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  • Recon: Novo sues Lilly over weight-loss drug ads; Gilead, Merck say HIV pill keeps HIV suppressed in two Phase 3 trials
    Welcome to Regulatory Reconnaissance, your regulatory news and intelligence briefing.
    raps · 9d ago↗ source
  • 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 · 9d 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…
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Psychiatry & CNS87
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Dermatology51
raps · 9d 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…
    Endpoints · 10d 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 · 10d 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 · 10d 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 · 10d 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 · 10d ago↗ source
  • Lilly’s AtaiBeckley buy validates space as Big Pharma takes note of psychedelics
    Eli Lilly’s proposed acquisition of AtaiBeckley is “the clearest strategic validation to date” of psychedelics as an emerging pharmaceutical category, according to H.C. Wainwright. The analyst caut…
    BioSpace · 10d 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 · 10d ago↗ source
  • ‘There is always a first’: Why US biotech Axiom will begin its IPO journey in Hong Kong
    Axiom Biosciences intends to pursue an IPO on the Hong Kong Stock Exchange (HKEX), followed by a co-listing on the Nasdaq—a strategy the company claims is the first U.S. biotech to use.
    Fierce Biotech · 10d ago↗ source
  • FDA’s radical transparency policy for rejections runs into legal uncertainty
    Having started to publish CRLs without consulting the public, the FDA is under pressure to change course amid concerns it failed to openly and fully evaluate a complex issue.
    BioSpace · 10d ago↗ source
  • Genetic medicine luminaries launch new center for personalized therapies
    A team of veteran scientists from elite institutions has come together to form a new center dedicated to the crafting of personalized genetic medicines, adding to the growing list of similar effort…
    Fierce Biotech · 10d ago↗ source
  • 2026 IPO class blooms again as BlossomHill, Latigo set sights on Nasdaq
    Eighteen companies have gone public this year so far, putting 2026 on pace to record the highest number of IPOs since the pandemic-driven high of 2021.
    BioSpace · 10d ago↗ source
  • Vertex’s IgA nephropathy drug derisked after Novartis, Vera approvals
    The FDA is currently reviewing Vertex Pharmaceuticals’ povetacicept, with a target action date of Nov. 30. If approved, the drug could benefit from campaigns from Novartis and Vera Therapeutics for…
    BioSpace · 10d 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 · 10d 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 · 10d ago↗ source
  • Kolon’s cell-based gene therapy fails phase 3 osteoarthritis trial
    A phase 3 trial of Kolon TissueGene’s cell-based gene therapy has missed its co-primary endpoints. With a second late-stage study scheduled to report data in October, the biotech is holding off on…
    Fierce Biotech · 10d ago↗ source
  • Tempus buys out cancer genomics partner Personalis in $1.5 billion deal
    Tempus is boosting its cancer offerings with a deal to buy out Personalis three years after the pair first teamed up in oncology.
    Fierce Biotech · 10d ago↗ source
  • Scribe aims for $96M IPO to fund clinical push for lipid-lowering genetic meds
    Scribe Therapeutics has put its IPO plans down on paper, showing the genetic medicine company hopes to raise $96 million through its public listing.
    Fierce Biotech · 10d ago↗ source
  • BMS expands AI footprint with Nvidia, aiming for ‘most powerful AI factory in life sciences’
    Bristol Myers Squibb has entered into an expanded collaboration with Nvidia to create the biggest supercomputer for drug R&D, according to the announcement.
    Fierce Biotech · 10d ago↗ source
  • Type 1 diabetes pipeline making ‘remarkable progress’ toward insulin independence
    After the trailblazing approval of Sanofi’s Tzield for stage 3 type 1 diabetes, several companies, including SAB Biotherapeutics and Eledon Pharmaceuticals, are vying for a spot in the landscape wi…
    BioSpace · 10d ago↗ source
  • How Kyverna rode CAR T’s autoimmune wave to the FDA’s door
    Poised to become the first company to achieve a regulatory filing for a cell therapy in autoimmune disease, Kyverna Therapeutics is building a pipeline-in-a-product to change the treatment paradigm.
    BioSpace · 10d 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 · 10d 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 · 10d ago↗ source