Policy
An inconsistent boom-and-bust cycle funding environment for early-stage biotech innovations and burdensome regulation threaten the U.S.’s half-century-long dominance in the biotech sector.
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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.
The record-setting government shutdown was just the latest blow to the U.S. biopharma industry. When science funding becomes a casualty of political gridlock, we lose valuable talent, erode public trust and jeopardize our position as a global leader in innovation.
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After a filibuster was broken Monday, the Senate confirmed Califf’s nomination in a 50-46 bipartisan vote.
After announcing that the FDA was investigating a possible death associated with its lymphoma drug Ukoniq (umbralisib), things are seemingly looking up for TG Therapeutics.
Robert Califf’s nomination to resume his role as FDA Commissioner continues to advance in the Senate, despite some opposition from a key Democrat, Sen. Joe Manchin.
Since 2016 the state has offered more than $70 million in tax credits to 114 different entities and has generated about $140 million in investments into the state’s life sciences ecosystem.
CMS says it would only cover the cost of Biogen’s Aduhelm and any required scans “if they are enrolled in qualifying clinical trials.”
Stoughton, Mass.-based Collegium Pharmaceutical is expanding its pain-treating portfolio with a $604 million buyout of Raleigh’s BioDelivery Sciences International (BDSI).
Although the Omicron surge appears to be waning in the U.S., the World Health Organization keeps an eye on four Omicron subvariants.
Pfizer indicated it will wait for the full data on a three-dose series of the vaccine for that population, believing it “may provide a higher level of protection in this age group.
Shares of Cassava Sciences are up more than 5% in premarket trading after the FDA denied a Citizen Petition filed last year to suspend the company’s Alzheimer’s clinical trials.
On Feb. 15, the FDA’s Vaccines and Related Biological Products Advisory Committee is scheduled to discuss an amended EUA for the Pfizer-BioNTech vaccine in the under 5 age group.