap, safe Alzheimer’s prevention pill
    Rudolph Tanzi has spent decades pursuing a way to stop Alzheimer’s disease before it starts. As a leading researcher, he has long spoken about the need for a simple, widely accessible solution. T…
    Endpoints · 7d agoPositive↗ source
  • Former Apogee Therapeutics leaders join Paragon Labs to expand R&D and company creation platform
    Michael Henderson, who previously led Apogee Therapeutics, is now serving as chief executive officer of Paragon Labs. He is accompanied by five other former Apogee executives who have moved to Par…
    Endpoints · 7d agoPositive↗ source
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FTC and seven states seek contempt order against Martin Shkreli for breaching lifetime pharma ban
Martin Shkreli is again under investigation by the Federal Trade Commission. The FTC, together with seven states, filed a petition in a New York federal court asking that Shkreli be held in contem…
Endpoints · 7d agoRegulatoryNegative↗ source
  • Health tech firms expand AI scribing tools toward prescribing and billing functions
    Health technology companies are accelerating development of artificial‑intelligence driven scribing solutions that can be deployed across health systems. While early versions focused on documentin…
    Endpoints · 7d agoNeutral↗ source
  • Syndax halts development of Niktimvo after Phase 2 failure in IPF trial
    Syndax announced it is stopping work on its experimental drug Niktimvo for idiopathic pulmonary fibrosis (IPF) after the compound did not meet its primary endpoints in a placebo-controlled Phase 2…
    Endpoints · 7d agoNegative readoutNegative↗ source
  • Pharma faces $500B risk as patents expire, with Merck most exposed by 2028
    More than $500 billion in global prescription sales could be threatened by generic competition between 2026 and 2032, according to Norstella data cited by Evaluate. Merck is the most immediately e…
    BioPharma Dive · 8d agoNeutral↗ source
  • Mirum's Livmarli cuts itching in ultra-rare liver disease trial, showing significant benefit
    Mirum Pharmaceuticals reported that its ileal bile acid transporter inhibitor Livmarli achieved a statistically significant reduction in cholestatic pruritus compared with placebo in a late‑stage s…
    Endpoints · 8d agoPositive readoutPositive↗ source
  • Asahi Kasei Therapeutics receives FDA approval for HSV drug acquired in $1 billion deal
    Asahi Kasei Therapeutics announced that the U.S. Food and Drug Administration granted approval for its herpes simplex virus (HSV) therapy. The drug, called Hovilpri, was purchased by Asahi Kasei e…
    Endpoints · 8d agoApprovalPositive↗ source
  • Aspen Neuroscience files for Nasdaq IPO to fund Parkinson’s cell therapy program
    Aspen Neuroscience, founded in 2018, announced plans to list on Nasdaq, aiming to raise additional capital for its Parkinson’s disease cell therapy program. The company's lead candidate, sasinepro…
    BioPharma Dive · 8d agoDealNeutral↗ source
  • Bristol Myers' lung drug admilparant meets Phase 3 goal at low dose, high dose falls short
    Bristol Myers Squibb reported that its experimental idiopathic pulmonary fibrosis therapy admilparant achieved its primary endpoint in a Phase 3 trial, showing a statistically significant slowing o…
    BioPharma Dive · 8d agoPositive readoutNeutral↗ source
  • Bristol Myers reports two Phase 3 successes for fibrosis and RayzeBio drug
    Bristol Myers Squibb announced Monday that two of its late-stage trials have met primary endpoints. The first trial involved its fibrosis program, where the experimental therapy demonstrated the e…
    Endpoints · 8d agoPositive readoutPositive↗ source
  • GSK allocates over $800 million to expand R&D and manufacturing hub in Pennsylvania
    GSK announced it will invest more than $800 million to expand its presence in Pennsylvania, marking its second expansion in the state within two years. The funds will be used to build a new resear…
    Endpoints · 8d agoDealPositive↗ source
  • FDA approves new treatments for persistent herpes and schizophrenia; Steris to acquire Xodus Medical for $2.1 billion
