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 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.
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The Federal Bureau of Prisons is investigating reports that Pharma Bro Martin Shkreli is using a contraband cellular telephone to continue to call the shots at his former company from prison.
The FY19 Defense Appropriation provides $3 million (M) to the Department of Defense Bone Marrow Failure Research Program (BMFRP) to support scientifically meritorious research focused on BMF diseases.
As drugmakers continue to develop an understanding of what pain is to the human body, it helps drive the development of innovative manners to treat it that transcend addictive options such as opioids.
The next couple of weeks look to be busy for the FDA, with a string of target action dates scheduled. This week marks three scheduled approvals, two for extra indications for already-approved biologics, and the third for a combination treatment for glaucoma. Here’s a look.
Sanofi has been hoping to secure approval from the U.S. Food and Drug Administration for its dengue vaccine, but a mixed review from a panel of experts could sink the chances of a green light for the medication.
The U.S. Food and Drug Administration (FDA) and some biosimilar and generic drug advocates were concerned that the naming for biosimilars—the branded drug’s name and a unique, four-letter suffix—made the drugs sound inferior to consumers than their branded counterparts.
Eisai Co., Ltd. has announced that a marketing authorization application has been submitted in Japan for lemborexant, an investigational agent for sleep-wake regulation, seeking approval for use in the treatment of insomnia disorder.
Perhaps the biggest mover and shaker announcement this week was the unexpected resignation of Scott Gottlieb, commissioner of the U.S. Food and Drug Administration. Gottlieb will leave his post later this month to spend more time with his family.
Gottlieb announced his intention to leave the FDA earlier this week. The Trump administration will have a list of candidates to choose from as it moves forward.
The European Patent Office has granted a patent for Sangui’s proposed technology/treatment (SBT 102) for septic shock patients, effective March, 6, 2019*.