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 U.S. Food and Drug Administration has given Emergency Use Authorization (EUA) to a COVID-19 test developed by Roche that measures antibodies within the blood.
On Tuesday, the CDC Advisory Committee on Immunization Practices voted 13-1 in support of this recommendation.
The United Kingdom’s Medicines & Healthcare Products Regulatory Agency granted temporary authorization for emergency use to Pfizer and BioNTech for their COVID-19 mRNA vaccine, BNT162b2.
The FDA uses special designations to get new, breakthrough treatments to patients in the greatest need.
As the year winds down, the top companies in the COVID-19 vaccine race are nearing the finish line in the United States and other countries around the world.
Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for December 1, 2020.
The FDA approval was based on results from the largest studies conducted to date in obesity associated with POMC, PCSK1 or LEPR deficiency.
Moderna announced that it plans to submit its request to the U.S. Food and Drug Administration for an Emergency Use Authorization for its COVID-19 vaccine, mRNA-1273.
Guardant Health is taking Roche-owned Foundation Medicine to court over a patent dispute for their liquid biopsy technology, further heating up the rivalry between the two cancer detection companies.
The interim final rule aligns payment for Medicare Part B therapeutics with international prices and removes incentives for physicians to prescribe more expensive drugs and biologics.