BioPharm International Editors

FDA sent a warning letter to Ecometics, Inc. after the agency found CGMP violations at the company’s Norwalk facility.

Gilead Sciences gains rights to clinical and preclinical programs in Galapagos’ portfolio through a 10-year global research and development collaboration.

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

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

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

Werum IT Solutions will provide a standardized, scalable, and compliant platform to blood centers for the cell and gene therapy processes.

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.

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

The Applications Center of Excellence in Durham, NC, will offer development studies for JSR Life Sciences customers.

Agilent Technologies Inc. announced that it signed a definitive agreement to acquire BioTek Instruments, a company that handles the design, manufacture, and distribution of innovative life science instrumentation for $1.165 billion.

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

The draft guidance provides industry with a guide for using the database to assist in the development of drug products.

FDA released draft guidance on using the USP pending monograph process in the drug application process.

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.

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

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

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

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

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.

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.

The companies will work to develop a liver tissue model for screening the toxicity of drugs.

Novavax will sell two Maryland-based vaccine development and manufacturing facilities for Catalent’s expanding gene therapy footprint.

Three months following his departure from FDA, former commissioner Scott Gottlieb joins Pfizer’s board of directors.

A survey conducted by Agilent Technologies and research and consulting firm Frost & Sullivan revealed pressing issues and objectives experienced by lab leaders around the world.

The new flow cytometer offers full automation and enhanced software to alleviate bottlenecking.

In anticipation of the loss of patent exclusivity for Humira, AbbVie makes $63-billion move to acquire Allergan.