Vertex Scores FDA Approval for CF Drug - Jan. 31, 2012

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Tuesday, January 31, 2012  |   |   |   |  PPD Central Labs Combine the expertise of a leading contract research organization (CRO) with global central laboratories that are among the world's largest dedicated exclusively to clinical trials. We offer: • Comprehensive range of central lab services • Extensive reach • High level of accuracy Please click here for more information. •  Vertex Pharmaceuticals Incorporated (VRTX) Scores FDA Approval for CF Drug More... •  FDA Approves Boehringer Ingelheim Pharmaceuticals, Inc., Eli Lilly and Company (LLY)'s Diabetics Therapy Jentadueto(TM) More... •  Lannett Company, Inc. (LCI) Receives FDA Approval for ANDA Supplement for Phentermine HCL Capsules, 15 mg More... •  Hi-Tech Pharmacal (HITK) Receives Final Approval for Lorazepam Oral Concentrate More... More Drug Approval News •  Pfizer Inc. (PFE) to Seek OK for Long-Stalled Menopause Drug More... •  NPS Pharmaceuticals, Inc. (NPSP) Announces FDA Acceptance of New Drug Application for GATTEX® (teduglutide) for the Treatment of Adult Short Bowel Syndrome (SBS) More... •  NanoViricides, Inc. (NNVC.PK) Submits Pre-IND Briefing Document for its Anti-Influenza Drug, FluCide(TM), to the US FDA More... More BLA/NDA/ANDA News More IND News More MAA News •  AcelRx Pharmaceuticals Announces its ARX-01 Phase 3 Program Expected to Start Late Q1 or Early Q2 2012 More... •  MediStem, Inc. (Formerly known as Medistem Laboratories, Inc.) and ERCell Initiate Phase II RECOVER-ERC Heart Failure Trial More... •  Mesoblast Limited Receives FDA Clearance for Phase 2 Clinical Trial of Proprietary Stem Cell Therapy in Type 2 Diabetes More... •  Results of NoNO Inc.-Sponsored Phase 2 Clinical Trial in Procedurally-Induced Strokes to be Announced at the International Stroke Conference More... •  Argos Therapeutics, Inc. Arcelis(TM) Immunotherapy AGS-003 in Combination With Sunitinib Shows Statistically Significant Correlation of Immune System Response to Overall Survival in Phase 2 Study in Patients with Advanced Renal Cell Carcinoma (RCC) More... More Phase III News More Phase II News More Phase I News More Pre-Clinical News More Post-Approval News Quantifying the Value of Pipeline Pilot, the Accelrys Scientific Enterprise Platform This white paper outlines the methodology, sources of value, and quantifiable results from bringing products to market faster, avoiding unproductive experiments, saving developer time, and more. Request Now! •  Diabetes Drugs Tied to Pancreatic Cancer Risk, University of California, San Francisco (UCSF) Study More... •  Alcohol and Your Heart: Friend or Foe? Centre for Addiction and Mental Health Study More... •  "Spam" Meat Tied to Diabetes Risk in Native Americans, University of Washington School of Medicine Study More... •  Music Training Has Biological Impact on Aging Process, Northwestern University Study More... •  Ampio Pharmaceuticals, Inc. (AMPE) Announces Statistically Significant Improvement in Pain Relief for its Lead Product, Ampion(TM) in the Osteoarthritis of the Knee Trial More... More General Clinical Research News Cambridge Healthtech Institute's 19th Annual Molecular Medicine Tri-Conference February 19-23, 2012 | San Francisco, California www.TriConference.com CHI's flagship event The 2012 program will feature compelling talks from industry, academia, government, and healthcare organizations. Spanning five days this year, the event now includes more activities including: 2 partnering forums, 5 symposia, 18 short courses, and 12 core programs. Join over 3,000 attendees in interactive lectures, discussions, and various receptions as a way to facilitate networking opportunities and hearing differing views and perspectives on poignant issues facing you and our industry today. Emerging Clinical Trial Locations • Provides insight into the background to the clinical trials market in the emerging geographic regions including specific issues in each geography. • Reviews of the structure of the healthcare system in each of the emerging clinical trial markets. • Reviews the principal CROs in each emerging location covering domestic and international players. Click Here for More Information. • BioCapital (Gaithersburg, Maryland) MedImmune, LLC Vice President, Clinical / R&D Quality Leads and directs the strategic direction of the Clinical/R & D Quality Operations organization and is accountable and responsible for the design, development, execution