Hamburg: FDA needs more authority for fakes-fighting; manufacturing mishap delays Onyx NDA filing;

> "The FDA needs new regulatory tools that provide the authority we need to meet the challenges in today's increasing globalized marketplace," Commissioner Margaret Hamburg told the Counterfeit Drug Interchange Conference. Article

> Following the discovery of product variations thought to be caused by faulty equipment during an early manufacturing-scale run, Onyx Pharmaceuticals has delayed its NDA filing for multiple myeloma drug candidate carfilzomib. Article

> The pharmaceutical sector is one of three manufacturing clusters in which U.K. and Singaporean capabilities "combine to create the ideal platform for companies seeking to serve Asian markets," says Singapore's Minister for Trade & Industry.  Article

> Big 3 distributor McKesson held a groundbreaking ceremony for a 340,000-square-foot distribution center in Carmel Church, Caroline County, VA. Article

> India's drug control officers are calling on the Union Health Ministry to form a national drug information center. Article

> ProximaRF Technology has announced a distribution agreement with Meridius for use of the former's passive temperature sensors and data loggers in cold chain applications. Article

> Metrics' senior formulations scientist Joe Cobb has earned the ISPE Certified Pharmaceutical Industry Professional credential. Metrics release

> Thermo Fisher Scientific says it has developed a method for the identification, confirmation and quantitation of illicit drugs and their salt forms. News


Using AI and RWD to Uncover Rare Disease Insights, Accelerate Commercialization and Improve Patient Outcomes

Wednesday, March 24 | 2pm ET / 11am PT

Learn how transformed real world data into real world insights to assist Audentes in their development of AT132 for the treatment of XLMTM. The session reviews how IPM.ia and Audentes collaborated to uncover the XLMTM patient population.