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The agency publishes draft guidance on assay development and validation for immunogenicity testing.

The Subcommittee for Advanced Manufacturing of the National Science and Technology Council highlights biopharmaceutical manufacturing as an emerging priority.

WHO report highlights goal of eliminating malaria in 35 countries by 2030.

Plasticell was recognized for its contribution to the advancement of regenerative medicine, cell and gene therapy, as well as other areas of biomedical research.

Pfizer announced the launch of Pfizer CentreOne, a CMO formed by the combination of Pfizer CentreSource and Hospira One 2 One.

Traditional methods of measuring the effectiveness of vaccines against the flu are called into question by new findings from the NIH.

The National Institutes of Health (NIH) released a statement on April 19, 2016 saying that it plans to suspend research in two laboratories after preliminary results found the labs not in compliance with CGMP practices.

Extract Technology’s portfolio will now include aseptic solutions, containment solutions, restricted access barriers, and mobile cleanrooms for the pharmaceutical, healthcare, biotech and chemical markets.

The guidance discusses the implementation of CMC postapproval changes through a comparability protocol.

Sanofi will invest in its Geel, Belgium facility in order to support its pipeline of monoclonal antibodies.

The facility located in Ware, UK, will be used to manufacture GSK’s Ellipta inhaler.

Shire announces plans to build a flexible biopharmaceutical manufacturing facility in County Meath, Ireland.

Linker technology and drug combinations play an important role in the efficacy of ADCs.

Through two acquisitions, Recipharm will acquire Kemwell’s United States, Swedish, and Indian operations.

The National Institute of Health will conduct an internal review of the National Cancer Institute’s cell manufacturing facilities, which will affect multiple Kite projects.

The agency published guidance on data integrity as it is relates to CGMP compliance.

FDA explains the rewards that may be associated with switching from batch to continuous manufacturing.

The agency published draft guidance on prescription requirements, hospital pharmacies, and outsourcing facilities for compounders.

FDA’s breakthrough drug initiative is more popular and successful than ever.

The company has recalled one lot of 50% magnesium sulfate injection, USP due to particulates.

The IMS Institute for Healthcare Informatics report examines spending on medicine in the US, drivers of growth, major market segments, prescription volume, patient costs, and healthcare delivery changes.

The valve received the highest cycle rating after completing the test at three times the required test pressure.

JW Biotechnology will focus on developing novel cell-based immunotherapies.

GE Healthcare Life Sciences has expanded production capabilities at its Pasching, Austria facility for sterile liquids.

The companies will collaborate on two CSCS supply chain security studies.

The agency issues safety guidance to minimize medication errors relating to product design and container closure design.

Cornell researchers reveal that an existing FDA-approved drug can facilitate the delivery of other large molecules across the blood-brain barrier.

The Ethiopian government said it is offering tax and loan incentives to encourage local pharmaceutical production in the country

The American College of Rheumatology released a statement encouraging FDA to apply distinct names to biosimilars and maximize clarity in labels.

Sanofi says the program will vaccinate one million students from 6000 public schools in dengue-epidemic regions of the Philippines.