Elvitegravir

Type: Keyphrase
Name: Elvitegravir
First reported Apr 09 2014 - Updated Apr 09 2014 - 1 reports

FDA is Asked to Reconsider Denial of NCE Exclusivity for STRIBILD; Gilead Says FDA Erred in Not Applying the New (and Old) Interpretation

By Kurt R. Karst –When FDA announced on February 21, 2014 that the Agency would, upon finalization of a draft guidance document, reinterpret the New Chemical Entity (“NCE”) exclusivity provisions of the FDC Act to award NCE exclusivity for a newly approved ... [Published FDA Law Blog - Apr 09 2014]
First reported Apr 09 2014 - Updated Apr 09 2014 - 1 reports

New combo pill of Prezista + cobicistat gets submitted to FDA

Facebook Twitter Google + Email PrintAccording to an April 1, 2014 press release from Janssen Research & Development, a new drug application has been submitted to the FDA for a new combination pill made up of the protease inhibitor Prezista (darunavir) ... [Published Project Inform - Apr 09 2014]
First reported Apr 02 2014 - Updated Apr 02 2014 - 1 reports

Starting Antiretrovirals Wasn't an Option

Aaron LaxtonStarting on ARVs [antiretrovirals] wasn't an option. From all the research I had done, I knew that the quicker that I started medications, the better chance I would have to remain healthy. I was diagnosed on June 6, 2011, and almost a month ... [Published The Body - Apr 02 2014]
First reported Mar 29 2014 - Updated Mar 29 2014 - 1 reports

The Kidney at CROI 2014

21st Conference on Retroviruses andOpportunistic InfectionsBoston, MA March 3 - 6, 2014 Christina M. Wyatt, MD Associate Professor, Medicine/ Nephrology Icahn School of Medicine at Mount Sinai New York, NYLast year's meeting was marked by exciting reports ... [Published National AIDS Treatment Advocacy Project - Mar 29 2014]
First reported Mar 29 2014 - Updated Mar 29 2014 - 1 reports

Starting HIV Treatment and Corporate Greed: An Activist's Perspective

Marco BenjaminLast month, I decided to start my antiretroviral treatment when I tested positive for an STI [sexually transmitted infection] for the first time ever [-- not including HIV]. Embarrassingly enough, I was asked why I was having condomless ... [Published The Body - Mar 29 2014]
First reported Mar 21 2014 - Updated Mar 22 2014 - 1 reports

In Battle of First-Line HIV Drugs, Raltegravir Beats Two Protease Inhibitors

Three commonly used first-line HIV medications -- boosted atazanavir (Reyataz), boosted darunavir (Prezista) and raltegravir (Isentress) -- all deserve their place among the list of preferred drugs in official U.S. treatment guidelines, according to results ... [Published The Body - Mar 21 2014]
First reported Mar 18 2014 - Updated Mar 18 2014 - 1 reports

Three ART Regimens Don't Differ in 144-Week "Target Not Detected" Response

Download the PDF hereCROI 2014, March 3-6, 2014, BostonMark MascoliniRegimens containing elvitegravir, efavirenz, or atazanavir/ritonavir did not differ in 144-week viral suppression to a "target-not-detected" (TND) response on the Amplicor assay, according ... [Published National AIDS Treatment Advocacy Project - Mar 18 2014]
First reported Mar 14 2014 - Updated Mar 14 2014 - 1 reports

GILEAD SCIENCES - New HIV + HCV Products to Sustain the Growth Trajectory

- - a new market research report on companiesandmarkets.comInitial sales of newly added HIV products - Complera/ Eviplera (L, truvada + rilpivirine), Stribild (L in US, R in EU, truvada+ cobicistat+ elvitegravir) along with growth in other marketed products ... [Published PR inside - Mar 14 2014]
First reported Mar 12 2014 - Updated Mar 12 2014 - 1 reports

Combo pill of atazanavir and cobicistat is equal to taking both drugs separately

Facebook Twitter Google + Email PrintIn this Phase 3 study of people reported at the 2014 CROI (Conference on Retroviruses and Opportunistic Infections) in Boston, 48-week results showed that the combo pill ATV+COBI was equal to taking the drugs separately, ... [Published Project Inform - Mar 12 2014]
First reported Mar 11 2014 - Updated Mar 11 2014 - 1 reports

GILEAD SCIENCES - New HIV + HCV Products to Sustain the Growth Trajectory

(live-PR.com) - Initial sales of newly added HIV products - Complera/ Eviplera (L, truvada + rilpivirine), Stribild (L in US, R in EU, truvada+ cobicistat+ elvitegravir) along with growth in other marketed products contributed to the impressive 4Q12/FY13 ... [Published Live-PR.com - Mar 11 2014]
First reported Mar 07 2014 - Updated Mar 08 2014 - 1 reports

In Battle of First-Line HIV Drugs, Raltegravir Beats Two Protease Inhibitors

It is an increasingly rare sight in HIV research: large, well-constructed studies directly comparing HIV antiretrovirals that are already in widespread use. (And it's likely to become even rarer, given in the U.S.) But the AIDS Clinical Trials Group study ... [Published The Body PRO - Mar 07 2014]

