therapeutics and clinical risk management

3988 results for therapeutics and clinical risk management

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  • Rodman & Renshaw 3rd Annual Global Healthcare Conference 2006 Presenter Profiles.

    ...Further key projects in clinical development comprise the three orally ...Company: Altea Therapeutics Corporation Investor Relations Contact: Steven P. ... and fentanyl patches for the rapid management of moderate to severe pain; and (ii) patches for ... of patients who experience, or are at risk of, life threatening episodes of liver failure. ...

  • Big Data and Pharmacovigilance: Using Health Information Exchanges to Revolutionize Drug Safety

    Data on individual patients collected through state and federal health information exchanges has the potential to usher in a new era of drug regulation. These exchanges, produced by recent health care reform legislation, will amass an unprecedented amount of clinical information on drug usage, demographic variables, and patient outcomes. This information could aid the Food and Drug Administration

  • BioPartnering Europe 2005 Exhibitor Profiles.

    ... of cancer and plans to initiate clinical trials in 2006. Ambit has raised a total of $51 ...Company: Arrow Therapeutics Ltd Booth/Stand: Open House Presenter: Group 4, ...: trial design and strategy, site management, project management, monitoring, ... discovery and development process, managing risk efficiently, thereby reducing the time and cost ...

  • MASS Opportunities: A Biotechnology Investment Conference Presenter Profiles.

    ... product candidates for which it has clinical data are designed to address unmet clinical needs ... that is developing enhanced natural therapeutics for health maintenance, and the treatment of ... and a novel vaccine for cholesterol management. AVANT has assembled technologies that enable the ... for colorectal cancer in the average-risk population. Colorectal cancer, which is the most ...

  • Biotech In Europe Investor Forum 2003 Exhibitor Profiles.

    ... company focused on the discovery, pre-clinical and early clinical development of new drug ... and production of virus-based therapeutics and vaccines. To date the company has grown to 33 ... sales as drugs, decreasing the development risk. The company operates on a business model that is ... and reverse nitrogen loss, which management believes will translate into a substantial market ...

  • Safety and Effectiveness of Consumer Antiseptics; Topical Antimicrobial Drug Products for Over-the-Counter Human Use; Proposed Amendment of the Tentative Final Monograph; Reopening of Administrative Record

    The Food and Drug Administration (FDA) is issuing this proposed rule to amend the 1994 tentative final monograph or proposed rule (the 1994 TFM) for over-the-counter (OTC) antiseptic drug products. In this proposed rule, we are proposing to establish conditions under which OTC consumer antiseptic products intended for use with water (referred to throughout as consumer antiseptic washes) are...

    ... ingredients have data that demonstrate a clinical benefit from the use of these consumer antiseptic ... submissions): Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 ... use requires consideration of the benefit-to-risk ratio for the drug for that use. If the active ...'' in The Pharmacological Basis of Therapeutics, 4th ed., Macmillian Publishing Co., New York, ...

  • Clinilabs Appoints Senior Medical Director of Clinical Pharmacology Unit (CPU).

    ... and currently serves on the editorial boards of Therapeutics and Clinical Risk Management and the Journal of Clinical ...

  • 2015 NCBiotech company directory.

    ... parenteral drug manufacturing for both clinical and commercial markets. . www.aaipharma.com . AbD ...Their portfolio Includes therapeutics In oncology, cardiology, neurology, nephrology, rology, psychiatry, diabetes and pain management. The North Carolina location is a sales office. . ... microblome to Identify products that reduce risk and improve yields. . www.agbiome.com . Agile ...

  • C21 BioVentures Conference Exhibitor Profiles.

    ... partnered several lead drugs for final clinical testing, marketing and sales. Company: Amphora ... and development of innovative therapeutics. Amphora has created an exceptional pipeline of ... development timelines and reduces risk in bringing cell therapies from bench to a ... testing, a breakthrough in patient management, is a clinically validated, non-invasive method ...

  • ROTH New York Conference 2006 Presenter Profiles.

    ...ArQule's lead clinical-stage programs are based on its Activated ..., a novel vaccine for cholesterol management, and a treatment to reduce complement-mediated ...Company: Cardium Therapeutics Ticker Symbol & Exchange: OTC BB: CDTP Investor ... tools and information for immediate risk assessment and therapeutic monitoring of heart ...

  • Safety and Effectiveness of Consumer Antiseptics; Topical Antimicrobial Drug Products for Over-the-Counter Human Use; Proposed Amendment of the Tentative Final Monograph; Reopening of Administrative Record

    The Food and Drug Administration (FDA or Agency) is issuing this proposed rule to amend the 1994 tentative final monograph or proposed rule (the 1994 TFM) for over-the-counter (OTC) antiseptic drug products. In this proposed rule, we are proposing to establish conditions under which OTC consumer antiseptic products intended for use without water (referred to throughout as consumer antiseptic rubs

    ...'s antimicrobial properties and in vivo clinical simulation studies showing that specified log ... submissions): Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 ... use requires consideration of the benefit-to-risk ratio for the drug under the specified conditions ... of Pharmacology and Experimental Therapeutics, 260:463-467, 1992. Available at ...

  • SEBIO 2003 Exhibitor Profiles.

    ... Services offers a full range of clinical and non-clinical development solutions to ... well-known, branded medicines in pain management, gastroenterology and critical care. The ...Company: Hemocellular Therapeutics, Inc. Media and Investor Relations Contact: E. S. ... Associates provides insurance brokerage, risk management and employee benefit services to ...

  • BioMed Expo 2004 Exhibitor Profiles.

    ... development of new diagnostics and therapeutics. Our inventory consists of over 45,000 fresh ...BioSolutions is a highly specialized risk management program designed for the Life Sciences ... growth of pharmaceutical, biotechnology, clinical and other related industries in Michigan. Eastern ...