    The U.S. Food and Drug Administration has granted approvals for two new drugs, one targeting persistent herpes infections and another for the treatment of schizophrenia. The herpes indication addr…
    raps · 9d agoApprovalPositive↗ source
  • FDA finalizes guidance aligning biosimilar post-approval manufacturing changes with global standards
    The U.S. Food and Drug Administration has issued its final guidance on how biosimilar manufacturers can implement post-approval changes to their production processes. The new recommendations bring…
    raps · 9d agoRegulatoryNeutral↗ source
  • First Tracks reports positive early-stage results for celiac drug ANB033
    First Tracks Biotherapeutics announced that its experimental celiac disease drug ANB033 showed statistically significant improvement in a six‑week early‑stage trial compared with placebo. The trial…
    BioPharma Dive · 8d agoPositive readoutPositive↗ source
  • Undecimal Bio raises $18 million to expand siRNA platform beyond liver diseases
    Undecimal Bio, founded by Yaniv Erlich and Shaul Ilan, announced a new financing round that brings in $18 million. The capital will support the company’s effort to develop siRNA therapeutics for ta…
    Endpoints · 8d agoDealPositive↗ source
  • Japan's PMDA Issues Guidance to Safeguard Participants in Generic Bioequivalence Trials
    The Pharmaceuticals and Medical Devices Agency (PMDA) in Japan has released new guidance aimed at protecting healthy adult volunteers who take part in generic bioequivalence studies. The document…
    raps · 9d agoRegulatoryNeutral↗ source
  • Europe’s share of clinical trials falls 13.5% as Asia’s research footprint expands
    The latest data show a 13.5% drop in the number of clinical trials authorized in the EU and EEA compared with pre-pandemic levels. At the same time, Asian countries have increased their share of g…
    raps · 9d agoNeutral↗ source
  • Merck's diabetic eye-disease drug hits primary goal but faces commercial doubts
    Merck announced results from a pivotal trial of its ophthalmology candidate remigromig, aimed at treating diabetic macular edema. The study achieved its primary endpoint, demonstrating that remigr…
    Endpoints · 8d agoNegative readoutNegative↗ source
  • Bausch + Lomb CEO Brent Saunders abruptly departs after failed multibillion-dollar sale
    Brent Saunders, known as a leading dealmaker and one of the highest-paid executives in biopharma, has left his role as chief executive of Bausch + Lomb. His departure ends a second stint as CEO of…
    Endpoints · 8d agoNegative↗ source
  • Bausch + Lomb appoints board chair Thomas Appio as interim CEO after Brent Saunders departs
    Bausch + Lomb announced that board chair Thomas Appio will serve as interim chief executive, taking over immediately from Brent Saunders, who is leaving the role. Appio, who has held several leade…
    BioPharma Dive · 8d agoNeutral↗ source
  • AstraZeneca attributes Phase 3 failure of bone disease enzyme therapy to trial design flaws
    AstraZeneca disclosed that its Phase 3 study of an enzyme replacement therapy for a rare genetic bone disorder did not meet its primary objectives. The company said the shortfall was largely due t…
    Endpoints · 9d agoNegative readoutNegative↗ source
  • Endpoints Weekly releases 2026 Women in Biopharma list of 20 honorees after reviewing 200 nominations
    Endpoints Weekly announced its annual Women in Biopharma 2026 project, highlighting leading women in the industry. The editorial team examined close to 200 nominations to select a shortlist. The…
    Endpoints · 10d agoPositive↗ source
  • Aspen Neuroscience and Bambusa Therapeutics announce plans to go public amid biotech IPO surge
    Aspen Neuroscience, a cell therapy company backed by Gilead, and Bambusa Therapeutics, an I&I biotech founded by former BioNTech scientists, have each filed paperwork to launch initial public offer…
    Endpoints · 11d agoDealNeutral↗ source
  • FDA review flags limited efficacy of Revolution's pancreatic cancer drug Rasonque, shares drop 6%
    Shares of Revolution Medicines fell about 6% after the Food and Drug Administration released review documents that suggest its pancreatic cancer therapy Rasonque may not work as well in all patient…
    BioPharma Dive · 11d agoRegulatoryNegative↗ source