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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Please check out the biopharma industry’s COVID-19 stories that are trending for April 20, 2021.
The government agency is asking for more information before approving a clinical study on the company’s Chimeric Antigen Receptor-T cell therapy (CAR-T).
The vaccine distribution has been paused in the country because of six or seven cases of rare blood clots.
Acting FDA Commissioner Janet Woodcock shared her thoughts on pandemic issues and outlined FDA modernization plans in a recent Q&A session with the Alliance for a Stronger FDA (Alliance).
Johnson & Johnson, Endo International, AbbVie’s Allergan unit and Teva Pharmaceutical will head to court this morning in California over claims the companies engaged in deceptive marketing practices that fueled the opioid crisis in America.
With its only approved drug product on the line, Pacira Biosciences is fighting back against what it’s calling “misrepresentation of the clinical effectiveness” of its non-opioid pain reliever Exparel.
The reason for the request was the monotherapy antibody therapy is less effective against the COVID-19 variants, such as have risen from the U.K., South Africa and Brazil, as well as the growing B.1.427/B.1.429 California variant.
The U.S. FDA’s Advisory Committee on Immunization Practices (ACIP) met yesterday to make a recommendation on the current pause of the Johnson & Johnson COVID-19 vaccine.
The U.S. CDC said up to 5,800 people who have been fully vaccinated against coronavirus disease 2019 (COVID-19) have been infected by the novel coronavirus following vaccination.
The approval marks the second approval for Trodelvy, which Gilead gained through its $21 billion acquisition of Immunomedics.