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.
FEATURED STORIES
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.
Subscribe to BioPharm Executive
Market insights and trending stories for biopharma leaders, in your inbox every Wednesday
THE LATEST
Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for July 6, 2020.
It’s a relatively slow month ahead for July in terms of PDUFA dates for the U.S. FDA. However, there are several dates pending throughout the month. Here’s a look at three for the next two weeks.
Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for July 3, 2020.
Meet with regulatory affairs professionals early and often. That’s the message from Neelu Gibson, VP, regulatory affairs, at BD, speaking at Biocom’s June virtual meeting, “Regulatory Affairs…Engagement Do’s & Don’ts.”
The U.S. Justice Department charged Glenmark Pharmaceuticals, headquartered in India, with conspiring with other generic drug companies to increase and hold prices for the cholesterol drug pravastatin between May 2013 and December 2015.
Bavencio is an anti-PD-L1 checkpoint inhibitor co-developed by Merck KGaA, Darmstadt, German and Pfizer via EMD Serono, a business unit of the two companies.
The FDA guidelines also indicated a vaccine would not be approved unless it had “clearly demonstrated” proof of the vaccine’s safety and effectiveness in a clinical trial.
Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for July 1, 2020.
The anti-PD-1 therapy was approved by the U.S. Food and Drug Administration alone for first-line treatment of unresectable or metastatic microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) colorectal cancer.
The U.S. Food and Drug Administration (FDA) issued Heron Therapeutics a Complete Response Letter (CRL) for its New Drug Application (NDA) for HTX-011 for the management of postoperative pain.