FDA to study quality-manufacturing-performance link; chemical companies lobby to protect security upgrades;

> Evaluating the link among product quality attributes, manufacturing processes and product performance is part of FDA's Center for Drug Evaluation and Research strategic science and research agenda, now available for review and comment. Release

> The chemical industry wants Congress to quickly approve a multiyear extension of the Department of Homeland Security antiterrorism program for chemical facilities, which expires later this year, to ensure that current security upgrades will continue to meet regulatory requirements. Story

> Salix Pharmaceuticals will pay an additional $21.5 million commitment fee to Glenmark Pharmaceuticals to meet higher anticipated demand for the HIV-associated diarrhea drug Crofelemer. Article

> U.S. drugmaker Sangart will build a manufacturing plant near Cork, Ireland, generating 120 jobs. Item

> Pluristem has entered into an agreement with MTM--Scientific Industries Center Haifa, for the leasing and construction of a regenerative medicine facility will be cGMP/GTP compliant for clinical cell manufacturing and designed to meet EMA and FDA regulatory requirements, as well as the standards outlined by the Israeli Ministry of Health. Story

> A paperless microbiological environmental monitoring system for life science manufacturing, SmartLab EM, is now available from VelQuest. Release

> Novasep has announced that it has completed two successful FDA inspections of Novasep Synthesis installations this year, at its Freeport, Bahamas facility in March and at its Lyon, France, facility in May. Announcement

> Contract manufacturer Pharmaceutics International has added hot melt extrusion to its portfolio of formulation and process development solutions. Release

Webinar

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.