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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As Moderna moves forward with its mRNA vaccine candidate for COVID-19, the U.S. federal government is helping accelerate the potential medication with a $483 million infusion from the Biomedical Advanced Research and Development Authority.
GenSight Biologics, a biopharma company focused on discovering and developing innovative gene therapies for retinal neurodegenerative diseases and central nervous system disorders, announces the completion of the pre-submission meeting with the European Medicines Agency for the Company’s lead product LUMEVOQ®.
Jelmyto is the first and only non-surgical treatment for patients with this indication. Here’s everything you need to know about it.
On Wednesday, U.S. District Judge Edward Davila set a new date of Oct. 27 to hear the criminal fraud case against Holmes and Theranos’ former president and her former boyfriend, Ramesh “Sunny” Balwani.
Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for April 16, 2020.
Antibody tests, also called serological tests, test if the individual has been exposed to SARS-CoV-2, the novel coronavirus that causes COVID-19.
Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for April 15, 2020.
The investigators assayed the levels and analyzed the expression patterns of more than 3,000 proteins in brain and cerebrospinal fluid samples collected at centers across the U.S.
Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for April 14, 2020.
Bristol Myers Squibb is prepared for an additional windfall of cash after a judge boosted the damages the company is due from Gilead Sciences over a patent infringement regarding the technology related to a novel cancer therapy.