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Janssen has moved to a continuous manufacturing process at one of its facilities after getting the green light Friday from the FDA to switch from batch production, making it the first drugmaker allowed to change its production method. Read More
The Kentucky state Senate has passed a bill in a 36 to 1 vote that would permit interchangeable biosimilar substitution. The FDA has not yet approved an interchangeable biosimilar. Read More
The biosimilars market could exceed $390 billion in value over the next five years, but only if nations improve the competitive landscape, according to a new market analysis. Read More
Following months of pressure from industry, the FDA has released draft guidance on biosimilars labeling, recommending that sponsors incorporate into product labeling information from the reference product labeling. Read More
Cynthia Schnedar, director of CDER’s Office of Compliance, stepped down from her role on March 18 to take an unspecified private sector job, according to an email from CDER Director Janet Woodcock. Tom Cosgrove, who until recently served as director of the OC’s Office of Manufacturing Quality, assumed her position on April 4. Read More
Drugmakers selling into the EU will have two years to begin complying with a new set of ISO global standards that will create a unique identifier for drugs. Read More
The FDA has slammed yet another Indian drugmaker for data integrity issues: This time it rebuked Ipca Laboratories for data falsification at three of the company’s manufacturing facilities. Read More
Weighing the risks and benefits of Intercept Pharmaceuticals’ obeticholic acid, an FDA advisory committee voted unanimously 17-0 on the significance of alkaline phosphatase levels as evidence to justify an accelerated approval of the primary biliary cirrhosis candidate. Read More
FDA unveiled April 6 the new Combination Products Policy Council, which will have decision-making authority on issues relating to combination products, cross-labeled products and medical product classification. Read More