BioPharm International Editors

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

The company voluntarily recalls product due to particulate matter.

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

The agency publishes draft guidance on assay development and validation for immunogenicity testing.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

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.

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.

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

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The agency published draft guidance on prescription requirements, hospital pharmacies, and outsourcing facilities for compounders.

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

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.

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.

The FDA guidance describes information to provide to the agency when submitting a proposed proprietary name.

The companies announced that they have mutually decided to terminate the planned merger after the US Department of Treasury and the IRS issue temporary and proposed regulations on tax inversion.

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.

As part of the partnership, Zenith Technologies’ methodologies, systems, and libraries will be offered as a service to GE Healthcare’s clients in bioprocessing.