Tuesday, July 31, 2012

FDA Rejects Regeneron's Arcalyst for Gout - July 31, 2012

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•  FDA Rejects Regeneron Pharmaceuticals, Inc. (REGN)'s Arcalyst for Gout More...
•  Arena Pharmaceuticals, Inc. (ARNA) Transfers Diet Pill Application to Eisai Company, Ltd. (ESALY.PK) More...
•  FDA Accepts NuPathe Inc. (PATH)'s Migraine Patch NDA Resubmission for Filing More...
•  Ariad Pharmaceuticals, Inc. (ARIA) Announces Submission of New Drug Application for Ponatinib to the FDA More...
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•  Vertex Pharmaceuticals Incorporated (VRTX) Lowers Incivek View; New Drug Data Lifts Shares More...
•  Nymox Pharmaceutical (NYMX) Reports Positive Results From Combined Statistical Analysis of Long Term Follow-Up Studies of BPH Drug More...
•  Rockwell Medical Technologies (RMTI) Completes Patient Enrollment in Phase III Clinical Trials for SFP Iron-Delivery in Hemodialysis Patients More...
•  Pfizer Inc. (PFE) Announces Positive Top-Line Results From the ORAL Start Phase 3 Study of Tofacitinib in Rheumatoid Arthritis More...
•  FDA Requests Teleconference to Discuss Repros Therapeutics Inc. (RPRX) Phase 2 Protocol for Proellex® in the Treatment of Endometriosis Last Week of August More...
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•  Mindreading Hormone? A Better Judge of Character With Nasal Spray? University of Oslo Study More...
•  Rejected Alzheimer's Drug Shows New Potential, Mount Sinai School of Medicine Study More...
•  Brains are Different in People With Highly Superior Autobiographical Memory, University of California, Irvine Study More...
•  Computer Scientists Present Smile Database, University of Amsterdam Study More...
•  Brain Development Delayed in ADHD, National Institutes of Health (NIH) Study More...
More General Clinical Research News
Events

The 6th Annual Pain Therapeutics
October 3 - 4, 2012
San Francisco, CA
Event Website

ARROWHEAD'S ANNUAL PAIN THERAPEUTICS SUMMIT is the US's premier conference covering the field of pain management and therapeutics. Leaders from the pharmaceutical, biotech, device and medical communities attend this conference to learn about the latest advances in the treatment of various types of pain and to network with colleagues from industry, the non-profit sector, academia, the medical community, government and investors. This conference will provide attendees with thoughtful insight from key industry leaders and academic researchers concerning cutting edge drug discovery science, preclinical development trends, analysis of key clinical-stage pain therapies and newly marketed products. We will highlight the most important developments in recent years in the field, including new research in CGRP antagonists, NGF antagonists, Nav 1.7 antagonists, new research in biologic therapies and the genetic component of pain, abuse-resistant opioids, analysis of FDA's REMS program and a plethora of other topics.

Please click here for more information.
Top Jobs
BioMidwest (Northbrook, Illinois)

Astellas Pharma US
Associate Clinical Program Director
Provide strategic input into clinical development plans, GMAP and other key global project team deliverables through participation on global project team. Deliver and manage the operational plan including budget, resources and timelines to global project team.

BioForest (Lake Oswego, Oregon)

Galena Biopharma
Global Clinical Project Manager
Responsible for the planning, development, implementation and ongoing management of all of the operational aspects of clinical trials including protocol development, defining scope of work, resource planning and allocation, recruitment of clinical investigators, training, planning and execution of investigator meetings, establishment and adherence to timelines, ensuring compliance with protocols and clinical/corporate objectives, adherence to regulations and company Standard Operating Procedures (SOPs), and clinical supply management.

Biotech Bay (Foster City, California)

Gilead Sciences
Associate Director, Clinical Research
Will primarily support the GS-7340 project, a new nucleotide reverse transcriptase inhibitor in development for the treatment of HIV, though work on other HIV development projects may also be required.

Pharm Country (Bedminster, New Jersey)

Allergan Inc.
Manager, Clinical Data Quality
Manages a team of professionals responsible for supporting independent Data Management and Programming quality activities including database, documentation and data trend assessments. Responsible for hiring and managing the performance of these professionals.

