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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The agency published draft guidance on prescription requirements, hospital pharmacies, and outsourcing facilities for compounders.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.
GE Healthcare Life Sciences Expands Production Capabilities in Europe
GE Healthcare Life Sciences has expanded production capabilities at its Pasching, Austria facility for sterile liquids.
CSCS and Gordian Knot Analytics Group Form Business Alliance
The companies will collaborate on two CSCS supply chain security studies.
FDA Releases Guidance on Safety Considerations and Product Design
The agency issues safety guidance to minimize medication errors relating to product design and container closure design.
Researchers Discover a Method to Penetrate the Blood-Brain Barrier
Cornell researchers reveal that an existing FDA-approved drug can facilitate the delivery of other large molecules across the blood-brain barrier.
Ethiopian Government Offers Incentives to Encourage Pharmaceutical Production
The Ethiopian government said it is offering tax and loan incentives to encourage local pharmaceutical production in the country
American College of Rheumatology Responds to Inflectra Approval
The American College of Rheumatology released a statement encouraging FDA to apply distinct names to biosimilars and maximize clarity in labels.
Sanofi Launches First Public Dengue Immunization Program
Sanofi says the program will vaccinate one million students from 6000 public schools in dengue-epidemic regions of the Philippines.
FDA Issues Guidance on Proprietary Names
The FDA guidance describes information to provide to the agency when submitting a proposed proprietary name.
Report Examines Price Increases on Most Widely Used Drugs in US
A report by Reuters found that four of the top 10 most widely used drugs increased 100% since 2011, while the other six increased 60%.
FDA Adds Warning Label to Two Diabetes Drugs
FDA added warning labels to medications containing saxagliptin and alogliptin after clinical trials linked the drugs to increased risk of hospitalization for heart failure.
FDA Approves First mAb Biosimilar
Inflectra is the second biosimilar to hit the market in the United States.
Pfizer and Allergan Terminate Merger Agreement
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.
EMA Proposes the Use of Data from Adults in Pediatric Drugs
The agency released a draft reflection paper on the extrapolation of data from adults to children in the development of pediatric drugs.
