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465 stories matching this filter · ← front page

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  • 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 · 17d 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 · 17d 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.
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fda medwatch18
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Vaccines517
Endocrinology & Metabolism290
Ophthalmology258
Infectious Disease253
Nephrology239
BioPharma Dive · 17d ago
↗ source
  • Draig bags another $65M to speed testing of brain drugs
    The cash will support mid-stage trials of a prospect the company claims to have “best-in-disease” potential treating major depressive disorder.
    BioPharma Dive · 17d ago↗ source
  • Biogen data highlight promise, questions surrounding tau-targeting Alzheimer’s drugs
    The study provides the clearest evidence yet that medicines like BIIB080 might improve cognition, but leaves unclear why higher doses didn’t perform better.
    BioPharma Dive · 17d ago↗ source
  • Positive Pressure Breathing Device Correction: Baxter Issues Correction for Volera Positive Pressure Breathing Devices
    Volara system patient circuits may leak air and medication from the nebulizer cup during therapy, leading to reduced oxygenation and ineffective nebulization.
    fda medwatch · 18d ago↗ source
  • Experts: Industry to benefit from focused follow-ups, major deficiency letters in MDUFA VI
    Industry experts say the draft commitment letter for the next Medical Device User Fee Amendments (MDUFA VI) program negotiated by the US Food and Drug Administration (FDA) and the medtech industry…
    raps · 18d ago↗ source
  • Freenome colorectal cancer test data improve on earlier results
    The new study results could make Abbott, which has an agreement with Freenome to market the blood-based test, the dominant player in colorectal cancer screening, Evercore ISI analysts said.
    BioPharma Dive · 18d ago↗ source
  • Q32 bounces back to claim study success for alopecia drug
    Nearly two years after clinical setbacks cratered Q32’s stock price, new results showed hair growth improvements that surpassed investors’ expectations.
    BioPharma Dive · 18d ago↗ source
  • Agenus surges on study pivot; Apnimed lines up an IPO
    Agenus is financially abandoning an ongoing study in late-line colorectal cancer. Elsewhere, an ebola vaccine began human testing and an important Bristol Myers medicine got an FDA decision date.
    BioPharma Dive · 18d ago↗ source
  • Biotech startup funding gap widens despite rebound in VC investment
    Though funding totals represented the highest first-half sum since the start of 2022, industry watchers are concerned that small startups are being left behind.
    BioPharma Dive · 18d ago↗ source
  • Pulmonary Valve Catheter Delivery System Recall: Medtronic Removes Harmony Delivery Catheter System (DCS)
    The distal tip in certain lots of the Medtronic Harmony Delivery Catheter System (DCS) may detach which can require endovascular retrieval or surgical intervention.
    fda medwatch · 19d ago↗ source
  • GSK, Hansoh ADC extends survival in lung cancer study
    GSK claimed the result was a first for an ADC aimed at the “B7-H3” protein, an increasingly popular target of late among cancer drugmakers.
    BioPharma Dive · 21d ago↗ source
  • ARPA-H puts $160M into bespoke drug therapies; Biohaven switches up scientific leadership
    The ARPA-H program could provide researchers with a roadmap to develop personalized gene editing drugs. Elsewhere, a Botox rival succeeded against migraines and two deals were struck.
    BioPharma Dive · 21d ago↗ source
  • Roche scraps two Ionis-partnered Huntington’s drugs
    The Swiss pharmaceutical giant told patient groups tominersen didn't delay disease progression in one trial, while a study of a second drug was scrapped because of a safety signal in animal testing.
    BioPharma Dive · 22d ago↗ source
  • GSK ends brain drug alliance with Alector
    Clinical setbacks derailed what was once a potentially $2.2 billion deal that marked GSK's return to neuroscience.
    BioPharma Dive · 22d ago↗ source
  • HHS plan to speed drug research won’t remove ‘self-inflicted’ delays
    U.S. clinical trials continue to lose ground to China, but is Operation Trialblazer enough to help America catch up?
    BioPharma Dive · 22d ago↗ source
  • AstraZeneca, Ionis drug fails big heart disease study in major setback
    Eplontersen’s failure in transthyretin-mediated amyloidosis cardiomyopathy caught Wall Street analysts by surprise and boosted the outlook of rival drugs from Alnylam and BridgeBio Pharma.
    BioPharma Dive · 22d ago↗ source
  • Early Alert: Convenience Kit Issue from Medical Action Industries
    Particulates have the potential to be introduced into blood circulation and become lodged within blood vessels.
    fda medwatch · 23d ago↗ source
  • Early Alert: Convenience Kits Issue from Medline
    Certain BD ChloraPrep Applicators in Convenience Kits manufactured by Medline may not be sterile.
    fda medwatch · 23d ago↗ source
  • AstraZeneca, GSK intensify China ties with Sino Biopharm deals
    The U.K. drugmakers added to a series of recent tie-ups with Chinese counterparts amid broader scrutiny of such transactions in the U.S.
    BioPharma Dive · 23d ago↗ source
  • Prime wins gene editing dispute; Saol claims latest post-Makary FDA reversal
    An arbitration panel ruled Prime didn’t breach a deal with Beam by developing a rare disease treatment. Elsewhere, European regulators are using a pancreatic cancer drug to test a new framework for…
    BioPharma Dive · 23d ago↗ source
  • Oberland pours up to $400M into MeiraGTx eye gene therapies
    The funding deal is a vote of confidence in the sales potential of multiple prospects in late-stage development — one of which MeiraGTx recently reacquired from J&J.
    BioPharma Dive · 24d ago↗ source
  • Kailera says obesity pill succeeds in late-stage trial in China
    The drug spurred about 10% weight loss over 10 months, though that finding came alongside high rates of gastrointestinal side effects that “alarmed” one analyst.
    BioPharma Dive · 24d ago↗ source
  • Vertex to acquire Crinetics in $10B foray into endocrine disease drugs
    Vertex claimed the two drugs in the deal could eventually bring in more than $5 billion annually. Still, the high price it paid stirred debate among analysts and investors.
    BioPharma Dive · 24d ago↗ source