Califf’s Vision: An FDA as Automated as Amazon
The FDA should take a page out of one online retail giant’s book, says Commissioner Robert Califf, as it works to update its technology infrastructure and make its processes and…
New Law Creates Registration Process for Marijuana-Based Drug Development
President Biden has signed into law a bill that creates a new registration process for carrying out marijuana-related research and for facilitating the development and manufacturing of marijuana-based drugs. Source:…
FDA Offers Guidance on Bioequivalence Studies, Presubmission Correspondence
Sponsors hoping to use equivalence criteria in analyzing bioequivalence (BE) studies for their drug applications just got more details on how the FDA wants them to undertake that. Source: Drug…
J&J Alleges Amgen’s Proposed Biosimilar Infringes on Stelara Patents
Johnson & Johnson (J&J) has sued Amgen for allegedly violating its patent protections for blockbuster Stelara (ustekinumab) — a biologic FDA-approved for treating ulcerative colitis, psoriatic arthritis, plaque psoriasis and…
Ongoing Drug Shortages More Challenging for FDA Than New Ones
The most challenging drug shortages the U.S. faces are not the new ones that crop up from illnesses like COVID-19 or the current spike in respiratory illnesses. Rather, the shortages…
EMA Safety Committee Recommends Pulling Cough Meds From EU Market
The European Medicines Agency (EMA)’s safety committee has recommended withdrawing medications containing pholcodine, an opioid active ingredient used alone or in combination with other substances, to treat dry cough, cold…
TauRx Keeps the Faith on Its Anti-Tau Agent
TauRx went big at the Clinical Trials on Alzheimer’s Disease (CTAD) annual meeting in San Francisco, insisting that its investigational anti-tau agent, hydromethylthionine mesylate (HMTM), exerted cognitive benefit and slowed…
Argenx Picks Up Priority Review Voucher for $102 Million
In a deal set to strengthen two different clinical research platforms, Bluebird Bio has sold one of its rare pediatric disease priority review vouchers (PRV) to the immunology company Argenx…
In Wake of Gantenerumab’s Failure, Roche Scraps All Studies
In the wake of twin phase 3 failures, Roche will discontinue all active trials of the antiamyloid antibody gantenerumab, the company confirmed at the Clinical Trials on Alzheimer’s Disease annual…
Sanofi’s Drug Candidate Targeting Sleeping Sickness Shows High Efficacy
A drug candidate developed by Sanofi and the Drugs for Neglected Diseases initiative (DNDi) has shown very high efficacy in treating sleeping sickness, a sometimes lethal condition that is endemic…
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