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938 stories matching this filter · ← front page

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  • Drug repurposing: Stakeholders say FDA should act within its authority, avoid disincentives
    Patient and healthcare industry stakeholders told the US Food and Drug Administration (FDA) that while there are significant opportunities to repurpose existing drugs, the agency should ensure any…
    raps · 13d ago↗ source
  • 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…
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Endpoints · 13d ago↗ source
  • Amid $55B US manufacturing push, J&J turns to streamlining its pharma supply chain
    After committing $55 billion last year to bolster U.S. manufacturing capabilities, Johnson & Johnson is making changes to its pharmaceutical supply chain.
    BioSpace · 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…
    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
  • Celcuity gains FDA approval for closely watched breast cancer drug
    Still, shares fell by nearly 20% after the company revealed a delay in the coming launch of Revtorpyk. Details in the drug’s prescribing information surprised some analysts, too.
    BioPharma Dive · 13d ago↗ source
  • Merck ADC, in China study, shows potential to replace chemo in lung cancer
    The results were seen by Wall Street analysts as “direct proof-of-concept” that sac-TMT, a drug Merck views as a “cornerstone,” could be part of a future treatment standard for front-line lung cancer.
    BioPharma Dive · 13d ago↗ source
  • Braveheart, Attovia join next wave of biotech IPOs
    The two startups are the third and fourth, respectively, to outline offerings this month and aim to capitalize on momentum that’s already yielded several big-ticket IPOs.
    BioPharma Dive · 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
  • Kelun’s Merck-partnered ADC notches late-stage NSCLC win alongside Keytruda
    The Phase 3 results are the first direct proof-of-concept for an ADC replacing platinum-based chemo in a first-line standard-of-care regimen for non-small cell lung cancer, according to Leerink Par…
    BioSpace · 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 · 13d ago↗ source
  • J&J dips despite upbeat outlook; AstraZeneca, Spero cut China deals
    J&J’s shares ticked down as oncology sales missed expectations. Elsewhere, AstraZeneca bet $600 million on a lung cancer drug and a pair of biotechs snagged two of the year’s top venture rounds.
    BioPharma Dive · 13d 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 · 13d 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 · 13d 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 · 13d 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 · 13d 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
  • Diamantas backtracks on Makary’s policies issued in journal articles
    The acting commissioner of the US Food and Drug Administration (FDA) has clarified that certain policies disseminated in medical journals by former FDA Commissioner Marty Makary are not official ag…
    raps · 14d ago↗ source
  • CVS Caremark reaches settlement with FTC over insulin suit
    Terms of the deal announced Tuesday are very similar to those the FTC reached with Express Scripts earlier this year, including requiring the PBM to stop preferring higher cost versions of drugs on…
    BioPharma Dive · 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
  • Judge orders Apple Tree partner to forfeit oversight of venture fund
    The ruling from a Cayman Islands court adds a new wrinkle to an ongoing legal dispute that’s already resulted in a bankruptcy filing — and a bid by general partner Seth Harrison for the firm’s port…
    BioPharma Dive · 14d ago↗ source
  • Fresh off buyout, Akero execs reunite to advance long-acting psoriasis pill
    Set to go public via a reverse merger, Avere has licensed from a prolific Chinese drugmaker rights to a potential threat to medicines like Skyrizi and Icotyde.
    BioPharma Dive · 14d ago↗ source