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
No safety issues were cited. Instead, it appears related to the company’s proposal to modify the trial’s analysis plan and various chemistry, manufacturing and controls (CMC) issues.
Patent broadens protection in infectious disease, including composition of matter claims
Potential New Indication Would Expand Use to Allow Treatment-Experienced Adults Living with HIV-1 Whose Virus is Suppressed to Switch to PIFELTRO (in Combination with Other Antiretrovirals) or DELSTRIGO
ChromaDex to move forward with patent infringement action, following unsuccessful challenge by Elysium Health during Inter Partes Review (IPR)
In its year-end financial report, Johnson & Johnson (J&J) predicted product sales for 2019 to range from $80.4 billion to $81.2 billion, about $1 to $2 billion below what Wall Street analysts projected. The company thinks this will largely be due to increased biosimilar competition.
Taiwan Liposome Company, Ltd. today announced that the European Medicines Agency (EMA) has granted orphan drug designation for TLC178 for the treatment of soft tissue sarcoma.
A documentary about Theranos will be shown at Sundance, while ABC News will unveil its own documentary on the company this week.
Translate Bio did not provide information as to what questions or concerns the FDA has regarding the planned early-stage trial for mRT5201.
FDA
The Journal of the American Heart Association (JAHA) published an article in December saying that paclitaxel-coated balloons and stents manufactured by Boston Scientific and others had an increased risk of death.
As opioid lawsuits continue to wind through the courts, some drugmakers are focused on developing treatments for opioid addiction.