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. Attorney’s Office for Massachusetts charged Ishtiaq Ali Saaem, 37, with obstruction of justice for lying about his attempts to acquire 100 castor bean packets in order to develop the bioterror poison ricin. The acquisition was not recent, it took place on June 24, 2015.
France and Germany are two out of more than a dozen countries that suspended deployment of the AstraZeneca-Oxford University vaccine after reports of blood clots were reported.
Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for March 16, 2021.
The COVID-19 pandemic is not only an international health crisis, but a burgeoning geopolitical exercise for Russia to win the hearts and minds of a large portion of the world while undermining the West.
The drug is a lipoglycopeptide antibiotic. It is given in a single, one-hour infusion.
With more European countries pausing dosing of AstraZeneca’s COVID-19 vaccine over concerns about potential blood clotting side effects, Russia is seeking to fill in the gaps with its Sputnik V vaccine.
Sanofi and Regeneron Pharmaceuticals’ checkpoint inhibitor Libtayo performed so well that the regulators anticipate that the trials may need to be halt early.
The second half of March is a busy month for the U.S. Food and Drug Administration (FDA), with quite a few PDUFA dates scheduled. Here’s a look at this week’s target action dates.
It has been one year since COVID-19 was declared a global pandemic. In that time, more than 118 million people have contracted the virus and 2,622,190 people, including 529,267 in the United States, have died as a result.
According to the Centers for Disease Control and Prevention, more than 35,000 Americans perish each year from antibiotic-resistant infections, and estimates have AMR claiming the lives of as many as 10 million globally by 2050.