Tuesday, August 30, 2011

FDA Rejects NuPathe Migraine Patch - Aug. 30, 2011

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Pharm-Olam International Acquires StatWorks, Inc.

With Pharm-Olam's acquisition of StatWorks we have expanded our team Data Management and Biostatistics experts for functional outsourcing and full service clinical trials. Our comprehensive biometric services include:

• Integration of randomization into EDC systems, eliminating IVRS costs, with added
• Adaptive, Sequential, and Bayesian design methods
• CDISC, SDTM and ADaM datasets
• SAS programming, eCRF design, and medical coding in MedDRA/WHO Drug
• Streamlining and reconciling across SAE, CTMS, and study DB
• Health Outcomes Research and Patient Reported Outcomes
• Protocol development, sample size, and randomization

Contact us for your resource planning atwww.pharm-olam.com, info@pharm-olam.com, USA 1-713-559-7900, UK 44-0-1344 891121
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•  FDA Rejects NuPathe Inc. (PATH) Migraine Patch; Stock Falls -1.34 (33.07%) @ 1:23PM EDT More...
•  Progenics Pharmaceuticals, Inc. (PGNX) and Salix Pharmaceuticals, Ltd. (SLXP) Announce FDA Acceptance of sNDA Filing for RELISTOR(R) in Patients with Non-Cancer Pain More...

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•  Perrigo Company (PRGO) Announces FDA Final Approval for Ketoconazole Foam, 2% More...

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•  Astellas Pharma Inc. (YPH.BE) Clot Drug Raises Bleeding in Heart Study More...
•  AEterna Zentaris (AEZS) Announces Favorable Top-Line Results of Completed Phase 3 Study on AEZS-130 as First Oral Diagnostic Test for Adult Growth Hormone Deficiency More...
•  AstraZeneca PLC (AZN) Bloodthinner Shows Mortality Benefit Versus Sanofi (France) (SASY.PA)'s Plavix More...
•  Eisai Company, Ltd. (ESALY.PK) Release: Results of Phase III Study for Perampanel Presented at 2011 International Epilepsy Congress More...
•  Ampio Pharmaceuticals, Inc. (AMPE) Release: Zertane(TM) Clinical Results Published in the Journal European Urology More...

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Featured Free Resource

Nature Methods

Nature Methods provides techniques for life scientists and chemists. It is a print and online publication dedicated to publishing novel methods together with significant advances to tried and tested techniques allowing researchers to perform faster, better and more efficient experimental research.

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Events

IBC's BioProcess International Conference & Exhibition
October 31 - November 4, 2011 - Long Beach, California
Event Website

Download the 2011 BioProcess International brochure and see why this is YOUR must attend event for 2011. Download your PDFhere.

You will see the 2011 program, features a stellar line up keynote presentations including, the US FDA, EMA, Pfizer, Merck and more. Plus, there are over 50 presentations with new, previously unpublished data, and new topic coverage areas including antibody drug conjugates, viral clearance and managing global manufacturing facilities and partners.

Register by September 9 and you will save $200 off the standard conference rates with priority code B11171BSEODS. Exhibit hall & keynote passes are now available. Mention priority code B11171BSEODS and the fee will be waived. All passes subject to approval.

Register here today or call 800-390-4078.
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Top Jobs
Pharm Country (Summit, New Jersey)

Celgene
Associate Manager, Clinical Contracts/Outsourcing Job
Perform all activities associated with the development and execution of contracts with clinical investigators, and other agreements as necessary (sponsored studies and investigator initiated studies) with supervision.

Genetown (Billerica, Massachusetts)

SPARKS
Clinical Trial Specialists
Act as an independent Coordinator on projects both locally and remotely. Apply knowledge across multiple projects. Contribute to the development and implementation of Study Start Up (SSU) related processes, tools, and training materials as well as provide training as needed.

BioMidwest (Indianapolis, Indiana)

Lundbeck Inc. (formerly Ovation Pharmaceuticals)
Senior Director, Regional Clinical Quality Assurance-Americas
Responsible for resourcing, budgeting and follow up for the region. Responsible for any outsourced CQA activities. Participate in the development of policies and procedures for Global CQA.

Biotech Bay (San Francisco, California)

FibroGen, Inc.
Manager/ Sr. Manager Clinical Supply Chain
Interpretation of a protocol or study overview to calculate total demand and translation of total demand into a demand forecast over time Managing clinical labeling including label design and manufacturing. Preparation of a supply plan to support the demand forecast, including determination of supply overage amounts.

Southern Pharm (Memphis, Tennessee)

St. Jude Children's Research Hospital
Clinical Research Associate-RN II
Acts as site Study Coordinator. Serves as a preceptor/mentor to new clinical research staff. Performs data abstraction, collection, and entry to support clinical research. Prepares submission for all reportable events. Develops, maintains, and/or monitors case report forms.

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


Biotech Beach Career Fair

Biotech Beach Career Fair

Job seekers can spend a day with HR representatives and Hiring Managers from top biotech, pharma, medical device and diagnostics companies in the Southern California region.

Candidates with a 4-year degree in the life sciences and a minimum of 2-years of industry related experience are invited to attend. (Equivalent work experience may be considered in lieu of a four-year college degree. PhD and Postdoc candidates welcome.)

Exhibiting companies are recruiting for positions in areas such as: QA/QC, clinical research, engineering, manufacturing, biostatistics, clinical data management, chemistry, regulatory affairs, and research.

Job seekers may register here.

Biotech Beach Career Fair, San Diego, CA September 22, 2011
BioMidwest Career Fair, Chicago, IL October 4, 2011
Pharm Country Career Fair, Bridgewater, NJ October 5, 2011
Biotech Bay Career Fair, Burlingame, CA October 11, 2011
Bio NC Career Fair, Durham, NC October 20, 2011
BioCapital Beach Career Fair, Bethesda, MD November 1, 2011
Genetown Career Fair, Cambridge, MA November 7, 2011

More information about BioSpace's Career Fairs

BioSpace White Paper
Biotech Career Fairs For Job Seekers 101: Control Your Experience
By June Salvati, BioSpace Director of Events and Corporate Services
Feature

Hot Company

Eli Lilly and Company
Lilly Corporate Center
Indianapolis, Indiana 46285 U.S.A.
Phone: 317-276-2000 Fax: n/a

Lilly makes medicines that help people live longer, healthier, more active lives. We were founded by Eli Lilly in 1876, and are now the 10th largest pharmaceutical company in the world. Lilly has major research and development facilities in eight countries and conducts clinical trials in more than 50 countries.

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