Navigation Links
Amgen and FDA Agree to Modify Nplate® (Romiplostim) Risk Evaluation and Mitigation Strategy
Date:12/6/2011

ed to determine the precise role of Nplate in the development of the adverse events. Based in part on this determination, and the data submitted from clinical trials, the FDA and Amgen have concluded that the restricted elements of the REMS can be eliminated. For this reason enrollment of prescribers, patients and institutions and mandatory collection of safety data is no longer required. 

As of Dec. 7, 2011, prescribing physicians and institutions will be able to order Nplate without enrolling themselves or patients in the Nplate® NEXUS Program. The program will continue to obtain information from already enrolled patients through Jan. 5, 2012, and Nplate® NEXUS Program support assistance will continue for 28 days after approval of the modified REMS.

About Adult ITP

In patients with immune thrombocytopenia (ITP), platelets - blood elements needed to prevent bleeding - are destroyed by the patient's own immune system. Low platelet counts leave adult ITP patients open to sudden serious bleeding events. The risk for serious bleeding events increases when platelet counts drop to less than 30,000 platelets per microliter; normal counts range from 150,000 to 400,000 platelets per microliter. ITP has historically been considered a disease of platelet destruction although recent data suggest that the body's natural platelet production processes in ITP are also unable to compensate for low levels of platelets in the blood. Increasing the rate of platelet production may address low platelet levels associated with ITP. Currently, there are approximately 90,000 adult chronic ITP patients in Europe and the U.S. ITP affects about twice as many adult women as men.

The Nplate FIRST STEP™ Co-Pay Coupon Card Program

Last year, Amgen announced its co-pay coupon umbrella program, the Amgen FIRST STEP™ Program, for commercially insured patients. As part of that program, the Nplate FIRST STEPT
'/>"/>

SOURCE Amgen
Copyright©2010 PR Newswire.
All rights reserved

Page: 1 2 3 4 5 6 7 8

Related biology technology :

