Missing Data Raise Doubts on J&J Drug: FDA Staff - May 21, 2012

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Monday, May 21, 2012  |   |   |   |  The Next Generation Dx Summit (Enabling Point-of-Care Diagnostics, Emerging Molecular Markers of Cancer, Molecular Diagnostics for Infectious Disease, Companion Diagnostics, Commercialization of Molecular Diagnostics, Mass Spec for the Clinic) is designed to bring together all of the major players in the evolving areas of diagnostics. This year, we have assembled an impressive faculty of speakers from industry, government, and leading academic institutions. This meeting will showcase improvements in technology research and development with an emphasis on applications in the clinic and commercialization. Plan to hear what the industry leaders are saying about future market opportunities and network with your peers this August 21-23 in Washington, DC. For more information, please visit: www.NextGenerationDx.com. •  Missing Data Raise Doubts on Johnson & Johnson (JNJ) Drug: FDA Staff More... •  Apricus Biosciences (APRI) Granted Regulatory Meeting With FDA for Femprox® for the Treatment of Female Sexual Arousal Disorder More... •  Cellceutix (CTIX) Files Amended IND With FDA for Its Novel p53 More... More BLA/NDA/ANDA News More IND News More MAA News •  Pfizer Inc. (PFE) Recalls 650,000 Bottles of Advil Liqui-Gels More... More Discontinuations News More Recalls and Warning News •  Perrigo Company (PRGO) Announces FDA Final Approval and Launch of Store Brand OTC Lansoprazole 15mg Capsules More... More Drug Approval News •  Peregrine Pharmaceuticals, Inc. (PPHM) Reports Positive Top-Line Data From Bavituximab Phase II Trial More... •  SLA Pharma AG Reports Successful Phase 3 Results for Treatment of Anal Fissure More... •  Helix Biopharma (CC:HBP) Receives Regulatory Approval to Conduct a European Phase III Clinical Trial of Topical Interferon Alpha-2b in Patients With Low-Grade Cervical Lesions More... •  600 Patients Recruited in Active Biotech AB (BTPC)'s and Ipsen's Tasquinimod Clinical Phase III Study More... •  Nymox Pharmaceutical (NYMX) Release: New Positive Data on NX-1207 Presented at Symposium and Panel Discussion at American Urological Association Annual Meeting More... More Phase III News More Phase II News More Phase I News More Pre-Clinical News More Post-Approval News University of Maryland Workshops in Biopharmaceutical Production: June 4-8, 2012 Advance your career by learning how to produce and purify biopharmaceutical products at the University of Maryland's Bioprocess Scale-Up Facility this June. Taught by world-class faculty and practitioners, this one-week training features two sessions, both of which include in-laboratory and classroom instruction: The Fermentation and Microbiology Workshop covers various fermentation systems and the techniques, methodologies, principles and applications of aerobic bacterial and fungal fermentation, including recent advances and up-to-date applications. The Downstream Processing & Protein Purification Workshop covers recovery and purification strategies for biotechnology products, especially proteins. Participants learn cell separation, cell disruption, chromatography theory and systems, sample preparation, columns and packing, adsorptive chromatography, and elution optimization. For more information and to register, visit: http://www.mtech.umd.edu/biotech/workforce_training.html. •  Red Meat and Butter "Could Raise Alzheimer's Risk," Harvard University Study More... •  Folic Acid May Reduce Some Childhood Cancers, Washington University in St. Louis Study More... •  Oxytocin Improves Brain Function in Children With Autism, Yale University School Of Medicine Sudy More... •  Research With Dogs Points to Early Test for Arthritis, University of Missouri Study More... •  Precision Therapeutics, Inc. Release: Three Abstracts on the ChemoFx® Drug Response Marker Accepted by American Society of Clinical Oncology More... More General Clinical Research News • Pharm Country (Kinnelon, New Jersey) ClinAudits Clinical GCP Compliance Operations Manager Responsibilities include managing operations to ensure each client receives high quality service. This requires a responsible self-starter who is mature, motivated, competent, ethical, organized, forthright and committed to serving the healthcare enterprise. • BioMidwest (Northbrook, Illinois) Astellas Pharma US Clinical Study Manager Plan, initiate and execute assigned clinical studies with operational excellenceBe accountable for effective management of budgets, timelines and resources for assigned clinical studies and implementation of appropriate standards and processes to ensure clinical study quality. Be responsible for effective training and management of interactions with study team, study sites and vendors for assigned clinical studies. • Biotech Bay (San Francisco, California) FibroGen, Inc. Associate Director/Director, Clinical Quality Assurance Will play an essential role in directing the company's Clinical QA program. Focus includes conducting internal and external Clinical audits to ensure the clinical trials are conducted in accordance with GCP regulations and ICH guidelines. • Biotech Beach (Carlsbad, California) Genoptix, Inc. Senior Clinical Lab Scientist Follow the laboratory's procedures for specimen handling and processing, test analyses, reporting and maintaining records of patient test results. Responsible for providing day-to-day supervision of personnel performing high complexity testing. • Pharm Country (Northeastern Region, New Jersey) Spectrum Pharmaceuticals, Inc. Senior Clinical Research Associate Assists with designing, planning, and implementation of clinical trials. Conducts clinical monitoring of field sites and coordinates activities of associates and investigators to ensure compliance with regulations, protocol and overall clinical objectives. • Get Noticed! Add your resume to the BioSpace Career Center! • See more than 5,000 job postings in the BioSpace Career Center! Biotech Bay 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 Bay 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. • 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 •  Aegis Therapeutics, LLC Awarded Patent for Octreotide Formulations Suitable for Oral and Metered Nasal Spray Delivery More... •  Rockwell Medical Technologies (RMTI) Announces European Patent Issuance for Proprietary SFP Formulation More... More Patent News •  Ranbaxy Laboratories (RANBAXY.BO) Plans to Relaunch Skin Drug in the US More... •  Merck & Co., Inc. (MRK) Says FDA Approved Labeling Update for ISENTRESS More... •  Dr. Reddy's Laboratories Ltd. (RDY) Announces the Launch of Over-the-Counter Lansoprazole Delayed-Release Capsules More... •  Actavis Launches First Generic Equivalent of Requip® XL (Ropinirole Extended-Release Tablets) More... More Drug Product News 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. Request Now! Optimizing Clinical Trials Through IT • Examine the trends shaping clinical trials. • Learn how social media are being used in patient recruitment. • Analyse the potential of electronic health record data in clinical development. Click Here for More Information. Hot Company SGS Life Science Services 201 Route 17 North Rutherford, New Jersey 07070U.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. 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