Genetown (Boston, Massachusetts)

Sterling-Hoffman Executive Search
Director of Clinical Research
Act as a key member of the early development team, providing a leadership role on the team with regard to design and execution of pre-clinical development strategy. Take responsibility to author initial program clinical plans and early development plan.

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• See more than 5,000 job postings in the BioSpace Career Center!


2012 Pharm Country 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 tri-state area.

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.

Pharm Country Career Fair, Bridgewater, NJ September 13, 2012
Biotech Beach Career Fair, San Diego, CA September 20, 2012
Biotech Bay Career Fair, Burlingame, CA October 3, 2012
BioCapital Career Fair, Bethesda, MD October 9, 2012
BioMidwest Career Fair, Lincolnshire, IL October 22, 2012
Bio NC Career Fair, Durham, NC October 25, 2012
Genetown Career Fair, Cambridge, MA November 5, 2012

More information about BioSpace's Career Fairs

BioSpace White Paper
Biotech Career Fairs For Job Seekers 101: Control Your Experience
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•  StemCells Inc. (STEM) Broadens HuCNS-SC® Patent Portfolio With Key Patent in Japan More...
•  GeNO LLC Receives Two Additional Patents For Inhaled Nitric Oxide Drug Delivery More...
•  Abon Announces CLOLAR® Patent Challenge More...
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•  GlaxoSmithKline (GSK) Shipping U.S. Flu Vaccine With New Strain Coverage Recommended for 2012-2013 More...
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Hot Company

Coldstream Laboratories Inc.
1500 Bull Lea Road, Suite 250
Lexington, Kentucky 40511 U.S.A.
Phone: 859-257-6600 Fax: 859-323-5985

At Coldstream Laboratories Inc. (CLI), we're seasoned at turning pharmaceutical development ideas into safe, pure, and effective clinical pharmaceutical dosage forms. Since 1986, we have completed more than 200 formulation development projects that led to clinical trials providing us extensive clinical manufacturing experience with both commercial product development and grant-funded projects from such sources as the National Institutes of Health.

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Editor & Publisher: Lana Ho
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ClinicaSpace.com - Clinical Trials. Clinical Research. Community.
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Dendreon Cuts 600 Jobs in Cost-Saving Move - July 31, 2012

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Deals & Dollars
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Planning allergy studies can be very challenging because of variable weather, pollen variance among site locations, indoor/outdoor lifestyle of patients, study medication compliance, and limited enrollment periods.

Pharm-Olam has offices worldwide, including South America and South Africa to conduct a variety of seasonal studies year round. Our locations in North America and Europe provide opportunities for seasonal studies in key markets. We also have experience with Environmental Exposure Units (EEU) which can help sponsors address study variables through strictly controlled conditions. This includes variables for air quality, temperature, humidity, and precise maintenance of allergen concentration.

Let Pharm-Olam conduct a complimentary feasibility study specific to your protocol and study budgets to use in your resource planning. Contact us at www.pharm-olam.com, info@pharm-olam.com, USA 1-713-559-7900, UK 44-0-1344-891121.
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•  Dendreon Corporation (DNDN) Cuts 600 Jobs in Cost-Saving Move More...
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•   Mersana Therapeutics, Inc. Raises $27 Million to Advance Antibody-drug Conjugates More...
•   Ultragenyx Raises $15 Million Toward $30 Million Goal More...
•   CytomX Therapeutics, Inc. Expands Series B Financing; Canaan Partners Joins Syndicate More...
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•   CMC Biologics Acquires XOMA Corporation (XOMA)'s Bay Area Manufacturing Facility More...
•   CytoDyn Announces Entry into Agreement With Progenics Pharmaceuticals, Inc. (PGNX) to Acquire PRO 140 More...
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•   Idenix Pharmaceuticals, Inc. (IDIX) Regains Drug Rights From Partner Novartis AG (NVS) More...
•   PolyMedix Inc. (PYMX.OB) and University of Pennsylvania Collaborate to Develop New Class of Defensin-Mimetic Antimicrobial Compounds to Treat Malaria More...
•   Furiex Pharmaceuticals, Inc. (FURX) Announces Closing of Priligy® Asset Transfer and License Agreements More...
•   Oncobiologics Inc. Announces a Collaboration Agreement with XOMA Corporation (XOMA) to Utilize XOMA's Fully Human Antibody Libraries for Their Discovery Platform More...
•   Anchor Therapeutics Enters Into Collaborative Research Agreement With Kyowa Hakko Kirin for its Pepducin Technology More...
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Events

