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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There was a lot of news and research studies today related to the COVID-19 vaccines. Here’s a look.
In the U.S., many states and organizations are using unique tactics to improve vaccination rates including setting up mobile vans, offering $100 incentives, and free beers.
Sanofi’s troubles stemming from the 2019 recall of Zantac appear to be far from over.
Please check out the biopharma industry’s COVID-19 stories that are trending for May 11, 2021.
May is a busy month for the U.S. Food and Drug Administration (FDA)’s calendar for new drug reviews. Here’s a look.
On Thursday, Pfizer Chief Executive Officer Albert Bourla who is “not at all” in favor of the U.S. position, stated that the real challenge is manufacturing capacity.
While the U.S. had been one of a few rich nations holding out – along with Canada, the European Union and Britain – on some level, Wednesday’s announcement of support for the proposal is not unexpected.
The U.S. FDA approved Keytruda combined with Genentech’s Herceptin (trastuzumab), fluoropyrimidine- and platinum-containing chemotherapy, for first-line treatment of locally advanced unresectable or metastatic HER2-positive gastric or gastroesophageal junction adenocarcinoma.
Theranos founder Elizabeth Holmes is back in the courtroom for the first time in 15 months for a three-day hearing ahead of her criminal fraud trial.
Here’s a look at Pfizer-BioNTech, Novavax and the COVID-19 vaccine’s sales, approval in children, additional trials, potential of booster shots, and more.