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 action data was extended by the agency to provide more time to review new data analyses submitted by Lilly, per information requests made by the FDA.
Please check out the biopharma industry’s COVID-19 stories that are trending for April 6, 2021.
Shares of Supernus Pharmaceuticals were climbing in premarket trading this morning after Friday’s announcement the U.S. FDA approved the company’s non-stimulant treatment for ADHD in pediatric patients 6 to 17 years of age.
The U.S. FDA issued a Complete Response Letter (CRL) over Acadia Pharmaceuticals’ supplemental New Drug Application (sNDA) for Nuplazid for hallucinations and delusions associated with dementia-related psychosis.
If you’re one of the 17% of Americans that have been fully vaccinated against SARS-CoV-2, you are probably feeling some level of relief. But the CDC warns not to throw your mask away just yet.
Sepsis is among the best-known and least effectively treated conditions in the modern world. The standard of care has failed for these infections, leaving the U.S. healthcare system with $62 billion and 270,000 deaths annually. Globally, 11 million die from sepsis each year. Effective drugs and diagnostics are available. They’re just not used.
In a statement, the company said, “Bristol Myers Squibb is in compliance with all applicable tax rules and regulations. We work with leading experts in this area and will continue to work cooperatively with the IRS to resolve this matter. Beyond that, we don’t comment on ongoing regulatory matters.”
Three members of the FDA’s Peripheral and Central Nervous System Drugs Advisory Committee published their objections to the drug in a JAMA article.
The U.S. Food and Drug Administration approved two new treatments for multiple myeloma and pulmonary hypertension.
Citing Russia’s agricultural regulatory agency, Reuters reported the new vaccine called Carnivac-Cov will be used against the virus in dogs, cats, foxes and mink.