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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Here is a cross-section of some of the surveys about the COVID-19 pandemic over the last few weeks.
Many of the tests that are available are giving false-positives, which means that some people who have not been exposed to COVID-19 are under the impression they have been.
Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for April 27, 2020.
Gilead Sciences filed a lawsuit against the United States government alleging the U.S. Centers for Disease Control and Prevention violated a contract that governed an HIV research collaboration between the company and government agency.
David Loew, head of Sanofi Pasteur, said U.S. approval of the vaccine is an important milestone in the fight against meningococcal meningitis, a serious global health challenge that can be fatal within 24 hours.
Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for April 24, 2020.
Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for April 23, 2020.
In a statement to the New York Times, Bright said he has pushed for science, not politics, as the key to battling the pandemic.
The FDA recently approved the combination of Imbruvica-Rituximab for treating chronic lymphocytic leukemia. Here’s everything you need to know.
Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for April 22, 2020.