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 cites concerns regarding clinical data for ChemoCentryx’s investigational rare autoimmune disease therapy avacopan. Shares in the company plunged 46.5% lower following the release of the document.
Pfizer reported its first-quarter 2021 revenues of $14.6 billion, an impressive 42% operational growth.
Please check out the biopharma industry’s COVID-19 stories that are trending for May 4, 2021.
The regulatory nod marks the first time the FDA approved an SGLT2 inhibitor for the treatment of CKD regardless of diabetes status.
This drug is made and manufactured by ViiV Healthcare and is a combination of cabotegravir and rilpivirine.
AstraZeneca’s COVID-19 vaccine road to approval has been anything but smooth.
The U.S. FDA’s Oncologic Drugs Advisory Committee did not agree in a recent meeting to maintain the accelerated approval of Bristol Myers Squibb’s Opdivo (nivolumab) as a second-line treatment of hepatocellular carcinoma.
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.
Cancer doesn’t care if you’re Democratic, Republican, Libertarian or Green. It strikes without prejudice or consideration. As President Joe Biden said Wednesday night in his first major speech to Congress, “I know of nothing that is more bipartisan.”