FDA: Feds Seize Crescendo's Unapproved Scar Drug - May 23, 2012

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Wednesday, May 23, 2012  |   |   |   |  Reduce Risk and Maximize Potential in Ophthalmology Development Ophthalmic study design and execution can be quite different than other therapeutic areas. Pharm-Olam's team has a proven track record of excellence in achieving trial objectives and can provide strategic, operational and consulting to sponsors for phase I to phase IV development. The majority of our clinical staff in emerging markets are MDs or PhDs, including Ophthalmologists in strategic areas for clinical trials. The incidence of disorders and standards of treatment can vary widely, so 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. •  FDA: Feds Seize Crescendo Therapeutics' Unapproved Scar Drug More... •  Prodigy Generics and eVenus Announce the Launch of Oncology Injectable Irinotecan More... More Drug Product News •  Allergy Therapeutics plc: Notification of Voluntary Product Recall of Anapen® by Lincoln Medical More... More Discontinuations News More Recalls and Warning News •  Novo Nordisk A/S (NVO) Diabetes Drug Gets FDA Nod for Toddlers More... •  Perrigo Company (PRGO) Receives FDA Approval for Butoconazole Nitrate 2% Vaginal Cream More... More Drug Approval News 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. •  FDA Delays Abbott Laboratories (ABT)'s New Use for Top Drug Humira More... •  Furiex Pharmaceuticals, Inc. (FURX) Confirms Takeda Pharmaceutical Co. Ltd. (TKDG.DE)'s Announcement on the Acceptance of the European Medicines Agency Submission of Alogliptin for the Treatment of Type 2 Diabetes More... •  Seattle Genetics, Inc. (SGEN) Announces Health Canada Accepts ADCETRIS® New Drug Submission for Review More... More BLA/NDA/ANDA News More IND News More MAA News •  Zytoprotec Completes Phase I/II Trial of Novel Dialysate, Enters into Negotiations With Global Pharmaceutical Company More... More Phase III News More Phase II News More Phase I News More Pre-Clinical News More Post-Approval News •  Do Bald Men Face Higher Risk of Prostate Cancer? University of Toronto Study More... •  Asthma Meds May be Linked to Irregular Heartbeat, University of Illinois Study More... •  Disagreeable People Prefer Aggressive Dogs, University of Leicester Study More... •  Senesco Technologies, Inc. (SNT)'s SNS01 is a Potent Regulator of Programmed Cell Death and Tumor Growth in Murine Models of Multiple Myeloma More... •  New Data Support Role of Prometheus Laboratories Inc.' Novel Assay in Optimizing IBD Treatment Management 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. • Genetown (Billerica, Massachusetts) PAREXEL International Clinical Logistics Leader Ensures that clinical logistics projects are progressing and systems are set up and maintained according to quality standards, SOPs and applicable ICH-GxP* and other applicable industry guidelines. • Pharm Country (Cranbury, New Jersey) Galderma Research & Development, Inc. Head of US Clinical Project Management Provides strategic, operational, and implementation oversight for dermatology clinical operational activities and studies under the guidance of the Global Head of Clinical Project Management. • 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. • 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 •  Avaxia Biologics, Inc. is Awarded U.S. Patent for Method to Treat Radiation Damage to the Digestive Tract and Mucositis Caused by Radiation More... •  MicuRx Pharmaceuticals Announces Issuance of U.S. Patent for Its Next-Generation Antibacterial Agent More... More Patent 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 SNBL Clinical Pharmacology Center 800 West Baltimore Street, 5th Floor Baltimore, Maryland 21201 U.S.A. Phone: 800-690-9110 Fax: 410-706-8963 SNBL-CPC partners with pharmaceutical companies, biotech firms and CROs to accelerate drug development utilizing our best-in-class facility, technology, operational excellence and strong affiliations with local academic medical institutions (University of Maryland and Johns Hopkins University). 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. 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