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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Disgraced pharma executive Martin Shkreli is pleading to be temporarily let out of prison in order to join in the fight against COVID-19, the disease that has swept across the globe infecting more than 1.3 million people across the globe.
Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for April 6, 2020.
One of the promising experimental drugs being tested to treat COVID-19, the disease caused by the novel coronavirus SARS-Cov2-, is Gilead Sciences’ remdesivir.
Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for April 3, 2020.
The U.S. Food and Drug Administration approved the first blood test that looks for the antibodies against the novel coronavirus that causes COVID-19.
With all the similarities, it should be emphasized that there are several significant differences between the two pandemics.
Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for April 2, 2020.
On Wednesday, the judge overseeing Holmes’ case set for late July refused to change the trial date after her defense team made the request.
Following months of concerns regarding the potential contamination of ranitidine-based products with known carcinogens, the U.S. Food and Drug Administration is asking manufacturers to immediately withdraw all prescription and over-the-counter drugs from the market.
The U.S. Food and Drug Administration is expediting the development of novel therapies for the pandemic through an accelerated evaluation process.