FDA rejects Navidea product on manufacturing issues; Whistleblower program in India a flop;

> Navidea Biopharmaceuticals says problems with its contract manufacturer led the FDA to reject its application for Lymphoseek, its radioactive tracing agent. Story

> Alan Cassels of the University of Victoria thinks Canadian regulators are so secretive about inspections of foreign plants that citizens cannot be sure of the safety of the drugs they receive. Story

> In a joint venture with AstraZeneca's ($AZN) biologics unit MedImmune, Chinese drugmaker WuXi AppTec will provide manufacturing, preclinical and clinical trials for MedImmune's antibody therapeutic for autoimmune and inflammatory diseases for the Chinese market. Story

> Indian drugmaker Biocon is looking to expand with a plant near Ahmedabad, Gujarat, India. Item

>  Boehringer Ingelheim has established a fully disposable setup and operational approach for disposable technologies as part of its drug development and manufacturing network that it believes will shorten turnaround times. Item

And Finally... A program set up in India in 2009 that would reward whistleblowers for offering up information about companies making fake or substandard drugs and selling them to the government has yet to result in one credible case, the Drug Controller General of India claims. 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 IPM.ai 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.