The U.S. Food and Drug Administration issued guidelines for where the regulatory agency will set the bar for approval of a vaccine for COVID-19.
India’s ability to produce affordable generic drugs has led to the country’s reputation of being the “pharmacy of the world,” according to Dr. Reddy’s Vice President Radha Iyer.
Noting that the U.S. Food and Drug Administration expects more than 200 investigational new drug applications (INDs) by 2020 per year – many of them cell and gene therapies – the regulatory agency issued an outline of new procedures planned to be implemented during 2019.
The FDA issued draft guidance for biopharma companies on developing therapies for NASH with liver fibrosis.
Chicago-based AbbVie and Cambridge, Mass.-based Voyager Therapeutics inked a collaboration deal to develop treatments for Alzheimer’s disease and other neurodegenerative diseases.
U.S. regulators proposed lowering the bar for clinical trial success for experimental Alzheimer’s drugs.