Teva, Bedford Labs antibiotic in short supply; FDA looks at ICH Q11 in draft guidance;

> Count antibiotic Amikacin injection among the drug shortages listed by the FDA. Both Teva and Bedford Labs cite manufacturing delays for lack of supply of 250 milligram per milliliter, 2- and 4-milliliter vials. Listing

> The FDA has published draft guidance for the ICH Q11 guideline on the development and manufacture of drug substances, which encompasses APIs and biopharmaceutical manufacturing. Article

> Combining its strengths in software and drug-making, India has convened a task force for developing anti-counterfeiting drug-tracking software. News

> Police raids of commercial buildings in the Thai city of Pattaya have uncovered more than $335,000 in illegal drugs, pirated clothing and smuggled cigarettes. Item

> Valeant Pharmaceuticals plans to move some U.S. production back to Canada within three years. Story

> Granules India of Hyderabad is setting up a bulk drugs and intermediaries manufacturing facility in Visakhapatnam with an investment of $20 million in joint venture with Belgium's Ajinomoto OmniChem. Report

> Ontario is helping Teva expand production, create jobs and save jobs at plants in Stouffville, Markham and Scarborough. Piece


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.