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7 January 2014

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IN THIS ISSUE
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Featured Topics

Using Analytical Techniques to Examine Tablet Sticking Analytical tests, correlated with statistical techniques, are used to predict material behavior. More...

Regulation of Biosimilars: A Matter of Variability, Similarity, and Comparability The European Union is strengthening its pioneering role in the regulation of biosimilars by further developing the basic rules for determining the levels of compatibility for this group of drugs. There are, however, some key issues that are not easy to resolve, as evident in a recent workshop on biosimilars organized by the European Medicines Agency (EMA). More...

Establishing a Minimum Incubation Time for Biological Indicators The industry lacks an accepted method for establishing a minimum incubation time (MIT) of less than seven days for biological indicators (BIs). The authors propose an MIT method that provides a means for reproducible determination of BI grow-out time. More...

Industry News

FDA Announces Voluntary Recall from Abrams Royal Compounding Pharmacy Abrams Royal Pharmacy is recalling all unexpired lots of sterile products dispensed in the US. More...

Bristol-Myers Squibb to Sell Diabetes Business to AstraZeneca Bristol-Myers Squibb agrees to sell global diabetes business to AstraZeneca for $2.7 billion upfront plus an addition $1.4 billion in potential regulatory- and sales-based milestone payments. More...

Pfizer, Teva Settle Patent Litigation on Viagra Pfizer settles its litigation against Teva Pharmaceuticals regarding Pfizer's patent covering the use of Viagra. More...

Biogen Idec, Samsung Bioepis Target Anti-TNF Biosimilars in Europe Biogen and Samsung Bioepis, a joint venture between Samsung Biologics and Biogen Idec, advance plans for anti-TNF biosimilar product candidates. More...

FDA and European Medicines Agency Announce Generic-Drug Application Inspections Initiative FDA and EMA launch initiative to share bioequivalence inspection information. More...

AstraZeneca Issues Statement on Competitor to Nexium AstraZeneca issues a statement regarding the launch of esomeprazole strontium in the United States. More...

Baxter Initiates Worldwide Voluntary Recall Baxter International recalls dextrose injection and four sodium chloride injections. More...

Supernus Announces FDA Approval of Orenitram Supernus Pharmaceuticals receives FDA approval of Orenitram for the treatment of pulmonary arterial hypertension. More...

Genzyme Receives Complete Response Letter from FDA on Lemtrada Application Genzyme plans to appeal FDA’s decision that the multiple-sclerosis treatment is not ready for approval. More...

Webcasts
Optimizing CMO Selection for High-Potency Pharmaceutical Product Development and Manufacturing Wednesday, January 8, 2014 at 10:00 AM - 11:00 AM Eastern Standard Time (EST) and Wednesday, January 15, 2014 at 10:00 AM - 11:00 AM Central European Time (CET) Sponsored by: Evonik Industries

Best Practices for Preventing Metal Contamination of Pharmaceutical Products Wednesday January 22, 2014 at 11:00 AM to 12:00 PM Eastern US Sponsored by: CEIA

Safe Automated Weighing of Potent Compounds in the Pharmaceutical Industry On Demand Sponsored by: Mettler Toledo

Meeting Regulatory and Technical Requirements for Organic Impurity Analysis On Demand Sponsored by: SGS Life Science Services

More Webcasts

Products/Services Profile

ETQ

Risk Management's Impact on QMS
Risk Management is everywhere, and is not some lofty strategic element that is limited to top floor suits making enterprise-wide decisions. Risk is just another tool in the quiver of the compliance process; it is a method for streamlining your business, like any other compliance process. Read more

Event Profile

Pharmapack Europe

12-13 February 2014
Paris Expo, Porte de Versailles – Paris – France
Pharmapack Europe 2014 will host, in this new venue, over 330 exhibitors (including more than 60 new companies) from over 70 countries offering a wide range of skills that cover the entire supply chain for health product packaging and drug delivery systems. Read more.

Is “Operational Excellence” a focus at your company?

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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