Pharmaceutical Technology Editors

FDA’s Center for Drug Evaluation and Research has published its second annual report on key safety programs and activities.

The contract renewal allows AMRI to continue to provide medicinal chemistry and ADME services for advancing drug discovery programs in neurotherapeutics.

The expanded Laboratory Testing Division, located in Cranbury, NJ, will expand the company’s testing services in the United States.

The transaction is part of Merck KGaA’s strategy to actively shape its product portfolio and focus on innovation-driven business.

Global investment firm Advent to acquire and invest in Sanofi’s European generics business, Zentiva, to boost its position in European market.

The new document answers questions regarding implementation of the ICH Q7 guidance on GMPs for APIs.

The company unveiled three new products to support single-use biomanufacturing and won an award for best technological innovation at INTERPHEX 2018.

Johnson & Johnson’s Janssen partners with Bristol-Myers Squibb to advance next-generation therapies for cardiovascular diseases.

The agency has granted breakthrough therapy designation to Roche’s hemophilia therapy for treating hemophilia A in patients without factor VIII inhibitors.

The European Pharmacopoeia Commission has approved a general monograph laying down harmonized requirements for LBPs for human use and two general chapters addressing microbiological contamination of LBPs.

The company is launching a new pre-fabricated, ready-to-run manufacturing facility that is expected to significantly decrease the production timeline for viral vector-based therapeutics.

According to Alexion, the acquisition will help rebuild its clinical pipeline.

The New York City-based company will relocate to another building in the city.

Honeywell’s Experion Batch visualization technology provides operators with improved visibility, simplified maintenance, and faster validation.

Sartorius Stedim Biotech will supply equipment for Penn State’s new Fermentation Facility in the university’s Center of Excellence in Industrial Biotechnology.

Under an Innovate UK grant for a three-year project, Arcinova and the University of Nottingham will develop a continuous, flexible modular manufacturing technology platform.

A new report gives an overview of the work of the International API Inspection Program.

Kemiex trading network is designed to increase safety in the sourcing of APIs and additives.

This workshop, to be held in Sheffield, United Kingdom, on June 7, 2018, will provide an introduction to the use of glass as primary pharmaceutical packaging.

Innomech has developed an innovative new test station for Fluidic Analytics to streamline R&D programs. The new test station serves as a labor-saving R&D tool to help process multiple test samples and to ensure product quality.

Pharmaceutical Technology will host a panel discussion focused on early drug development on April 24, 2018 at CPhI North America.

A $5.5-million expansion at its Philadelphia, PA clinical supplies facility gives Catalent additional packaging and storage capacity.

The company will build a high-volume manufacturing facility for their glass packaging product in Durham County, NC.

Premier Pharmacy Labs is voluntarily recalling multiple products because of the potential lack of sterility assurance.

Thermo Fisher Scientific and the University of Pittsburgh have established a new pharmacogenomics center of excellence to support translational research that demonstrates the value of PGx in precision medicine.

The contract development and manufacturing organization will discuss its capabilities in topical drug products at CPhI North America, taking place April 24–26, 2018 in Philadelphia, PA.

The new facility, to be built in Toronto, Canada, will significantly increase capacity for pediatric and booster vaccines.

ReForm Biologics and KBI Biopharma will collaborate to improve biopharmaceutical formulations and development.

FDA sent a warning letter to Tris Pharma Inc. after investigators found the company had failed to properly investigate batch failures and establish quality control procedures.

The agency has assigned new EU member state rapporteurs and co-rapporteurs to medicines previously assigned to the UK’s Medicines and Healthcare products Regulatory Agency.