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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New data continues to emerge that seems to add to the possibility of COVID-19 originating from a lab leak at China’s Wuhan Institute of Virology.
Concerns over vaccination links to heart inflammation are valid, a U.S. Centers for Disease Control and Prevention advisory committee announced this afternoon.
The drug was approved on June 7 under the agency’s accelerated approval pathway, despite the agency’s Peripheral and Central Nervous System Drugs Advisory Committee voting against the drug in November 2020 and having been assured at that time the agency was not considering an accelerated approval.
The medical regulator’s green light is a milestone in the global fight against specific types of late-stage blood cancer, as CAR T-cell therapy has been found to be effective against them.
Crisis has a way of opening doors of opportunity for fraud around the globe. The COVID-19 pandemic has brought not only a fresh slew of financial schemes, but pharmaceutical fraud as well.
Please check out the biopharma industry’s COVID-19 stories that are trending for June 22, 2021.
This program limits the prices drug manufacturers can charge for therapies sold to specific healthcare facilities, including public hospitals and community health centers.
The U.S. CDC issued new guidance for long COVID, and the NIH is figuring out how to deal with the disease, while Tonix Pharma plans to develop TNX-102 SL.
Incyte had a particularly big week scheduled with the U.S. FDA, which included two PDUFA dates and an advisory committee meeting. In addition, Ascendis had a target action date.
In the report to the Committee on the Judiciary in the U.S. Senate, the GAO says drug makers have spent nearly $8.2 billion on DTC drug ads in three therapeutic areas from 2016 to 2018.