BioPharm International Editors

FDA cited a Las Vegas compounding pharmacy for sterility violations.

The agency published guidance on the nonclinical evaluation of osteoporosis treatments.

FDA approved Vaxchora intended for travelers who are at risk for the disease.

Merck will acquire Afferent Pharmaceuticals for $500 million in cash with the potential for additional payments.

At the conference, industry experts discussed regional trends and challenges for the Middle East and North Africa for 2016.

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 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 new company is the product of a merger with Formex.

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

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

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

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.

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.

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

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

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

Jazz will acquire Celator for approximately $1.5 billion.

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

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

The agency cited Tai Heng Industry with CGMP deviations, including failure to ensure data integrity.

Sandoz is seeking approval for the same indications as Roche’s reference product MabThera.

Cell and Gene Therapy Catapult and the Australian CRC for Cell Therapy Manufacturing will collaborate on a project to test technology for T-cell stimulation and expansion.