-
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].
-
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
-
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].
-
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:
-
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
-
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…
-
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
-
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
-
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
-
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 company … Company 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.
-
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
-
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
-
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].
-
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.
-
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
-
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
-
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
-
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
company … Company 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.
-
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.
-
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