Pharmaceutical Technology ePT Weekly:
Having trouble viewing this e-mail? Click here.
ePT by PharmTech logo
News
Product Spotlight
Industry Briefs
PharmTech,
the magazine

About Us

Subscribe to Pharmaceutical Technology

Whitepaper Library

Podcasts

Webcast: Recent USP Changes - Regulatory and Quality Aspects of Sample Preparation
September 18, 2012—Sponsored by Mettler Toledo

Webcast: Osmotic Controlled Release Oral Delivery System
September 19, 2012—Sponsored by Patheon

Webcast: Risk Management in Sterile Manufacturing
September 27, 2012—Sponsored by DPT

Webcast: Increasing Your Chances for Success in First-In-Man Studies
October 3, 2012—Sponsored by Patheon

MORE WEBCASTS

Podcast: Topical Drug Development for Dermatology Products

Podcast: The Awesome Power of Virtual "Quality" in a Regulated Environment

MORE PODCASTS

Events

Biological Production Forum
September 24, 2012–September 26, 2012
Dusseldorf, Germany

10th Anniversary Cold Chain & Temperature Global Management Forum
September 24, 2012–September 28, 2012
Chicago, Illinois

Downstream Technology Forum Cambridge
September 26, 2012
Cambridge, Massachusetts

INTERPHEX Puerto Rico 2012
October 4, 2012–October 5, 2012
San Juan, Puerto Rico

CPhI Worldwide
October 9, 2012–October 11, 2012
Madrid, Spain

More events


FindPharma Search
September 13, 2012 PharmTech.com


News

Pfizer Settles Patent Litigation with Mylan
Pfizer and Mylan have agreed on terms by which Mylan may launch its generic version of Pfizer’s Detrol LA (tolterodine tartrate) extended-release capsules, pending final approval by FDA.
Click Here to Read More

Eli Lilly Receives FDA Warning Letter
Eli Lilly has received an FDA Warning Letter because of a "misleading" image of a multicolored brain that appeared on the company's website for the diagnostic PET tracer, Amyvid.
Click Here to Read More

CDER to Expand Office of Generic Drugs
As a result of the passage of the Generic Drug User Fee Amendments Act, Janet Woodcock, director of the Center for Drug Evaluation and Research, announced her plan to reorganize the Office of Generic Drugs (OGD) into a super office that would include subordinate offices. The new super office would report directly to Director Woodcock, with Greg Geba continuing his role as OGD director.
Click Here to Read More

Despite Setbacks, PhRMA Awards Encourage Research into and Fight against Alzheimer's
Delaying the onset of Alzheimer’s disease by just five years could reduce the cost for care of Alzheimer’s patients by $447 billion a year by 2050, according to a new PhRMA report.
Click Here to Read More

Advertisement:
Pharmaceutical starches from Grain Processing Corporation (GPC) range from basic unmodified starches for tableting to very specialized, innovative starches for unique applications.  Spress® Pregelatinized Corn Starches NF perform as binders, disintegrants and lubricants for granulations, direct-compression tablets, capsules, dry blends and roller compaction.  PURE-COTE® film-forming starches are designed for coating applications, oral thin films, capsules and any applications where clear, flexible films are required. Read More

PhRMA's Research and Hope Award Recipients Announced
The Pharmaceutical Research and Manufacturers of America unveiled its 2012 Research and Hope Award recipients in a special Sept. 12, 2012, ceremony in Washington, DC, at the Newseum.
Click Here to Read More




Product Spotlight

Vacuum sterilization for biotechnology applications

Bosch Packaging Technology’s ADV is designed for vacuum sterilization of porous loads and sterilization of liquids. The machine is intended for applications in the pharmaceutical and biotechnology industries, as well as in research laboratories, and is suitable for the sterilization of liquids in open, semiclosed, and closed containers.

The unit is especially suited for sterilizing machine parts, filters, rubber stoppers, and other equipment. Rigid and porous loads, as well as machine cavities, can be sterilized using the ADV’s steam–vacuum process. Its prevacuum steps ensure the elimination of air from the chamber, and heating and sterilizing is then achieved by saturated steam.

The ADV combines equipment sterilization through its vacuum process with product sterilization via its steam–air mixture process. The sterilizer can be used for almost any product and is also suited for the development of new products.

Company Notes

Biogen Idec has sold its royalty and other rights relating to Benlysta (belimumab), for treating systemic lupus erythematosus, to a DRI Capital-managed fund. Biogen Idec’s entitlement results from a license agreement with the GlaxoSmithKline subsidiaries Human Genome Sciences (HGS) and Glaxo Group Limited. Under the agreement between Biogen Idec and DRI, HGS and Glaxo Group Limited will make royalty payments directly to DRI instead of to Biogen Idec. DRI will in turn pay Biogen Idec a multiple of certain of the royalties received for the period covering October 2011 to September 2014. Following that period, DRI will retain the royalty payments from the sales of Benlysta, with certain exceptions, including a one-time contingency payment that could be triggered if the cumulative royalties to DRI exceed an agreed amount. Read More

Advertisement:
The FDA has taken the next step in increasing efficiency of electronic regulatory reporting through the implementation of the eMDR Electronic Submissions Gateway. Learn the benefits and best practices of using the FDA's eMDR program to meet specific business needs, and the future of eMDR for Life Science organizations. Read More

