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1,048 stories matching this filter · ← front page

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  • What health system execs are talking about
    Earlier this week, I swung by the American Hospital Association’s Leadership Summit in downtown Denver. When I wasn’t giving out ice cream recommendations, I was trying to get a sense of what hos…
    Endpoints · 10d ago↗ source
  • Veradermics keeps ‘momentum going’ as baldness drug helps women with hair loss
    <figure><div><img src="https://imgproxy.divecdn.com/1t2735bLf2pFiAc5XoslOwKIkl5O8g-p7viDbIw1C94/g:ce/rs:fill:1600:900:1/Z3M6Ly9kaXZlc2l0ZS1zdG9yYWdlL2RpdmVpbWFnZS9HZXR0eUltYWdlcy0yMjA2NDE3NzE0LmpwZ…
    BioPharma Dive · 10d ago↗ source
  • Kelun pads efficacy profile of Merck-partnered ADC; Europe will have to wait for Boehringer's Hernexeos
    Plus, news about Vogenx and Orakl Oncology. 🇨🇳 Kelun touts China data for sac-TMT: Kelun-Biotech announced on Tuesday that its Merck-partnered antibody-drug conjugate sacituzumab tirumotecan su…
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Endpoints · 10d ago
↗ source
  • Q&A: Betty Tijms wants to stop treating Alzheimer’s as a single disease
    LONDON — For more than a century, scientists studying Alzheimer’s have largely focused their efforts on two proteins — amyloid and tau — that clearly accumulate in the disease. But not everyone wit…
    Endpoints · 10d ago↗ source
  • US drug shortages rise for third straight quarter, hurt by lone suppliers
    The number of drugs in shortage in the US rose for a third straight quarter, a situation complicated by the fact that almost half of the medicines in tight supply rely only on a single ...
    Endpoints · 10d ago↗ source
  • FDA’s first AI-focused cGMP warning letter signals new scrutiny for manufacturers
    The FDAs enforcement action against Purolea Cosmetics Lab offers an early look at how the agency expects AI-generated work to fit within existing quality systems, with experts saying human oversigh…
    BioSpace · 10d ago↗ source
  • Lilly makes up to $3.8B psychedelics play in AtaiBeckley takeover
    With the AtaiBeckley acquisition, Eli Lilly is jumping into psychedelics, a drug class that Jefferies analysts say could herald the “biggest change” for the field of psychiatry.
    BioSpace · 10d ago↗ source
  • Merck wins first approval of a PCSK9 cholesterol pill
    <figure><div><img src="https://imgproxy.divecdn.com/fBH5yVoS6G-IUV5sTGP2zy7wuLAX60VYZCXs0QOEVRo/g:ce/rs:fill:1600:900:1/Z3M6Ly9kaXZlc2l0ZS1zdG9yYWdlL2RpdmVpbWFnZS9TY3JlZW5zaG90XzIwMjItMDctMjRfMS40M…
    BioPharma Dive · 10d ago↗ source
  • Merck dives into cholesterol with first FDA approval for oral PCSK9 inhibitor
    Merck’s once-daily pill is the first oral PCSK9 inhibitor to hit the market for high cholesterol, beating AstraZeneca in the race to develop more accessible treatment options.
    BioSpace · 10d ago↗ source
  • Braveheart, Attovia, Vogenx keep IPOs ballooning with plans to compete in cardiometabolic, immuno
    Braveheart Bio is looking to take on Bristol Myers Squibb in hypertrophic cardiomyopathy, while Attovia Therapeutics wants to challenge Sanofi and Regeneron’s Dupixent. Vogenx, meanwhile, is lookin…
    BioSpace · 10d ago↗ source
  • The future of pain relief: Exploring opioid alternatives
    In this episode of Denatured, you’ll hear from Lance Alstodt, chairman and CEO at Biorestorative Therapies, and Paul Mieyal, chief business officer at South Rampart Pharma. We explore why pain has…
    BioSpace · 10d ago↗ source
  • J&J sees Spravato sales surge as psychedelic competitors loom
    Psychedelics, chiefly Compass Pathways' COMP360, are unlikely to make an immediate dent in the sales of Johnson & Johnson’s depression drug Spravato, H.C. Wainwright’s Patrick Trucchio told BioSpace.
    BioSpace · 10d ago↗ source
  • Updated: Sanofi, Arbutus file separate suits against mRNA vaccine makers over LNP tech patents
    Sanofi and Arbutus are each going to court over alleged violations of their respective mRNA delivery patents, adding to a growing list of companies making similar complaints. The French pharma is…
    Endpoints · 10d ago↗ source
  • Lilly bets $2.8B upfront on psychedelics in deal to buy AtaiBeckley
    Eli Lilly said on Thursday it will buy psychedelic drug developer AtaiBeckley for $2.8 billion upfront, in a move that further spotlights big pharma’s increasing interest in the space after years o…
    Endpoints · 10d ago↗ source
  • 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 · 10d ago↗ source
  • Spurred by deep cuts and M&A activity, H1 layoffs could oust 14,000+ in biopharma
    Takeda’s cuts will go the deepest, affecting over 4,700 employees. Layoffs tied to M&A activity include BioNTech letting go of around 800 people at CureVac.
    BioSpace · 11d 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 · 11d 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 · 11d 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 · 11d 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 · 11d 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 · 11d 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 · 11d 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 · 11d 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 · 11d 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 · 11d ago↗ source