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Thursday, May 15th, 11AM (ET)

Featuring Equipment from Millennium & a Recently Operating Biotech LAB and More!

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•  FDA Sets Panel Review of GlaxoSmithKline (GSK) Clotting Drug According to Amgen (AMGN) More...
•  AstraZeneca PLC (AZN) Submits sNDA for SEROQUEL XR(TM) for the Treatment of Generalized Anxiety Disorder - a First for the Atypical Antipsychotic Class of Medicines More...

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•  FDA Approves Eli Lilly and Company (LLY)'s Strattera(R) for Maintenance of ADHD in Children and Adolescents More...
•  Osiris Therapeutics, Inc. (OSIR) Receives Approval for Use of Prochymal(TM) Under FDA Expanded Access Treatment Program More...
•  Dutch Authorize Manufacture of Vaccinogen's New Cancer Vaccine; License Clears Path to European Production, Final FDA Trial More...
•  Amneal Pharmaceuticals Receives US FDA Approval for Three Generic Prescription Drugs More...
•  Roxane Laboratories, Inc. Announces the Launch of Acarbose Tablets More...

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•  FDA Advisory Committee Votes in Favor of Approval for Eisai Company, Ltd. (ESALY.PK)'s Fospropofol Disodium Injection More...
•  New Abbott Laboratories (ABT) Study of Investigational Vicodin CR(TM) Meets Primary Efficacy Endpoints in Phase III Trial More...
•  Array BioPharma, Inc. (ARRY) Presents Additional Positive Phase 2 Results in Inflammatory Pain Clinical Trial; ARRY-797 Achieved its Primary and Secondary Endpoints More...
•  BioDelivery Sciences International (BDSI) BEMA(TM) Fentanyl Phase III Data Demonstrating Efficacy and Tolerability to be Presented at American Pain Society Annual Meeting More...
•  BiPar Sciences, Inc. Expands Phase 2 Clinical Trials of BSI-201, a Novel DNA Repair Inhibitor, in Ovarian Cancer More...

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•  Amnis Corporation and Gene Company, Ltd. Announce Agreement to Market ImageStream Technology in China More...
•  LFB Biotechnologies and GTC Biotherapeutics (GTCB) to Collaborate on rhAAT Program More...

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•  Quintiles Transnational Corp. Signs Agreement to Acquire Eidetics More...
•  AMDL, Inc. (ADL) Signs Letter of Intent to Purchase a China Based Pharmaceutical Distribution Company More...
•  DOR BioPharma, Inc. (DORB) Acquires Option for Third-Generation Anthrax Vaccine From Harvard University More...

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Latest Market Insight
Drug Approval Trends at the FDA and EMEA

Process improvements, heightened scrutiny and industry response

• Delayed approvals. Regulators are requesting more data to validate or refute conclusions about product risks. This is creating a rise in the size and number of clinical trials as well as overall research budgets.

• Rising R&D costs. Drug developers are continually increasing their R&D expenditures to generate approvable drug applications, despite rising financial pressures in the industry. Emerging technologies such as stem cells, genomics and proteomics are among the most prevalent initiatives being used to identify appropriate drug candidates.

• US generics focus. The FDA is allocating resources to generic drug approvals in an attempt to speed these products to market. However, although Europe has recently developed a clear regulatory path for generic versions of biologicals, this is yet be achieved in the US.

• Regulatory process improvements. Regulators are enhancing their drug review processes with new technologies such as electronic drug applications and technology-based standards for drug review.

Click Here for More Information

What Are You Worth?
Top Jobs
BioTechxus (Fort Worth, Texas) Hot Job of the Day:

Alcon Laboratories
Clinical Team Leader
Implement clinical pharmacology studies and project-related activities to support the clinical evaluation of Alcon lead candidates. Provide strong leadership to subordinates and facilitate and support their roles within the CP Unit.

