Policy
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.
FEATURED STORIES
With five CDER leaders in one year and regulatory proposals coming “by fiat,” the FDA is only making it more difficult to bring therapies to patients.
The record-setting government shutdown was just the latest blow to the U.S. biopharma industry. When science funding becomes a casualty of political gridlock, we lose valuable talent, erode public trust and jeopardize our position as a global leader in innovation.
Representatives from companies such as Sanofi and Forge Biologics point to the potential for PreCheck to drive activation of idle production capacity and help companies that are already building plants.
Subscribe to BioPharm Executive
Market insights and trending stories for biopharma leaders, in your inbox every Wednesday
THE LATEST
Mark Cuban Cost Plus Drug Company now boasts over 700 prescription generic drugs for a variety of conditions, ranging from acid reflux to dementia to autoimmune diseases like Rheumatoid Arthritis.
Three physicians filed a lawsuit against the FDA alleging the organization acted outside its authority and with their ability to practice medicine by discouraging the use of ivermectin to treat COVID-19.
For years, PTC Therapeutics has attempted to win regulatory approval for its DMD drug, Translarna. Now, the company believes it has data that will support another filing for FDA approval.
The government of France launched its Healthcare Innovation 2030 strategy that aims to turn the country into a European innovation leader within the next eight years.
An FDA advisory committee voted against Acadia Pharmaceutical’s supplemental New Drug Application of Nuplazid tablets for the treatment of Alzheimer’s-related psychosis.
BMS, TG Therapeutics, Spero and Merck are all preparing for PDUFA dates over the next couple of weeks. Here’s a closer look.
The World Trade Organization approved vaccine patent waivers to increase the availability of COVID-19 vaccines to lower-income countries.
The vote came just over one week after the FTC announced it would probe claims regarding the role the middlemen play in determining retail prices of prescription drugs.
Checkpoint Therapeutics announced that its checkpoint inhibitor cosibelimab is showing positive objective response rate data in patients with locally advanced cutaneous squamous cell carcinoma.
Frederick National Laboratories, the American Cancer Society and other leaders are picking up the pieces - both good and bad - as COVID-19 becomes endemic.