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Podcasts

Webcast: Quality Control: Preventing Cross-Contamination in a Pharmaceutical Manufacturing Environment
June 21, 2011 (North America) and June 23, 2011 (Europe)—Sponsored by SGS

Webcast: Winning Regulatory Strategies and Opportunities in Dermatology
July 20, 2011—Sponsored by Dow Pharmaceutical Sciences

Podcast: A Conversation with NIH Director Francis Collins

Events

CoSMoS 2011
August 1–August 3, 2011
Chapel Hill, NC

Regulatory Affairs: Part I: The IND Phase and Part II: The NDA Phase
August 8–August 12, 2011
Boston, MA

Introduction to Signal Detection and Data Mining
August 16, 2011
Boston, MA

The Immunotherapeutics & Vaccine Summit
August 16–August 18, 2011
Cambridge, MA

2nd Annual Pharmacovigilance 2011
August 19, 2011
Mumbai, India

The Bioprocessing Summit
August 22–August 25, 2011
Boston, MA

More events


FindPharma Search
July 28, 2011 PharmTech.com

News

CDER Identifies Key Regulatory Science Needs and Strategies
FDA released this week a report from its Center for Drug Evaluation and Research (CDER) that identifies regulatory science needs that will guide CDER’s strategic planning in the years ahead and allow it to fulfill its regulatory mission.
Click Here to Read More

BMS to Acquire Amira for $325 Million
Bristol-Myers Squibb has signed an agreement to acquire Amira Pharmaceuticals, a small-molecule company with a focus on treatments for inflammatory and fibrotic diseases, for $325 million.
Click Here to Read More

WHO Predicts Flu-Vaccine Production Will Double by 2015
The global production of seasonal influenza vaccine will double to 1.7 billion doses by 2015, according to a World Health Organization presentation. Click Here to Read More

EMA Improves the Readability of Packaging Leaflets
The European Medicines Agency has updated the template for package leaflets to make the information easier for patients to understand. Click Here to Read More

Foreign Scientists Welcome, Sort Of
The age of globalized industry should result in fewer barriers between countries, but in practice it is rarely that straightforward, according to a report by ScienceInsider. Click Here to Read More


Product Spotlight

Pretorqued holder ensures accurate loading and sealing

HPX-PT pretorqued holders from Continental Disc incorporate high-strength steel socket head cap screws to ensure accurate loading and sealing of the HPX rupture disc. The HPX-PT pretorqued holder allows the disc to be correctly fitted in the workshop using precise recommended torque levels before the complete assembly is installed between the flanges in the process-system relief stream.

The unit’s cap screws maintain a seal between the holder and rupture disc to prevent the disc from slipping or leaking in the holder after it is removed from the vessel nozzle or pipe flange for inspection. Once the disc has been inspected, the holder and disc may be reinstalled.

In addition, the HPX-PT pretorqued holder has a durable tapered seating surface designed to prevent rupture disc slippage and to provide a bubble-tight seal over various HPX rupture disc sizes, materials, and burst ratings. The HPX-PT pretorqued holder is appropriate for active-ingredient processing plants and fill–finish plants that require sanitary connections and environments.

Company Notes

AstraZeneca has received FDA approval for Brilinta (ticagrelor) a new molecular entity for treating acute coronary syndrome.

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The sterile injectables contract manufacturing organization (CMO) JHP Pharmaceuticals has agreed to produce clinical-trial batches of a drug used to treat heart failure with an undisclosed biotech company.

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Laureate Biopharmaceutical Services, a biopharmaceutical contract development and manufacturing organization (CDMO), has entered into a multiyear development and manufacturing agreement with a generic pharmaceutical company to produce a biosimilar product. Under the agreement, Laureate’s services will include transfer of the manufacturing process to Laureate and cGMP manufacture of this product for clinical trials through 2013. The agreement includes a customer option for long-term commercial supply. Laureate expects to supply the first batch of clinical product during the first half of 2012. Terms of the manufacturing agreement were not disclosed.