and administration of a GxP Quality System meeting all MedImmune and regulatory agency Good Laboratory Practices (GLP), Good Clinical Practice (GCP) and Pilot Plant Good Manufacturing Practices (GMP) compliance requirements. • Genetown (Cambridge, Massachusetts) Vertex Clinical Safety Manager Responsible for providing daily support to the Clinical Study Teams in the management of all aspects of the safety letter distribution process. The Clinical Operations (CO) Safety Manager is responsible for centralization, distribution, tracking and quality control of the safety information which is submitted to investigational sites and Ethics Committees across all compounds. • Biotech Bay (Redwood City, California) Abbott Senior Section Manager, Clinical Data Management Responsible for a given compound(s) or therapeutic area. Ensures that: a) CRFs or eCRFs, clinical databases and clinical data management plans are prepared and approved within project timelines. • Biotech Bay (Mountain View, California) BN ImmunoTherapeutics Inc. Senior Director - Clinical Operations Will provide operational clinical, project management, and administrative leadership, direction, and oversight for all clinical operations programs in the company. Responsibilities include design of department objectives, selection of clinical investigation techniques and service providers, supervision of ethical and good clinical practices, supervision of clinical trials within the programs, development of clinical relationships with partners of the corporation, including interactions with corporate partners and physicians. • BioMidwest (Deerfield, Illinois) Baxter International, Inc. Project Leader, Clinical and Scientific Affairs Supports clinical trials utilizing stem cells in therapeutic areas of regenerative medicine. Specifically, the individual will support the manufacture of the biological components of the Isolex system used for the selection of CD34+ stem cells from mobilized apheresis products. • Get Noticed! Add your resume to the BioSpace Career Center! • See more than 5,000 job postings in the BioSpace Career Center! Genetown 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 Northeast 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. • Genetown Career Fair, Cambridge, MA February 21, 2012 • BioSpace Career Fair at CALBIO2012, San Francisco, CA March 7, 2012 • BioMidwest Career Fair, Bridgewater, NJ March 22, 2012 • Biotech Beach Career Fair, La Jolla, CA April 17, 2012 • BioCapital Career Fair, Bethesda, MD April 25, 2012 • Pharm Country Career Fair, King Of Prussia, PA May 1, 2012 • BioNC Career Fair, Durham, NC May 2, 2012 • Biotech Bay Career Fair, Burlingame, CA May 29, 2012 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 •  Proteus Biomedical, Inc. Announces Issuance of U.S. Patent for Digital Health Communications More... •  Immunomedics, Inc. (IMMU) Awarded Broad Patent for Anti-CD20 and Anti-CD22 Combination Therapy More... •  GeNO LLC Receives New Patent for Nitric Oxide Delivery Technology More... More Patent News •  FDA Panel Wants Suicide Risk on Novartis AG (NVS) ADHD Drug Label More... More Drug Product News Hot Company SGS Life Science Services 201 Route 17 North Rutherford, New Jersey 07070 U.S.A. Phone: 201-508-3000 SGS Life Science Services is a leading contract service organization providing clinical research, analytical development, biologics characterization, and quality control testing. SGS serves various life science companies, including pharmaceutical, biopharmaceutical, biotechnology, and medical-device manufacturers. More Company Profiles Post Your: News | Jobs | Company Profile | Event | Advertising / Sponsorship ClinicaSpace 6465 South Greenwood Plaza, Suite 400 Centennial, Colorado 80111 U.S.A. Phone: 877-277-7585 Fax: 800-595-2929 ClinicaSpace 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 ClinicaSpace News Beat Team. Editor & Publisher: Rosemary Do Editorial & Production Staff: Lana Ho, Maysa Darwish, Tammy Liu, Michelle Wong ClinicaSpace.com - Clinical Trials. Clinical Research. Community. • ClinicaSpace is a registered trademark of BioSpace, Inc. • Please distribute this e-cast freely. • Credit any excerpts as follows: Copyright 2012 ClinicaSpace http://www.clinicaspace.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. If someone forwarded this news to you and you'd like to receive your own copy FREE of charge, simply Subscribe here. Safely unsubscribe from ClinicaSpace.com e-mail at any time by managing your account here.

