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Webcast: Protect IP and Reduce the "Sign and Witness" Burden in Lab Informatics Systems
On-Demand—Sponsored by Surety

Topical Drug Product Development: Overcoming CMC Issues and Pitfalls- Analytical & Regulatory
On-Demand—Sponsored by Dow Pharmaceutical Sciences

Webcast: Pharmaceutical Melt Extrusion: A Strategy for Poorly Soluble Drugs
On-Demand—Sponsored by Evonik Degussa

Webcast: Building Quality into the Selection and Sourcing of Pharma Ingredients Strategies — from research through commercial manufacture
On-Demand—Sponsored by Spectrum Chemical

Podcast: Thomas Otto on Vetter Secondary Packaging

Podcast: Lou Schmukler on Pfizer's Manufacturing Strategy

Podcast: Joseph Forth of AMRI on Clinical Formulations

Podcast: CRS and Sustainability Forum: Science and Human Rights

Events

Qualified Person Forum 2010
Nov. 25–26
London

Chemspec Middle East 2010
Nov. 29–30
Dubai

9th Annual World Drug Manufacturing Summit
Nov. 30–Dec. 2
Berlin

Good Manufacturing Practices
Dec. 1–3
Costa Mesa, CA

CGMP Quality Principles for Pharmaceuticals, Biopharmaceuticals, Biologics and Medical Devices
Dec. 6–8
King of Prussia, PA

Analysis and Testing: Quality Leadership Program
Dec. 7–9
Boston

Biologic Manufacturing World India
Dec. 7–8
Mumbai

More events


FindPharma Search
November 24, 2010 PharmTech.com

News

EMA Committee Makes Decisions on Opioids, Follow-on Biologics
The European Medicines Agency's Committee for Medicinal Products for Human Use issued a summary of its latest meeting.
Click Here to Read More

Novartis to Seek Innovation and Efficiencies
Novartis disclosed its long-term business strategy, which emphasizes diversification in what the company described as high-growth healthcare segments. Click Here to Read More

Bayer Announces Restructuring, Increased Focus in Healthcare Business
Bayer announced a restructuring program and a strategy to strengthen its focus in research, development, and marketing of new products in its healthcare and crop-sciences businesses. Click Here to Read More



Product Spotlight

Roller compactor provides efficiency and flexibility

The Fitzpatrick Company (Elmhurst, IL) designed its CCS 1025 contained Chilsonator system to process various products efficiently. The system's high-speed vertical precompression feed screw provides a uniform downward force on the product, thus helping to feed it to the nip region of the rolls. The vertical orientation and speed of the screw are intended to ensure that product is distributed across the face of the rolls evenly. The feed screw's vertical orientation provides a path upward for air that is aspirated from the process, thus creating an efficient deaeration system.

The CCS 1025 system is designed to positively seal the product inside the process areas. Operators can disassemble the device easily for cleaning and reconfiguration. The system includes a wash-in-place to simplify cleaning. The CCS 1025 machine's roll and size-reduction housing is designed as an integrated unit to minimize headroom requirements. Users can install the device in wall or as a freestanding unit.



Company Notes

The US Food and Drug Administration approved Amgen's (Thousand Oaks, CA) Xgeva (denosumab), a drug designed to help prevent skeletal-related events (SREs) in patients with bone metastases from solid tumors. Xgeva is a monoclonal antibody that targets a protein involved in cancer-related bone destruction called human RANKL.

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AstraZeneca (London) said last week that it commenced a review of its strategic options for Astra Tech, a business unit that develops, manufactures, and markets dental implants and healthcare (urological and surgical) products.

Baxter International (Deerfield, IL) agreed to acquire all of the hemophilia-related assets of Archemix (Cambridge, MA), a biopharmaceutical company. Baxter also entered into an exclusive license agreement for certain related intellectual property assets. The lead product associated with the arrangement is ARC19499, a synthetic, subcutaneously-administered hemophilia therapy currently in a Phase I clinical trial in the UK.

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Bristol-Myers Squibb (New York) and Pfizer (New York) discontinued their Phase III clinical trial in patients with recent acute coronary syndrome (ACS) treated with apixaban or placebo in addition to mono or dual antiplatelet therapy. The study was stopped early based on the recommendation of an independent Data Monitoring Committee after evidence showed an increase in bleeding among patients using apixaban.

Healthcare services company Cardinal Health (Dublin, OH) agreed to acquire Kinray (Whitestone, NY), a pharmaceutical distributor serving the New York metropolitan area, for $1.3 billion in cash. The transaction will expand Cardinal's ability to serve retail independent pharmacies in the northeastern United States.

Genzyme (Cambridge, MA) agreed to sell its diagnostic-product business to Sekisui Chemical for $265 million. Sekisui agreed to offer employment to the unit's approximately 575 employees, and plans to maintain operations in all of the business's current locations. The companies expect the sale to close by the end of the year.

Laboratory Corporation of America Holdings (LabCorp, Burlington, NC) reported last week that it had received clearance from the Federal Trade Commission for its $925-million acquisition of Genzyme Genetics from Genzyme (Cambridge, MA). Genzyme had announced its agreement to sell it genetic-testing business to LabCorp in September 2010. Genyzme Genetics provides reproductive, maternal fetal medicine, and oncology testing services.

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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 ptpress@advanstar.com

People Notes

Ablexis (San Francisco), a biotechnology company developing the AlivaMab Mouse, a next-generation platform for antibody drug discovery, appointed Sean Stevens as vice-president of research. Stevens will report to Larry L. Green, the company's CEO.

C3 Jian (Los Angeles), a biotechnology company, appointed Todd Patrick as its president and CEO. The company's former CEO, Max Anderson, will remain a special advisor and a member of the company's board of directors.

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CytomX Therapeutics (Santa Barbara, CA), a biotechnology company focused on the development of proteolytically-activated antibodies, appointed Mark Rolfe as its chief scientific officer and Henry Lowman as vice-president of research.  

Omeros (Seattle), a biopharmaceutical company focused on treatments for inflammation and disorders of the central nervous system, appointed Kenneth M. Ferguson vice-president of development.

Prolong Pharmaceuticals (South Plainfield, NJ) named Richard Prince vice-president of quality and Andy Burger vice-president of information services. The company also recently announced $30 million in funding from a private investment group.

Topaz Pharmaceuticals (Horsham, PA), a specialty pharmaceutical company, appointed Bob Radie president and CEO. Thomas Beck, who was serving as interim CEO, will resume his role as chief medical officer of the company.

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  PharmTech Talk blog
Regulatory Roundup

Last week, FDA urged consumers to be “smart” about the way they use antibiotics. “Antibiotics can be used to treat bacterial infections; however, they are commonly over-prescribed. Patients sometimes ask their healthcare professional to prescribe antibiotic drugs for viral infections, like the common cold, despite the fact that they will not work and may lead to potentially harmful side effects,” said the agency in a Nov.15, 2010, online announcement. FDA specifically advised that patients take their medicine as prescribed, not save antibiotics for future use, and not use antibiotics that are prescribed for other individuals.

PharmTech, the magazine
Current Issue cover
A Proposed Content-Uniformity Test for Large Sample Sizes
James Bergum and Kim Erland Vukovinsky
The authors describe a modified version of the Large-N test used to determine content uniformity.
Click Here to Read More

Coming Soon: A position paper discusses the importance of equivalence in validation activities in the December issue of Pharmaceutical Technology.

 

 
 

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