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Lilly Ends Phase 3 Development of Diabetes Candidate
China to Reform Vaccine Management System
FDA Grants Fourth Breakthrough Designation to Keytruda Read More
To bridge the gulf between the promise of biosimilars on drug pricing and the reality, payors should incentivize biosimilar utilization, a new report states. Read More
The UK’s National Institute for Health and Care Excellence has recommended reimbursement for PTC Therapeutics’ Translarna for the treatment of Duchenne muscular dystrophy. Read More
The FDA has thrown a wrench into Chiasma’s plans to market Mycapssa, the company’s acromegaly candidate, issuing a complete response letter that asks for more data. Read More
The FDA has slapped Puerto Rico-based AIAC Pharma with a six-observation Form 483 over complaint management, cleaning records and apparent lapses in laboratory controls. Read More
The FDA is looking to shed light on the sometimes murky rules governing compounding operations to distinguish heavily regulated outsourcing facilities from tiny compounding operations that are lightly regulated. Read More
In response to a slew of warning letters regarding data integrity issues, the FDA is addressing questions on the matter that have come up in recent inspections. Read More