India’s top drug regulatory body plans to fast-track approvals for combination products recommended by the World Health Organization to treat HIV and hepatitis B and C. Source: Drug Industry Daily
A federal judge ruled that three generics manufacturers infringed on Novartis’ patents related to its Zortress treatment, used during kidney and liver transplants. Source: Drug Industry Daily
Four major patents for Acorda Therapeutics’ successful MS treatment Ampyra were invalidated by a federal judge nearly a decade before they were set to expire — less than a month…
Fiscal 2017 could be a record-setting year for ANDA applications if trends continue. Source: Drug Industry Daily
The FDA hit drugmaker Opto-Pharm with a warning letter, citing a lack of written procedures for preventing contamination of sterile drug products, as well as problems with validation, testing and…
The FDA has accepted for review the first two novel, personalized cancer treatments — known as chimeric antigen receptor T-cell therapies, or CAR-T — using immune system cells drawn from…
More than a dozen state pharmacy regulatory authorities told the GAO they have trouble communicating with the FDA on drug compounding issues. Source: Drug Industry Daily
In a regulatory science update to Congress, the FDA cited its successes with the use of specialized consortia and improvements in clinical evaluation. Source: Drug Industry Daily
Democrats in the House and Senate are seeking support for a proposal aimed at bringing down prescription drug prices — compiling ideas proposed in separate bills since the start of…
A broad group of industry organizations is urging the FDA to delay its quality metrics reporting program, which would require drugmakers to aggregate information on the number of lots started,…