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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In a statement, the FDA said “objectionable conditions were found and documented” but did not meet the threshold for regulatory action against the Swiss pharma giant.
Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for April 1, 2020.
Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for March 31, 2020.
On Monday, a judge ruled against patents blocking the way for generic drugmakers Hikma Pharmaceuticals and Dr. Reddy’s Laboratories to file Abbreviated New Drug Applications for Vascepa generics.
Scientists and physicians have been cautious about use of the drug for the disease, while President Trump touted it as a “game changer.”
Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for March 30, 2020.
Here’s a look at the next two target action dates on the calendar for early April.
A summary of daily biopharma industry news. Please check out stories that are trending on March 27, 2020.
The NDA is for a new formulation of the drug as one-dose granules for oral suspension, would which largely be aimed at children and people who have difficulty swallowing.
Although Zeposia has now been approved in the United States, BMS said it was delaying commercialization due to the “unprecedented COVID-19 pandemic.”