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555 stories matching this filter · ← front page

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  • India’s life sciences sector at turning point for innovation: Report
    Structural gaps in areas including clinical execution and funding limit India’s ability to scale up innovation, according to a report from Boston Consulting Group and HealthKois.
    BioSpace · 13d ago↗ source
  • Arbutus, Sanofi escalate mRNA patent fights; InnoCare’s TYK2 contender advances
    The new lawsuits add to a web of legal disputes over technology involved in COVID vaccines. Elsewhere, a prolific AI biotech inked another deal and Insmed strengthened support for a closely watched…
    BioPharma Dive · 13d ago↗ source
  • Compounders maintain a firm grip on the GLP-1 market
    Despite an FDA crackdown, numerous pharma lawsuits and possible safety risks, nearly 1 in 5 patients are still taking cheaper weight-loss alternatives.
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BioPharma Dive · 13d ago
↗ source
  • GSK shelves cough drug acquired in $2B deal
    Mixed Phase 3 data for camlipixant prompted the British pharma to cease development, making the drug the third from its class to fail.
    BioPharma Dive · 13d ago↗ source
  • How well are AI-discovered drugs faring in the clinic?
    Some of the industry’s most closely-watched AI drugs could provide insight into the success of technology-assisted development.
    BioPharma Dive · 13d ago↗ source
  • GSK culls cough program for drug at the heart of $2B Bellus bet after Phase 3 fail
    Camlipixant, which GSK picked up in its $2 billion buyout of Bellus Health in April 2023, “is unlikely to transform patient care,” the pharma said.
    BioSpace · 13d ago↗ source
  • Insmed moves closer to $6B opportunity as PAH drug shows long-term durability
    Insmed’s inhalable candidate showed “impressive” long-term efficacy in pulmonary arterial hypertension, according to analysts at Guggenheim Partners, with functional and biomarker improvements thro…
    BioSpace · 13d ago↗ source
  • FDA disavows Makary, Prasad’s papers as lawmaker blasts ‘shoot-from-the-hip’ policymaking
    Journal publications that suggested changes in FDA guidelines do not “communicate FDA policy or interpretation of a regulatory issue,” acting director Kyle Diamantas wrote in a letter to House Ener…
    BioSpace · 13d ago↗ source
  • Experts: Ending adequate provision would shut down prescription drug ads
    The US Food and Drug Administration’s (FDA) plans to eliminate adequate provision in direct-to-consumer (DTC) prescription drug ads could result in a de facto ban on drug advertising due to the hig…
    raps · 14d ago↗ source
  • Industry wants more clarity on NGS for assessing gene therapy safety
    The pharmaceutical industry has largely endorsed the US Food and Drug Administration's (FDA) guidance on next-generation sequencing (NGS) for assessing the safety of human gene therapy products. Ho…
    raps · 14d ago↗ source
  • This Week at FDA: FDA staff raise concerns about peptide conflicts, top Democrat wants DOGE investigation, and more
    Welcome to another installment of This Week at FDA, your weekly source for updates – big and small – on FDA, drug and medical device regulation, and what we’re reading from around the web. This wee…
    raps · 14d ago↗ source
  • Lilly to buy AtaiBeckley for $2.8B, further validating psychedelics
    The latest in a prolific streak of buyouts by Lilly is the strongest sign yet that large pharmaceutical companies may finally be embracing a long-dismissed field of research.
    BioPharma Dive · 14d ago↗ source
  • Veradermics keeps ‘momentum going’ as baldness drug helps women with hair loss
    The Phase 2 data exceeded expectations, lifting company shares as high as nearly $130 apiece and building the case for what may be the first pill specifically approved for female pattern hair loss.
    BioPharma Dive · 14d 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 · 14d 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 · 14d ago↗ source
  • Merck wins first approval of a PCSK9 cholesterol pill
    The speedy clearance of Lipfendra is an important milestone for Merck and the result of a controversial voucher program put in place by former FDA commissioner Marty Makary.
    BioPharma Dive · 14d 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 · 14d 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 · 14d 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 · 14d 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 · 14d 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 · 15d ago↗ source
  • Recon: Lilly to buy psychedelic developer AtaiBeckley for up to $3.8B; FDA approves Merck’s novel cholesterol drug
    Welcome to Regulatory Reconnaissance, your regulatory news and intelligence briefing.
    raps · 15d ago↗ source
  • Euro Roundup: EMA posts guidance on preventing microbial contamination of non-sterile products
    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.
    raps · 15d ago↗ source
  • CDER plans new guidance on AI, electronic safety report submissions, and more
    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 new…
    raps · 15d ago↗ source
  • 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 · 15d ago↗ source