  • SEBIO 2005 Exhibitor Profiles.

    ... being evaluated in the pivotal Phase III clinical trial called ARISE, as an oral therapy for the ... companies to strategic real estate, management talent, manufacturing partners and healthcare ... Innovations, Intrexon, Ocucure Therapeutics, and Surgicaltools.com. Company: GE Healthcare ... a specialty medical company focused on high risk pregnancy care (maternal-fetal medicine). Its ...

  • CED Venture 05 Exhibitor and Sponsor Profiles.

    ...'s most trusted provider of Storage Management Services. The company's comprehensive portfolio ... is a global provider of applied clinical pharmacogenomics services and diagnostic product ... while decreasing associated expenses, risks, and development timelines. Integrated with the ...Company: Oriel Therapeutics Public Relations Contact: Amy Barefoot, ...

  • Medical or recreational marijuana and drugged driving.

    ... between BAC level and impairment or crash risk and that a person's B AC level changes slowly ..., Cannabis Effects on Driving Skills, 59 Clinical Chemistry 478, 479 (2013) ("Cannabis smokers ...See Alliance for Cannabis Therapeutics v. DEA, 930 F.2d 936, 937 n.1 (D.C. Cir. 1991). ...Barnett, et al., Contingency Management for Alcohol Use Reduction: A Pilot Study Using a ...

  • 16th Annual Wall Street Analyst Forum Presenting Company Profiles.

    ... performs development, acquisition, management, leasing and brokerage services for its portfolio ... growth hormone and cromolyn sodium into clinical trials. Emisphere has strategic alliances with ... prescription and over-the-counter therapeutics. The Company's proprietary technology uses a ...The Company has also lowered its portfolio risk on the downside with fixed price royalties and ...

  • Companies.

    ...-dose manufacturing facility provides clinical and commercial supplies on contract. . ...(RTP) develops cancer therapeutics. Its lead product under development is ... technologies in the areas of pain management and oncology supportive care. . www.bdsi.com . ...(RTP) develops products that reduce the risk of injury or death from counterfeit drugs. . ...

  • BioMed Expo 2002 Exhibitor Profiles.

    ... and sensor analysis, supply chain management, product lifecycle and process control, and ... solutions, disease management, and clinical trials/program management support. These ...DMA provides insurance and risk management services to a significant number of ...Company: Esperion Therapeutics, Inc Ticker Symbol: ESPR (NASDAQ) Booth: 412 ...

  • SPECIALISED THERAPEUTICS PARTNERS W/ GENOMIC HEALTH.

    ... a patient's likely benefit from chemotherapy and the overall risk of breast cancer recurrence. This technology has been shown to ... logistics in Australia, including tissue sample management. . Announcing the distribution agreement with Genomic Health, STA ... Genomic Health, Oncotype DX has been evaluated in 15 clinical studies in more than 6,000 patients. These studies include a ...

  • Alnylam Pharmaceuticals Reports Fourth Quarter and Full Year 2012 Financial Results

    - Continued to Execute on "Alnylam 5x15(TM)" Product Strategy with Positive Clinical Data in Multiple RNAi Therapeutic Programs Including ALN-TTR02 for Treatment of Transthyretin (TTR)-Mediated Amyloidosis (ATTR) and ALN-PCS for Treatment of Hypercholesterolemia - - Advanced Proprietary Conjugate Delivery Platform Enabling Subcutaneous Delivery of RNAi Therapeutics Towards the Clinic,...

    ...(Nasdaq: ALNY), a leading RNAi therapeutics company, today reported its consolidated ..."2012 was a remarkable year of clinical achievement for Alnylam and for the advancement ... Advisory Board and Developed Management Team. Alnylam elected Daniel J. Rader, M.D. to ... unexpected expenditures, as well as those risks more fully discussed in the "Risk Factors" filed ...

  • Exclusivity Without Patents: The New Frontier of FDA Regulation for Genetic Materials

    Over the last twenty years, the legal and scientific academic communities have been embroiled in a debate about the patent eligibility of genetic materials. The stakes for both sides could not be higher. On one hand are the potential multi-billion dollar profits on the fruits of research (from newly discovered genes), and on the other is scientists’ ability to continue and expand research into...

  • The Road To IPO: Legal And Regulatory Insights Into Going Public (April 2014)

    ... Aquinox Pharmaceuticals, a clinical-stage pharmaceutical company discovering and ... company developing non-opioid therapeutics for the treatment of pain, initially in the ... provider of payroll and human capital management software solutions for medium-sized ... Semler Scientific, an emerging medical risk-assessment company with a product allowing ...

  • Nondiscrimination in Health Programs and Activities

    This final rule implements Section 1557 of the Affordable Care Act (ACA) (Section 1557). Section 1557 prohibits discrimination on the basis of race, color, national origin, sex, age, or disability in certain health programs and activities. The final rule clarifies and codifies existing nondiscrimination requirements and sets forth new standards to implement Section 1557, particularly with respect

    ... designed by a pharmacy and therapeutics committee, be deemed compliance with the final ... Information Technology for Economic and Clinical Health (HITECH) Act of 2009,\32\ is preferable to ...Office of Personnel Management, Guidance Regarding the Employment of Transgender ... Section 1557 might expose the entity to the risk of civil liability, because Section 1557 allows ...

  • ValueRich Small-Cap Financial Expo New York 2005 Exhibitor Profiles.

    ...Biophan's management team includes former executives of J&J and ...Company: Chemokine Therapeutics Corp Booth/Stand: 144 Ticker Symbol & Exchange: ... with two lead product candidates in clinical trials; CTCE-0214, for enhancing the immune ... identify opportunities, spot potential risks or anomalies and analyze competitors through an ...