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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Shares of Tonix Pharmaceuticals were up nearly 11% in premarket trading after the company announced plans to initiate a Phase II study of TNX-102 SL as a potential treatment for Long COVID Syndrome following a positive meeting with the U.S. FDA.
President Biden is expected to be briefed on the lab leak theory conducted over the last 90 days. Very few expect solid results, although this might provide direction for more lines of inquiry.
The new authorization is expected to be the final reassurance for many of those who had hesitated when the vaccine was approved under emergency use only.
Anti-aging organization SENS Research Foundation sacked Chief Science Officer Aubrey de Grey over concerns he has attempted to influence an investigation of sexual harassment claims filed against him.
Many expect the full approval will lead to vaccine mandates, as that was one of the obstacles to it for many organizations.
“You are not a horse. You are not a cow. Seriously, y’all. Stop it.” This is the FDA’s recently tweeted advice to Americans seeking out alternative, unapproved treatments for COVID-19.
The U.S. FDA has a busy schedule for the end of August and beginning of September. Let’s take a look.
Woodcock faces heavy opposition from an evenly divided U.S. Senate, particularly from West Virginia Sen. Joe Manchin, who has been critical of the approval process for Biogen’s Aduhelm, formerly known as aducanumab.
As governments and now even businesses push citizens to get vaccinated against COVID-19, anti-vaxxers are loading up more ammo for their argument with this week’s report.
The decision is largely based on three studies.