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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FDA
This week will have moderate activity by the U.S. Food and Drug Administration (FDA). Although they jumped the gun on Regeneron and Sanofi’s cancer drug, there are still plenty of other decisions being made this week. Here’s a look.
The U.S. Federal Trade Commission has cracked down on clinics that are making claims that certain stem cell therapies can treat a number of serious diseases such as Parkinson’s disease, autism, macular degeneration, cerebral palsy, multiple sclerosis, and heart attacks.
Part of the Trump Administration and the U.S. Food and Drug Administration (FDA)’s strategy to push down drug prices is to develop ways to increase competition. As such, the agency launched a Drug Competition Action Plan that has several components.
Shares of Clovis Oncology are up more than 7 percent in premarket trading after the company announced positive results from a mid-stage clinical trial that showed patients treated with Rubraca achieved a 44 percent objective response rate in some patients with metastatic castration resistant prostate cancer (mCRPC).
As more and more lawsuits are filed by state and local governments over the opioid epidemic, drugmakers are fighting back in court by demanding the allegations include specifics on how the companies are to blame.
Distributor will supply Chirascan circular dichroism spectrometers and SX stopped-flow spectrometers to Ireland and Northern Ireland
Santhera Pharmaceuticals announces that the Committee for Orphan Medicinal Products (COMP) of the European Medicines Agency (EMA) has issued a positive opinion on orphan drug designation for POL6014 in the treatment of cystic fibrosis (CF), a rare pulmonary disease affecting around 35,000 people in the European Union.
This announcement contains inside information for the purposes of Article 7 of the Market Abuse Regulation (EU) No 596/2014.
Program part of Itmenan’s ‘Universal Periodic Examination’ & ‘Early Detection of Cancer’ initiatives
Buried deep in an announcement touting a 6 percent growth in net sales driven by strong revenue gains of Cosentyx, Swiss pharma giant Novartis reported it received a Complete Response Letter from the U.S. Food and Drug Administration for canakinumab as a potential treatment for cardiovascular risk reduction.