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.
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U.S. federal lawmakers are discussing various legislative plans that could lower the out-of-pocket expenses many Americans pay for their medications. The plans are coming from both chambers of Congress and with a divided government, lines in the sand will likely be drawn.
Although that is good news, cancer is the second-most common cause of death in the U.S., with more than 1.7 million new cancer cases each year and more than 600,000 cancer deaths. The report notes that one of the biggest factors in decreased cancer rates are lower tobacco smoking rates.
On Jan. 11, President Donald Trump announced via Twitter that 2018 was marked by a decline in prescription drug prices – the first time that had happened in 50 years. Also, the president said that Americans saved $26 billion on drug prices in the first 19 months of his presidency.
The notorious legacy of OxyContin continues to be a major black mark against Purdue Pharmaceuticals. And that mark is only getting worse as a court case against the opioid manufacturer has revealed company officials used deceptive marketing practices to boost sales of the drug.
Noting that the U.S. Food and Drug Administration (FDA) expects more than 200 investigational new drug applications (INDs) by 2020 per year, many of them cell and gene therapies, the agency issued an outline of new procedures it plans to implement this year.
Office Covering the Use of MANF or CDNF as a Treatment for Glaucoma, Macular Degeneration and Retinitis Pigmentosa
CarTher today announces it has secured approval from the French National Agency for Medicines and Health Products Safety (ANSM) to start a Phase I-II clinical trial of its SonoCloud-9 device in the treatment of recurrent glioblastoma.
Eisai Co., Ltd. and Purdue Pharma L.P. today announced that a new drug application has been submitted to the U.S. Food and Drug Administration (FDA) for lemborexant, an investigational agent for sleep-wake regulation, seeking approval for the treatment of insomnia, a sleep-wake disorder.
In 2018, the FDA approved 59 novel drugs, meaning approved new molecular entities. BioSpace analyzed new drug approvals from 2014 to 2018 to determine which companies were responsible for the most drug approvals in that period. Here’s a look.
The FDA approved Cabometyx based on the Phase III CELESTIAL trial that showed the drug provided a statistically significant and clinically meaningful improvement in median overall survival.