Biotech Bay (South San Francisco, California) Hot Job of the Day:

Breightworth Recruiters
Associate Director Clinical Operations
Manages resources, timelines and budgets for clinical programs run globally and within the United States to meet clinical and corporate goals and metrics.

Biotech Beach (Irvine, California) Hot Job of the Day:

ClinAssure, Inc.
Senior Clinical Research Associate ( Senior CRA )
As a member of the clinical team under supervision, this position is responsible for performing clinical research activities related to all clinical research studies and projects according to Federal Regulations and ICH guidelines.

Genetown (Cambridge, Massachusetts) Hot Job of the Day:

Clinical Brokers
Clinical Project Manager
The Study Manager manages and leads a cross-functional Study Team for the entire duration of the study. The overall objective of the Study Manager is to manage the planning, implementation, analysis and reporting of assigned less complex global and local studies within the established timeframes and budget, with the quality and requirements necessary for global regulatory approvals.

Pharm Country (Parsippany, New Jersey) Hot Job of the Day:

Daiichi-Sankyo
Study Manager, Clinical Pharmacology
The incumbent will be responsible for the implementation and day-to-day coordination of TMCP studies conducted in North America and Europe. Drug candidates under investigation may belong to any therapeutic area.

Get Noticed! Add your resume to the BioSpace Career Center!
See more than 5,000 job postings in the BioSpace Career Center!

BioSpace.com is pleased to present the Boehringer Ingelheim Career Fair TODAY at The Sheraton Boston Hotel in Boston, Massachusetts from 11:00 a.m. to 4:00 p.m. You must pre-register in order to attend this event.

For this event, Boehringer Ingelheim is ONLY interviewing candidates with the following backgrounds:

• Immunology/Inflammatory Disease Research - Scientists with BS, MS, and/or PhD
• Medicinal Chemistry - Scientists and Principal Scientists with MS or PhD
• Cardiovascular Disease Research - Scientists and Principal Scientists with MS or PhD
• Translational Sciences - Director level with PhD experience in Systems Biology and/or Electronic Biology
• Biologics/Biomolecular Sciences - Scientists and Principal Scientists with BS, MS, or Ph.D. and experience in Antibody/protein engineering
• Animal Resources - Facility Managers with BS and GLP experience
• Clinical Trial Support - Scientists with BS or MS degree in related field

We look forward to seeing you at the Boehringer Ingelheim Career Fair!

Boehringer Ingelheim Career Fair, May 8, 2008
Pharm Country Career Fair, June 5, 2008
DDT - BioSpace 2008 Career Fair, August 6, 2008
DeviceSpace Career Fair, September 8, 2008
BioCapital Career Fair, September 30, 2008
Biotech Bay Career Fair, October 14, 2008

More information about BioSpace's Career Fairs
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•  Nektar Therapeutics (NKTR) Receives Patent Covering Pulmonary Targeted Antibiotics More...
•  US WorldMeds, LLC Completes Development of Instantaneous Reconstitution Dantrolene Sodium for Injection Product More...

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•  Alpharma Inc. (ALO) Data Show FLECTOR(R) Patch Yields Significant Pain Reduction for Acute Strains, Sprains and Contusions More...

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Events
Drug Development Clearly Explained

• Clear text explaining all aspects of global development, from laboratory to market hyperlinked to relevant guidelines
• Suitable for scientists, developers, business people wanting a clear but comprehensive summary.
• 21 Chapters, with key points and questions/answers to insure understanding
• E-book/pdf format/secure download only

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Feature
Hot Company



Resolvyx Pharmaceuticals, Inc.
6A Preston Court
Bedford, Massachusetts 01730 U.S.A.
Phone: 781-541-5045 Fax: 781-541-5046
View Jobs

Resolvyx is a biopharmaceutical company committed to the discovery and development of therapies based on the novel concept of inflammation resolution through activation of the body’s own off-switch mechanisms. With their endogenous origin we believe the breakthrough concept of resolvins will provide a unique risk/benefit offering for the treatment of chronic inflammatory conditions.
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