Pharmaceutical Technology Editors

Mandatory use of the periodic safety update report repository becomes mandatory on June 13.

Alvotech prepares for commercial biosimilar production in new facility with single-use bioreactors in Reykjavik, Iceland.

Brammer Bio establishes late-phase development and commercial manufacturing facility for advanced cell and gene therapies in Lexington, MA.

The agency publishes three final guidance documents on drug compounding.

The agency cited KO DA Pharmaceutical Co. with cGMP violations.

The company plans to introduce HDX–MS in quarter three of 2016 at its West Chester, PA facility.

The company showcased new technologies at ASMS for biopharmaceutical characterization.

The company opened a 200,000-square-foot facility in Kakegawa, Japan to serve the needs of domestic and global clinical trial sponsors.

MilliporeSigma surveyed 250 biopharmaceutical executives on how their companies will manage new risks associated with the changing biopharmaceutical landscape.

The new company is the product of a merger with Formex.

The wearable devices for the delivery of biologic products are now being manufactured and will be tested in clinical trials in the near future, according to the company.

The collaboration will provide GMP manufacturing ahead of future clinical studies.

A new 20,000-L microbial biologics facility in Ireland will be operational by 2018 for Fujifilm Diosynth's contract development and manufacturing customers.

Amyris will use its platform technology to develop a library of natural and natural-like compounds to test against Janssen’s therapeutic target.

The agency published a report on fostering the development of advanced therapy medicinal products.

FDA approved dalizumab a monoclonal antibody for the treatment of multiple sclerosis.

Production of kilogram-scale batches of synthetic molecules for early-stage development are now available to US customers.

During its May 2016 meeting the CHMP recommended the approval of six medications in the EU, including three generic drugs, treatments for hepatitis C, and Type 2 diabetes.

The Start-up Hub is designed to give start-up companies the opportunity to network at Pharmapack.

The company opened its 62,000 square foot facility, called the BioProcess Innovation Center, in Triangle Park, NC.

The company opened a new sales office located in Seoul, South Korea.

The company expanded its topicals capacity with an investment in the Becomix RW30 model homogenizer.

FDA issues a warning letter to Megafine Pharma Limited for data integrity violations.

Jazz will acquire Celator for approximately $1.5 billion.

The company received a warning letter at its Latina facility in Sermoneta, Italy following a May 2015 inspection.

The agency publishes draft guidance on assessing the adhesion of transdermal delivery systems and topical patches.

Lagarde will be based out of the company’s Boston office and will lead Patheon’s global corporate and cross-enterprise operations.

Xellia, a generic anti-infective drug manufacturing company, is constructing a laboratory services building at its manufacturing site in Budapest, Hungary.

The United States Geological Survey study detected one or more pharmaceuticals in 59 streams throughout the Southeast United States.

The AAPS Foundation presented five graduate students each with a $10,000 fellowship for their research in the pharmaceutical sciences.