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  • Q&A: Lilly returns to neuropsych and looks ahead to Alzheimer's prevention
    LONDON — Eli Lilly, the world’s biggest drugmaker, appears to be getting more ambitious about tackling brain diseases. Last week, the company announced it would pay $2.8 billion upfront to acquir…
    Endpoints · 2d ago↗ source
  • Crystalys gets $130M to take Sobi-rivaling gout drug to market
    A San Diego biotech has raised an additional $130 million to get a gout drug that's already approved in Japan and China onto the US and European markets. Crystalys Therapeutics reeled in the Seri…
    Endpoints · 2d ago↗ source
  • Summit reports two-year survival data for Western patients, though context lacking
    Summit Therapeutics unveiled additional follow-up data on its experimental cancer drug ivonescimab, and how its benefit compares between Asian and Western patients. But key context remains unknown.…
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Endpoints · 2d ago
↗ source
  • Celldex scraps antibody in prurigo nodularis after Phase 2 flop
    Celldex said on Tuesday it will stop investigating its mast cell-targeting monoclonal antibody in a type of chronic itch disease after it failed on all efficacy measures in a mid-stage trial. Top…
    Endpoints · 2d ago↗ source
  • Biopharma dealmaking in 2026: The recovery gathers speed in Q2
    It’s always darkest before the biotech dawn, and at no time was that more true than last summer, as biotech was experiencing a crisis of confidence. We tracked an industry-wide downturn in expect…
    Endpoints · 2d ago↗ source
  • Vertex was only bidder for Crinetics in year's second-highest M&A premium
    To gain control of Crinetics Pharmaceuticals, Vertex Pharmaceuticals was willing to pay the second-highest premium so far in biopharma's banner year for M&A. And the Boston drugmaker was biddin…
    Endpoints · 2d ago↗ source
  • Trump pledges new tariffs on generic drugs not made in the US
    President Donald Trump on Tuesday evening said he will impose up to 200% tariffs on generic drugs sold in the US, if companies do not manufacture those medicines in America. Trump said that for t…
    Endpoints · 2d ago↗ source
  • MDCG: Only manufacturers should assign UDI-DIs
    <p>The European Commission's Medical Device Coordination Group (MDCG) says unique device identifiers and device identifiers (UDI-DI) codes used between manufacturers and distributors need to be bet…
    raps · 2d ago↗ source
  • FDA issues untitled letters to Sanofi and Viatris for false advertising
    <p>The FDA’s Office of Prescription Drug Promotion recently reprimanded Sanofi and Viatris for making misleading claims about their products in emails and a television advertisement.</p>
    raps · 2d ago↗ source
  • Novo sues Lilly over 'deceptive' ads comparing GLP-1 drug doses
    The two biggest players in the obesity market are headed to court. Novo Nordisk sued Eli Lilly on Tuesday over what it claims are “maliciously and deceptively false” ads comparing the highest dos…
    Endpoints · 2d ago↗ source
  • Indian generic drugmaker gets FDA warning over clinical study consent
    Indian generic drugmaker Alembic Pharmaceuticals has been hit with an FDA warning letter after failing to get informed consent from patients for a clinical study. In a breakaway from typical FDA…
    Endpoints · 2d ago↗ source
  • FDA plans to name permanent center heads alongside FDA chief
    The FDA is planning to announce a slate of senior personnel announcements when a new commissioner is named, including permanent heads of CBER and CDER, according to three sources familiar with the…
    Endpoints · 2d ago↗ source
  • Novartis CEO says latest China deals are just following the science
    Novartis isn't making deals in China just for the sake of buying there. That's the word from CEO Vas Narasimhan, who told reporters on a second-quarter earnings call that the Swiss pharma is “agn…
    Endpoints · 2d ago↗ source
  • Gilead and Merck provide HIV data; Dimension Capital announces $800M fund
    Gilead and Merck’s HIV data: The duo will present more detailed results of the Phase 3 trials of their once-weekly oral HIV treatment regimen at AIDS 2026, one of the largest ...
    Endpoints · 2d ago↗ source
  • Agios’ second shot at sickle cell disease falls short
    Agios said it is dropping a next-generation sickle cell disease drug after lackluster results from a mid-stage trial. The drug, known as tebapivat, represented Agios’ second shot at the disease,…
    Endpoints · 2d ago↗ source
  • Notes from a peptide meetup
    With an FDA advisory committee set to decide this week whether it recommends that several popular peptides be reclassified, I wanted to learn more. Cue a last-minute ticket purchase to ...
    Endpoints · 3d ago↗ source
  • Broad Institute launches Center for Therapeutic Genetics for rare diseases
    The Broad Institute of MIT and Harvard is teaming up with Boston Children’s Hospital and The Jackson Laboratory to launch a new center focused on genetic treatments for rare diseases, the triumvira…
    Endpoints · 3d ago↗ source
  • A-Alpha Bio starts AI antibody data consortium with GSK, Boltz
    Biopharma's AI engines need more data. And David Younger thinks there's a great business to sell those data to them. Younger's startup, A-Alpha Bio, has spent months studying how protein-designin…
    Endpoints · 3d ago↗ source
  • Recon: Novo sues Lilly over weight-loss drug ads; Gilead, Merck say HIV pill keeps HIV suppressed in two Phase 3 trials
    <p>Welcome to Regulatory Reconnaissance, your regulatory news and intelligence briefing.</p>
    raps · 3d ago↗ source
  • FDA cites companies for CGMP violations, informed consent failure
    <p>The US Food and Drug Administration has issued warning letters to several drug makers for failing to meet its current good manufacturing practices (CGMP) requirements and a company for failing t…
    raps · 3d ago↗ source
  • European Commission publishes guideline on transparency obligations under AI Act
    <p>The European Commission on Monday published new guidelines to assist providers and deployers of artificial intelligence (AI) systems in fulfilling transparency obligations under the EU’s AI Act,…
    raps · 3d ago↗ source
  • UnitedHealth Group lays out progress in AI push
    After announcing a hefty investment in AI earlier this year, UnitedHealth laid out how it's using the technology across its business in a quarter that landed better than expected. The health insu…
    Endpoints · 3d ago↗ source
  • House lawmakers back trade probe of China biotech, sequencing
    At least 10 House lawmakers are backing a US trade panel’s probe of China’s biotech sector and related pricing practices, encouraging future executive action. In a letter sent to Secretary of the…
    Endpoints · 3d ago↗ source
  • Samsung Bio to step into peptides in $1.8B buy for PolyPeptide
    Samsung Biologics is set to branch out to peptide ingredient manufacturing with plans to buy Swiss CDMO PolyPeptide for $1.8 billion in cash. The purchase, announced Monday, would be the Korean ...
    Endpoints · 3d ago↗ source
  • Anthropic's life sciences plans: Mystery programs, Nobel hires, M&A and big ambition
    A year ago, Anthropic’s life sciences plans were basically just a blog post by its CEO. In late 2024, Dario Amodei wrote a 13,000-word memo naming biology and neuroscience among his ...
    Endpoints · 3d ago↗ source