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 hold is related to a report of a SUSAR of myelodysplastic syndrome in a patient treated with eli-cel, also known as Lenti-D, in a Phase III clinical trial.
The company indicated they plan to meet with the FDA to determine the next course of action.
As COVID-19 vaccines near full approval by the U.S. FDA, Dr. Anthony Fauci expects several organizations across the country, including businesses and schools, will issue their own vaccine mandates before people can enter their establishments.
Although August is a fairly busy month for PDUFA dates, there were only two on the U.S. FDA’s calendar for this week, and one of those has already been reported. Here’s a look.
It was a busy week for clinical trial announcements. Take a look.
U.S. authorization is likely not a priority for Novavax since half the population is already vaccinated. But with other parts of the world, there’s still plenty of room for a Novavax vaccine.
Legal firms are lining up to lead litigation against the company on behalf of shareholders who saw their stock dive.
CytoDyn files a lawsuit against the activist group led by Rosenbaum and Patterson, alleging that they are “waging an illegal proxy contest to take over control of the Company’s Board of Directors.”
Specifically, the FDA states Syntec has critical issues with how the pharmaceutical manufacturer handles active pharmaceutical ingredients, issues that may compromise the safety of the firm’s manufactured drugs.
Biosimilars have gained traction in Europe, but not in the U.S. AbbVie’s Humira is often made as an example of how companies are using legal tactics to delay biosimilar competition.