Policy
Nader Pourhassan, who led CytoDyn for nearly 10 years, was convicted in December 2024 of misleading investors regarding the biotech’s investigational COVID-19 and HIV drug, which artificially inflated its share price.
FEATURED STORIES
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.
Acadia Pharma’s Catherine Owen Adams is one of the founders of a group of small- to mid-cap biotechs advocating against a ‘peanut butter blanket’ approach to drug pricing for small companies.
Former European Trade Commissioner Phil Hogan and former U.S. 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.
Subscribe to BioPharm Executive
Market insights and trending stories for biopharma leaders, in your inbox every Wednesday
THE LATEST
There’s no doubt that drug prices, particularly sky-high prices for new biologics and companies jacking up the prices of older drugs, is a problem. And it’s definitely a political issue, especially now that candidates are declaring their plans to run for president in 2020.
After the U.S. Food and Drug Administration (FDA) took a hard line on the use of real-world evidence in clinical trials, industry leaders are beginning to back the idea, but with some minor changes.
Lawmakers continue to hear concerns over drug prices, as well as proposals to fix the issue.
On Tuesday, a U.S. Food and Drug Administration advisory panel overwhelmingly supported approval of the nasal spray treatment.
Darzalex (daratumumab) for intravenous infusion is approved in the U.S. in combination with bortezomib, melphalan and prednisone for patients with newly diagnosed multiple myeloma (MM) who are ineligible for autologous stem cell transplant.
At the same time, recognizing that use of supplements is widespread in the U.S., the agency also announced a plan for modernizing its regulation and oversight of dietary supplements.
Soligenix, Inc. announced the allowance of a new United States patent protecting its ricin toxin vaccine, RiVax®.
When biotech companies post openings for new positions, hiring managers often face the immense task of sorting through numerous resumes of qualified candidates. However, in South Korea, hiring managers are facing a different problem – a dearth of qualified candidates.
When the U.S. Food and Drug Administration approved Genentech’s Xofluza, a single-dose treatment for the flu, it was met with great fanfare, particularly in Japan, where the treatment was first discovered.
On Feb. 12, a U.S. Food and Drug Administration (FDA) advisory committee will debate whether to recommend Johnson & Johnson’s esketamine spray for major depression. It may be an uphill battle, although any positive results in this extremely difficult-to-treat patient population will no doubt be taken into account.