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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Total payment amounts are contingent on the number of governments that will agree to suspend their lawsuits as part of the deal.
WHO Investigators have attempted to return to the Wuhan lab to find the origins of the novel coronavirus but are now being blocked by the Chinese government.
The U.S. Food and Drug Administration has recently granted Breakthrough Device Designation to two medical device companies, with California-based healthcare tech company Endologix leading the mix.
Biogen’s Aduhelm was approved on June 7, 2021, for Alzheimer’s patients, and the controversy continues to grow.
Notably, Koselugo was studied in pediatric populations first, a reversal of the typical development path taken by the majority of drugs.
The lawsuit alleges that Ocugen made “materially false and misleading statements” about its operations and compliance policies.
With billions of dollars at stake in potential legal liabilities, the life sciences giant is exploring a possible solution – bankruptcy of a sort.
On Friday, the agency approved belumosudil as a new treatment option for anyone over 12 with cGVHD after two prior lines of therapy have failed.
There are two PDUFA dates on the U.S. Food and Drug Administration’s calendar for this week. Here’s a look.
In 2016, Mylan’s EpiPen became the flashpoint of drug pricing outrage when it became widely reported the life-saving drug had increased more than 400% in price over a period of seven years.