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  1. CARDIOVASCULAR (pdf file)

    effectivehealthcare.ahrq.gov/sites/default/files/cardiovascular-horizon-scan-high-impact-1412.pdf
    December 01, 2014 - The company reports continued quarterly U.S. market growth, with plans for further expansion in the … In July 2014, a company press release reported results from 106 patients in that trial (the Freedom … in a July 2014 company press release. … Although the company resolved the issue and reintroduced the device in those countries, the recall … Plymouth Meeting (PA): The Advisory Board Company; 2014 Mar 05 [accessed 2014 Aug 04]. [4 p].
  2. effectivehealthcare.ahrq.gov/sites/default/files/pdf/psoriasis-chronic_research-protocol.pdf
    January 10, 2012 - Drug name is the generic formulation and/or the developmental name as determined by the manufacturing company … the generic formulation, if available, or the developmental name as determined by the manufacturing company … ; Phase II: complete (2009) Hydroxyurea‡ Hydrea ® (oral capsule) Bristol-Myers Squibb Company … ) • 3-series Phototherapy Cabinet (Daavlin Company) • MultiClear XL (Curelight Ltd.) … ) • 3-series Phototherapy Cabinet (Daavlin Company) 8-MOP ® : For the symptomatic control of severe
  3. Obesity (pdf file)

    effectivehealthcare.ahrq.gov/sites/default/files/obesity-horizon-scan-high-impact-1506.pdf
    June 01, 2015 - In April 2015, the company announced that FDA would not require an advisory panel meeting for the … The company submitted a premarket approval (PMA) application to the U.S. … The company must also conduct multiple postmarketing studies for liraglutide: trials to evaluate dosing … New York (NY): The New York Times Company; 2012 Apr 10 [accessed 2013 Feb 01]. [3 p]. … New York (NY): The New York Times Company; 2012 Jul 17 [accessed 2013 Feb 01]. [3 p].
  4. effectivehealthcare.ahrq.gov/sites/default/files/pdf/ongoing-studies-evidence_research.pdf
    December 01, 2010 - Eli Lilly appears to have created the first independent pharmaceutical company registry which began … While specific pharmaceutical company registries were not mentioned, two respondents indicated that … For instance, it may be worthwhile to search pharmaceutical company registries when studying a new drug … Do you use pharmaceutical company registries to identify ongoing studies? i. … Please list any pharmaceutical company registries that you have used to identify ongoing studies:
  5. effectivehealthcare.ahrq.gov/sites/default/files/related_files/colorectal-cancer-screening_disposition-comments.pdf
    February 01, 2012 - describing Exact Sciences as a “manufacturer” in this document: Please change to: Thus far a single company … Thus far a single company, Exact Sciences, has been the major manufacturer and commercial developer … Thus far a single company, Exact Sciences, has been the major developer of fecal DNA testing in the … A lot of people lost money investing in the company lobbying for guideline coverage of the fecal DNA … Thus far a single company, Exact Sciences, has been the major developer of fecal DNA testing in the
  6. Gibbons (pdf file)

    effectivehealthcare.ahrq.gov/sites/default/files/gibbons.pdf
    January 01, 2010 - Gibbons Slide  1: Social Media  and Health Care  Disparities M. Chris Gibbons, M.D., M.P.H. Associate Director Johns Hopkins Urban Health Institute Baltimore, MD Slide  2: Can Social Media  Help Address Health Care  Disparities? • Are there determinants of disparities…
  7. effectivehealthcare.ahrq.gov/sites/default/files/pregnancy_hi_impact.pdf
    January 01, 2012 - The company reported that an insured patient’s cost for the test would be no more than $235 and that … The company stated that it expects reimbursement for the test to be similar to that for amniocentesis … failed in 13 pregnancies (0.8%; [95% CI, 0.4-1.3]); all were euploid.” 53 In October 2011, the company … The company reported that an insured patient’s cost for the test would be no more than $235 and that … The company stated that it expects reimbursement for the test to be similar to that for amniocentesis
  8. effectivehealthcare.ahrq.gov/sites/default/files/arthritis-horizon-scan-high-impact-1406.pdf
    June 01, 2014 - has an FDA- approved autologous MSC product at this point, although one company in Texas has stated … Another company, in Colorado, had offered a cultured, highly processed autologous MSC product, but … was ordered by FDA to stop; the company subsequently moved its operations for that product offshore … FDA asserted that the company was manufacturing these agents without its approval, without following … good manufacturing practice, and without proving the treatment’s safety and efficacy.15 The company
  9. effectivehealthcare.ahrq.gov/sites/default/files/12_pregnancy_potential_high_impact_june_2012.pdf
    January 01, 2012 - o The first company to make such a test available in the U.S. is Sequenom, Inc. … In May 2012, the company announced the prenatal test’s commercial launch in the United States and … failed in 13 pregnancies (0.8%; [95% CI, 0.4-1.3]); all were euploid.” 1 In October 2011, the company … The company reported that an insured patient’s cost for the test would be no more than $235 and that … operate as an out-of-network provider to ensure eligible patients have coverage for the test. 56 The company
  10. effectivehealthcare.ahrq.gov/sites/default/files/ahrq-healthcare-horizon-scan-protocol-operations-manual_130826.pdf
    August 01, 2013 - For example, one company may cease development while another company proceeds to market. … quotation marks exactly as issued by study authors from meeting abstracts, published articles, or company … rigorous conflict-of-interest rules that prohibit ownership of any drug or biotechnology or device companyCompany mergers that affect product development (product development may be delayed or halted altogether … Company financing or selling of R&D rights for a product 6.
  11. Obesity (pdf file)

