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624 stories matching this filter · ← front page

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  • FDA acting chief walks back Makary's practice of policymaking through journals
    The FDA is continuing to rewind actions by former Commissioner Marty Makary, saying that two medical journal articles published over the last year did not constitute agency policy. The about-face f…
    Endpoints · 13d ago↗ source
  • Senate committee questions CDC pick on political interference over vaccines
    Lawmakers in the Senate pressed the Trump administration’s nominee for CDC director on whether she will cave to political pressure during a confirmation hearing on Wednesday. The CDC has been witho…
    Endpoints · 13d ago↗ source
  • J&J restructures pharma manufacturing footprint at cost of up to $750M
    Johnson & Johnson is anticipating as much as $750 million in costs to restructure its pharmaceutical supply chain and exit factories, moves that are coming as it pushes ahead with its $55 billion p…
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Endpoints · 13d ago↗ source
  • Eli Lilly invests in Oura to support patients on GLP-1 drugs
    Eli Lilly on Wednesday made an equity investment in wearable ring startup Oura as the drugmaker looks for ways to support patients taking its GLP-1 medications. An Oura spokesperson declined to sha…
    Endpoints · 13d ago↗ source
  • Radiopharma maker AdvanCell hauls in $315M for Pluvicto challenger
    AdvanCell raised a $315 million Series D to study a lead-based prostate cancer agent and shore up its US manufacturing of the radioactive treatment. The round marks one of the largest yet for a rad…
    Endpoints · 13d ago↗ source
  • J&J touts Icotyde prescriptions, but not sales, in first full quarter
    Johnson & Johnson teased some details on Wednesday morning about how the launch of its expected blockbuster Icotyde performed in the second quarter. Without disclosing how much revenue the plaque p…
    Endpoints · 14d ago↗ source
  • Nava Therapeutics emerges with $89M for lipid nanoparticles
    Nava Therapeutics, a secretive startup that’s been working on a new generation of lipid nanoparticles that target the bone marrow, immune cells and the kidney, has raised $89 million, the company t…
    Endpoints · 14d ago↗ source
  • Braveheart files for IPO to fund Phase 3 of Hengrui's Cytokinetics rival
    Biotechs are sprinting to the IPO queue. In the industry's fourth IPO filing in two weeks, Braveheart Bio is seeking a Nasdaq listing to fuel Phase 3 testing of a cardio drug that could potentially…
    Endpoints · 14d ago↗ source
  • Insilico, Bora Pharma reveal plans for AI-driven manufacturing company
    Insilico Medicine and Taiwan-based CDMO Bora Pharmaceuticals are launching a new company with an AI-driven biologics manufacturing platform in a bid to compete with service providers headquartered…
    Endpoints · 14d ago↗ source
  • Veradermics declares first efficacy win in women for hair loss drug
    Veradermics is for the first time reporting positive efficacy of its oral formulation of minoxidil in female pattern hair loss, which broadens the market potential of its flagship asset. In a mid-s…
    Endpoints · 14d ago↗ source
  • I&I startup Attovia files to go public as biotech listings momentum builds
    The tally of biotechs waiting to list in the coming weeks has increased to three, as biologics maker Attovia Therapeutics filed for an initial public offering on Tuesday after the market closed. At…
    Endpoints · 14d ago↗ source
  • Early Alert: Ventilator Issue from Resmed
    Failure of an electrical component in certain Astral ventilators may cause an interruption or failure in therapy which may result in serious injury or death
    fda medwatch · 14d ago↗ source
  • Celcuity wins approval for breast cancer drug Revtorpyk
    A small public biotech won approval for a breast cancer drug that was designed to improve on similar treatments from Novartis and Roche. The FDA on Tuesday cleared Celcuity's Revtorpyk in combinati…
    Endpoints · 14d ago↗ source
  • What's next for BINSA, the House bill restricting China deals
    After setting the industry ablaze last month, a bipartisan bill aimed at restricting US biotech companies from striking deals with Chinese counterparts is in limbo. The Biotech Investment National ...
    Endpoints · 14d ago↗ source
  • Post-Hoc Live: What’s making biotech IPOs work again?
    Late last year, I found myself talking a lot about what it would take for biotech’s budding rally to become a full one. We had deals, good pipeline readouts and a rising public stock market ...
    Endpoints · 14d ago↗ source
  • A health tech workaround is under fire
    At the end of June, a settlement between California’s attorney general and bankrupt clinic company Carbon Health put the digital health industry on notice. The state’s Justice Department accused Ca…
    Endpoints · 14d ago↗ source
  • Erasca's $550M offering; Summit sells an antibiotic
    Plus, news about subcutaneous Leqembi, WuXi AppTec and Q32 Bio. 📊 Erasca targets $550M for KRAS drugs: The biotech's public offering came after it shared a small ...
    Endpoints · 15d ago↗ source
  • Chai Discovery gets $400M, tripling valuation from seven months ago
    Chai Discovery, one of the hottest startups in the AI-generated drug discovery landscape, has corralled $400 million in a Series C that triples its paper value from its last round of financing. In…
    Endpoints · 15d ago↗ source
  • Biogen's tau drug reports mixed Alzheimer's results, as low dose performs better
    LONDON — Biogen's attempt to treat Alzheimer's by going after a protein that forms toxic tangles in the brain showed some of the strongest proof yet that it could slow dementia. But the results wer…
    Endpoints · 15d ago↗ source
  • Draig nets $65M to advance depression drug aimed at rebuilding synapses
    Draig Therapeutics has secured $65 million in an oversubscribed Series B raise to advance a pipeline of neuropsychiatry drugs, including its lead depression program designed to modulate the AMPA re…
    Endpoints · 15d ago↗ source
  • Genetic medicine startup Lyora launches with programs from Editas, Biogen
    Lyora Therapeutics will try to revive several early-stage genetic eye disease programs previously held by Editas Medicine and Biogen. The biotech was co-founded by Luk Vandenberghe and Eric Pierce,…
    Endpoints · 15d ago↗ source
  • AstraZeneca to take rights to Dizal's lung cancer pill Zegfrovy
    AstraZeneca is set to pay Dizal Pharmaceutical, which it part-owns, $600 million upfront for worldwide development and sales rights to the lung cancer drug Zegfrovy. The UK pharma said Tuesday that…
    Endpoints · 15d ago↗ source
  • In latest deal, Innovent seeds Spero's future beyond GSK-owned antibiotic
    After partnering with four of the largest pharmaceutical companies over the past 18 months, Innovent Biologics is turning to a smaller partner for its next bet. An autoimmune drug candidate from th…
    Endpoints · 15d ago↗ source
  • Former Akero team announces new I&I company, Avere, with China drug
    Everything around China biotech really does seem to be speeding up. On Tuesday, the former executive team behind Akero Therapeutics unveiled a new company, a pipeline drug from China and a reverse…
    Endpoints · 15d ago↗ source
  • Positive Pressure Breathing Device Correction: Baxter Issues Correction for Volera Positive Pressure Breathing Devices
    Volara system patient circuits may leak air and medication from the nebulizer cup during therapy, leading to reduced oxygenation and ineffective nebulization.
    fda medwatch · 15d ago↗ source