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- Breaking News:
- OSI Licenses Diabetes Program to Lilly
OSI Pharmaceuticals’ subsidiary, Prosidion Ltd., and Eli Lilly and Co. have entered into a licensing agreement granting Lilly exclusive rights to OSI's Glucokinase Activator (GKA) program, which includes the lead compound PSN010....
Read More
- DSM Biologics, Crucell License PER.C6 to Biotecnol
DSM Biologics, a business unit of DSM Pharmaceutical Products, and Dutch biotechnology partner, Crucell, have signed a PER.C6 license agreement with Biotecnol SA, a Portuguese biotechnology company and its U.S.-based subsidiary Biotecnol, Inc.... Read More
- Enzon Files IND for Cancer Drug
Enzon Pharmaceuticals, Inc. has submitted an IND to the FDA for its HIF-1alpha (hypoxia-inducible factor 1alpha) antagonist, a highly visible, validated target in many cancer types, including solid tumors.... Read More
- Biogen Idec To Acquire Syntonix
Biogen Idec has signed a definitive agreement to acquire Syntonix Pharmaceuticals for $40 million. Syntonix focuses on discovering and developing long-acting therapeutic products to improve treatment regimens for chronic diseases.... Read More
- Raven, Wyeth Enter Antibody Pact
Raven Biotechnologies, Inc., has entered into an agreement with Wyeth Pharmaceuticals to develop and commercialize selected MAbs from Raven’s portfolio of antibodies to a specified target.... Read More
- Features:
- Newsmakers: Wyeth R&D
An interview with Dr. Frank Walsh, Head of Discovery Research, on Wyeth’s outsourcing strategy
by Gil Roth
How do you cope with success? Wyeth’s drug pipeline has grown by leaps and bounds, with a 400% increase in productivity from 2001-2005, in terms of compounds entering the clinic. With chemistry as the major bottleneck, the company elected to find an outsourcing partner. Searching worldwide and running pilot projects with partners in Russia, China and India, Wyeth signed an agreement Hyderabad-based GVK Bio in November 2005.
To find out how the company developed its R&D outsourcing strategy, and to see how that strategy fits into the company’s overall approach to outsourcing, we interviewed Frank Walsh, Ph.D., executive vice president, Head of Discovery Research, Wyeth Pharmaceuticals. Dr. Walsh joined Wyeth in 2002 and was named to his current post in January 2005.... » Read entire article
- Risk Management in the Biomaterial Cold Chain
Mitigating risks & ensuring compliance
by Jeff Clark
The biopharmaceutical cold chain has begun to play an increasingly critical role in pharmaceutical and biotherapeutic development processes. It defines how temperature-sensitive biological assets are packaged, transported and stored throughout the R&D cycle. When building or evaluating their cold chain processes, drug developers must remain aware of one basic, yet often-overlooked principle: the cold chain is the same as any other chain in one key area—it is only as strong as its weakest link.... » Read entire article
- Aseptic Process Validation
Is a new FDA guidance imminent?
by Tom Spurgeon
What are the regulatory pressures facing aseptic process validation today and what will they be like over the next few years? An inquiry into existing literature and with current industry personnel reveals a corner of the pharmaceuticals industry driven by a lattice of suggested improvements, a constant hum of activity and improvements that fight to keep pace with general industry trends and emerging technology. Those working in aseptic processing validation must consistently look five years ahead and five years behind, at rules and informative processes and market realities, all of which play off one another like so many strings on a musical instrument. With an important FDA guidance revision just now beginning its long fade into routine and a brand new one described as imminent, aseptic processing and its regulatory outlook is at the forefront of pharma and biopharma business plans.... » Read entire article
- Online Exclusive:
- Bio News & Views Interview
by Gil Roth
In September 2006, Tandem Labs acquired PharmaKD, a Boston-based, mass spectrometry-oriented provider of drug metabolite and biomarker identification services. With the acquisition, Tandem obtained proprietary informatics that can "reduce the difficulty, complexity, and time-consuming nature of developing and launching a drug to market," according to the company. This included MarkerScan, a biomarker discovery and screening process to "efficiently identify potential biomarkers that can be used to increase the understanding of disease, diagnosis, and predictive models as well as drug compound safety, efficacy, and side-effect profiles."... » Read entire article
- Major Meetings:
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Feb 13-16: Informex 2007
The Moscone Center West, San Francisco, CA
Contact: Informex, Tel: 202-721-4100, Fax: 202-296-8120, Web: www.informex.com
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Apr 24-26: Interphex 2007
Jacob K. Javits Convention Center, New York, NY
Contact: Reed Exhibitions, Tel: 203-840-5648, Web: www.interphex.com
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May 6-9: BIO 2007
Boston Convention & Exhibition Center, Boston, MA
Contact: BIO, Tel: 202-962-6655, Fax: 202-589-2545 Web: www.bio.org
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See all the meetings at http://www.contractpharma.com/meetings.php
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