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Race to the Bottom Generic Model Threatens Quality/Supply: Expert

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A Brookings commentary warns that intense price competition in the U.S. generic drug market is undermining manufacturing quality a...

Ocugen Reports Positive Phase 2 Data for Vision Loss Gene Therapy

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Ocugen announces positive 12-month results from a mid-stage clinical trial of its experimental gene therapy OCU410, aimed at treat...

ImmunityBio Warning Letter Over Misleading Promotion of Anktiva

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FDA sends a Warning Letter to ImmunityBio, citing misleading promotional claims about its cancer therapy Anktiva (nogapendekin alf...

Adventa Nintedanib Petition Granted, Denied

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FDA grants in part and denies in part an AdvantaPharma petition seeking specific requirements on ANDA holders for generic nintedan...

FDA Requires New Seizure Warning for Parkinsons Drugs

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FDA requires an updated safety warning for Parkinsons drug products containing carbidopa/levodopa due to their potential to cause ...

Pfizer, Valneva to File BLA for Lyme Disease Vaccine

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Pfizer and Valneva plan to submit a BLA for their investigational Lyme disease vaccine candidate based on data demonstrating more ...

Legal Update Highlights FDAs Guide on 3 Year Exclusivity

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A legal update from Wilson Sonsini Goodrich & Rosati addresses FDAs release earlier this month of a draft guidance clarifying the ...

Priority Review for Ionis Alexander Disease Drug

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FDA grants a priority review to an Ionis Pharmaceuticals NDA for zilganersen, an experimental treatment for Alexander disease.

Influencers Drug Promotions Pose Public Health Risks: JAMA

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A new study published in JAMA Network Open highlights growing public health concerns over prescription drug promotion by social me...

ICH Signals New Standards for Advanced Drug Manufacturing

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The International Council for Harmonization outlines a roadmap for future global standards on advanced drug manufacturing, highlig...