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FDA and EMA Collaborate on Pharmacovigilance
FDA and EMA set up regular meetings to harmonize drug safety actions.
FDA Initiates Secure Supply Chain Pilot Program
Thirteen companies are accepted for participation in the supply chain program.
Ben Venue Laboratories Issues Voluntary Recall Of Acetylcysteine Solution
Ben Venue issues a voluntary patient level recall of Acetylcysteine Solution 10% due to glass particle in vial.
BDP Week Covers Bioprocessing Methods
Conference sessions, keynote events, exhibits, and poster sessions cover different aspects of bioprocessing.
Ecolab Rebrands Shield Medicare Division
Ecolab's Shield Medicare division will now be called Ecolab Contamination Control.
Tandem Diabetes Care Expands Recall
Tandem Diabetes Care expands its voluntary recall of select lots of insulin cartridges used with t:slim insulin pump.
New European Program Targets Novel Antibiotics
Innovative Medicines Initiative will develop novel antibiotics against gram-negative pathogens in a project called ENABLE.
Agilent Technologies, Cell Line Genetics Collaborate
Agilent Technologies and Cell Line Genetics will collaborate on services for regenerative medicine and cancer research.
Debiopharm Group to Acquire Affinium Antibiotic Clinical Assets
Debiopharm acquires Affinium's clinical and preclinical assets and its technology platform.
Nearly 200 New Medicines in Development for Diabetes
New medicines in development include treatments for type 1 and type 2 diabetes.
European Medicines Agency Updates Seasonal Flu Vaccine Guidance
EMA releases an update on its flu vaccine guidance.
EMA Clarifies New Variation Classification Categories
EMA and the European Commission revise Q&A document on implementation of marketing authorization guidelines.
GMP Certification Extended for Cobra Biologics
Cobra Biologics' GMP Compliance Certification has been extended to include QC testing.
Shimadzu Opens New Solution Center in Maryland
Shimadzu's new Solution Center features additional research space.
Cytovance Biologics Expands GMP Warehouse and Manufacturing Operations
Cytovance Biologics continues to work on the expansion of a manufacturing operations and GMP warehousing facility in Oklahoma.
Mylan Launches First Trastuzumab Biosimilar in India
Mylan Pharmaceuticals launches Hertraz, the world's first trastuzumab biosimilar in India.
Aesica Appoints Commercial Managing Director
Aesica appoints Ian Muir to the newly created position of commercial managing director.
Sartorius Appoints New Head of Lab Products & Services Division
Sartorius appoints Michael Melingo to head marketing, sales, and services of the Lab Products & Services Division.
FDA Outlines Agenda for New Guidances in 2014
FDA plans to issue a number of new guidances in 2014 that will address drug development and manufacturing practices.
NIH, Biopharmaceutical Companies, Non-profits Work to Speed Validation of Disease Targets
NIH, 10 biopharmaceutical companies, and several nonprofit organizations form a partnership to develop new treatments earlier for Alzheimer's, type 2 diabetes, and autoimmune disorders.
Thermo Fisher Scientific Completes Acquisition of Life Technologies
Thermo Fisher Scientific outlines new business segments with acquisition of Life Technologies.
Edison Pharmaceuticals Enters Alliance with Dainippon Sumitomo Pharma
Edison and DSP partner to develop drugs targeting cellular energy metabolism.
ISPE CEO to Step Down at End of 2014
International Society for Pharmaceutical Engineering will continue strategic plan initiated by Nancy Berg; search begins for replacement.
EMD Millipore Expands its Emprove Raw Materials Portfolio
EMD Millipore's expands its Emprove raw materials portfolio to include 400 products.
PharmaCell to Purchase Cell Therapy Production Facility from TiGenix
PharmaCell enters an agreement purchase TiGenix therapy production facility.
How Will CMOs Provide Sufficient Capacity for Growing Biologics Demand?
With numerous biologics set to come off patent soon and the percentage of new therapeutics based on biomolecules growing, demand for contract manufacturing in the biopharma space is heating up.
EMA Releases Pharmacogenomics Guidance
EMA's guidance focuses on the use of pharmacogenomics to improve drug safety monitoring.
National Cancer Institute Announces Genetic Sequencing Trial
NCI launches trial to assess the utility of genetic sequencing to improve patient outcomes.
Novozymes Biopharma's Technology Demonstrates Potential for Monthly Drug Dosing
Novozymes Biopharma has released new study data on extending the serum half-life of albumin in vivo.
