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575 stories matching this filter · ← front page

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  • GSK ends $2.2 billion brain drug partnership with Alector after trial failures
    GSK and California‑based biotech Alector have ended their collaboration after both experimental brain drugs failed to meet development milestones. The partnership, announced in July 2021, gave GSK…
    BioPharma Dive · 1mo agoDealNegative↗ source
  • HHS launches Operation Trialblazer to accelerate U.S. drug research amid growing competition from China
    The Department of Health and Human Services introduced a new initiative called Operation Trialblazer aimed at speeding early-stage drug research in the United States. The plan calls for coordinate…
    BioPharma Dive · 1mo agoRegulatoryNeutral↗ source
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Infectious Disease360
  • FDA issues early alert on non‑sterile BD ChloraPrep applicators in Medline convenience kits
    FDA CDRH issued an early alert about a potentially high‑risk device issue involving BD ChloraPrep applicators in Medline convenience kits that may not be sterile. Medline sent a letter on June 12…
    fda medwatch · 1mo agoRegulatoryNegative↗ 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 · 1mo agoRegulatoryNeutral↗ source
  • Medical Action Industries issues recall of convenience kits due to risk of particulate contamination
    The FDA’s Center for Devices and Radiological Health issued an early alert about a potential high‑risk issue with a Medical Action Industries convenience kit. The alert says that particulates coul…
    fda medwatch · 1mo agoCRLNegative↗ source
  • AstraZeneca and GSK strike new China partnerships with Sino Biopharm
    Sino Biopharm announced two separate agreements with the United Kingdom's largest drugmakers, AstraZeneca and GSK, to deepen their presence in the Chinese market. AstraZeneca will license rights t…
    BioPharma Dive · 1mo agoDealPositive↗ source
  • Arbitration panel rules Prime Medicine did not breach Beam deal over AATD therapy
    An arbitration panel has ruled that Prime Medicine did not violate its 2019 collaboration agreement with Beam Therapeutics by advancing a treatment for alpha‑1 antitrypsin deficiency (AATD). The de…
    BioPharma Dive · 1mo agoNeutral↗ 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 · 1mo 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 · 1mo 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 · 1mo ago↗ source
  • Vera Therapeutics wins FDA nod for closely watched kidney disease drug
    The clearance marks another step forward in treatment for IgA nephropathy and sets up a commercial battle with Otsuka, which brought a similar medication to market last year.
    BioPharma Dive · 1mo ago↗ source
  • Infusion Pump Correction: Fresenius Kabi Issues Correction for Ivenix Large Volume Infusion Pump
    A software anomaly may cause a false battery-health value. The pump should remain plugged in at all times.
    fda medwatch · 1mo ago↗ source
  • Infusion Pump Correction: Fresenius Kabi Issues Correction for dropped or jarred Ivenix Large Volume Infusion Pumps
    If dropped, the Ivenix pump touchscreen may become unresponsive and should be removed from use.
    fda medwatch · 1mo ago↗ source
  • Gene editing developer Scribe plots an IPO
    The California drugmaker, which has collaborations in place with Biogen, Sanofi and Eli Lilly, could be the 14th biotech to go public in 2026.
    BioPharma Dive · 1mo ago↗ source
  • Novartis to acquire ADC developer in a deal worth up to $1.5B
    The deal hands over two ADCs with a different mechanism of action targeting cell growth, and marks Novartis' entry into ADC development.
    BioPharma Dive · 1mo ago↗ source
  • Cancer, immune drugmakers dominate VC funding so far in 2026
    Drug developers focusing on either disease area made up more than 40% of the number of biotech companies and amount raised so far in 2026, per BioPharma Dive data.
    BioPharma Dive · 1mo ago↗ source
  • Beyond Boston: Unlikely cities stake biotech claims
    As Greater Boston’s biotech industry sheds jobs, three unlikely regions are showing promise as up-and-coming hubs.
    BioPharma Dive · 1mo ago↗ source
  • Convenience Kit Correction: Windstone Medical Packaging, Inc. Issues Correction for Convenience Kit
    Certain Cardinal Health Webcol Large Alcohol Prep Pads in Custom Convenience Kits manufactured by Aligned Medical Solutions are not sterile.
    fda medwatch · 1mo ago↗ source
  • A PureTech startup banks $180M for a new IPF drug
    Celea, backed by investors such as RA Capital and Leaps by Bayer, is making what it says is an improved version of Roche's Esbriet.
    BioPharma Dive · 1mo ago↗ source
  • Roche KRAS drug succeeds in head-to-head lung cancer study
    The Phase 3 trial compared Roche’s divarasib with treatments sold by Amgen and Bristol Myers in patients with non-small cell lung cancer.
    BioPharma Dive · 1mo ago↗ source
  • Heart Pump Recall: Abiomed Removes Impella CP Sets with SmartAssist
    Specific Impella CP Sets are out of specification; use may result in low purge pressure events from the onset of the case
    fda medwatch · 1mo ago↗ source
  • Breathing Circuit Set Correction: Hamilton Medical Updates Use Instructions for Breathing Circuit Set
    The ventilator breathing circuits are intended to connect a ventilator to a patient tube or mask. Obstruction may result in inadequate ventilation.
    fda medwatch · 1mo ago↗ source
  • BridgeBio gets funding for drug launch; United buys into cell therapy
    Elsewhere, Otsuka’s kidney drug hit the goal of a confirmatory trial and Vertex’s CRISPR sickle cell drug secured expanded approval.
    BioPharma Dive · 1mo ago↗ source
  • Ipsen to buy Swiss biotech Memo Therapeutics in potential $800M deal
    The purchase hands Ipsen an experimental medicine in late-stage testing for a virus that often affects kidney transplant patients.
    BioPharma Dive · 1mo ago↗ source
  • 5 FDA decisions to watch in the third quarter of 2026
    A group of coming decisions could provide important insights into how flexible the agency is willing to be under new leadership.
    BioPharma Dive · 1mo ago↗ source