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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Senator Charles Schumer unveiled draft legislation that would decriminalize cannabis and expunge federal sentences associated with the drug, but it likely faces an uphill battle.
The CMA said some pharmaceutical firms charge the NHS with excessively high prices for hydrocortisone tablets and paid off potential competitors to stay out of the market.
Biden calls out the Health and Human Services department to submit a plan in the next 45 days to combat excessive drug prices and enhance domestic pharmaceutical supply chains.
Kevin Mulleady and Jason Aryeh attempted to back a slate of candidates for the Phoenixus Board of Directors but failed as shareholders overwhelmingly supported the current board.
The U.S. appears to be beating back COVID-19 but it’s still raging in many parts of the world, and studies and trials are still ongoing. Here’s a look at some of today’s top COVID-19 stories.
The data may show the need for one, but vaccine and immunologists are pushing back against Pfizer and BioNTech’s contention that one is necessary now.
The WHO panel recommends adopting global standards, giving structure to prevent the unscrupulous, inequitable, and possibly dangerous uses of CRISPR technology.
Approximately 100 preliminary reports of GBS have been identified out of 12.8 million doses of the J&J vaccine in the U.S., according to the Centers for Disease Control and Prevention.
HHS issued their announcement, saying, “Americans who have been fully vaccinated do not need a booster shot at this time.”
A former CEO of Vyera and other activist investors are pushing a slate of new company directors who would steer control of Phoenixus and Vyera away from Shkreli.