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December 2010
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News
Complex Relationship Between FDA and Life Sciences
Haydia Haniff
Approvals, politics, and user fees are among the issues that make for an uneasy relationship between the US Food and Drug Administration and the life sciences industry, according to findings from a recent PricewaterhouseCoopers (PwC) survey of the industry. 
PDUFA Discussions Continue, New Review Models Proposed
Angie Drakulich
The US Food and Drug Administration posted on its website the minutes of the latest meetings between the agency and industry, and among stakeholders, regarding the reauthorization of the Prescription Drug User Fee Act V. The meetings were held Nov 17-18.
China and India to be World Leaders of Innovation
Stephanie Sutton
China and India will become the world leaders in innovation during the next decade, according to an international survey released by AstraZeneca.
Deals
GE Healthcare and G-CON Collaborate to Develop “Vaccine Factory in a Box”
GE Healthcare (Uppsala, Sweden) and G-Con Manufacturing LLC (College Station, TX) will develop a modular portable bioprocess manufacturing solution for vaccines and therapeutics.
Merrion Pharmaceuticals and Rebel Pharmaceuticals Sign Drug Feasibility and Option Agreement
Merrion Pharmaceuticals, Plc (Dublin, Ireland), a product development company, has signed an oral drug delivery feasibility and option agreement with Rebel Pharmaceuticals, LLC (Thousand Oaks, CA) for two undisclosed compounds.
Aushon BioSystems and LightArray to Offer Protein Biomarker Testing Services and Products in China
Aushon BioSystems, Inc. (Billerica, MA), a provider of multiplex immunoassay products and services for biomarker discovery, development, and analysis, will partner with LightArray Biotech Company, Ltd. (Shanghai, China) to provide Aushon’s suite of multiplex biomarker products and services.
Vaccine Report
Tolerx and the Cancer Research Institute to Develop Anti-GITR Antibody
Tolerx, Inc. (Cambridge, MA) and the Cancer Vaccine Acceleration Fund (CVAF, New York, NY) have signed a research agreement to support the development of Tolerx’s drug candidate, TRX518.
Tubing Lasts 6-10 Times Longer
AdvantaFlex™ biopharmaceutical tubing outlasts similar tubing tested in peristaltic pumps by 6 to 10 times. It’s heat sealable, weldable, and free of silicone oils and animal-derived ingredients. Ideal for aseptic tubing welds – eliminates costly aseptic connectors and multiple tubing surfaces. Complies with USP Class VI, ISO, EP, and FDA standards. Made in USA
AdvantaPure®  Click here to learn more.
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Baxter and Takeda Complete Agreement for Vero Cell-Based Influenza Vaccines in Japan
Baxter International Inc. (Deerfield, IL) and Takeda Pharmaceutical Company Limited (Osaka, Japan) have completed a development, license, and technology transfer agreement.
FindPharma Careers
Scientist, Process Development in Antibody Drug Conjugates
Agensys, Santa Monica, CA
Director/Senior Director, Global Development Project Lead, Oncology
Astellas Pharma, Deerfield, IL
Director, Analytical Services
Cambridge Major Laboratories, Germantown, WI
For more job listings, visit FindPharma Careers
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| Washington Vaccine Forum 2011
Cell & Gene Therapy Forum 2011
Phacilitate’s 2 sector-leading conferences take place together for the 6th time in ’11. The 2 programs run in parallel, with shared networking. 500+ life science leaders attended in ’10. The combined meeting takes place from the 24th to the 26th of January at The Grand Hyatt, Washington DC.
Visit  www.phacilitate.co.uk for more information, or e-mail [email protected] |
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Pharma IQ's 8th Annual PAT and QbD Conference
Date: 14 - 16 February, 2011,
Venue: ETC Venues, Dexter House, London, UK.
With 2 dedicated streams (Pharmaceutical and Biopharmaceutical), this year's agenda will provide a platform for interactive discussion and networking to help delegates tailor their conference experience. With Key Insight From Leading Global Experts from Irish Medicines Board, Pfizer, Eli Lilly, GlaxoSmithKline, MSD, Vertex Pharmaceuticals, Abbott Diagnostics, Novo Nordisk, GlaxoSmithKline and many more.  www.patandqbd.com
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Pharma IQ’s 3rd Annual Disposable Solutions for Biomanufacturing conference
Date: 1s t- 2nd February 2011,
Venue: Hotel Le Plaza, Brussels.
This is Europe’s leading event dedicated to developing, implementing and validating single use bioprocessing systems and provides you with a unique opportunity to gain insight from 17 industry experts, sharing their experiences with ten case studies and six discussion sessions! Plus exclusive for this year is a site visit to one of Belgium’s most comprehensive and developed multipurpose disposable biomanufacturing pilot facilities. (Limited places available) .  www.disposablebiomanufacturing.com |
INTERPHEX China is co-location with API China - where you obtain the fastest access to the Chinese pharmaceutical market
API China is the largest pharmaceutical ingredients trade show in China. Taking place biannually in spring and autumn, it provides a meeting place for pharmaceutical ingredient, intermediate and fine chemical manufacturers and finished drug producers.
With 55,000 square meters of stand space, the recent API China attracted 1,400 exhibitors and more than 30,000 professional visitors.
Of the 1,400 exhibitors, 600 were showing processing and packaging machinery and packaging materials.
Among the visitors, 4,000 specifically focused on pharmaceutical packaging and 2,000 on pharmaceutical manufacturing equipment.
 http://en.interphexchina.com/subpage.jsp?url=about_interphexchina.htm
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8th Annual Global BioManufacturing Survey: Participation Requested (FREE SUMMARY) MAKE SURE YOUR VOICE IS HEARD!
Dear Colleague,
Thank you for your participation in this year's 8th Annual Biopharmaceutical Manufacturing Report and Survey. Click here to take survey Your input is more important than ever, as we benchmark global and regional trends affecting our industry:
- Budget trends, new technologies, capacity, outsourcing and hiring issues, downstream processing, disposables, cost cutting, quality initiatives, are just a few of the important topics covered in this year's 8th Annual Biopharmaceutical Manufacturing Report and Survey.
- Last year over 400 biomanufacturers and suppliers participated globally. This year we're expecting even more.
- You will receive a FREE summary of the results from this important global study.
AND for each completed survey we'll donate $10 (up to $10,000) on your behalf to:
- Global Alliance for Vaccine Initiative (GAVI), or
- American Cancer Society (ACS).
If you're directly involved in biomanufacturing, please complete this survey! Click here to take survey
- Survey results support industry benchmarking.
- Responses are aggregated and confidential.
- Completion time estimated between 10-25 minutes, depending on your area of expertise.
The survey allows you to participate at your own pace. Just re-click the link to start where you left off, if needed.
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Industry Events
January 9: CMC Strategy Forum
Location: Washington, DC
January 10–12: WCBP
Location: Washington, DC
January 10–13: PepTalk
Location: San Diego, CA
January 17–18: 2nd Annual Drug Delivery and Formulation 2011
Location: Berlin, Germany
January 17–21: IFPAC 2011
Location: Baltimore, MD
January 24–25: Biomanufacturing Summit
Location: San Diego, CA
January 24–26: Phacilitate
Location: Washington, DC
Complete calendar listing
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