Policy
A renewal of the FDA’s pediatric rare disease voucher program is couched within a massive $1.2 trillion spending bill the House is set to vote on later this week.
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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 target action date is August 21, 2020.
The company indicated then that it still believes all four HHS PrEP patents are invalid and should not have been granted.
The approval marks the first once-per-day 24-hour, intravenous COX-2 preferential NSAID, the company said.
Here’s a look at the two drugs that had dates this week but were approved early and are now on the market.
Padcev, which was approved by the U.S. Food and Drug Administration in December, secured Breakthrough Therapy designation for the treatment of patients with another type of bladder cancer.
To date, there are more than 72,000 confirmed and suspected cases of COVID-19 and 1,023 deaths from COVID-19, most in mainland China.
Hector Armando Kellum, a former senior executive with the Novartis subsidiary Sandoz, pleaded guilty for his role in a price-fixing scheme for generic drugs developed by his company.
Frank Reynolds, the founder and chief executive officer of PixarBio, was also ordered to repay $7.5 million to investors who backed the company’s non-opioid painkiller, NeuroRelease.
It doesn’t happen that often, but Merck’s checkpoint inhibitor Keytruda received a rejection from the U.S. Food and Drug Administration.
The U.S. Food and Drug Administration issued a statement on Friday outlining what the agency is doing at home and abroad in response to the outbreak, which has infected more than 73,000 people worldwide.