Policy
Robert Kramer, former CEO of Emergent BioSolutions, allegedly earned more than $10.1 million by executing trades with information related to the company’s manufacturing operations that had yet to be made public.
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Only a handful of the top pharmas have signed Most Favored Nation drug pricing deals with the White House, while smaller biotechs continue to hang in limbo.
Policy initiatives have come fast and furious at the FDA this year. While guidances on rare diseases and vaccines have consumed most of the ink, policy shifts aimed at improving FDA efficiencies and reshoring U.S. manufacturing also got some attention. Here, BioSpace rounds up more than a dozen initiatives relevant to the biopharma industry.
With five CDER leaders in one year and regulatory proposals coming “by fiat,” the FDA is only making it more difficult to bring therapies to patients.
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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.
Drug pricing tends to be a somewhat bipartisan issue, although how the Democrats and GOP approach the topic tends to be different.
Please check out the biopharma industry’s COVID-19 stories that are trending for April 27, 2021.
A new study published online has provided some hope for the citizens in India, with researchers suggesting that the Covaxin vaccine, developed by Bharat Biotech and Pennsylvania-based Ocugen, could neutralize the SARS-CoV-2 variant leading the second wave in the country.