    effectivehealthcare.ahrq.gov/sites/default/files/10_obesity_potential_high_impact_2012-12-11.pdf
    January 01, 2012 - The company will consider submitting a premarket approval application following this trial’s results … the EndoBarrier and sham arms, respectively. 27 Results from three trials were reported in a company … device were published in 2010, 23,27 and updated results from three studies were reported by the company … inclusion in its therapeutic goods registry for treating T2DM and obesity for up to 12 months. 29 The company … The company believes trial results will support PMA submission for this device. 30 8 Clinical
  12. #14 SUBSTANCE ABUSE (pdf file)

    effectivehealthcare.ahrq.gov/sites/default/files/substance-abuse-horizon-scan-high-impact-1312.pdf
    December 01, 2013 - The company submitted a new drug application to the U.S. … In March 2013, an FDA advisory panel voted to recommend approval; however, on April 30, 2013, the company … The company has stated that it believes it has met the evidence requirements for approval and is formulating … The company was scheduled to meet with FDA on November 19, 2013, to discuss issues regarding the Probuphine
  13. Obesity (pdf file)

    effectivehealthcare.ahrq.gov/sites/default/files/obesity-horizon-scan-high-impact-1406.pdf
    June 01, 2014 - The company has indicated that it will submit premarket approval application to FDA in 2014. … The company has two introductory pricing programs to support diffusion that provide the initial 14- … To aid diffusion, the company is offering special pricing programs in which patients can receive a … To aid diffusion, the company is offering special pricing programs in which patients can receive a … New York (NY): The New York Times Company; 2012 Jul 17 [accessed 2013 Feb 01]. [3 p].
  14. Diabetes Mellitus (pdf file)

    effectivehealthcare.ahrq.gov/sites/default/files/diabetes-horizon-scan-high-impact-1406.pdf
    September 26, 2014 - In September 2011, the company submitted new drug applications (NDAs) to FDA for insulin degludec … In February 2013, the company announced that FDA issued a complete response letter regarding the NDAs … According to the company, “the new Enlite Serter provides a simpler sensor insertion process with a … The company advises that patients’ out- of-pocket costs for CGM vary according to their health plan … Intarcia CEO to present company progress, interim phase 3 data, and key milestones at J.P.
  15. effectivehealthcare.ahrq.gov/sites/default/files/arthritis-horizon-scan-high-impact-13121.pdf
    December 05, 2013 - No company has an FDA-approved autologous MSC product at this point, although one company in Texas … Another company, in Colorado, had offered a cultured, highly processed autologous MSC product, but … was ordered by FDA to stop; the company subsequently moved its operations for that product offshore … FDA asserted that the company was manufacturing these agents without its approval, without following … good manufacturing practice, and without proving the treatment’s safety and efficacy.39 The company
  16. effectivehealthcare.ahrq.gov/sites/default/files/arthritis-horizon-scan-high-impact-1306.pdf
    June 01, 2013 - No company has an FDA-approved autologous MSC product at this point, although one company in Texas … Another company in Colorado that had offered a cultured, highly processed autologous MSC product was … ordered by FDA to stop and moved its operations for that product offshore; the company now offers … drugs according to the FDCA and biological products under the Public Health Service Act and that the company … completes the required FDA regulatory approval processes.43 http://www.regenexx.com/ 9 The company
  17. Obesity (pdf file)

    effectivehealthcare.ahrq.gov/sites/default/files/10_obesity_potential_high_impact_june_2012.pdf
    January 01, 2012 - The company intends to submit a premarket approval application to FDA, pending outcomes of ongoing … device were published in 2010, 18,21 and updated results from three studies were reported by the company … inclusion in its therapeutic goods registry for treating T2DM and obesity for up to 12 months. 23 The company … the EndoBarrier and sham arms, respectively. 21 Results from three trials were reported in a company … antidiabetic medications in 16 of 17 patients. 22 Two other clinical trials reported on in a company
  18. effectivehealthcare.ahrq.gov/sites/default/files/pdf/horizon-scan_research-protocol.pdf
    December 01, 2011 - For example, one company may cease development while another company proceeds to market. … quotation marks exactly as issued by study authors from meeting abstracts, published articles, or company … rigorous conflict of interest rules that prohibit ownership of any drug or biotechnology or device companyCompany mergers that affect product development (product development may be delayed or halted altogether … Company financing or selling of R&D rights for a product 6.
  19. effectivehealthcare.ahrq.gov/sites/default/files/arthritis-horizon-scan-high-impact-1512.pdf
    December 29, 2015 - Eli Lilly and Company. A moderate to severe rheumatoid arthritis study (RA-BEACON). … Eli Lilly and Company. … Eli Lilly and Company. … Eli Lilly and Company. … Eli Lilly and Company.
  20. effectivehealthcare.ahrq.gov/sites/default/files/crosscutting-horizon-scan-high-impact-1312.pdf
    December 01, 2013 - The company received marketing clearance from the U.S. … The company is working with various pharmaceutical manufacturers to select medications for sensor … The company has termed oral medications embedded with the sensor “digital medicines.” … The company states that the sensor is made of “materials found in the food chain,” such as silicon, … No definitive marker-related adverse effects were reported.”4 The company has also made a strategic

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