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EMD Serono Expands Biopharma R&D Facility
EMD Serono, the North American biopharmaceutical business of Germany’s Merck KGaA, will expand its R&D facility in Massachusetts, US.
EMA Approves Gazyvaro for Treatment of White Blood Cell Cancer
The agency extends the indication of the drug in combination with bendamustine.
EMA Collaborates with Physicians
The agency holds a workshop to strengthen collaboration with healthcare providers.
WHO Campaigns to Close Immunization Gap
MSD joined the WHO campaign in Africa, which is focused on staying polio free.
AbbVie to Acquire Stemcentrx
AbbVie will acquire Stemcentrx and its lead late-stage asset rovalpituzumab tesirine (Rova-T), a novel biomarker-specific therapy derived from cancer stem cells.
Fresenius Kabi Recalls Sensorcaine-MPF Injection, USP
The company voluntarily recalls product due to particulate matter.
MilliporeSigma Introduces Multi-Use Disposable Sterile Connectors at INTERPHEX
The company announced the launch of its first-in-class Lynx CDR connectors at INTERPHEX 2016.
FDA Releases Guidance on Immunogenicity Testing of Therapeutic Proteins
The agency publishes draft guidance on assay development and validation for immunogenicity testing.
US National Science and Technology Council Promotes Advanced Manufacturing
The Subcommittee for Advanced Manufacturing of the National Science and Technology Council highlights biopharmaceutical manufacturing as an emerging priority.
WHO Releases Report on Eliminating Malaria
WHO report highlights goal of eliminating malaria in 35 countries by 2030.
Plasticell Receives Queen’s Award for Enterprise in Innovation 2016
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 Launches Newly Combined CMO
Pfizer announced the launch of Pfizer CentreOne, a CMO formed by the combination of Pfizer CentreSource and Hospira One 2 One.
NIH Study Identifies Better Parameter to Predict Flu Vaccine Effectiveness
Traditional methods of measuring the effectiveness of vaccines against the flu are called into question by new findings from the NIH.
NIH Suspends Research in Sterile Production Facilities
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.
Walker Barrier Systems Products to be Rebranded as Extract Technology
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.
FDA Issues Guidance on Comparability Protocols
The guidance discusses the implementation of CMC postapproval changes through a comparability protocol.
Sanofi Invests €300 Million in Biologics Manufacturing Facility
Sanofi will invest in its Geel, Belgium facility in order to support its pipeline of monoclonal antibodies.
GSK Opens New Respiratory Manufacturing Facility
The facility located in Ware, UK, will be used to manufacture GSK’s Ellipta inhaler.
Shire Builds Biologics Manufacturing Campus in Ireland
Shire announces plans to build a flexible biopharmaceutical manufacturing facility in County Meath, Ireland.
Seattle Genetics Presents New Antibody-Drug Conjugate Data at AACR
Linker technology and drug combinations play an important role in the efficacy of ADCs.
Recipharm AB to Acquire Kemwell’s CDMO Businesses
Through two acquisitions, Recipharm will acquire Kemwell’s United States, Swedish, and Indian operations.
Kite Pharma Pauses Selected Clinical Trials
The National Institute of Health will conduct an internal review of the National Cancer Institute’s cell manufacturing facilities, which will affect multiple Kite projects.
FDA Releases Data Integrity Guidance
The agency published guidance on data integrity as it is relates to CGMP compliance.
FDA Blog Encourages Use of Continuous Manufacturing
FDA explains the rewards that may be associated with switching from batch to continuous manufacturing.
FDA Issues Three New Compounding Guidance Documents
The agency published draft guidance on prescription requirements, hospital pharmacies, and outsourcing facilities for compounders.
Modern Manufacturing Required for Breakthrough Drugs
FDA’s breakthrough drug initiative is more popular and successful than ever.
Hospira Recalls Magnesium Sulfate Injection
The company has recalled one lot of 50% magnesium sulfate injection, USP due to particulates.
IMS Institute Report Examines Medicine Use and Spending in 2015
The IMS Institute for Healthcare Informatics report examines spending on medicine in the US, drivers of growth, major market segments, prescription volume, patient costs, and healthcare delivery changes.
ITT Corporation Diaphragm Passes ASME BPE Seal Test
The valve received the highest cycle rating after completing the test at three times the required test pressure.
Juno Therapeutics and WuXi AppTec form JW Biotechnology
JW Biotechnology will focus on developing novel cell-based immunotherapies.