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.
FEATURED STORIES
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.
Subscribe to BioPharm Executive
Market insights and trending stories for biopharma leaders, in your inbox every Wednesday
THE LATEST
The U.S. Food and Drug Administration approved Janssen Pharmaceuticals’ Darzalex Faspro for adults with newly diagnosed light chain amyloidosis.
After a start-of-the-year lull, activities at the U.S. Food and Drug Administration are starting to pick up. Here’s a look.
Although there are now two authorized vaccines against COVID-19 available in the United States and a third likely on the way with Johnson & Johnson’s candidate, the nation and world are nowhere near being done with the novel coronavirus, especially with new, more contagious variants now circulating.
The U.S. FDA approved Pfizer’s Xalkori (crizotinib) for pediatric patients one year of age and older and young adults with relapsed or refractory, systemic anaplastic large cell lymphoma that is anaplastic lymphoma kinase (ALK)-positive.
The filing to the U.S. District Court District of New Jersey, dated December 31st, 2020, states that the materials include compound data, strategic plans related to translational and biomarker data, therapeutic program reviews, abstract publications, plans for Congressional presentations, drug monitoring, and compound publication.
In many regards, the incoming Biden Administration is expected to be a redux of the Obama Administration, likely with strong support for scientific research and a reinvigoration of the Affordable Care Act. Yet concerns of pricing controls still loom.
Janet Woodcock, the longtime director of the Center for Drug Evaluation and Research (CDER) at the U.S. Food and Drug Administration is set to take over the top spot of the regulatory agency on an interim basis following the presidential inauguration of Joe Biden.
Merck announced the U.S. Food and Drug Administration (FDA) had accepted its Biologics License Application (BLA) for V114, its 15-valent pneumococcal conjugate vaccine, for Priority Review.
Slaoui will stay on as an adviser for one month. His resignation from the vaccine program was made at the request of the incoming Biden administration.
The U.S. Food and Drug Administration is experiencing abrupt and noticeable personnel changes as it continues to clash with the Health and Human Services, the department that oversees the agency and its operations.