Policy
Former European Trade Commissioner Phil Hogan and former US Senator Richard Burr, speaking on a panel at the J.P. Morgan Healthcare Conference, pushed to see a larger picture beyond the Trump administration’s year of chaos and confusion.
FEATURED STORIES
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.
Representatives from companies such as Sanofi and Forge Biologics point to the potential for PreCheck to drive activation of idle production capacity and help companies that are already building plants.
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Voting 19-2, the Vaccines and Related Biological Products Advisory Committee favored redesigning booster shots to include the coronavirus’ Omicron variant.
Spero Therapeutics received a Complete Response Letter from the U.S. Food and Drug Administration for its complicated urinary tract infection therapy, tebipenem HBr oral tablets.
Monday morning, Nuvation Bio announced that the U.S. Food and Drug Administration placed a partial clinical hold on its Phase I dose escalation study of NUV-422.
The FDA has placed Astellas Pharma’s Phase I/II FORTIS trial on clinical hold after one of its study participants experienced a serious adverse event.
Talks between Merck and Seagen are heating up as the former looks to buy the latter, according to a report published by The Wall Street Journal.
FDA releases new draft guidance that addresses Breakthrough Therapy designation and action plan for rare, neurodegenerative diseases.
AbbVie has redeemed a Rare Pediatric Disease Priority Review Voucher for Rinvoq (upadactinib), following its FDA approval for adults with moderately to severely active ulcerative colitis in March.
In an overwhelming vote of support, the U.S. House of Representatives approved the creation of a new department within the National Institutes of Health that is focused on biomedical innovation.
Although COVID-19 appears to be on the run in the U.S., there is still a threat of resurgence. Here’s a look at some of the most recent COVID-19 stories and research.
The WHO will decide whether to declare a public health emergency following the recent outbreaks of monkeypox, and poliovirus has been detected in London water samples.