Industry News

The agency publishes draft guidance on assay development and validation for immunogenicity testing.

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

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.

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

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The agency published draft guidance on prescription requirements, hospital pharmacies, and outsourcing facilities for compounders.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

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.

A report by Reuters found that four of the top 10 most widely used drugs increased 100% since 2011, while the other six increased 60%.

FDA added warning labels to medications containing saxagliptin and alogliptin after clinical trials linked the drugs to increased risk of hospitalization for heart failure.

The agency released a draft reflection paper on the extrapolation of data from adults to children in the development of pediatric drugs.

The agency has announced the creation of the Combination Products Policy Council to address issues related to combination products.

Even though the organizers of New York’s Tribeca Film Festival decided not to air the anti-vaccine film by discredited British researcher Andrew Wakefield, the so-called documentary is getting a healthy run and further perpetuating the myth of a link between childhood vaccination and autism.

Solutions to circumvent heterogenous mixtures of antibody-drug conjugates and to ensure uniform drug-to-antibody ratio were discussed at a recent Catalent Applied Drug Delivery Institute symposium.

The draft guidance states information concerning a clinical study of a biosimilar should only be included if it is necessary to demonstrate the safety and efficacy of the drug.

Although many immunotherapies focus on tumor-associated antigens, many of the peptide targets on the surface of cells have not be validated.

Researchers at the University of Pittsburgh say the compound may be more potent and selective than drugs currently available to treat epilepsy.

Industry is joining with academia and global health leaders to examine new approaches to biotech manufacturing.

The report examines the increased number of companies cited by regulators for data integrity issues.

A new 3D modeling and data-extraction technique Improves X-ray crystallography analysis of proteins.

The draft guidance outlines ways applicants can test for abuse deterrence in solid oral opioid drugs.

Generic drugs, market access, and foreign manufacturing are conference topics at CPhI Japan 2016.

The conference discussed key industry issues including serialization, innovation, and patient-centricity.