Cambridge Major Laboratories (CML) is planning a significant expansion of its large-scale API manufacturing facility in Germantown, Wisconsin. The expansion comes three years after commissioning the new site. The expansion will include additional reactor capacity as well as isolation equipment. Alongside capacity additions, CML has made additional investments in engineering controls to ensure the sustainability of the business. Read More

Advertisement:
Free Technical Posters for Tablet Manufacturers
The latest edition to Natoli's extensive collection of free technical resources, the Technical Poster Series features 3 large-format posters packed with helpful tips, charts, terminology, and more. For a limited time, all 3 posters are available at no charge — shipping included — so order yours now! http://www.natoli.com/Posters-PT.html

Spectrum Pharmaceuticals has completed the acquisition of Allos Therapeutics on Sept. 5, 2012 through a short-form merger of Sapphire Acquisition Sub, a wholly owned subsidiary of Spectrum, with and into Allos, with Allos surviving the merger and continuing as a wholly-owned subsidiary of Spectrum. Read More

Advertisement:
Realize Effective Pharmaceuticals
Reliable solutions enable pharmaceutical scientists to innovate in disease research, accelerate drug discovery and have greater confidence throughout development and manufacturing. Agilent solutions in genomics research, automation, separation and detection technologies along with workflow driven software solutions helps deliver the answers to bring effective therapeutics to market www.agilent.com/lifesciences/realizepharma

Takeda Pharmaceutical has completed construction of its pharmaceutical manufacturing facility in Yaroslavl, Russia. The company has invested approximately EUR 75 million ($96.4 million) in the 24,000-m2 (258,334 ft2) production plant, which the company expects to be fully operational by 2014. The plant will have initial capacity to manufacture 90 million ampuls and more than two billion tablets per year.

Advertisement:
Agilent ICP-MS/ICP-OES
Reliable solutions for regulated pharmaceutical laboratories
Complying with new elemental impurity limits as defined by draft USP methods <232>/<233> could pose a significant challenge. You need to choose qualified hardware and software, ensure verification, and maintain electronic records. But there is a simple answer – Request a free copy of our primer on Elemental Impurity Analysis to learn more.

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

Advertisement:
Recent USP Changes: Regulatory and Quality Aspects of Sample Preparation
Live Webcast: Tuesday, September 18 2012 at 11:00 AM EDT
www.pharmtech.com/sampleprep

Do you have news to report on facility expansions, contracts, service agreements, mergers, acquisitions, or personnel appointments? Send press releases to [email protected]


Advertisement:
Osmotic Controlled Release Oral Delivery System
Event Date: September 19, 2012 at 11:00 AM EDT
http://www.pharmtech.com/osmoticcontrolled

PharmTech, the magazine
Current Issue cover
Strategies in Outsourcing Facilities Management
by: Rakesh Kishan, Andrew Cieslak
The authors highlight costs, benefits, and implementation success factors across first, second, and third generations of facility management outsourcing contracts.
Click Here to Read More

Coming soon: Don't miss our special coverage on disposable chromatography in Pharm Tech's October issue.


Advertisement:
Risk Management in Sterile Manufacturing
WEBCAST: Thursday, September 27, 2012 from 2:00 PM - 3:00 PM EDT
Register Free at http://www.pharmtech.com/dpt2


Thank you to all who have participated in Pharmaceutical Technology's 2012 Annual Readership Studies!

CONGRATULATIONS to the lucky winners of Apple's new iPad:
CATHERINE PIZZOLANTI & JERLINE JOSEPH

CONGRATULATIONS to the lucky winner of a $100 American Express Gift Card: YUE LI

We appreciate your enthusiasm in helping Pharmaceutical Technology continue to be a top source of information for professionals in the global bio/pharmaceutical industry.

PharmTech's online Gateway is your guide to the season's leading shows.


Advertisement:
Achieving Sensory Benefits and Mildness in Dermatology Products
Live Webcast: Thursday, October 4, 2012 at 10:00 AM EDT
Register Free at www.pharmtech.com/sensory


Know Before You Go—2012 Conference Previews

Visit our Show & Exhibition Gateway 2012 to see which companies are exhibiting at upcoming industry conferences.

Find company backgrounds, new product releases, booth materials, and more.

PharmTech's online Gateway is your guide to the season's leading shows.



Advertisement:
Overcoming Challenges with Pediatric Oral Solid Dose Development
Live Webcasts: Wednesday, October 3, 2012 at 3:00 pm IST (India Standard Time) and 10:00 am EDT (Eastern Daylight Time)
Register Free at www.pharmtech.com/oralsolid



Advertisement:
Increasing your chances for success in First-In-Man studies
Live Webcast: Wednesday, October 3, 2012 at 11:00 AM EDT
Register Free at www.pharmtech.com/success

 

PharmTech Poll

Generic Drug User Fees Amendments of 2012
What do you think will be the greatest benefit of FDA's Generic Drug User Fees Amendments of 2012 (GDUFA)?

Vote here
View the poll archive.
 
On Our Blog PharmTech Talk

>>Recent Posts

Global Health, Manufacturing, North America News
Be Prepared

Drug Delivery, Formulation, R&D, Trends
Omega-3s Prescription Products: A Case Study of Innovation

Regulation
Colored Brain Sparks FDA Warning Letter

>>Go to the Blog Homepage

| Subscribe | Send Feedback | Advertise With Us | Visit PharmTech.com |

Visit PharmTech.com Visit PharmTech.com About Us Subscribe Today! Start your RSS subscription today! Manufacturing Outsourcing Formulation Ingredients Testing Drug Delivery IT Packaging Regulation Visit PharmTech.com