Topic

Articles

PTC Therapeutics has received a positive opinion from EMA for Upstaza for the treatment of AADC deficiency.

PTC Therapeutics Receives Positive Opinion for Upstaza

The final guidance addresses safety aspects of container and carton labeling design.

FDA Issues Labeling Guidance

The agency is asking drug manufacturers to ensure a strong supply chain by developing risk management plans.

FDA Stresses Risk Management Plans

FDA has approved Mounjaro (tirzepatide) injections as a treatment to improve blood sugar control in adults with type 2 diabetes.

FDA Approves Lilly’s Novel, Dual-Targeted Treatment for Type 2 Diabetes

Pfizer and BioNTech’s COVID-19 vaccine has been granted EUA for booster doses in children five through 11 years of age.

Pfizer and BioNTech Granted EUA for Booster Dose of COVID-19 Vaccine in Young Children

The companies have reached an agreement with the European Commission to update their COVID-19 vaccine supply agreement.

Pfizer and BioNTech Update COVID-19 Vaccine Supply Agreement with EC

Chris Spivey is director of Industry Relations and Strategic Partnership, MJH Life Sciences.

Podcasts

In this episode of the Drug Solutions Podcast, Chris Spivey, editorial director, interviews Michael Kopcha, Sau Lee, and Cindy Buhse of FDA about not being afraid to try new approaches and how they invite fresh ideas and abundant communication.

Drug Solutions Podcast: FDA Weighs in on Advancing the Science of Pharmaceutical Manufacturing

Richard Denk is Head Sales Containment at SKAN AG, www.skan.ch, Richard.Denk@skan.ch.

Julien Janda is Head of Process and Technology at Takeda.

Markus Stuebchen is Robotics Network Team Lead at Roche.

David Wolton is Global Engineering Technology Lead at Takeda.

Several steps need be taken to achieve lights-out, fully automated operations.

Using Robotics in the Aseptic Manufacturing Facility of the Future

The agency’s Center for Drug Evaluation and Research has launched the new program to increase development of treatment options for patients with rare diseases.

FDA Launches Accelerated Rare Disease Cures Program

The draft guidance describes the benefit-risk principles used to conduct product quality-related assessments of CMC information submitted to FDA for assessment as part of NDAs, BLAs, or supplements.

Quality Systems