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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

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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.
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.


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.

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.

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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.

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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.
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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
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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
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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
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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
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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.
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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
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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
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Do you have news to report on facility expansions, contracts, service agreements, mergers, acquisitions, or personnel appointments? Send press releases to [email protected] |
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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.
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Coming soon: Don't miss our special coverage on disposable chromatography in Pharm Tech's October issue. |
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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 |
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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.
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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 |
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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.
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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 |
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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 |
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