The 4th Annual Personalized Medicine
September 12 - 13, 2012
Boston, MA
Event Website

Arrowhead's 4th Annual Personalized Medicine Conference will tackle the issues driving as well as restraining the clinical delivery of personalized medicine, including coding and reimbursement, the economics of personalized medicine and medicare policy.

Featured Speakers:

Robert C. Green, MD, MPH, Director, G2P Research Program, Associate Director for Research, Partners Center for Personalized Genetic Medicine, Brigham and Women's Hospital and Harvard Medical School

Deneen Vojta, MD, Senior Vice President, UnitedHealth Group

Vincent A. Miller, MD, Senior Vice President, Clinical Development, Foundation Medicine, Consultant, Thoracic Oncology, Memorial Sloan-Kettering Cancer Center

Topics include:

• CLINICAL delivery of personalized medicine
• WHOLE GENOME SEQUENCING in practice of medicine
• CODING & reimbursement for companion diagnostics
• CLINICAL APPLICATION of genetic testing
• ECONOMICS of personalized medicine
• MEDICARE coverage for companion diagnostics
• MARKET ACCESS challenges for companion diagnostics

Please click here for more information.

The Life Sciences Report: Special Report Reveals Biotech Stock Drivers: Michael Hay
By: George S. Mack of The Life Sciences Report

Certain predictable dates and events bring profound effects to bear on biotech stocks. Michael Hay, vice president of Sagient Research Systems, successfully applies the art and science of important catalysts to predict when biotech stocks will move up or down. In this exclusive interview with The Life Sciences Report, Hay discusses his strategy and names companies that will produce meaningful gains for investors. More...
 

•   KV Pharmaceutical CEO Gets Hefty Raise, Despite All the Problems More...
•   Soren Tulstrup to Lead Shire plc (SHPG) HGT's MPS Franchise More...
•   Cytovance Biologics Inc. Announces Don Wuchterl as Senior Vice President of Manufacturing Operations More...
•   Quick-Med Technologies (QMDT) Appoints Bernd Liesenfeld as President More...
•   A.P. Pharma, Inc. (APPA) Appoints Robert Rosen to Its Board of Directors More...
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•   Bayer AG (BAY.F) Lifts Guidance, Provisions Weigh on Earnings More...
•   Acura Pharmaceuticals, Inc. (ACUR) Announces Second Quarter 2012 Financial Results More...
•   Agennix AG Reports Financial Results for Second Quarter and First Half of 2012 More...
•   Amarin Corporation PLC (AMRN) to Report Second Quarter 2012 Financial Results and Host Conference Call on August 8, 2012 More...
•   Acasti Pharma First Quarter Results More...
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•   Teva Pharmaceutical Industries Limited (TEVA) Sues Genzyme Corporation (GENZ) for Poaching Employees More...
•   EU Antitrust Charge for Servier, Teva Pharmaceutical Industries Limited (TEVA), Others Over Generics More...
•   Immunovative Inc. Announces the Retention of Winston & Strawn LLP as Its Legal Counsel More...
•   Vitrolife's Subsidiary in the USA has Been Sued More...
•   IntelliPharmaCeutics Settles Patent Litigation With AstraZeneca PLC (AZN) Concerning Generic Seroquel XR® More...
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•   Theorem Clinical Research Relocates Headquarters to Accommodate Growth More...
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Real Estate



Existing Laboratory For Sublease
1545 Route 22 East
Annandale, New Jersey U.S.A

Floor: 1st Floor
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Rental Rate: $34.00 / SF

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Featured Free Resource

Building Novel Applications with Pipeline Pilot to Drive Next Generation Sequencing

This case study shows how scientists are streamlining the process of analyses of DNA sequence information. Enabled by new DNA sequencing technologies, many more scientists and informaticians are interrogating larger and more complex data set.

