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.
FEATURED STORIES
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.
Subscribe to BioPharm Executive
Market insights and trending stories for biopharma leaders, in your inbox every Wednesday
THE LATEST
After allegations of bullying became public, Dr. Eric Lander, the director of the federal government’s Office of Science and Technology Policy, resigned from his executive branch role.
The U.S. Food and Drug Administration announced they are investigating a possible death risk for TG Therapeutics’ Ukoniq (umbralisib).
According to Politico, an internal White House investigation confirmed the alleged abuses from Lander, the president and founding director of the Broad Institute.
COVID-19 is a respiratory illness and presents many other symptoms, including blood clots. For more details and other COVID-19 news, continue reading.
FDA Action Alert for February 7
This particular renewal panel discussion took an unexpected turn, focusing on Biogen’s controversial drug.
The company indicated that its timeline for an accelerated approval request for its own Alzheimer’s drug, donanemab, was no longer on schedule for the first quarter after the CMS draft guidance.
Pfizer has filed a lawsuit against execs at Regor Therapeutics after an investigation pointing company trade secrets were used to develop therapeutics at the center of Regor’s partnership with Eli Lilly.
The Omicron surge appears to be waning in the U.S., but a subvariant of Omicron seems to be surging in other countries where the Omicron surge faded.
Gilead Sciences revealed in a call with analysts that the hold has now been expanded to additional magrolimab studies.