The FDA continues to break records in approving generics to ramp up competition in the U.S. drug market. In fiscal 2019, the agency approved 1,171 generic drug approvals – 935 full approvals and 236 tentative approvals. That breaks fiscal 2018's record of 971 approvals, Acting FDA Commissioner Ned Sharpless said. The 2019 approvals included 125 applications for first generics of drugs that had no generic competition.
Sosei Group Corp., of Tokyo, said its partner, Genentech Inc., a member of the Roche Group, of Basel, Switzerland, plans to select a new G protein-coupled receptor, or GPCR, disease target, which triggered a $3 million payment to Sosei Heptares.
Even as the U.S. House of Representatives fast tracks H.R. 3, the Lower Drug Costs Now Act, as its solution to making prescription drugs more affordable, other bills aimed at drug pricing continue to roll in.
After proposing an undisclosed alternative price, Clovis Oncology Inc., of Boulder, Colo., got the approval of the U.K.'s National Institute for Health and Care Excellence (NICE) for coverage of its ovarian cancer drug Rubraca (rucaparib) under the Cancer Drugs Fund (CDF) while the company continues to collect long-term overall survival data.
The Institute for Clinical and Economic Review (ICER), of Boston, said it released an updated draft evidence report assessing the comparative clinical effectiveness and value of treatments for rheumatoid arthritis.
The FDA’s Office of Pediatric Therapeutics will hold a public workshop at the agency’s Silver Springs, Md., campus Nov. 12 to discuss pediatric patient-specific engagement in the development of clinical trial endpoints for rare diseases.