Cellectis bioresearch, a provider of genome-engineering tools and expertise and a subsidiary of Cellectis, and the CMO Lonza have reached a milestone in the development of a newly bioengineered cell line. Using their meganuclease technology, Cellectis bioresearch has deactivated the cell-based glutamine synthetase (GS) in CHO-K1SV, Lonza’s host cell line.

In other news, Lonza has signed an exclusive contract for the production of Immune Pharmaceutical’s human immunoglobulin monoclonal antibody, Bertilimumab, under investigation for the potential treatment of several inflammatory disorders. Under the agreement, Lonza will produce Phase II clinical-trial material at its mammalian development and manufacturing facility.

Merck and Astellas US, the US subsidiary of Astellas Pharma, have formed an agreement under which Merck, through a subsidiary, will acquire from Astellas the exclusive rights to develop and commercialize the investigational intravenous formulation of vernakalant (vernakalant IV) in Canada, Mexico, and the US. Vernakalant IV is currently approved in more than 10 European countries for the conversion of recent onset atrial fibrillation (AF) to sinus rhythm. Under the terms of the agreement, Merck will pay Astellas an undisclosed upfront fee, and Astellas will be eligible for milestone payments associated with development and regulatory approval as well as sales thresholds achieved in Canada, Mexico, and the US.

Additionally, Merck has has signed a joint venture with the Chinese pharmaceutical company Simcere Pharmaceutical. The establishment of the joint venture is subject to satisfying certain agreed to closing conditions. The potential partnership will focus on development, registration, manufacturing, and sales with an initial focus on branded pharmaceutical products for metabolic diseases.

Pfizer and the biopharmaceutical company Icagen have entered into a definitive merger agreement. Pfizer, which currently owns approximately 11% of Icagen’s fully diluted shares, will acquire the remaining 8.3 million shares at a price of $6.00 per share. The aggregate transaction value, including the value of the shares currently owned by Pfizer, is approximately $56 million. The agreement, subject to customary conditions and regulatory approval, has been targeted to close before the end of 2011. Icagen partnered with Pfizer in 2007 for developing compounds that modify specific ion channels for treating pain and related disorders.

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

People Notes

The specialty pharmaceutical company Adventrx has appointed Gregory D. Gorgas as senior vice-president of the company’s commercial division. He was previously with Biogen Idec, where he was head of global marketing.

The biopharmaceutical company Amylin Pharmaceuticals has appointed Robert MacKay as general manager of its West Chester, Ohio, manufacturing facility. His previous experience includes leadership roles at Eli Lilly.

Patheon, a CDMO, has appointed Gary Shope to the newly created position of chief of staff. Shope will report to James C. Mullen, Patheon’s CEO.

RecipharmCobra Biologics, a biopharmaceutical CMO, has named Julian Hanak as commercial director. Hanak was formerly the senior vice-president of development at Renovo, a biopharmaceutical drug-development company.

Sanofi has announced the appointments of two senior executive positions. President and CEO Greg Irace was appointed to the newly created role of senior vice-president of global services. He will lead Sanofi’s global information systems funtion and will manage the development of a global strategy for shared services. Anne C. Whitaker has been named president of Sanofi’s North American pharmaceutical division, effective Sept. 1, 2011. She will report to Hanspeter Spek, Sanofi’s president of global operations, and join the global management committee.

PharmTech, the magazine
Current Issue cover
Multiunit Particulate Systems: A Current Drug-Delivery Technology
By Mitesh D. Phale, Abhijit V. Gothoskar
The current review describes the role and selection of excipients, pellet core, coating materials, and compression with various cushioning agents.
Click Here to Read More

Coming soon: The August special report will address big pharma's manufacturing strategies.


PharmaFaceoff

The Challenges of Research & Development
Should pharma search for external drug candidates to refill the pipeline or develop internal R&D capabilities? Renee Cohen (vice-president of corporate strategy at Shire) and Ray Jupp (vice-president of the fibrosis and wound repair therapeutic strategy unit at Sanofi) join Barbara Ryan, Ken Kaitin, and Charlotte Sibley to debate how pharma can replenish its drug development pipeline in this Pharma Faceoff episode.
PharmaFaceoff

 

PharmTech Poll

Highly potent APIs
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