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81 stories matching this filter · ← front page

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STAT1670Endpoints1315Fierce Biotech632BioSpace632BioPharma Dive494raps211onclive165fda recalls108fda medwatch
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  • Pfizer reports positive Phase 3 results for Elrexfio in relapsed multiple myeloma
    Pfizer announced that its antibody-drug conjugate Elrexfio achieved a statistically significant and clinically meaningful improvement in progression-free survival for patients with relapsed or refr…
    Endpoints · 6mo agoPositive readoutPositive↗ source
  • FDA pilots real-time clinical trials as Amgen, AstraZeneca join proof-of-concept studies; AbbVie eyes KRAS biotech Kestrel
    The U.S. Food and Drug Administration announced a pilot program for "real-time" clinical trials, designed to cut the lag between data collection and regulatory review. AstraZeneca and Amgen have l…
    BioPharma Dive · 6mo agoRegulatoryNeutral↗ source
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  • Chiesi to acquire KalVista for $1.9 billion, adding hereditary angioedema pill to rare-disease portfolio
    Italian pharmaceutical group Chiesi announced it will purchase KalVista Therapeutics for $1.9 billion. The transaction values KalVista at $27 per share, a 40 percent premium to its last closing pri…
    STAT · 6mo agoDealPositive↗ source
  • Pfizer settles with generics to extend tafamidis patent until 2031, protecting revenue
    Pfizer announced settlements with three generic manufacturers-Dexcel Pharma, Hikma Pharmaceuticals and Cipla-to delay the launch of generic versions of tafamidis, the active ingredient in its rare‑…
    BioPharma Dive · 6mo agoDealPositive↗ source
  • Pfizer secures two-year extension on Vyndamax patent, delaying competition
    Pfizer announced it has obtained an extension that pushes back the start of generic competition for its heart-failure drug Vyndamax (tafamidis) by about two years. Vyndamax ranks among Pfizer’s to…
    Endpoints · 6mo agoRegulatoryPositive↗ source
  • Pfizer strategy chief Andrew Baum departs, stays on as senior advisor; Helus Pharma appoints new CEO after two months
    Andrew Baum, formerly chief strategy and innovation officer at Pfizer, has left that role. He will continue to work with the company as a senior strategic advisor to CEO Albert Bourla. Meanwhile,…
    Endpoints · 6mo agoNeutral↗ source