Policy
A renewal of the FDA’s pediatric rare disease voucher program is couched within a massive $1.2 trillion spending bill the House is set to vote on later this week.
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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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Vaccine expert Rick Bright, who was abruptly dismissed from his post as director of the Biomedical Advanced Research and Development Authority (BARDA) last month, filed a whistleblower complaint against the administration over its failures to heed warnings about the COVID-19 pandemic and accused the White House of cronyism in awarding contracts.
Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for May 6, 2020.
The U.S. Federal Trade Commission gave the green light to the $63 billion merger of AbbVie and Allergan. That leaves one last hurdle for the two companies, approval from the Irish High Court.
In an interview with National Geographic, Fauci once again sided with the evidence that indicates the virus is a species jumper and originated in the animal kingdom.
Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for May 5, 2020.
Leaders from all over the world met for a virtual summit on Monday, May 4 to pledge billions of dollars to fund development of a vaccine against COVID-19, the disease caused by the novel coronavirus SARS-CoV-2. Noticeably absent was the United States.
The Hill reports that the six or eight selected will go into clinical trials, where “health experts are looking to weed out faulty candidates and come out with three or four vaccines that clear final testing to be used by early 2021.”
Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for May 4, 2020.
The U.S. Food and Drug Administration green-lit Roche’s new Elecsys Anti-SARS-CoV-2 antibody test that will help determine whether or not people have been infected by the novel coronavirus and developed antibodies to the disease.
The U.S. Food and Drug Administration (FDA) approved Gilead’s remdesivir under Emergency Use Authorization as a treatment for COVID-19 following reports the drug met its primary endpoint in a U.S. National Institute of Allergy and Infectious Diseases (NIAID) clinical trial.