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March 28, 2025
Three of the five are biosimilars, and seven additional medicines received recommendations for indication extensions.
Sherwin-Williams’ advanced coating systems are designed to ensure safety, sterility, and efficiency in pharma manufacturing environments.
In this exclusive Drug Digest video interview John McQuaid from Almac Pharma Services and Sridevi Khambhampaty from Shilpa Biologics delve into the evolution of the bio/pharma outsourcing market and look at how service-providers’ strategies have adapted to meet demand.
March 27, 2025
In the latest of a series of warning letters to India-based API manufacturers, FDA issued a warning letter to Aspen for deviations in CGMP in the production of APIs.
In response to a presidential Executive Order, the Department of Health and Human Services is planning to reduce its workforce, including cutting FDA staff by 3500 full-time employees, and reorganize some key departments.
March 26, 2025
The company’s state-of-the-art sterile drug product manufacturing site in Saint-Beauzire, France, opened in February 2023.
March 25, 2025
The contract will support R&D of high-quality APIs for substance use disorders and mental health conditions, starting with synthesis and scale-up of psilocybin, which is derived from mushrooms.
Fabhalta (iptacopan) received a positive opinion for treatment of C3G from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) and has been approved twice before by FDA.
March 24, 2025
The EU medicines agencies’ network strategy, EMANS, is an update of the five-year strategy previously developed to cover the period 2021 to 2025.
March 20, 2025
Dirk Margosch, Vice President Visual Inspection, Assembly & Secondary Packaging at Vetter Pharma-Fertigung GmbH & Co KG, provides advice on final product inspection for small batch sizes. He also discusses how to maintain cold chain during visual inspection.