We use cookies to provide you with a better experience. By continuing to browse the site you are agreeing to our use of cookies in accordance with our Cookie Policy.
Calls for clarification of FDA guidance on interpreting the sameness of gene therapies under orphan drug regulations featured in comments submitted to the agency. Read More
The FDA offers recommendations to sponsors for setting endotoxin limits for early and late-stage development of investigational oncology products in a draft guidance released yesterday. Read More
Stason Pharmaceuticals did not ensure that capsules of the brain cancer drug temozolomide that it manufactured met dissolution attributes throughout their shelf life, and did not ensure proper computer security for its quality control data, the FDA said in a warning letter. Read More
Following the cancellation of a meeting yesterday at the White House to discuss drug pricing, PhRMA and BIO have come out strongly against a Trump administration executive order that would require Medicare to purchase certain drugs at the lower prices paid by other countries, arguing that the move will hurt innovation and the industry’s efforts during the COVID-19 pandemic. Read More
The U.S. Court of Appeals for the Ninth Circuit has nixed the Association for Affordable Medicines’ challenge against a California law banning pay-for-delay arrangements, finding that the generics group and its constituents did not suffer economic setbacks as a result of the legislation. Read More
Eastman Kodak has landed a $765 million government loan to manufacture drug starting materials and active pharmaceutical ingredients in the U.S. Read More
The House coronavirus subcommittee has asked the Government Accountability Office (GAO) to begin a review of the Trump administration’s Operation Warp Speed initiative. Read More