
The draft guidance describes how content should be organized in electronic submissions for all submission types under section 745A(a) of the FD&C Act.

The draft guidance describes how content should be organized in electronic submissions for all submission types under section 745A(a) of the FD&C Act.

Suheung’s new facility in Vietnam is dedicated to vegetarian capsule manufacturing.

An agreement with Sanofi gives Catalent access to commercial spray drying facility in Haverhill, UK.

Boehringer Ingelheim will combine assets from its cancer immunology portfolio with the KISIMA immunization platform from AMAL Therapeutics.

Pharmaceutical Technology's In the Lab eNewsletter
Gilead Sciences gains rights to clinical and preclinical programs in Galapagos’ portfolio through a 10-year global research and development collaboration.

A new starch manufacturing plant near Amsterdam, The Netherlands will give Colorcon customers a second source of supply.

Lubrizol’s purchase intravascular and nonvascular devices developer Bavaria Medizin Technologie, extends its scope of services.

Kite, a Gilead company, announced plans to build a new facility for the development and manufacturing of the starting material for the production of cell therapies, viral vectors.

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.

Pharmaceutical Technology's In the Lab eNewsletter
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.

Pharmaceutical Technology's In the Lab eNewsletter
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.

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.

Pharmaceutical Technology's In the Lab eNewsletter
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.