Biopharma sees tougher FDA approval process

The Wall Street Journal offers more bleak assessments from the pharma industry on their ability to win an FDA approval for a new therapy. Schering-Plough has already shuttered two programs it once held high hopes for and it may soon axe a third. Delays on prasugrel and Cordaptive are adding to the uncertainty and tomorrow an FDA panel will ponder tougher approval standards for diabetes drugs.

"What will it take to get new drugs approved?" Schering-Plough CEO Fred Hassan asks. "The point is, we don't know."

The WSJ notes that it's getting tougher to win an FDA approval even as the number of NDAs is already scraping a 24-year low.

- read the report from the Wall Street Journal

ALSO: Developers say FDA may force higher costs, more time for diabetes programs. Article

Suggested Articles

Xcovery's ALK inhibitor shrank tumors in 75% of lung cancer patients, compared to 67% for Pfizer's Xalkori, the first FDA-approved drug of that class.

The FDA accepted the regulatory filing for Biogen's once-failed Alzheimer's drug, aducanumab, with plans to decide its fate by March 7, 2021.

Alexion named a chief diversity officer, while COVID-19 vaccine player has two new members of its C-suite.