News

EMD Serono, the North American biopharmaceutical business of Germany’s Merck KGaA, will expand its R&D facility in Massachusetts, US.

The agency found no differences in risk of pneumonia for different products.

The agency extends the indication of the drug in combination with bendamustine.

The agency recommends the approval of Zavicefta to treat infections caused by resistant bacteria.

Hacene Mekerri will serve as vice-president of PPD’s central laboratory organization.

Air Cargo Community Frankfurt takes steps to make Frankfurt Europe’s largest certified pharmaceutical hub.

Quotient Clinical has expanded its clinical spray drying capability through the acquisition of a Niro Mobile Minor Spray Dryer.

Worthington’s CryoScience by Taylor Wharton business will design and manufacture biostorage and logistics equipment for use in Cryoport’s life-sciences cryogenic logistics solutions.

Platinum Press provides serialization-ready printed materials to apply final track-and-trace data onto packaged pharmaceutical products.

Almac partnered with Optel Vision to provide a line-level solution (hardware and software) integrated with Almac’s proprietary level three, site-level software.

The agency holds a workshop to strengthen collaboration with healthcare providers.

MSD joined the WHO campaign in Africa, which is focused on staying polio free.

AbbVie will acquire Stemcentrx and its lead late-stage asset rovalpituzumab tesirine (Rova-T), a novel biomarker-specific therapy derived from cancer stem cells.

The company voluntarily recalls product due to particulate matter.

The company’s preservative-free multidose eyedropper wins award.

The company announced the launch of its first-in-class Lynx CDR connectors at INTERPHEX 2016.

The VeriPac UBV Leak Detection System is designed specifically for multi-cavity blister packs.

The ink has a fast dry time, making it suitable for pharmaceutical packaging and labeling.

The agency publishes draft guidance on assay development and validation for immunogenicity testing.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

Beckman Coulter Life Science’s new Vi-Cell Metaflex is designed to be operational for more than 22 hours a day.

The Opadry QX from Colorcon is suitable for tablets containing temperature-sensitive active ingredients.

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

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

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

BÜCHI Rotavapor R-300 received the German Design Awards 2016, the RedDot Award 21, and the iF International Forum Design Award.

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.

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

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.