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

THOUSAND OAKS, Calif., Dec. 6, 2011 /PRNewswire/ -- Amgen (NASDAQ: AMGN) today announced the U.S. Food and Drug Administration (FDA) has modified the requirements of the Nplate® (romiplostim) Risk Evaluation and Mitigation Strategy (REMS) Program. Prescribing physicians, patients and institutions are no longer required to enroll in the safety monitoring program, called the Nplate® NEXUS (Network of EXperts Understanding and Supporting Nplate and Patients) Program, in order to prescribe or receive Nplate. 

"The goals of the Nplate® NEXUS Program were to educate physicians and patients about treatment risks and benefits, and to define the long-term safety profile of Nplate," said Roger M. Perlmutter, M.D., Ph.D., executive vice president of Research and Development at Amgen. "The FDA has now concluded that enrollment in a restricted distribution program is no longer necessary to prescribe or receive Nplate. Amgen will continue to monitor the safety profile of Nplate through clinical trials and post-marketing pharmacovigilance programs."

The primary modification of the REMS is the removal of the elements to assure safe use; however, a modified REMS communication plan will remain in place.  In addition, the Medication Guide will no longer be part of the REMS, but will be part of approved product labeling.

From 2008 to 2011, the Nplate® NEXUS Program has collected long-term safety data from more than 5,200 patients. The restrictive elements of the REMS included enrollment of prescribers, patients and institutions to assist in collecting long-term safety information. Upon further review, the FDA and Amgen have determined that the safety information collected through the REMS, which is based on individual case safety reports, is inherently confounded by underlying medical conditions in the treated patient population and thus cannot be us
'/>"/>

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:12/19/2014)... The empty capsules market is ... population and technological innovations in the empty capsules ... catalysing the growth of the empty capsules market. ... , Scope of Report , The report will ... entrants/smaller firms to gauge the pulse of the ...
(Date:12/19/2014)... , Dec. 18, 2014  Decision Resources Group finds ... biomaterial market will grow moderately through 2023 as the ... growing awareness of dental biomaterials all spur procedure volumes. ... as China and ... dental procedures within reach for a larger proportion of ...
(Date:12/19/2014)... Dec. 18, 2014   ISN has released ... Performance Indicators publication series. With data aggregated ... reported in 2013 within its online contractor management platform, ... key performance indicator (KPI) statistics. The ... publication is available in two industry specific ...
(Date:12/17/2014)... 16, 2014 The Activated Carbon ... which is why IBISWorld updated its original industry research ... benefit from an intensified focus on environmental policy. Over ... emission standards for power plants and a range of ... IBISWorld Industry Analyst Sarah Kahn, “a range of downstream ...
Breaking Biology Technology:Empty Capsules Market Hit to Reach $1,820 Million by 2019 - New Research Report by MarketsandMarkets 2Empty Capsules Market Hit to Reach $1,820 Million by 2019 - New Research Report by MarketsandMarkets 3Empty Capsules Market Hit to Reach $1,820 Million by 2019 - New Research Report by MarketsandMarkets 4Asia Pacific Dental Biomaterial Market Will Grow Strongly Through 2023 2Asia Pacific Dental Biomaterial Market Will Grow Strongly Through 2023 3ISN Releases Third Edition of US Contractor Health & Safety Performance Indicators Publication Series 2ISN Releases Third Edition of US Contractor Health & Safety Performance Indicators Publication Series 3Activated Carbon Manufacturing in the US Industry Market Research Report Has Been Updated from IBISWorld 2Activated Carbon Manufacturing in the US Industry Market Research Report Has Been Updated from IBISWorld 3
... Spherix Incorporated (Nasdaq: SPEX ), an innovator ... technical and regulatory consulting services to food, supplement, biotechnology ... Annual Meeting of Shareholders. , At the meeting, shareholders ... following members to the Board of Directors: , ...
... /PRNewswire/ - Aegera Therapeutics Inc. announced today the dosing ... study of AEG35156, a targeted antisense therapeutic in mid-stage ... "An Open-Label Randomized Phase 2 Study of the X-Linked ... with High-dose Cytarabine and Idarubicin in AML Following Failure ...
... ... ... 16, 2009 -- Popular Science Magazine has named the Lyric “invisible” hearing aid from ... Health category.    Chosen from thousands of entrants, Lyric is designed to reside deep in the ...
Cached Biology Technology:Spherix Announces Results of Annual Shareholders Meeting 2Spherix Announces Results of Annual Shareholders Meeting 3Spherix Announces Results of Annual Shareholders Meeting 4Aegera Therapeutics Initiates a Randomized Phase 2B Study with AEG35156 for the Treatment of Acute Myeloid Leukemia (AML) 2Popular Science Awards Lyric “Invisible” Hearing Aid 2009 “Best of What's New” Award 2Popular Science Awards Lyric “Invisible” Hearing Aid 2009 “Best of What's New” Award 3
(Date:12/4/2014)... , Dec. 3, 2014  Crossmatch™, a leading ... that its DigitalPersona ® Pro Enterprise software ... been deployed throughout First Bank branch locations in ... South Carolina and Virginia. First Bank, a ... Southern Pines, North Carolina , selected the ...
(Date:11/21/2014)... November 18, 2014 According to ... by Systems (Video, RFID, Access Control, Intrusion Detection, Parking ... Banks, Government), Component Service Geography - Global Forecasts to ... is projected to be around $25 Billion in 2014 ... growing at a CAGR of 8.69%. Browse ...
(Date:11/21/2014)... C-Labs LLC, a leading provider of remote ... today announced the appointment of John Traynor ... strategic advisor to the firm, Mr. Traynor will now ... based out of the C-Labs office in ... Muench , Chief Executive Officer. Photo - ...
Breaking Biology News(10 mins):First Bank Partners with Crossmatch to Increase Log In Security 2First Bank Partners with Crossmatch to Increase Log In Security 3Industrial Security Systems Market Worth $38 Billion by 2020 2Industrial Security Systems Market Worth $38 Billion by 2020 3C-Labs Names Former Microsoft and Bsquare Executive as Chief Operating Officer 2
... Seabirds are the surprising culprits in delivering pollutants ?through ... Canadian study shows. , The most common form of ... most of the human-made contaminants to some coastal ecosystems, ... of pollutants such as mercury and DDT to as ...
... Medical Institute researchers have discovered a novel way in ... regulated. They have identified a signaling pathway that controls ... cleaved during development. , The way these cells are ... of neurogenesis, vertical cleavage gives rise to two mature ...
... clarify how one of the body's molecules controls the trafficking ... to tissues to fight infection -- a crucial response that ... autoimmune diseases. , The traffic control system -- composed of ... cells -- usually prevents T cells from launching harmful reactions. ...
Cached Biology News:Industrial contaminants spread by seabirds in High Arctic, new Canadian study shows 2Brain size may depend upon how neural cells are cleaved 2Brain size may depend upon how neural cells are cleaved 3Discovery of T-cell 'traffic control' boosts new drug promise 2Discovery of T-cell 'traffic control' boosts new drug promise 3Discovery of T-cell 'traffic control' boosts new drug promise 4
...
Experion spin filters are used to filter the gel matrix and gel stain solution prior to use with the Experion automated electrophoresis system. Supplied as 10 spin filters....
...
... to PRKAR2 cAMP is a signaling ... functions. cAMP exerts its effects by activating ... the signal through phosphorylation of different target ... a tetramer composed of two regulatory and ...
Biology Products: