Industry News
CGT and CTM CRC Collaborate on Scaffold Technology Project
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.
Well Care Compounding Pharmacy Issues Recall
The company recalls products due to sterility concerns.
EMA Publishes Annual Report
The agency detailed its 2015 achievements in an annual report.
NIH to Launch Large-Scale HIV Vaccine Trial
The NIH and partners will launch a large-scale clinical trial in South Africa to evaluate the effectiveness of an HIV vaccine regimen
FDA Issues Biomarker Qualification Guidance
The agency provides guidelines on generating histopathology data in nonclinical biomarker qualification studies.
FDA Warns of Serious Side Effects Associated with Fluoroquinolone Drugs
FDA is advising there may be serious and potentially permanent side effects associated with taking fluoroquinolone antibacterial drugs consistently.
Any Chance for “Cures” Legislation This Year?
Biomedical innovation legislation may stall in 2016.
ISSCR Releases Updated Guidelines on Stem Cell Research
The updated guidelines detail best practices for conducting research with human embryonic stem cells.
What’s Behind NIH’s Quality Problems?
Drug manufacturing lapses undermine NIH research programs.
EMA Discusses Drug Prices
The agency and national authority representatives talk about regulators’ role in keeping drug prices affordable.
EMA’s SME Initiative Shows Positive Results
The agency summarizes the results of its 10-year-long initiative to support small- and medium-sized enterprises.
EU Pharma Industry Representatives Pen Letter on Brexit
Members of ABPI, GSK, AstraZeneca, and the BioIndustry Association composed a letter explaining why the UK remaining part of the EU benefits the life-sciences sector.
Investigational Malaria Vaccine May Protect Healthy Adults for More Than One Year
Phase I clinical trials of PfSPZ revealed it may protect healthy adults, who have not been exposed to Malaria before, for more than on year.
FDA Issues Warning Letter to Repackaging Facility
The agency cited Apotheca Supply, a repackager and relabeler of pharmaceuticals for CGMP violations.
Report Shows Increase in Capacity in Cell and Gene Therapy Manufacturing in the UK
The Cell and Gene Therapy Catapult released a review of their third annual survey of GMP cell and gene therapy facilities in the United Kingdom.
CPhI China Returns to the Shanghai New International Exhibition Center
CPhI China is expected to bring together approximately 35,000 attendees from more than 120 countries worldwide.
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.
Fresenius Kabi Recalls Sensorcaine-MPF Injection, USP
The company voluntarily recalls product due to particulate matter.
FDA Releases Guidance on Immunogenicity Testing of Therapeutic Proteins
The agency publishes draft guidance on assay development and validation for immunogenicity testing.
WHO Releases Report on Eliminating Malaria
WHO report highlights goal of eliminating malaria in 35 countries by 2030.
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.
FDA Issues Guidance on Comparability Protocols
The guidance discusses the implementation of CMC postapproval changes through a comparability protocol.
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.
CSCS and Gordian Knot Analytics Group Form Business Alliance
The companies will collaborate on two CSCS supply chain security studies.
