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February 18, 2010 PharmTech.com

News

A Boost for Personalized Medicine
A joint investment of approximately 28 million Euros ($38 million) for seven projects may bring personalized medicine closer to reality. Click Here to Read More

SOCMA Lends Support for Senate Chemical Security Bill
The Society for Chemical Manufacturers and Affiliates offered its support for a Senate proposal to extend to 2015 current chemical-security standards, the Chemical Facility Anti-Terrorism Standards, which are set to expire this year.
Click Here to Read More

Pfizer Outlines Postacquisition Manufacturing Strategy
Following its $68-billion acquisition of Wyeth, Pfizer is integrating its manufacturing and outsourcing activities (Podcast).
Click Here to Read More

EMA and Swissmedic to Share H1N1 Medicine Information
The European Medicines Agency and the Swiss Agency for Therapeutic Products have agreed to exchange information about the authorization and safety of H1N1 pandemic medicines.
Click Here to Read More

Russian Groups Agree to Produce Anticancer Nanodrugs
RUSNANO, a corporation established by the Russian government to foster the development of nanotechnology, launched a project to manufacture targeted-delivery nanodrugs to treat malignant neoplasms.
Click Here to Read More


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Product Spotlight

Product image hspace=Tablet coater operates with high efficiency
L.B. Bohle’s (Warminster, PA) Bohle Tablet Coater (BTC) was designed for efficient operation. The machine’s coating pan is longer and has a smaller diameter than coating pans in conventional units. This design results in a thin tablet bed that creates less static force than a typical coater bed. The BTC unit’s tablet bed is designed to eliminate slow-moving zones and reduces tablet twinning. The large bed surface area allows the machine to have more spray guns than common coaters.

Unlike traditional devices, the BTC brings air directly into the tablet bed from below. All airflow in the coater is through the bed in the direction of spray. Almost no air movement occurs in the spray zone, thus solution is not dried before it reaches the tablets. This design allows the BTC machine to operate with 96–98% efficiency, says Martin Hack, L.B. Bohle’s vice-president and general manager.


Company Notes
Abbott Laboratories (Abbott Park, IL) completed its acquisition of Solvay Pharmaceuticals (Belgium) for EUR $4.5 billion ($6.2 billion). Abbott expects the acquisition to add approximately $2.9 billion to the company’s 2010 total sales and about $500 million to Abbott's annual R&D investment.

Albemarle (Baton Rouge, LA), a provider of custom-manufacturing services, will partner with PharmaCore (High Point, NC) to provide manufacturing for customers needing high-volume capacity. PharmaCore provides organic synthesis.

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The US Food and Drug Administration approved the Amgen (Thousand Oaks, CA) and Centocor Ortho Biotech Products (Horsham PA) risk evaluation and mitigation strategy for erythropoiesis-stimulating agents (ESAs), which include Aranesp (darbepoetin alfa), EPOGEN (epoetin alfa) and PROCRIT (epoetin alfa). The drugs are used to treat patients with breast, non-small cell lung, head, neck, lymphoid, and cervical cancers.

AstraZeneca (London) and drug-development company Rigel Pharmaceuticals (South San Francisco, CA) will collaborate on the global development and marketing of fostamatinib disodium (R788), Rigel’s late-stage investigational product for rheumatoid arthritis (RA) and additional indications. Fostamatinib disodium is the furthest developed oral-spleen tyrosine kinase inhibitor being evaluated for RA. AstraZeneca will make an upfront payment to Rigel of $100 million. Rigel could receive with an additional $345 million from AstraZeneca if specified development, regulatory, and sales milestones are reached.

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Materials-characterization expert Malvern Instruments (Malvern Worcestershire UK) opened a third center of excellence in Delhi, India. The new center, designed to serve customers in the north and northeast regions of India, houses laboratories equipped with Malvern systems and staffed by a full-time applications team that will provide demonstrations, training, applications and technical support, and sample analysis.

Novartis (Basel) gained exclusive rights to develop and market Debio 025 (alisporivir), a potential first-in-class antiviral agent in Phase IIb development for the treatment of hepatitis C. Debio 025, the first in a new class of drugs called cyclophilin inhibitors, has been licensed from Debiopharm Group (Lausanne, Switzerland), an independent biopharmaceuticals company.

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analytica, March 23 – 26, 2010 in Munich, Germany
The world’s leading trade fair for Laboratory Technology, Analysis and Biotechnology. More than 1,000 exhibitors and 33,000 trade visitors attended analytica 2008. The 2010 show promises to be the most international analytica to date - there has been a 13% increase in international exhibitors so far. More information at www.analytica.de/en

Regis Technologies (Morton Grove, IL), a provider of current good manufacturing practice and non-good manufacturing practice synthesis and separations services for active pharmaceutical ingredients and intermediates, received FDA approval to manufacture 4-Aminopyridine, the active ingredient in Ampyra.  FDA has approved Ampryra as a treatment to improve walking in patients with multiple sclerosis.

Roche (Basel) announced that results from the first five Phase III studies confirm Roche’s weekly taspoglutide has a positive effect on reducing blood glucose compared with other diabetes treatment options. Roche’s taspoglutide is the first weekly human GLP-1 analogue in late-stage development.

sanofi-aventis (Paris) completed its tender offer for all outstanding shares of common stock of Chattem (Chattanooga TN), which will become a wholly owned subsidiary of sanofi-aventis. The company hopes the transaction will strengthen its presence in the US healthcare market.

Generic-drug company Teva Pharmaceutical Industries (Petach Tikva, Israel) settled a patent dispute with Novartis (Basel) over a herpes treatment. In 2007, Teva launched a generic version of the Novartis’ drug famvir. Under the terms of the settlement, Teva will make a one-time payment to Novartis and provide royalties from US sales.

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


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PharmTech Talk blog

People Notes

Merck & Co. (Whitehouse Station, NJ) appointed Bridgette P. Heller executive vice-president and president, consumer healthcare. Heller will report to Richard T. Clark, Merck’s chairman, president and chief executive officer.

NextPharma Technologies (Surrey, UK) appointed Ronald Collins interim general manager and Alan Sanders director of finance of its San Diego, California facility. Bruce Johnson was named director of operations; and Mary Richardson was named director of quality.

PharmTech, the magazine
Current Issue cover
Implications and Opportunities of Applying QbD Principles to Analytical Measurements
By Mark Schweitzer, Matthias Pohl, Melissa Hanna-Brown, Phil Nethercote, Phil Borman, Gordon Hansen, Kevin Smith, and Jaqueline Larew

The authors present two concepts to improve robustness and facilitate continuous improvement in analytical methods.

Click Here to Read More

Coming Soon: PharmTech's March issue features a preview of the Interphex 2010 conference and exhibition.

 

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