Court: No judicial reviews of warning letters; MedImmune to hire 100 in MD;

> The U.S. Court of Appeals for the District of Columbia has ruled that FDA warning letters "are not final agency actions;" companies therefore can't seek judicial review of them under the Administrative Procedures Act. Story (sub. req.)

> AstraZeneca's ($AZN) MedImmune biologics unit plans to add 100 employees to the staff of its manufacturing plant in Frederick, MD. Article

> Wilfried Hoffmann has joined Dublin-based Scale-up Systems as principal consultant, after 28 years with Pfizer ($PFE). Release

> India's High Court has directed that teams be formed to check pollution by pharmaceutical companies in Nalgonda, Andhra Pradesh, in response to villager complaints. Item

> Arnall Golden Gregory LLP announces the opening of a Miami, FL, office that will specialize in providing services to clients with global logistics and supply chain interests, including third-party logistics providers. Release

> Mustard Tree Instruments has launched a YouTube channel to spotlight its techniques and instruments for drug manufacturing QC; among them, Raman spectroscopy and raw material identity verification. Release | Channel

> NeoStem's ($NBS) cell therapy manufacturing division, Progenitor Cell Therapy, will provide contract manufacturing of Islet Sciences' microencapsulated insulin-producing, pancreatic islet cells. Release

> Nephron Pharmaceuticals will work with architect/developer ACi on a $313 million facility that aims for LEED silver certification. Story


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.