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  • Wainua flop narrows AstraZeneca’s path to $80B goal ahead of high-risk readouts
    With a Phase 3 failure denting the rare disease drug’s prospects, AstraZeneca has little room for error as it plots a path toward its ambitious 2030 sales target.
    BioSpace · 3d 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 · 3d 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…
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raps · 3d 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 · 3d 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 · 3d ago↗ source
  • Samsung Biologics targets $1.8B PolyPeptide buyout to expand in obesity
    With PolyPeptide manufacturing peptides such as GLP-1 medicines, Samsung Biologics has identified the deal as a way to tap into fast-growing demand for obesity drug production services.
    BioSpace · 3d 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 · 3d 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 · 3d ago↗ source
  • Agios scraps sickle cell drug
    <figure><div><img src="https://imgproxy.divecdn.com/IiZTvtDA9eY9PoU6z9Ed0haIV_AWxuu_mTZM3XObZMk/g:nowe:0:88/c:4896:2766/rs:fill:1600:900:1/Z3M6Ly9kaXZlc2l0ZS1zdG9yYWdlL2RpdmVpbWFnZS9HZXR0eUltYWdlcy…
    BioPharma Dive · 3d ago↗ source
  • Novo sues Lilly, alleging ‘misleading’ advertising of obesity drugs
    <figure><div><img src="https://imgproxy.divecdn.com/kw1AmHZ9iuWuwJs64qGVc7NH8w1twh5k8aIFqw3zDIg/g:nowe:0:388/c:5567:3145/rs:fill:1600:900:1/Z3M6Ly9kaXZlc2l0ZS1zdG9yYWdlL2RpdmVpbWFnZS9HZXR0eUltYWdlc…
    BioPharma Dive · 3d 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 · 3d 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 · 3d 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 · 3d ago↗ source
  • Dimension restocks with $800M to capitalize on AI’s ‘rapid ascent’
    <p>The young venture firm, which has bet heavily on tech and biotech’s convergence, has now invested in 35 companies and recently saw one of them acquired by AI giant Anthropic.</p>
    BioPharma Dive · 3d ago↗ source
  • Novartis climbs on upbeat drug sales as key readouts loom
    <figure><div><img src="https://imgproxy.divecdn.com/zfRhQ6UdoLhrnrg6WnOJHxS_autlpVcZwuWId9Q7ZSI/g:ce/rs:fill:1600:900:1/Z3M6Ly9kaXZlc2l0ZS1zdG9yYWdlL2RpdmVpbWFnZS9HZXR0eUltYWdlcy0yMjA5Nzg4MDE4LmpwZ…
    BioPharma Dive · 3d 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
  • Agios axes next-gen sickle cell candidate after it fails to best Novo’s asset
    Agios Pharmaceuticals’ sickle cell disease candidate didn’t prove any better than Novo Nordisk’s investigational PK activator or the biopharma’s own asset that is currently under FDA review for the…
    BioSpace · 3d ago↗ source
  • Novartis stays 'geography-agnostic' in dealmaking amid flurry of China deals
    Novartis will continue to be on the lookout for bolt-on deals below $2 billion, CEO Vas Narasimhan said Tuesday on the pharma's second quarter earnings call—though major pickups aren’t completely o…
    BioSpace · 3d ago↗ source
  • The FDA’s 505(b)(2) pathway is an underestimated engine of value creation
    The biopharma industry would do well to re-embrace the 505(b)(2) path, which allows sponsors to draw on previous findings around an existing drug even as they propose modifications to it.
    BioSpace · 4d 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 · 4d ago↗ source
  • Dyne gets early 2027 decision date for Duchenne therapy, analysts expect ‘smooth’ review
    If approved, Dyne Therapeutics’ zeleciment rostudirsen could “capture the majority” of the exon-51 Duchenne muscular dystrophy market, given its better efficacy and dosing profile versus Sarepta Th…
    BioSpace · 4d ago↗ source
  • Axiom plans Hong Kong IPO, hoping to carve new path for US biotechs
    Axiom Biosciences is thinking outside of the box, betting on a public debut in Hong Kong to raise capital and grow into a global company.
    BioSpace · 4d 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 · 4d 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 · 4d 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 · 4d ago↗ source