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  Pharmaceutical Technology Europe E-Alert
 
27 May 2014
IN THIS ISSUE
News
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Featured Topics
Data Integrity in the Analytical Laboratory
Data integrity in the analytical laboratory is an area of increasing focus for regulators such as FDA. More...
 
Achieving Zero-Order Release Kinetics Using Multi-Step Diffusion-Based Drug Delivery
Zero-order release of a freely water-soluble active drug can be obtained using release-controlling polymers. More...
 
Scientific Advances in Cocrystals are Offset by Regulatory Uncertainty
Drug developers are taking a wait-and-see approach to the use of cocrystals. More...
 
 
Top Stories
FDA Approves Entyvio for Ulcerative Colitis and Crohn's Disease
FDA approves Entyvio, an injection to treat adult patients with moderate to severe ulcerative colitis and Crohn's disease. More...
 
Hospira Issues Recall Due to Particles from Glass Defects in Vials
Hospira has recalled one lot of labetalol hydrochloride injection, USP, due to visible particulates. More...
 
BMS and AbbVie Receive FDA Breakthrough Therapy Designation for Elotuzumab
BMS and AbbVie receive FDA breakthrough therapy designation for elotuzumab, an investigational humanized monoclonal antibody for multiple myeloma. More...
 
Pfizer To Submit NDA to FDA for Palbociclib
Pfizer will submit a NDA with FDA for palbociclib, a treatment for locally advanced or metastatic breast cancer. More...
 
Novartis Settles Patent Litigation Over Gleevec
Novartis settles its litigation with the US subsidiary of Sun Pharma regarding Gleevec. More...
 
FDA Issues Complete Response Letter for Novartis' RLX030
FDA issues complete response letter for Novartis' RLX030 for acute heart failure. More...
 
Industry News
Meissner Begins Operations At New Headquarters
Meissner moves into its new headquarters in Camarillo, California. More...
 
SGS Announces Appointments at New Facility in California
SGS makes two senior appointments at its new GMP/GLP laboratory in Carson, California. More...
 
Webcasts
Delivering Biologics with a Difference
Thursday June 5, 2014 at 11:00 AM EDT
Sponsored by: Baxter Biopharma Solutions
 
Lyophilization Cycle Design and Scale Up – Practical Methodologies for Developing Cycles
Wednesday, June 11, 2014 at 11:00 AM EDT
Sponsored by: Patheon
 
Achieving GMP Compliance for Environmental Monitoring Systems
On Demand
Sponsored by: Vaisala
 
More Webcasts

Product Profiles
LB Bohle
With the Bohle Uni Cone BUC ® process, L.B. Bohle can protect a new development method for precise coating of particles as a utility model right now. Read more
Sepha
New Non-Destructive Inspection, Blister Recovery and Packaging Technologies launched by Sepha Ltd.
Three new products aimed at meeting the changing demands of global pharma-companies are being introduced by the pharmaceutical packaging equipment specialist, Sepha Ltd. Read more
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Solid Dosage and Excipients
Review emerging trends in the formulation and manufacture of solid dosage drugs, as well as the role of excipients in enhancing the functionality of these drug forms.Download Now
 
Bioprocessing and Sterile Manufacturing
View technical articles on the development and manufacturing of parenteral and biologic drugs, including continuous manufacturing, monitoring, sterilization procedures, modular manufacturing, and more.Download Now

Reference Library

Pharmaceutical Technology presents its Process Analytical Technology resource guide combo
A compilation of informative, useful articles designed to help you meet the challenges of process analytical technology, be more efficient in testing, reduce over-processing, enhance consistency, and minimize rejects. ... Click here


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