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 end of November and beginning of December is marked by several PDUFA dates at the U.S. Food and Drug Administration (FDA). Here’s a look.
Days after Purdue Pharma reached a combined $8.4 billion criminal and civil settlement with the U.S. Department of Justice, the OxyContin drugmaker pleaded guilty to three criminal charges to resolve its role in the ongoing opioid crisis in the United States.
Genentech’s influenza treatment Xofluza® (baloxavir marboxil) has been granted approval by the U.S. Food and Drug Administration for use in people 12 years and older, making it the first single-dose post-exposure prophylaxis strategy approved by the agency.
Two months after he was stepped down from the role of chief executive officer of Legend Biotech, Fangliang “Frank” Zhang has been arrested for smuggling genetic resources from the People’s Republic of China.
The U.S. FDA approved Alnylam Pharmaceuticals’ Oxlumo (lumasiran) for primary hyperoxaluria type 1 (PH1) to lower urinary oxalate levels in children and adults.
Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for November 24, 2020.
Eiger’s Zokinvy is the first-ever approved treatment for children with Huchinson-Gilford Progeria Syndrome and processing-deficient Progeroid Laminopathies.
Late Friday, the FDA gave the green light to Regeneron’s REGN-COV2, a combination of casirivimab and imdevimab.
The U.S. Food and Drug Administration (FDA) has a busy end of November planned, with numerous PDUFA dates to address. Here’s a look at the upcoming week.
The U.S. Food and Drug Administration has accepted ADC Therapeutics’ Biologics License Application (BLA) and granted priority review for the company’s relapsed/refractory diffuse large B-cell lymphoma (DLBCL) treatment, loncastuximab tesirine (Lonca).