Policy
The current state of political affairs in the U.S. does not bode well for the direction of that turn. The country is at real risk of losing its long-held lead in biotech innovation.
FEATURED STORIES
Bristol Myers Squibb, GSK and Merck are contributing drug ingredients as part of their deals with the White House but are keeping many of the terms of their agreements private.
Some 200 rare disease therapies are at risk of losing eligibility for a pediatric priority review voucher, a recent analysis by the Rare Disease Company Coalition shows. That could mean $4 billion in missed revenue for already cash-strapped biotechs.
The FDA’s rare pediatric disease priority review voucher program missed reauthorization at the last minute in 2024; advocates have been fighting to get it back ever since.
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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.
Leaked documents from provincial and municipal governments in China reveal a slew of previously unreported severe adverse events related to COVID-19 vaccines made and administered in China.
On Friday April 23, the U.S. Food and Drug Administration (FDA) and the Centers for Disease Control and Prevention (CDC) lifted the restrictions on the Johnson & Johnson COVID-19 vaccine.