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 FDA-initiated partial hold on Novartis’ gene therapy trial for spinal muscular atrophy has been lifted recently. Here’s everything you need to know about it.
The filing accused Mayne Pharma, which also has operations in the U.S., of breaching disclosure obligations with regard to anti-competitive conduct.
Seventeen years after buying global rights, AstraZeneca is finally announcing a win for the lupus community with an FDA approval for Saphnelo.
Rep. Michael McCaul issued a third installment today into the origins of the COVID-19 virus and blames the pandemic on a leak from the Wuhan Institute of Virology in China.
The U.S. FDA is starting off August with a mix of PDUFA dates for acne products, seizure medications and a new manufacturing process for a non-opioid pain killer. Here’s a look.
The U.S. Centers for Disease Control and Prevention issued a warning that the Delta variant is as infectious as chickenpox and can cause a much more severe COVID-19 infection.
The U.S. Securities and Exchange Commission has halted registrations of U.S. initial public offerings (IPOs) by Chinese companies.
The panels discussed key issues such as expanded access programs (EAPs), clinical trial diversity, conditional approval pathways, and patient experience data.
Kaiser Permanente has reportedly filed a lawsuit against drug maker Merck for allegedly allowing a “pay-for-delay” scheme that cost the former millions of dollars.
As COVID-19 infections continue to increase in the U.S., the FDA has expanded the EUA for Eli Lilly’s monoclonal antibody to include treatment with or without remdesivir.