Regulatory
A study found in India that the existing COVID-19 vaccines should be effective against the Indian variant, not just the Pfizer-BioNTech vaccine.
An investigational Alzheimer’s disease drug from Tetra Therapeutics appeared to improve language ability and learning in adults with Fragile X Syndrome, according to a new study reported in Nature Medicine.
The U.S. FDA says it is unable to approve Biogen supplemental Biologic License Application (sBLA) for subcutaneously delivered TYSABRI® for the treatment of relapsing multiple sclerosis (MS), at least while the sBLA remains in its present form.
The FDA is threatening Acceleron with a $10,000 fine or criminal prosecution, charging the company with failure to post a summary of study data on its cancer combo dalantercept and axitinib in the ClinicalTrials.gov online database.
The companies indicated they are studying the CRL to determine the best way to understand the problems and what course of action they might take.
Pfizer is expanding its presence in infectious diseases with the acquisition of San Diego-based Amplyx Pharmaceuticals and its lead antifungal compound Fosmanogepix.
Levitt has practiced law for over 20 years in the FDA regulatory space. Previously chief regulatory counsel for Pfizer Inc., Levitt has had extensive experience working with an interdisciplinary team of scientists, executives and lawyers to push a candidate to market.
A U.S. FDA committee gave the nod to continue using Genentech’s checkpoint inhibitor Tecentriq in combination with chemotherapy to treat adults with mTNBC.
Takeda’s non-small cell lung cancer treatment Mobocertinib is leading closer to regulatory approval after the U.S. Food and Drug Administration granted priority review to the New Drug Application.
Please check out the biopharma industry’s COVID-19 stories that are trending for April 27, 2021.
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