1. Amgen’s Third Quarter 2011 Revenue and Adjusted Earnings Per Share (EPS) Each Increased 3 Percent to $3.9 Billion and $1.40
2. Amgen Appoints Anthony (Tony) Hooper Executive Vice President Global Commercial Operations
3. Amgen Appoints Robert A. Bradway to the Companys Board of Directors
4. Amgen Announces 2011 Fourth Quarter Dividend
5. Amgen to Present at the UBS Global Life Sciences Conference
6. Amgen Staff Volunteer Efforts Result in $5,000 For Each of Their Favorite Nonprofits
7. Award-Winning Actress Blythe Danner and Amgen Launch Act 2 Reduce Fractures(TM) Educational Campaign
8. Award-Winning Actress Blythe Danner and Amgen Launch Act 2 Reduce Fractures™ Educational Campaign
9. Amgen Highlights Data to Be Presented at American Society for Bone and Mineral Research Meeting
10. Amgen Submits Application to Expand Indication for XGEVA® (Denosumab) to Prevent or Delay Spread of Prostate Cancer to the Bone
11. Amgen Receives Positive CHMP Opinion for Vectibix® (Panitumumab) in Combination With Chemotherapy
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:9/17/2014)... (PRWEB) September 17, 2014 NASA’s MESSENGER ... Valcor Engineering Corporation is proud to have one of ... The MESSENGER mission is a scientific investigation of the ... to be sent there, and has provided a vast ... Valcor’s V27200 family of latch valves utilize solenoids that ...
(Date:9/17/2014)... The Alliance for Clinical Research ... collaborative building a global system to enhance safety, ... Phase 3 of its Site Accreditation and Standards ... Kalali, Vice-President, Global Head, Neuroscience Center of Excellence ... Quality Integration (CQI) Consulting will lead the effort ...
(Date:9/16/2014)... , Sept. 16, 2014 This report analyzes the ... Product Segments: Software, Hardware, and Biocontent. The report provides separate ... Japan , Europe , ... , and Rest of World. Annual estimates and forecasts are ... historic analysis is provided for these markets. Market data and ...
(Date:9/16/2014)... 2014  Biocom, the association representing the ... 9 th Annual National Health Information Technology Week, ... in improving our health care system. ... the world,s most vibrant hubs for health IT and ... to genomic testing to remote patient monitoring," said ...
Breaking Biology Technology:Global Standards Initiative for Clinical Research Sites Advances 2Global Standards Initiative for Clinical Research Sites Advances 3Global Standards Initiative for Clinical Research Sites Advances 4Global Bioinformatics Industry 2Global Bioinformatics Industry 3Global Bioinformatics Industry 4Global Bioinformatics Industry 5Global Bioinformatics Industry 6Global Bioinformatics Industry 7Global Bioinformatics Industry 8Global Bioinformatics Industry 9Global Bioinformatics Industry 10Global Bioinformatics Industry 11Global Bioinformatics Industry 12Global Bioinformatics Industry 13Global Bioinformatics Industry 14Global Bioinformatics Industry 15Global Bioinformatics Industry 16Global Bioinformatics Industry 17Global Bioinformatics Industry 18Global Bioinformatics Industry 19Global Bioinformatics Industry 20Global Bioinformatics Industry 21Global Bioinformatics Industry 22Global Bioinformatics Industry 23Biocom Recognizes National Health IT Week 2
... NIH funds human ... ... announced today that it is one of the recipients in a 4-year $1.95M grant from ... evaluate Cell Sense, the Company’s fluorocarbon-based magnetic resonance imaging (MRI) cell tracking reagent, for clinical ...
... vital in helping to save up to 90 per cent ... to scientists. The research team led by Durham ... the UK) looked at the effects of climate change on ... on the network of sites designated for them (termed Important ...
... N.J., June 1 BD (Becton, Dickinson and Company) (NYSE: BDX ), a ... conferences in June: , , Goldman Sachs 30th ... 11:40 a.m. EDT, ... 11, 2009, 10:00 a.m. EDT, , ...
Cached Biology Technology:Celsense, Inc Receives NIH Grant to Translate Cell Imaging Technology for Clinical Use 2Celsense, Inc Receives NIH Grant to Translate Cell Imaging Technology for Clinical Use 3Nature parks can save species as climate changes 2Nature parks can save species as climate changes 3
(Date:9/16/2014)... take up residence in and on the human body ... according to new research at Washington University School of ... individuals carry about five types of viruses on their ... Biology . The study is the first comprehensive analysis ... , The research was conducted as part of ...
(Date:9/16/2014)... The meteorite impact that spelled doom for the dinosaurs ... flowering plants to a much greater extent than their ... researchers. The results are published in the journal ... a treasure trove of thousands of fossilized leaves of ... team was able to reconstruct the ecology of a ...
(Date:9/16/2014)... school year, a new football season and another commercial ... SpaceX,s Dragon spacecraft is scheduled to blast off to ... of the company,s fourth contracted mission to the complex. ... suite of research investigations sponsored by the Center for ... role of managing the U.S. National Laboratory on the ...
Breaking Biology News(10 mins):Healthy humans make nice homes for viruses 2Healthy humans make nice homes for viruses 3Meteorite that doomed dinosaurs remade forests 2Meteorite that doomed dinosaurs remade forests 3Meteorite that doomed dinosaurs remade forests 4CASIS research set for launch aboard SpaceX mission to space station 2CASIS research set for launch aboard SpaceX mission to space station 3
... BROOK, NY, February 20, 2013As the nations of the ... trade in endangered sharks in early March, a team ... the oceanic whitetip shark regularly crosses international ... apex predator within their own maritime borders may therefore ...
... The University of Texas at Arlington are pioneering a new ... make liquid methanol fuel by using copper oxide nanowires and ... expensive than previous methods to convert the greenhouse gas associated ... interim associate vice president for research at UT Arlington and ...
... from 375 past teen participants in a Canadian biotechnology ... -- show a majority of respondents were influenced by ... offering a model for countries worldwide to advance their ... of 375 past participants by Bioscience Education Canada, which ...
Cached Biology News:New research on migratory behavior of oceanic whitetip sharks can help shape conservation strategies 2New research on migratory behavior of oceanic whitetip sharks can help shape conservation strategies 3Researchers say sunlight yields more efficient carbon dioxide to methanol model 2'Inspiring' teens with 'research virus': Expert-mentored bioscience contest proves a powerful vector 2'Inspiring' teens with 'research virus': Expert-mentored bioscience contest proves a powerful vector 3'Inspiring' teens with 'research virus': Expert-mentored bioscience contest proves a powerful vector 4'Inspiring' teens with 'research virus': Expert-mentored bioscience contest proves a powerful vector 5'Inspiring' teens with 'research virus': Expert-mentored bioscience contest proves a powerful vector 6'Inspiring' teens with 'research virus': Expert-mentored bioscience contest proves a powerful vector 7'Inspiring' teens with 'research virus': Expert-mentored bioscience contest proves a powerful vector 8'Inspiring' teens with 'research virus': Expert-mentored bioscience contest proves a powerful vector 9'Inspiring' teens with 'research virus': Expert-mentored bioscience contest proves a powerful vector 10'Inspiring' teens with 'research virus': Expert-mentored bioscience contest proves a powerful vector 11
Acetylcholinesterase from human and monkey....
...
... Dye runs faster than Bromophenol blue,or ... gels.,Orange G dye migrates with DNA ... migration at this size,prevents the obscuring ... the front of DNA migration.,The Orange ...
... solution, Type I is ... and agarose gel electrophoresis ... offers the advantage of ... blue and xylene cyanole). ...
Biology Products: