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 U.S. Food and Drug Administration approved Abbott’s molecular test for the novel coronavirus that causes COVID-19 under an Emergency Use Authorization.
A summary of daily Biopharma industry news. Please check out stories that are trending on March 19, 2020.
As the world shifts toward a concept of social distancing as part of an attempt to protect against the novel coronavirus, new research is showing the virus that causes COVID-19 is quite stable on hard surfaces, and even in the air.
Haselmeier officially announces that it has received Master File Number MAF3202 from the Food and Drug Administration of the United States for its D-Flex product platform, a new generation of injection pen systems for subcutaneous self-administration.
The U.S. Food and Drug Administration granted Eli Lilly and Company and Incyte Corporation Breakthrough Therapy designation for baricitinib for alopecia areata.
This announcement contains inside information for the purposes of Article 7 of the Market Abuse Regulation (EU) No 596/2014.
A bill to encourage the manufacture of active pharmaceutical ingredients in America was introduced in the U.S. Senate Tuesday by Senators Marsha Blackburn (R- TN) and Bob Menendez (D- NJ).
The U.S. Food and Drug Administration has two PDUFA dates this week, one for a type of epilepsy and the other for a triple-combination drug for cystic fibrosis. Here’s a look.
The U.S. Centers for Disease Control and Prevention has alerted the country that increased person-to-person spread of novel coronavirus is likely, and that measures to contain the disease will become more and more disruptive to daily life.
Hospitals and laboratories will be able to run the test on Roche’s fully automated cobas 6800 and cobas 8800 Systems, which are already in wide use in the U.S. and internationally.