Regulatory
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.
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.
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.
The fate of three cancer immunotherapies that had been authorized under the U.S. Food and Drug Administration’s Accelerated Approval pathway will be determined next week following failures in confirmatory trials.
Molecular Partners announced yesterday it has filed for a $100 million initial public offering with the Securities and Exchange Commission in the U.S., funding which will go toward supporting the company’s work in the development of protein-based treatments for COVID-19 and various cancers.
The long and strange journey of Biogen’s Alzheimer’s drug aducanumab is coming to an end. Whether it will be a complete ending—with the U.S. FDA rejecting it—or a new chapter, with an approval, remains to be seen.
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