Quotes

When I met with the physician to discuss starting HIV meds, he looked at me and asked, "What medication would you like to take? You are knowledgeable enough, which one would you like to start?" This threw me back because I didn't even know if I was currently resistant to any particular drugs...
...at week 96 for atazanavir (+284 cells/mm 3 ) and raltegravir (+288 cells/mm 3 ), with darunavir slipping slightly behind (256 cells/mm 3 ). "These modest differences do achieve statistical significance compared to the other two arms" Landovitz said in his presentation, but "their clinical relevance is questionable."
chief Dr. Andrew Cheng stated in a corporate press release: "With new government guidelines recommending that people diagnosed"
Gilead's executive vice president of Corporate and Medical Affairs, Gregg H Alton said, "The appointment of Mylan as our branded medicine business partner in India is a result of their strong knowledge of the Indian healthcare system and demonstrated capabilities of supporting and distributing antiretroviral therapies. We have established an excellent working relationship with Mylan over the past few years, and believe that their operations in India will allow the company to best serve the needs of patients in that country."

More Content

All (24) | News (20) | Reports (0) | Blogs (4) | Audio/Video (0) | Fact Sheets (0) | Press Releases (0)
sort by: Date | Relevance
FDA is Asked to Reconsider Denial of NCE Exclus... [Published FDA Law Blog - Apr 09 2014]
New combo pill of Prezista + cobicistat gets su... [Published Project Inform - Apr 09 2014]
Starting Antiretrovirals Wasn't an Option [Published The Body - Apr 02 2014]
HIV [Published Lancet - Apr 01 2014]
The Kidney at CROI 2014 [Published National AIDS Treatment Advocacy Project - Mar 29 2014]
Starting HIV Treatment and Corporate Greed: An ... [Published The Body - Mar 29 2014]
21st Conference on Retroviruses and Opportunist... [Published National AIDS Treatment Advocacy Project - Mar 22 2014]
In Battle of First-Line HIV Drugs, Raltegravir ... [Published The Body - Mar 21 2014]
Three ART Regimens Don't Differ in 144-Week "Ta... [Published National AIDS Treatment Advocacy Project - Mar 18 2014]
CROI 2014: Raltegravir Has Edge Over 2 HIV Prot... [Published HIV and Hepatitis.com - Mar 14 2014]
GILEAD SCIENCES - New HIV + HCV Products to Sus... [Published PR inside - Mar 14 2014]
Combo pill of atazanavir and cobicistat is equa... [Published Project Inform - Mar 12 2014]
GILEAD SCIENCES - New HIV + HCV Products to Sus... [Published Live-PR.com - Mar 11 2014]
Global Stribild market: Latest market research ... [Published Live-PR.com - Mar 11 2014]
Global Quad 2 market: New market research publi... [Published Live-PR.com - Mar 11 2014]
Global elvitegravir market: New market research... [Published Live-PR.com - Mar 11 2014]
In Battle of First-Line HIV Drugs, Raltegravir ... [Published The Body PRO - Mar 07 2014]
FDA Denies 3 Petitions Seeking NCE Exclusivity ... [Published FDA Law Blog - Feb 24 2014]
Opinion/decision on a Paediatric Investigation ... [Published Opinion/decision on a Paediatric Investigation ... - Feb 20 2014]
Product Positioning 2.0 [Published Pharmaceutical Executive - Feb 05 2014]
Opinion/decision on a Paediatric Investigation ... [Published Opinion/decision on a Paediatric Investigation ... - Feb 04 2014]
Mylan named as Gilead's exclusive branded medic... [Published PharmaBiz - Jan 31 2014]
European Commission approves Gilead’s Vitekta f... [Published Pharmaceutical Business Review - Nov 19 2013]
US FDA approves ViiV Healthcare's Tivicay for H... [Published PharmaBiz - Aug 13 2013]
1
In Focus
  •  
  •  
  •  
  •  
  •  
  •  
  •  
  •  
  •  
Content Volume
Document Volume
Network
Network

Blogs

sort by: Date | Relevance
FDA is Asked to Reconsider Denial of NCE Exclus... [Published FDA Law Blog - Apr 09 2014]
By Kurt R. Karst –When FDA announced on February 21, 2014 that the Agency would, upon finalization of a draft guidance document, reinterpret the New Chemical Entity (“NCE”) exclusivity provisions of the FDC Act to award NCE exclusivity for a newly approved ...
FDA Denies 3 Petitions Seeking NCE Exclusivity ... [Published FDA Law Blog - Feb 24 2014]
By Kurt R. Karst –In moves that may displease both brand-name and generic drug manufacturers, and that could lead to litigation from both sides, FDA has with one hand proposed to giveth New Chemical Entity (“NCE”) exclusivity to certain Fixed-Dose Combination ...
Opinion/decision on a Paediatric Investigation ... [Published Opinion/decision on a Paediatric Investigation ... - Feb 20 2014]
Opinion/decision on a Paediatric Investigation ... [Published Opinion/decision on a Paediatric Investigation ... - Feb 04 2014]
1
Contact Us
Sales
Support


Freebase CC-BY Some image thumbnails are sourced from Freebase, licensed under CC-BY

Copyright (C) 2014 Silobreaker Ltd. All rights reserved.
The selection and placement of stories and images on any Silobreaker page are determined automatically by a computer program.
The time or date displayed reflects when an article was added to or updated in Silobreaker.