 

BioSante Slashes 25 Pct. of Workforce - Jan. 31, 2012

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Tuesday, January 31, 2012  |   |   |   |  The Pharmaceutical Compliance Forum (PCF) International Pharmaceutical Compliance Congress, www.InternationalPharmaCongress.com, May 14-16, 2012, takes place at the Hilton Budapest in Budapest, Hungary and features tracks on EU, CEE, MEA, global compliance audits and monitoring, FCPA and global anticorruption, global transparency, discourse and aggregate spend and global compliance case studies. For more information, please visit: www.InternationalPharmaCongress.com •  BioSante Pharmaceuticals, Inc. (BPAX) Slashes 25 Pct. of Workforce More... More Job Industry News •   AssureRx Secures $8 Million Financing With Silicon Valley Bank to Support Growth More... More Finance News Quantifying the Value of Pipeline Pilot, the Accelrys Scientific Enterprise Platform This white paper outlines the methodology, sources of value, and quantifiable results from bringing products to market faster, avoiding unproductive experiments, saving developer time, and more. Request Now! •   GlaxoSmithKline (GSK), Eli Lilly and Company (LLY), Pfizer Inc. (PFE) Said to be Interested in Turkey's MN Pharma More... •   McKesson Corporation to Acquire Independent Banner and Franchise Businesses of Katz Group Canada Inc. More... More Mergers and Acquisitions News •   Orexo AB, Janssen Pharmaceutical K.K. Axe Preclinical-Stage Deal in Respiratory Diseases More... •   Fluidigm Corporation and AH Diagnostics Sign Distribution Deal for Scandinavia More... •   Spectrum Pharmaceuticals, Inc. (SPPI) In-Licenses a Novel, Long-Acting GCSF Drug in U.S. Clinical Trials from Hanmi Pharmaceutical, Co., Ltd More... •   Royal DSM Announces Marketing and Sales Alliance With Indoco More... •   Isotechnika Pharma Inc. (ISA.TO) Terminates Existing Agreement With ILJIN More... More Alliances News •   Johnson & Johnson (JNJ) Shakes Up McNeil Consumer Healthcare Unit Again More... •   Bob Temple Changes His Role at FDA, Again More... •   Tech Council of Maryland Appoints Art Jacoby as Interim CEO More... •   Swedish Orphan Biovitrum: Wills Hughes-Wilson Appointed Vice President Government Affairs & Policy More... •   Array BioPharma, Inc. (ARRY) Names Gwen A. Fyfe, M.D. to Board of Directors More... More Personnel News •   Eli Lilly and Company (LLY) Profit Slumps on Schizophrenia Drug More... •   Daiichi Sankyo, Inc. (D4S.F) Logs Loss More... •   Affymetrix (Santa Clara, California) (AFFX) to Host Conference Call on February 8, 2012 to Announce Fourth Quarter and FY11 Operating Results More... •   Array BioPharma, Inc. (ARRY) Reports Financial Results for the Second Quarter of Fiscal 2012 More... •   Amylin Pharmaceuticals, Inc. (AMLN) to Webcast 2011 Year-End Financial Results More... More Earnings Report News Property Available Intertech Science Park 500 West Cartier Boulevard Laval, Quebec City Canada • Over 900 linear feet of laboratory work stations with attendant built-in services distributed throughout chemistry and biology labs • Biological safety cabinets/fume hoods of assorted sizes, (including walk-ins) • 2 UPS systems More Real Estate Listings Hot Company PharmaCore, Inc. 4180 Mendenhall Oaks Parkway, Suite 160 High Point, North Carolina 27265 U.S.A Phone: 336-841-5250 Fax: 336-841-5251 PharmaCore® is a contract research organization with expertise in custom organic synthesis, cGMP scale-up, chemical process research and development, GMP analytical services, and medicinal chemistry services. For projects requiring long-term research and support, PharmaCore offers full time equivalent (FTE) contracts to maximize resources. More Company Profiles Online Auction February 8 at 9 AM ET Featuring lab equipment from leading global firms! Lot catalog includes Lot catalog includes HP 1100 Series HPLC Components, Perkin Elmer HS40 Headspace Sampler, Gow-Mac 590-Series Gas Chromatograph, Beckman Coulter Laboratory Centrifuge Model GS-6KR and much more. Register and bid online!   • Genetown (Billerica, Massachusetts) EMD Millipore Lab Water Field Marketing Manager Drive the long term sales growth and market penetration of EMD Millipore Lab Water products by collaborating with the Lab Water Marketing group, and NA Operations to ensure that objectives are aligned with the Lab Water strategy and plans that benefit from the application of Lab Waters product and technologies • Rocky Bio (Denver, Colorado) Cubist Pharmaceuticals, Inc. Regional Business Director Achieving area sales and expense management goals. Leading and managing a team of 8-10 Clinical Business Managers. Recruiting/hiring qualified Clinical Business Managers. • Biotech Beach (San Diego, California) HUYA Bioscience International Director, Global Business Development Will identify, negotiate, and complete strategic partnerships with pharmaceutical companies to expand the commercial potential of HUYAs product portfolio. Identify pharmaceutical partners and the key decision makers. Expand pharmaceutical corporate contacts and keep them aware of HUYA developments. • BioMidwest (St. Louis, Missouri) Sigma-Aldrich Corporation Market Segment Manager, Diagnostics Will develop and execute strategic marketing programs to achieve worldwide sales goals, expand customer base and increase market share of the SAFC Diagnostics business. They will manage the development and implementation of marketing plans, analyze current and identify new business opportunities, lead acquisition of technologies and establish business collaborations. • Southern Pharm (Fort Lauderdale, Florida) Watson Pharmaceuticals, Inc. Executive Director, Inside Sales Responsible for the strategic direction and management of 4+ Regional Sales Managers and an inside national sales force of 40+ employees. Prepares and implements all of the necessary activities for measuring and providing incentives to sales team, such as report development, frequency and reach of goals, targeting, incentive plans and performance management.· • Get Noticed! Add your resume to the BioSpace Career Center! • See more than 5,000 job postings in the BioSpace Career Center! Genetown 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 Northeast 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. • Genetown Career Fair, Cambridge, MA February 21, 2012 • BioSpace Career Fair at CALBIO2012, San Francisco, CA March 7, 2012 • BioMidwest Career Fair, Bridgewater, NJ March 22, 2012 • Biotech Beach Career Fair, La Jolla, CA April 17, 2012 • BioCapital Career Fair, Bethesda, MD April 25, 2012 • Pharm Country Career Fair, King Of Prussia, PA May 1, 2012 • BioNC Career Fair, Durham, NC May 2, 2012 • Biotech Bay Career Fair, Burlingame, CA May 29, 2012 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 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: Rosemary Do Editorial & Production Staff: Lana Ho, Maysa Darwish, Tammy Liu, Michelle Wong BioSpace.com - Life. Science. Community. • 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. If someone forwarded this news to you and you'd like to receive your own copy FREE of charge, simply Subscribe here. Safely unsubscribe from Biospace.com e-mail at any time by managing your account here.