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
Shares of GlaxoSmithKline took a slight dip Wednesday afternoon after the U.S. Food and Drug Administration approved Mylan NV’s generic version of Advair Diskus, a staple blockbuster drug in the U.K. pharmaceutical company’s pipeline.
The regulatory agency issued a Complete Response Letter to the Marlborough, Mass.-based Sunovion, the company said this morning. After reviewing the New Drug Application, the FDA said it could not approve the application for the apomorphine sublingual film in its present form.
In November, Chinese researcher He Jiankui of the Southern University of Science and Technology of China announced he had used CRISPR to alter the embryos of seven couples to make them resistant to HIV. To date, a set of twins were born and there is another pregnancy. This was met by near-universal condemnation in the global scientific community.
The court documents in Massachusetts reveal not only how much the family made from sales of the opioid, but also the tactics used to promote sales.
As the trial against John Kapoor and other former executives at Insys Therapeutics continues, more sordid details of an aggressive campaign to boost sales of the company’s fentanyl-based sublingual spray for cancer pain are being brought to light.
The U.S. Senate Finance Committee and the House Oversight Committee started hearings on Tuesday, January 29, focused on dealing with high drug prices.
The U.S. Food and Drug Administration issued a Complete Response Letter to the company in November, one month after an advisory committee rejected the drug. When the FDA issued the CRL, the regulatory agency requested additional clinical data on QT prolongation and indicated that the submitted safety database is not of adequate size for the proposed dosing.
Real-world evidence (RWE) or real-world data (RWD) relates to the collection of information about a drug’s safety and efficacy outside the structure of a clinical trial. Speaking yesterday, FDA Commissioner Scott Gottlieb laid out the FDA’s new framework for dealing with RWE and RWD.
MorphoSys AG announces that it was informed that in its lawsuit against Janssen Biotech and Genmab A/S, the United States (U.S.) District Court of Delaware has ruled in a Court Order on January 25, 2019, that the asserted claims of three MorphoSys patents with U.S. Patent Numbers 8,263,746, 9,200,061 and 9,758,590 are invalid.
Numerous biotech companies had filed for initial public offerings (IPOs) during the five-week government shutdown, but were unlikely to actually be able to be listed until the U.S. Securities and Exchange Commission (SEC) had a chance to review their filings.