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  • Updated: Merck beats AstraZeneca to approval for first PCSK9 pill
    As in football, so in pharmaceuticals: The English have been beaten. Merck has outpaced AstraZeneca in the race to get the first US approval for an oral form of a particular kind of cholesterol-l…
    Endpoints · 12d ago↗ source
  • Takeda’s zasocitinib proves ‘top-notch’ for difficult-to-treat psoriasis in phase 3 update
    Takeda has unveiled more data from its phase 3 trials of zasocitinib, demonstrating that the once-daily pill was able to clear or almost clear scalp psoriasis in 75% of patients.
    Fierce Biotech · 12d ago↗ source
  • Racing Takeda, InnoCare reports TYK2 inhibitor win in phase 2 vitiligo trial
    A phase 2 trial of InnoCare Pharma’s TYK2 inhibitor soficitinib in nonsegmental vitiligo has hit its primary endpoint, clearing the Chinese biotech to advance into the phase 3 part of the study.<br>
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Fierce Biotech · 12d ago↗ source
  • Recon: Lilly to buy psychedelic developer AtaiBeckley for up to $3.8B; FDA approves Merck’s novel cholesterol drug
    <p>Welcome to Regulatory Reconnaissance, your regulatory news and intelligence briefing.</p>
    raps · 12d ago↗ source
  • Euro Roundup: EMA posts guidance on preventing microbial contamination of non-sterile products
    <p>The European Medicines Agency (EMA) has released guidance on technical and organizational measures that companies should consider to prevent microbial contamination of non-sterile products.</p>
    raps · 12d ago↗ source
  • CDER plans new guidance on AI, electronic safety report submissions, and more
    <p>The US Food and Drug Administration’s (FDA) Center for Drug Evaluation and Research (CDER) has updated its list of new and revised guidance documents it plans to issue this year to include four…
    raps · 12d ago↗ source
  • Drug repurposing: Stakeholders say FDA should act within its authority, avoid disincentives
    <p>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 a…
    raps · 12d 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…
    Endpoints · 12d 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 wit…
    Endpoints · 12d 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 billi…
    Endpoints · 12d 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 s…
    Endpoints · 12d ago↗ source
  • Celcuity gains FDA approval for closely watched breast cancer drug
    <figure><div><img src="https://imgproxy.divecdn.com/f5a4VRDXQg-SwH2yBDKHbtLeyVHpX8cemnSbe-t-6xU/g:ce/rs:fill:1600:900:1/Z3M6Ly9kaXZlc2l0ZS1zdG9yYWdlL2RpdmVpbWFnZS9HZXR0eUltYWdlcy0xMjI3NzEwNDk4X0F5Q…
    BioPharma Dive · 12d ago↗ source
  • Merck ADC, in China study, shows potential to replace chemo in lung cancer
    <figure><div><img src="https://imgproxy.divecdn.com/lM3CYabLlmazQYt-COfrxYzxdsO20VnU3PS1vfCq2lE/g:ce/rs:fill:1600:900:1/Z3M6Ly9kaXZlc2l0ZS1zdG9yYWdlL2RpdmVpbWFnZS9HZXR0eUltYWdlcy0xMjEwOTMxMjkxXzEua…
    BioPharma Dive · 12d ago↗ source
  • Braveheart, Attovia join next wave of biotech IPOs
    <figure><div><img src="https://imgproxy.divecdn.com/Z8dYUynyAGfRpaERds4uqJPo8FGtQPXgqxIr2sImOmo/g:ce/rs:fill:1600:900:1/Z3M6Ly9kaXZlc2l0ZS1zdG9yYWdlL2RpdmVpbWFnZS9HZXR0eUltYWdlcy0xNDUxMTE2NzE0LmpwZ…
    BioPharma Dive · 12d ago↗ source
  • Nobel Laureate Jennifer Doudna enters AI protein design arena
    Jennifer Doudna, Ph.D., the Nobel Laureate best known for co-inventing the CRISPR system that has become the foundation for gene-editing, is dipping her toes into a new, buzzy field: AI-powered pro…
    Fierce Biotech · 12d ago↗ source
  • Why early de-risking is redefining the path to IND
    Lonza explains why early de-risking has become a strategic imperative for biotech teams working to reach IND with confidence.
    Fierce Biotech · 12d 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 r…
    Endpoints · 12d ago↗ source
  • Understanding Agentic AI in Clinical Development
    Earlier this year, my colleague Matt Harrington suggested that clinical leaders should stop asking whether their organizations have an “AI strategy”, not because strategy doesn’t matter, but becaus…
    Fierce Biotech · 12d 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 pl…
    Endpoints · 12d ago↗ source
  • J&J dips despite upbeat outlook; AstraZeneca, Spero cut China deals
    <figure><div><img src="https://imgproxy.divecdn.com/idsdMAHsPbXObDUtQW2qRG7uveBUVv6HCTn9NTtlDOI/g:nowe:0:0/c:1207:682/rs:fill:1600:900:1/Z3M6Ly9kaXZlc2l0ZS1zdG9yYWdlL2RpdmVpbWFnZS9HZXR0eUltYWdlcy0x…
    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 potential…
    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…
    Endpoints · 13d ago↗ source
  • Why Axiom hopes it’s ‘solved 2 major potholes’ that have hurt other stem cell biotechs
    When Axiom's stem cell therapy demonstrated a 0% mortality rate over two years in potentially fatal newborn neurological diseases this week, the biotech's leadership saw a broader validation for th…
    Fierce Biotech · 13d ago↗ source