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  Pharmaceutical Technology Europe E-Alert
 
25 February 2015
IN THIS ISSUE
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Featured Content
Chiral Resolution with and without Resolving Agents
Resolution technologies remain crucial for commercial-scale chiral API production. More...
 
Ligand-Binding Assays and the Determination of Biosimilarity
Ligand-binding assays are fundamental to characterizing biosimilars. More...
 
Reinventing the Cold Chain in a High-Stakes Market
Market changes are driving pharmaceutical companies to consider new ways to mitigate risk in the cold chain. More...
 

 
Top Stories
First Hospira Biosimilar mAb Approved in West Europe
Hospira's Inflectra (infliximab), a biosimilar for Remicade, is approved by the European Commission. More...
 
EMA Establishes Drug Identification Task Force
The agency is enlisting members of European pharmaceutical associations and industry representatives to participate in IDMP task force. More...
 
Industry News
BMS Furthers its Immuno-Oncology Pipeline with Nearly $1.6 Billion in Investments
Bristol-Myers Squibb announced that it reached an agreement to acquire Flexus Biosciences and has entered into a $309-million partnership with Rigel Pharmaceuticals. More...
 
Celltrion Announces that its Remicade Biosimilar Could Save Up to $380 USD
Celltrion announced that its Remicade biosimilar, Rensima, could save France, Italy, and the UK up to €336 million in costs to treat Crohn's disease. More...
 
Revlimid Gains FDA Approval for NDMM Patients
Celgene announced that its drug, Revlimid, gained FDA approval for the treatment of newly diagnosed multiple myeloma. More...
 
Sanofi Appoints Bayer's Brandicourt as New CEO
Brandicourt will leave Bayer HealthCare AG to begin his new role as CEO of Sanofi in April 2015. More...
 
Is It Time to Ditch QbD for Development by Design? Questions From a QbD Cheerleader
QbD represents a breakthrough in thinking, but does it go far enough to address today's business challenges? More...
 
Siegfried Announces Resolution of Hameln Pharma Regulatory Issues
The company announces that FDA has closed out a 2012 warning letter. More...
 
NIST Partners with MedImmune on Protein Characterization Venture
MedImmune will provide funds and access to monoclonal antibodies to seven postdoctoral associates for the creation of protein measurement and characterization tools. More...
 
Johnson & Johnson's Remicade Patent Invalidated
The Patent and Trademark Office sends notice rejection of the company's Remicade patent. More...
 
FDA Announces Approval of Lenvima for Differentiated Thyroid Cancers
FDA announced that it approved Lenvima to treat patients with differentiated thyroid cancer after it was submitted under a priority review and orphan drug programs. More...
 
FDA Issues Guidance on Drug Compounding
The agency releases five draft guidance documents related to drug compounding and repackaging. More...
 
Webcasts
Pharma Supply Chain Security: Are You in Control?
February 25, 2015 at 11AM ET
Sponsored by Spectrum Chemical Mfg. Corp.
 
Fundamentals of Spray-Dried Dispersion Technology
March 19, 2015 at 11AM ET
Sponsored by Bend Research
 
More Webcasts

Product/Service Profiles
ABITEC Corporation

CAPMUL® — Where Formulation Begins™
ABITEC’s CAPMUL bioavailability enhancers are medium-chain mono- and di-glycerides and propylene glycol esters. These functional lipid excipients act as solubilizers and emulsifiers in oral, topical, transdermal, and parenteral drug delivery systems.
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AirbridgeCargo Airlines

Efficient connections via Russia
AirBridgeCargo Airlines the largest Russian cargo airline provides customers with efficient connections from Asia to Europe and to the United States via Russia onboard Boeing 747 freighters.
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I Holland

I Holland’s Metalized Bellows and Drip Cups
Granule contamination during the tabletting process can cause costly manufacturing problems. Punch bellows and drip cups help to prevent tablet and punch guide contamination during the tablet compression process.
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Műller GmbH

Müller Handling Systems
Müller’s lifting columns to feed your process machines: Maximum repeatability for all travel positions makes Müller lifting columns the perfect choice especially when working with split valve systems.
Read more
Starna Scientific

NIST traceable FTIR Wavelength Reference
Starna Scientific Ltd is the manufacturing headquarters of the Starna range of specialised products, which include photometer cells and accessories, optical components and Certified Reference materials to ISO/IEC 17025 standards.
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Reference Library

Pharmaceutical Technology Drug Delivery Guides
A three-volume set of drug delivery system handbooks. A compilation of articles related to methods and processes of manufacturing and administering pharmaceutical compounds to achieve therapeutic effects.  Topics include the development of controlled-release formulations and reformulating injectable drugs for oral delivery. ... Click here

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