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  • FDA cites companies for CGMP violations, informed consent failure
    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 to s…
    raps · 8d ago↗ source
  • European Commission publishes guideline on transparency obligations under AI Act
    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, in…
    raps · 8d 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 insure…
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Endpoints · 9d 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 U…
    Endpoints · 9d 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 · 9d 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 · 9d ago↗ source
  • Scribe's $96M IPO; Scholar Rock awaits site classification for apitegromab
    Scribe writes in $96M IPO: The gene editing biotech expects net proceeds of about $96 million if it prices its Nasdaq listing at $14 per share, the midpoint of the ...
    Endpoints · 9d ago↗ source
  • J&J, AbbVie said to have also looked at AtaiBeckley before Lilly’s $2.8B deal
    Johnson & Johnson and AbbVie, the two pharma giants already in the psychedelic space, also eyed AtaiBeckley, according to a source familiar with the situation, but didn’t make an offer before Eli L…
    Endpoints · 9d ago↗ source
  • UK biotech VC funding rebounds and reaches record high
    UK biotechs attracted more venture capital funding in the second quarter of 2026 than in any full year since 2022, in a sign that the country is amid a fundraising revival as investors get attracti…
    Endpoints · 9d ago↗ source
  • Bristol Myers, Nvidia say they'll build 'most powerful' AI supercomputer in pharma
    Bristol Myers Squibb said Monday it will build "the most advanced and energy-efficient AI" supercomputer system in the biopharma industry, deepening its relationship with Nvidia. The New Jersey-hea…
    Endpoints · 9d ago↗ source
  • Recon: BMS to construct AI supercomputer with Nividia; Tempus to acquire cancer diagnostic maker Personalis for $1.5B
    Welcome to Regulatory Reconnaissance, your regulatory news and intelligence briefing.
    raps · 9d ago↗ source
  • Asia-Pacific Roundup: TGA seeks feedback on Australian regulations for digital mental health tools
    Australia’s Therapeutic Goods Administration (TGA) is holding a consultation to inform changes to the regulatory framework for digital mental health tools (DMHTs).
    raps · 9d ago↗ source
  • Study: China outpaces the US in cancer approvals, lags behind on first approvals
    While China's National Medical Products Administration (NMPA) approved more oncology drugs compared to the US Food and Drug Administration (FDA) from 2020 to 2025, the US regulator approved more fi…
    raps · 9d ago↗ source
  • MHRA touts uptick in approvals in 2025-2026 annual report
    The UK's Medicines and Healthcare products Regulatory Agency (MHRA) touted its achievements over the last year its 2025-2026 annual report to Parliament, which includes approving more new drugs tha…
    raps · 9d ago↗ source
  • Relay Peak Research LLC Recalls Zen Principle® Moringa Capsules Because of Possible Health Risk
    Relay Peak Research LLC (Zen Principle Naturals) of Incline Village, NV is voluntarily recalling its Zen Principle® brand Moringa Capsules dietary supplement because the product has the potential t…
    fda recalls · 10d ago↗ source
  • Unique Pharmaceutical Laboratories (A Div. of J. B. Chemicals & Pharmaceuticals Ltd.) Issues Voluntary Nationwide Recall of Cetirizine Hydrochloride Tablets USP 5 mg Due to Potential Cross Contamination with Ranitidine
    FOR IMMEDIATE RELEASE – July 18th, 2026 – Panoli, Gujarat, Unique Pharmaceutical Laboratories (A Div. of J. B. Chemicals & Pharmaceuticals Ltd.) is voluntarily recalling four lots of Cetirizine Hyd…
    fda recalls · 11d ago↗ source
  • Biogen’s mixed Alzheimer’s data; Two new startups launch; and more
    Welcome back to another edition of Endpoints Weekly! We hope you all have been staying safe indoors as the Canadian wildfires blanketed much of the US Northeast this week. Hopefully things calm dow…
    Endpoints · 11d ago↗ source
  • Fayus Inc., dba Yusol International Foods Expands Recall of OLA-OLA POUNDED YAM Due to Undeclared Milk Allergen
    Fayus Inc., doing business as Yusol International Foods (Sacramento, CA) is expanding its recall of OLA-OLA POUNDED YAM to include product sizes 2lbs, 4lbs, 5lbs, and 10lbs due to product labeling…
    fda recalls · 11d ago↗ source
  • Midsized biotechs press White House to drop CMS pricing rules
    A number of midsized biotech companies have met with White House and HHS officials in the last week, presenting their case for why two pending CMS pricing models could hinder their business and sho…
    Endpoints · 12d ago↗ source
  • Celcuity got its cancer drug approved. Then its stock dipped
    The FDA’s approval for Celcuity’s cancer drug Revtorpyk on Tuesday was widely anticipated. What Wall Street didn’t expect was that the drug could take until the end of the quarter to launch. ...
    Endpoints · 12d ago↗ source
  • GSK plans large study to see if shingles vaccine can prevent dementia
    LONDON — Over the past several years, data scientists searching through national health records have noticed something surprising about people who had been vaccinated for shingles: They were less l…
    Endpoints · 12d ago↗ source
  • Dimerix buys a kidney injury drug; Arpeggio appears to be winding down
    Plus, news about Takeda, Novartis and Regenxbio. 🤝 Mission sells kidney injury drug to Dimerix: Dimerix will pay $5 million upfront for Mission’s Phase 2-ready candidate for acute kidney injury, k…
    Endpoints · 12d ago↗ source
  • Updated: BlossomHill and Latigo join flourishing IPO queue with cancer, pain drugs
    Last summer, zero biotechs made it onto the public markets as the industry weathered a seven-month dry spell for initial share sales. This time around, it's a summer IPO party as six
    Endpoints · 12d ago↗ source
  • GSK drops Phase 3 chronic cough drug in a blow to $2B Bellus Health buyout
    In a major stumble for GSK’s $2 billion acquisition of Bellus Health, the UK pharma said Friday it is ending development of camlipixant in refractory chronic cough (RCC) after the drug ...
    Endpoints · 12d ago↗ source
  • Zealand Pharma gets its US marketing leader from Lilly; Bexorg turns to Biohaven for CSO hire
    → Silvia Luque announced on LinkedIn that she was named head of US marketing at Zealand Pharma after 13 years in various roles at obesity competitor Eli Lilly. She had been ...
    Endpoints · 12d ago↗ source