Pharmaceutical Technology Editors

Slovakia becomes the final European Union country to be recognized by FDA, and the mutual recognition agreement for inspections of manufacturing sites between the US and the EU is now fully implemented.

TaskMate Robotic Systems from ESS Technologies with Fanuc America’s robots create an ultra-compact robotic cell that integrates with cartoners, case packers, and monoblock filler/cappers for collation and machine loading and unloading.

Omega Design’s auto-indexing machine dispenses canister desiccants into a wide range of containers for pharmaceutical and nutraceutical applications.

The new guidance offers information for new drug application and biologics license application sponsors regarding population pharmacokinetic analysis.

The expansion of Lonza’s Tampa site includes development and manufacturing capabilities for oral solid-dose drugs.

The FDA guidance defines changes to approved risk evaluation and mitigation strategies and clarifies submission guidelines.

GSK announced the opening of its new manufacturing facilities in Singapore after a $130-million investment.

The draft guidance provides industry with a guide for using the database to assist in the development of drug products.

FDA released draft guidance on using the USP pending monograph process in the drug application process.

The companies announced their collaboration to provide a human-induced pluripotent stem cell (iPSC)-based integrated platform for drug discovery solutions.

Fresenius Kabi recalls chemotherapy drug because of possible glass particulate within the drug vials.

Metabolic-disease biotech Amicus Therapeutics announced a manufacturing agreement with Catalent’s Paragon Gene Therapy unit for gene therapy manufacturing.

The guidance document provides recommendations for developing content for Instructions-for-Use documents for human prescription drugs, biological products, and drug-device or biologic-device combination products.

FDA sent warning letters detailing violations of current good manufacturing practices to three companies that repack APIs.

CHMP of the European Medicines Agency has recommended a change to the European marketing authorization for AstraZeneca’s Forxiga (dapagliflozin) in patients with Type-2 diabetes.

The Bittium Wearable Platform with Philips EmoGraphy & CardioSense solution has been unveiled as one of five winners of GSK’s “Transform the Future of Self-Care” innovation content.

Cegedim has announced the launch of its Health Data Business in support of pharmaceutical companies, clinical research organizations, and academic institutions.

AstraZeneca has revealed that the CHMP of the European Medicines Agency has given a positive opinion to adding a self-administration option for Fasenra (benralizumab).

German-based company, Velabs Therapeutics, has closed its Series B financing round, raising EUR3 million (US$3.4 million).

New figures published by the ABPI have revealed the continuation of significant investment by the pharmaceutical industry into R&D in the United Kingdom.

Amicus Therapeutics has entered into a strategic gene therapy development and manufacturing collaboration with Brammer Bio, which is a part of Thermo Fisher Scientific.

Pfizer has successfully completed its acquisition of Therachon, a privately held clinical-stage biotechnology company.

Fujifilm Irvine Scientific has announced plans to open a third manufacturing facility in Tilburg, The Netherlands.

FDA proposes rule to help ensure availability of hormones and enzymes formerly classified as drugs, and to stimulate biosimilars competition.

Lonza Pharma & Biotech announced a binding contractual commitment for the purchase of a sterile drug product fill and finish facility.

The Galien Foundation has selected nominees for its award, which recognizes those therapies and technologies with the greatest potential impact on human health.

Research from the Institute for Research in Biomedicine offers insight into the source of asymmetry between nucleic acid hybrids.

The companies will join forces to develop new immuno-oncology therapies in a deal worth up to $470 million.

FDA is collecting public comments on a draft guidance for bioanalytical method validation developed by ICH.

FDA approved first treatment for neuromyelitis optica spectrum disorder, a rare autoimmune disease of the central nervous system.