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334 stories matching this filter · ← front page

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  • Roche Diagnostics growth remains muted amid China headwinds
    Roche’s Diagnostics division continues to battle growth headwinds, notching a 3% increase in sales.
    Fierce Biotech · 5d ago↗ source
  • Australian biopharma Clinuvel to shed up to 20% of workforce in move to US
    Australian biopharma Clinuvel Pharmaceuticals is moving its headquarters to the U.S.— but up to a fifth of the company’s workforce won’t be staying for the trans-Pacific pivot.
    Fierce Biotech · 5d ago↗ source
  • Roche drops TCE for lupus, but hasn’t given up on autoimmune cell therapies
    Roche may have scrapped work on a T-cell engager being evaluated for lupus, but the company’s head of pharma told Fierce that still has a strategy for developing cell therapies for autoimmune disea…
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Hematology6
Pulmonology5
Infectious Disease4
Ophthalmology3
Dermatology2
Fierce Biotech · 5d ago
↗ source
  • FDA clears Johnson & Johnson’s surgical robot for ‘the next era in surgery’
    The FDA has authorized Johnson & Johnson’s Ottava Robotic Surgical System as the company looks to compete with Intuitive Surgical and Medtronic.
    Fierce Biotech · 5d ago↗ source
  • Recon: J&J nabs FDA authorization for general surgery robot; FDA urged to ban DTC drug ads
    Welcome to Regulatory Reconnaissance, your regulatory news and intelligence briefing.
    raps · 6d ago↗ source
  • Euro Roundup: EMA seeks feedback on planned changes to guidance on biosimilar efficacy studies
    The European Medicines Agency (EMA) has released a draft concept paper on planned changes to its guideline on similar biological medicinal products.
    raps · 6d ago↗ source
  • Study: Most sponsors complete postmarketing trials, publish results
    Postmarketing requirements and commitments were completed for nearly nine out of ten drugs approved by the US Food and Drug Administration, with such requirements or commitments assigned at the tim…
    raps · 6d ago↗ source
  • FDA advisory committee backs two controversial peptides
    An advisory committee to the US Food and Drug Administration (FDA) voted 8-6 with one abstention on Thursday to recommend that two peptides – BPC-157 to treat ulcerative colitis and KPV for wound t…
    raps · 6d ago↗ source
  • Vertex was sole bidder in high-premium Crinetics acquisition
    Analysts expect new details on the lead-up to the deal “are likely to reignite” investor scrutiny that Vertex overpaid in what’s poised to be its largest-ever transaction.
    BioPharma Dive · 6d ago↗ source
  • GSK lung cancer drug gets speedy approval following $10.6B deal
    The clearance is GSK’s first for a lung cancer medicine and the latest step forward in a yearslong push by the British drugmaker into oncology.
    BioPharma Dive · 6d ago↗ source
  • Arrowhead hits ‘best-case scenario’ with latest results for fat-lowering drug
    To analysts, the drug’s apparent safety and effects on both triglyceride levels and pancreatitis cases should make it competitive with a rival Ionis therapy.
    BioPharma Dive · 6d ago↗ source
  • Trump threatens tariffs on imported generic drugs
    While the possibility of levies on branded pharmaceuticals have had a limited impact on drugmaker revenues, tariffs of up to 200% on copycat medicines could — depending on the specifics — prove mor…
    BioPharma Dive · 6d ago↗ source
  • NIH joins Trump’s $5B AI mission with biomedical research push
    The U.S. Department of Health and Human Services announced new efforts Wednesday aligned with President Donald Trump’s artificial intelligence-driven Genesis Mission. The centerpiece of HHS’ partic…
    Fierce Biotech · 6d ago↗ source
  • Summit counters PD-1/VEGF skeptics; Celldex drug fails skin disease study
    A new analysis could address some doubts investors have had about ivonescimab, one analyst said. Elsewhere, Gilead and Merck debuted data for a once-weekly HIV tablet and a new pyschedelics competi…
    BioPharma Dive · 6d ago↗ source
  • Crystalys nets $130M more to push gout drug through late-stage tests
    The startup has a broad global development program underway — and the support of more than 20 investment firms — for a treatment that’s approved in many Asian countries but isn’t yet available in t…
    BioPharma Dive · 6d ago↗ source
  • House passes bill directing FDA to update animal testing rules
    The U.S. House of Representatives passed the FDA Modernization Act 3.0 this week, and lawmakers and animal welfare advocates are celebrating the bill as a step toward a new era in preclinical testi…
    Fierce Biotech · 6d ago↗ source
  • Royalty Pharma pens $425M deal for slice of sales on AstraZeneca’s ATTR drug
    Royalty Pharma has secured a stake in another transthyretin-mediated amyloidosis drug, this time paying $125 million upfront to Neurimmune for a cut of the sales of its AstraZeneca-partnered med.
    Fierce Biotech · 6d ago↗ source
  • Celldex ends skin disease program after failing phase 2 test
    A phase 2 study of Celldex’s barzolvolimab in a chronic skin disease has missed its primary endpoint, driving the biotech to end development in the indication and raising doubts about an upcoming e…
    Fierce Biotech · 6d ago↗ source
  • MDCG: Only manufacturers should assign UDI-DIs
    The European Commission's Medical Device Coordination Group (MDCG) says unique device identifiers and device identifiers (UDI-DI) codes used between manufacturers and distributors need to be better…
    raps · 7d ago↗ source
  • FDA issues untitled letters to Sanofi and Viatris for false advertising
    The FDA’s Office of Prescription Drug Promotion recently reprimanded Sanofi and Viatris for making misleading claims about their products in emails and a television advertisement.
    raps · 7d ago↗ source
  • ‘We’re moving quickly’: Startup bags rare disease drug as Thiel-backed CEO eyes $50M fundraise
    A rare disease startup with a mission to repurpose proven drugs has licensed a Chinese formulation of a well-known medicine and set its sights on a $50 million fundraise.
    Fierce Biotech · 7d ago↗ source
  • Biotech industry leaders file brief backing FDA against ‘malicious’ mifepristone challenge
    A group of 61 biopharma companies, executives and investors has filed an amicus brief in support of the FDA in an ongoing case brought by Louisiana meant to remove access to the abortion pill mifep…
    Fierce Biotech · 7d ago↗ source
  • Agios scraps sickle cell drug
    The study failure costs Agios a chance to one-up Novo Nordisk and represents yet another setback in a disease that’s frustrated drugmakers of late.
    BioPharma Dive · 7d ago↗ source
  • Novo sues Lilly, alleging ‘misleading’ advertising of obesity drugs
    The lawsuit follows a cease-and-desist request and argues Lilly is using “deceptive” ads to claim its GLP-1 products are broadly superior to Novo’s medicines. Lilly countered that its campaign is “…
    BioPharma Dive · 7d ago↗ source
  • Dimension restocks with $800M to capitalize on AI’s ‘rapid ascent’
    The young venture firm, which has bet heavily on tech and biotech’s convergence, has now invested in 35 companies and recently saw one of them acquired by AI giant Anthropic.
    BioPharma Dive · 7d ago↗ source