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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A summary of daily biopharma industry news. Please check out stories that are trending on March 23, 2020.
The U.S. Food and Drug Administration has a busy week of possible drug approvals on its calendar. Here’s a look.
“What we have could be a very powerful weapon against these types of viral outbreaks or pandemics because it isn’t pathogen- or virus-specific and could be broadly relevant in these types of situations,” Gil Van Bokkelen, Ph.D., Athersys CEO, told BioSpace.
A summary of daily Biopharma industry news. Please check out stories that are trending on March 20, 2020.
The recommended dose of the drug for this age group is based on weight and liver function.
As the number of diagnosed cases of COVID-19 continues to rise in the United States, Eli Lilly has partnered with the Indiana State Department of Health to accelerate testing for the virus in that state.
Every week there are numerous scientific studies published. Here’s a look at some of the more interesting ones.
The U.S. National Institutes of Health announced that a Phase II clinical trial of AstraZeneca and Merck’s selumetinib in neurofibromatosis type 1 shrank inoperable tumors.
The FDA Guidance on Conduct of Clinical Trials of Medical Products During COVID-19 Pandemic, released Wednesday, are “a really good first step in ensuring that clinical trials continue with minimum disruption,” according to Jim Kremidas, executive director of the Association of Clinical Research Professionals (ACRP).