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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AbbVie and its partner company, Medytox of South Korea, have settled a years-long intellectual property legal dispute with California’s Evolus over Jeuveau, a potential rival to AbbVie’s blockbuster Botox, which it gained through the acquisition of Allergan.
An open letter from a group of academics is urging the Biden administration to implement updates to guidance and standards that will better protect high-risk workers from the novel coronavirus that causes coronavirus disease 2019 (COVID-19).
BeiGene’s Bruton’s kinase inhibitor Brukinsa (zanabrutinib) could be on its way for regulatory approval as a potential treatment for Waldenström’s macroglobulinemia (WM), a type of non-Hodgkin lymphoma.
In an editorial letter in The New England Journal of Medicine, Jeff Shuren, M.D., the FDA’s device center director, and the agency’s in vitro diagnostics chief Timothy Stenzel, M.D., Ph.D., wrote that the agency planned to revisit their policy on antibody testing after it had authorized several serology tests.
The U.S. FDA granted Amgen Priority Review for sotorasib for patients with KRAS G12C-mutated locally advanced or metastatic non-small cell lung cancer (NSCLC), after at least one previous systemic therapy.
According to a statement made by Cortexyme, the partial hold was placed on the development program for atuzaginstat after an FDA review of the trial data identified hepatic adverse events.
The companies have announced their intent to appeal the decision.
Pfizer’s COVID-19 vaccine data has once again been threatened by hackers. The alleged theft of intellectual property has been laid at the feet of North Korea’s government.
Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for February 16, 2021.
The WHO’s Emergency Use Listing (EUL), a prerequisite for COVAX Facility vaccine supply, evaluates the safety, quality, and efficacy of the COVID-19 vaccines. As such, today’s approval allows the vaccine to be used by agencies and NGOs around the world.