Aurobindo again under FDA fire; Bureaucrats still trying to define "counterfeit;"

> The FDA wants a detailed action plan from Aurobindo Pharma for packaging and labeling compliance at its facility near Hyderabad in southern India. Story

> The World Health Assembly has decided it needs another year before it can make recommendations to fight drug counterfeiting; still problematic is the untangling of trade and intellectual property issues from counterfeiting. Article

> Pfizer says it will spend $21 million to upgrade sterile manufacturing ops at its Portage, MI, facility. Report

> Contract drug developer and manufacturer The Almac Group last week opened its new North American headquarters in Souderton, PA. Release

> Texas A&M University has stepped forward to become one of the U.S. centers for defense against infectious diseases and other biological threats. Item

> AstraZeneca says it's cutting 145 manufacturing jobs at its Westborough, MA, plant. Story

> India plans to announce details about whether the makers of patented drugs are meeting domestic demand at reasonable prices. News

> Nigeria has mandated that patent medicine dealers establish self-regulatory mechanisms for adherence to ethical standards. Article


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.