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.
FEATURED STORIES
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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Sinopharm, a Chinese biopharmaceutical company controlled by the state, announced that its COVID-19 vaccine candidate had an efficacy rate of 79% based on interim analysis of Phase III trials.
Keeping in mind that COVID-19 has dominated the news cycle, here are the top 10 stories of 2020 in no particular order.
Overnight, U.K. health authorities authorized the COVID-19 vaccine developed by AstraZeneca and Oxford University for emergency use.
Operation Warp Speed succeeded on the development component but is failing in the early stages of distribution. Here’s everything you need to know about it.
The U.S. Department of Defense awarded Moderna a contract worth $1,966,598,000 for an additional 100 million doses of its COVID-19 vaccine.
The agency placed the hold on the Astellas company’s trial after two patients died in the trial.
The United Kingdom is expected to give the green light to the vaccine developed by AstraZeneca and Oxford University this week.
In October, the FDA placed a clinical hold on the company’s Huntington’s disease gene therapy before that asset could make its way into the clinic.
Yesterday it was reported that the two companies were working to make more of their vaccine than the 1.3 billion it promised to manufacture in 2021.
Former U.S. Rep. Chris Collins spent less than a year in federal prison for pleading guilty to violating felony insider trading laws when he sat on the board of directors of Innate Therapeutics. On Tuesday, Collins received a pardon from President Donald Trump.