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Podcasts

Webcast: What's the matter with Sample Prep? - Novel approaches and solutions
April 24, 2012—Sponsored by Mettler Toledo AG

Webcast: Making Sense of Excipient Performance for Quality by Design (QbD)
April 19, 2012—Sponsored by Colorcon

Webcast: Risk Management in Sterile Manufacturing
April 12, 2012—Sponsored by DPT

Webcast: Overcoming Challenges in Complex Formulation Development: Bilayer Tablets & Beads-in-Capsules
April 3, 2012—Sponsored by Patheon

Webcast: Topical Semi-Solid Formulations: CMC Considerations for Stability, Analytical, and Safety Studies
March 22, 2012—Sponsored by Dow Pharmaceutical Sciences

MORE WEBCASTS

Podcast: DCAT President Discusses Industry Trends and Association Activities

Podcast: Informex Roundup

Podcast: Process Validation for Sterile Manufacturing (Cook Pharmica)

Podcast: Pharmaceutical Forensics for Identification and Source Determination of Particulate Contamination in a Parenteral Manufacturing Process (Gateway Analytical)

MORE POCASTS

Events

Biotherapeutics Analytical Summit
March 19, 2012—March 22, 2012
Baltimore, Maryland, USA

8th World Meeting on Pharmaceutics, Biopharmaceutics and Pharmaceutical Technology
March 19, 2012—March 22, 2012
Istanbul, Turkey

CPhI Japan
March 21, 2012—March 23, 2012
Tokyo, Japan

World Companion Diagnostics Summit Europe
March 26, 2012—March 29, 2012
Frankfurt, Germany

9th Annual Controlled Release
March 28, 2012—March 29, 2012
London, United Kingdom

More events


FindPharma Search
March 15, 2012 PharmTech.com

News

FDA Issues Guidance for Industry Direct-to-Consumer Television Advertisements
On Mar. 12, 2012, FDA released a draft guidance document for industry direct-to-consumer television advertisements that describes FDA's plans for implementing predissemination review.
Click Here to Read More

GE Healthcare to Acquire Xcellerex
On Mar. 7, 2012, GE Healthcare announced an agreement to acquire Xcellerex, a supplier of manufacturing technologies for the biopharmaceutical industry, for an undisclosed amount.
Click Here to Read More

EMA Announces Electronic Applications Pilot Program
The European Medicines Agency has launched a pilot program for submitting centralized marketing authorization applications electronically.
Click Here to Read More

Excellence United Strategic Alliance to Make North American Debut at INTERPHEX 2012 in New York
Excellence United, an alliance of six specialty equipment companies, will make its first North American appearance at INTERPHEX 2012, held May 1–3 at the Javits Center in New York.
Click Here to Read More

GSK Launches UK Apprenticeship Program
GlaxoSmithKline is launching a new program that will create apprenticeships in several areas including manufacturing and R&D at the company's United Kingdom sites.
Click Here to Read More


Product Spotlight

Microbial colony pickers for large cell-population management

Molecular Devices’s QPix 400 series of microbial colony pickers manages of large, diverse populations of cells. The QPix 400 series, which includes the QPix 400, 450, and 460 models, features the option to simultaneously detect colonies and quantify fluorescent markers. This prescreening step enables the colonies of interest to be objectively identified and selected. The specific colony can then be chosen using highly accurate robotics and organism-specific colony-picking pins.

The device's application-driven software contains tools to track sample histories throughout a workflow. Its applications include areas such as protein expression, biofuel research, enzyme evolution, phage display, DNA sequencing and library generation and management. The QPix 460 is the most advanced system of the QPix 400 range, offering automation of the entire workflow from sampling and spreading onto bioassay plates. Additional features include imaging, analysis, and transferring selected colonies to up to 140 destination plates in two stacker lanes, thereby shortening timelines and increasing overall lab productivity.

Company Notes

AstraZeneca filed a lawsuit against FDA in the United States District Court for the District of Columbia to overturn the FDA's Mar. 7, 2012 denial of Citizen Petitions filed by AstraZeneca with regard to the Seroquel (quetiapine fumarate) tablets and Seroquel XR extended-release tablets, a treatment for bipolar disorder. AstraZeneca seeks an injunction which would bar FDA from granting final marketing approval of generic quetiapine until Dec. 2, 2012, when regulatory exclusivity expires on important clinical trial data, or at least until a federal court has a meaningful opportunity to review imminent FDA action regarding the pending generic marketing applications. Read More

Advertisement:
8 Ways to Reduce Tablet Manufacturing Costs
Are you working with a reduced budget for 2012? Want to learn how to get more and spend less? In an effort to help our customers get the most from their budgets, we put together this valuable list complete with tips, products, and video. Click here now for access to the exclusive details!

The biotechnology company Biocon and Pfizer have ended their alliance to commercialize Biocon's biosimilar versions of Insulin and Insulin analog products. The companies have agreed that, due to the individual priorities for their respective biosimilars businesses, it is in their best interest to move forward independently. Read More

Advertisement:
Podcast - Process Validation for Sterile Manufacturing
Join William (JR) Humbert, the Validation Manager at Cook Pharmica, as he discusses the 2011 FDA Guidance for the Industry, Process Validation: General Principles and Practices, and the impact the guidance has for biotechnology and pharmaceutical companies performing sterile manufacturing process validation.

DSM, the custom manufacturing business of Royal DSM, and the biopharmaceutical company Agennix have signed a new contract under which DSM will manufacture the oral dendritic cell mediated immunotherapy talactoferrin for Agennix at commercial levels in anticipation of positive Phase III clinical-data and product approval. DSM is currently manufacturing talactoferrin for use in ongoing clinical trials, including the Fortis-M trial in nonsmall cell lung cancer, and will continue to supply talactoferrin for clinical trials as well as to support a potential commercial launch. Read More

Advertisement:
Topical Semi-Solid Formulations: CMC Considerations for Stability, Analytical, and Safety Studies.
Live Webcast: Thursday, March 22, 2012 at 1:00 PM EST
Register Free at http://pharmtech.com/formulations

The Generic Pharmaceutical Association (GPhA) has pledged its support to the Pharmaceutical Traceability Enhancement Code (RxTEC), a new system for ensuring the security of the US pharmaceutical supply chain. The RxTEC model, which was developed by the Pharmaceutical Distribution Security Alliance, a multistakeholder initiative designed to increase patient access to safe medicines while improving the security of the American drug-distribution system. Read More

Advertisement:
Making Sense of Excipient Performance for Quality by Design (QbD)
Live Webcast: Thursday, April 19, 2012 at 10:00 EST, 15:00 GMT, 16:00 CET, 20:30 IST
Register Free at http://www.pharmtech.com/excipient

Industry Briefs:

A roundup of additional company and people news from pharmaceutical and biopharmaceutical companies, their suppliers, and contract-service providers. Read More


Do you have news to report on facility expansions, contracts, service agreements, mergers, acquisitions, or personnel appointments? Send press releases to ptpress@advanstar.com

PharmTech, the magazine
Current Issue cover
Tackling Solubility Challenges
by: Patricia Van Arnum
Nanosupensions are among the ways formulation scientists seek to address the problem of solubility.
Click Here to Read More

Coming soon: Pharm Tech's April 2012 issue delves into geographic diversification and leveraging legacy technology transfers as a strategy to avoid product shortages.


 

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