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Feature

Hot Company

Helsinn Therapeutics (US) Inc.
1160 US Highway 22, Suite 104
Bridgewater, New Jersey 08807 U.S.A.
Phone: 908-203-6549 Fax: 908-231-1459

Helsinn is a privately owned, self-financing pharmaceutical group with headquarters in Lugano, Switzerland and subsidiaries in Ireland and the USA. The Helsinn Group has been built on the basis of a licensing of pharmaceuticals, with the recent addition of medical devices in therapeutic niche areas.

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Top Jobs
Pharm Country (Princeton, New Jersey)

Otsuka America Pharmaceutical, Inc.
Associate Manager Sales Training and Development
Assumes role of primary Neuroscience trainer and also assists with Specialty sales force for product training. Trains Neuroscience Specialists in product knowledge, marketplace competition, effective communication, basic to advanced selling and negotiation skills, business acumen, computer operations, administrative procedures, general medical terminology, managed care, and disease management.

BioCapital (Gaithersburg, Maryland)

MedImmune, LLC
Manager / Senior Manager Market Research
Influences the organization by strategically managing and providing information, intelligence and insights that drive critical business decisions. The Manager / Senior Manager leads the collection and interpretation of primary and secondary research and will provide strategic recommendations and insights on the direction of pipeline assets.

Rocky Bio (Flagstaff, Arizona)

W.L. Gore & Associates Inc.
MPD Strategic Marketing Specialist
Will work with a business and sales leadership team accountable for a market leading portfolio of endovascular stent grafts and accessory products serving the clinical needs of the abdominal aortic aneurysm (AAA) stent graft market.

Biotech Beach (Culver City, California)

Sequenom Inc.
Senior Marketing Manager
Will manage all aspects of the product life cycle for product lines under the area of responsibility within the Genetic Analysis business. The ideal candidate will solicit, analyze and communicate feedback from customers and work closely with Sales, Customer Support, Regulatory and other departments to ensure that the products meet the company's high standards and are marketed effectively.

Biotech Bay (Menlo Park, California)

Johnson & Johnson Family of Companies
Product Manager, Rhinology
Responsible for developing, implementing and supporting key marketing initiatives to drive the continued adoption of Acclarent's innovative Balloon Sinuplasty technology within the Ear, Nose and Throat (ENT) space. As part of a small and fast-moving team, the individual in this position will leverage analytics along with Customer and Sales Force feedback to drive the business.

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

2012 Pharm Country 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 tri-state area.

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.

Pharm Country Career Fair, Bridgewater, NJ September 13, 2012
Biotech Beach Career Fair, San Diego, CA September 20, 2012
Biotech Bay Career Fair, Burlingame, CA October 3, 2012
BioCapital Career Fair, Bethesda, MD October 9, 2012
BioMidwest Career Fair, Lincolnshire, IL October 22, 2012
Bio NC Career Fair, Durham, NC October 25, 2012
Genetown Career Fair, Cambridge, MA November 5, 2012

More information about BioSpace's Career Fairs

BioSpace White Paper
Biotech Career Fairs For Job Seekers 101: Control Your Experience
Contact Us

Post Your: News | Jobs | Company Profile | Event | Advertising / Sponsorship

BioSpace, Inc.
6465 South Greenwood Plaza, Suite 400
Centennial, Colorado 80111 U.S.A.
Phone: 877-277-7585
Fax: 800-595-2929
BioSpace, Inc.
90 New Montgomery Street, Suite 414
San Francisco, California 94105 U.S.A.
Phone: 877-277-7585
Fax: 415-576-9217

Send questions and comments to the BioSpace News Beat Team.

Editor & Publisher: Lana Ho
Editorial & Production Staff: Maysa Darwish, Tammy Liu

BioSpace.com - Life. Science. Community.
Legal Notice

• BioSpace is a registered trademark of BioSpace, Inc.
• Please distribute this e-cast freely.
• Credit any excerpts as follows:
Copyright 2012 BioSpace http://www.biospace.com
• While BioSpace and its agents used their best efforts in collecting and preparing the information published herein, we do not assume, and hereby disclaim, any liability for any loss or damage caused by errors or omissions, whether such errors or omissions resulted from negligence, accident or other causes.
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