AbbVie Reconsiders Shire Offer; ISPE Releases its Drug Shortages Prevention Plan

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Developing a Comprehensive Tool Kit for Microbial Identification
Tuesday, November 18, 2014 at 8 AM CET PST/ 11 AM EST/ 4 PM GMT/ 5 PM CET
Sponsored by: Eurofins Lancaster Laboratories

Optimizing CMO Selection for High-Potency Pharmaceutical Product Development and Manufacturing
Available until Jan. 15, 2015
Sponsored by: Evonik Industries

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20^th Annual Validation Week
October 28-30, 2014
Philadelphia, PA

AAPS Annual Meeting 2014
November 2-6, 2014
San Diego, CA

BIO-Europe 2014
November 4-6, 2014
Vienna, Austria

October 16, 2014

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Solving Poor Solubility with Amorphous Solid Dispersions
Weighing the pros and cons of hot-melt extrusion and spray drying.

Biopharma Manufacturers Respond to Ebola Crisis
Demand for new therapies and vaccines spotlights production challenges.

Using the Guard Band to Determine a Risk-Based Specification
A risk-based guard band surrounds a specification limit and is derived from the uncertainty of the reportable value of the analytical procedure, which includes the uncertainty in the reference standard.

ISPE Releases its Drug Shortages Prevention Plan
The International Society for Pharmaceutical Engineering (ISPE) released its Drug Shortages Prevention Plan as part of an initiative to address drug shortage prevention due to manufacturing and quality issues.

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Natoli introduces the NP-RD20, an automated single station, cGMP and CE compliant mobile lab press. Use the RD20 to manufacture single tablets or test tablet parameters during research and development. It features programmable precompression parameters and dwell time, as well as Data Acquisition capabilities to collect and track test results, including compression curve and elasticity in single, bi-layer, and multi-layer tablets.

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AbbVie Reconsiders Shire Offer
AbbVie sends Shire notice that it is reconsidering its offer recommendation.

Report Explores Factors Contributing to Success and Failure in Cancer Treatments
A report from PhRMA highlights how drugs that failed in clinical trials are a crucial part of development for melanoma, lung cancer, and brain cancer.

Hospira Recalls Certain Lots of Intravenous Products
Hospira voluntary recalls certain lots of several LifeCare products due to potential for leakage.

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API Characterization for a Speedy and Successful Formulation Strategy
September 18, 2014 at 11:00 AM EDT
To Register Free:

www.pharmtech.com/strategy

FDA Grants Priority Review for Pfizer’s HER2- Advanced Breast Cancer Treatment
Pfizer announced that it has received FDA Priority Review for palbociclib, in combination with letrozole, as a treatment for HER2- advanced breast cancer.

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Systematic and Efficient Analytical Method Development for A Speedy Clinical Product Development
October 15, 2014 at 11:00 AM EDT
To Register Free:

www.pharmtech.com/Efficient

PhRMA Releases 2014 Cancer Report Detailing Nearly 800 New Medicines
The Pharmaceutical Research and Manufacturers of America released their 2014 Cancer Report that highlights the biopharmaceutical companies developing new medicines and vaccines used for the treatment of cancer.

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Choosing the Proper Dissolution Method When Testing Solubilization Performance
Wednesday, October 22, 2014 at 2:00 PM EDT
To Register Free:

www.pharmtech.com/dissolution

Ascension Health Bans Genentech Sales Reps After Losing Drug Discounts
A change in the supply chain for three important Genentech cancer medications elicits a strong reaction from one of the nation’s largest operators of hospitals.

NIH Invests in Biomedical Research Data
The National Institutes of Health announces grants for the development of strategies for the utilization of biomedical data sets.

Genentech Receives FDA Priority Review for Diabetic Retinopathy Treatment
FDA granted Genentech priority review for its diabetic retinopathy treatment, Lucentis.

Endo to Acquire Auxilium Pharmaceuticals
Endo will acquire Auxilium Pharmaceuticals in a cash and stock transaction for approximately $2.6 billion.

IDT Biologika Certifies Facility to Fill and Lyophilize Biologics and Vaccines
IDT Biologika completes large-scale biologics finishing facility in Dessau, Germany.

No Change to Approved Indication for Ariad's Iclusig
Iclusig’s original indication will remain unchanged after a thorough examination of its safety information by EMA.

Dow Strengthens Affinisol Portfolio for Drug Formulators
New polymers from Dow presented at CPhI 2014 help maximize a pharmaceutical product's solubilization performance.

PharmTech Europe
25th Anniversary
Pharmaceutical Technology Europe celebrates 25 years of publishing with a retrospective of drug development trends and expert insight into emerging trends.

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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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