The new cleanroom, designed and built by WHP, is part of ADC Bio’s new bioconjugation facility in the UK.

Industry has responded positively to the United Kingdom government’s new pharmaceutical payment system to incentivize development of new drugs to tackle AMR.

The Native Antigen Company has revealed its appointment of Biozol and Shanghai Bioleaf as its distributors in Germany, Switzerland, Austria, and China

Certara has unveiled the formation of a new product development innovation practice area that will be focused on global health.

CatSci has received two accolades from Welsh organizations, demonstrating its contributions to the Welsh economy in the field of process R&D.

Oncology drug discovery and development company, ADC Therapeutics, has closed its Series E financing expansion, in which it raised $103 million.

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

Patient consent is potentially tricky for pharma R&D to navigate as a result of new data protection rules in Europe.

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The draft guidance provides industry with a guide for using the database to assist in the development of drug products.

FDA released draft guidance on using the USP pending monograph process in the drug application process.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