Elvitegravir

Type: Keyphrase
Name: Elvitegravir
First reported Jul 31 2014 - Updated Jul 31 2014 - 1 reports

Lack of Clinically Relevant Drug Interactions Between Elvitegravir plus Ritonavir Boosted-Atazanavir and Telaprevir

20th International AIDS ConferenceJuly 20-25, 2014Melbourne, Australia Reported by 20th International AIDS Conference, July 20-25, 2014, MelbourneJM Custodio, S Guo, EB Lawson, H Cao, A Silva, BP Kearney, and S Ramanathan Gilead Sciences, Inc., Foster ... [Published National AIDS Treatment Advocacy Project - Jul 31 2014]
First reported Jul 29 2014 - Updated Jul 29 2014 - 2 reports

Week 144 Renal Safety of Elvitegravir/Cobicistat/Emtricitabine/Tenofovir DF (STB) from Two Phase 3 Randomized Controlled Trials

20th International AIDS ConferenceJuly 20-25, 2014Melbourne, Australia Reported by 20th International AIDS Conference, July 20-25, 2014, MelbourneC Cohen1, F Post2, J Winston3, B Hendry2, B Gazzard4, P Girard5, G Faetkenheur6, A Antinori7, M Fisher8, ... [Published National AIDS Treatment Advocacy Project - Jul 29 2014]
First reported Jul 28 2014 - Updated Jul 28 2014 - 1 reports

Gilead Sciences Posts 2Q 2014 Financial Results

Gilead Sciences has reported its results of operations for the quarter ended June 30. In its release on July 23, the company noted that total revenues for the second quarter of 2014 increased to $6.53 billion compared to $2.77 billion for the second quarter ... [Published Individual.com - Jul 28 2014]
First reported Jul 24 2014 - Updated Jul 25 2014 - 3 reports

Medicines Patent Pool broadens collaboration with Gilead Sciences

The Medicines Patent Pool (MPP) has entered into a new licensing agreement with US biotech firm Gilead Sciences (Nasdaq: GILD) for tenofovir alafenamide (TAF), a promising new medicine currently in Phase III studies for the treatment of AIDS, it was announced ... [Published Pharma Letter - Jul 24 2014]
First reported Jul 24 2014 - Updated Jul 24 2014 - 3 reports

Gilead beats forecasts as Sovaldi sales soar

US anti-virals specialist biotech firm Gilead Sciences (Nasdaq: GILD) has reported surging second-quarter 2014 sales and profits, boosted by a sharp quarter on quarter rise in revenues from its latest hepatitis C drug Sovaldi (sofosbuvir) and exceed analysts’ ... [Published Pharma Letter - Jul 24 2014]
First reported Jul 22 2014 - Updated Jul 22 2014 - 1 reports

New Guidelines for Treatment of HIV Infection in Adults

Experts update 2012 recommendationsA panel of international experts in human immunodeficiency virus (HIV) research and patient care has provided updated treatment recommendations for adults with HIV, emphasizing when to start treatment; what treatment ... [Published PT Community - Jul 22 2014]
First reported Jul 17 2014 - Updated Jul 17 2014 - 1 reports

Dolutegravir: Clinical Efficacy and Role in HIV Therapy

Achhra, A. and Boyd, M. (2013) Antiretroviral regimens sparing agents from the nucleoside(tide) reverse transcriptase inhibitor class: a review of the recent literature. AIDS Res Ther 10: 33.Akil, B., Blick, G., Hagins, D., Ramgopal, M., Richmond, G. ... [Published General Medicine eJournal - Jul 17 2014]
First reported Jul 07 2014 - Updated Jul 07 2014 - 1 reports

Gilead Sciences Has A Realistic Path To $100

author name submits:Gilead Sciences ( GILD ) is an appealing holding for long-term investors for three reasons: it possesses high earnings quality right now, is currently buying back large amounts of stock, and offers a track for long-term growth.Related ... [Published BioPortfolio - Jul 07 2014]
First reported Jul 03 2014 - Updated Jul 03 2014 - 1 reports

Injectable PrEP studyseeks SF volunteers

A single injection might allow sexually active people to throw away the condoms and be completely protected from HIV infection for up to three months. This form of PrEP - or pre-exposure prophylaxis - could be a reality in as little as five years, say ... [Published Bay Area Reporter - Jul 03 2014]
First reported May 15 2014 - Updated May 15 2014 - 1 reports

Human medicines European public assessment report (EPAR): Vitekta, elvitegravir, Revision: 1, Authorised

Entities: Elvitegravir
First reported Apr 23 2014 - Updated Apr 24 2014 - 1 reports

US FDA accepts Gilead’s NDA for cobicistat & elvitegravir for HIV therapy

The US Food and Drug Administration (US FDA) has accepted the Gilead Sciences' refiling of two New Drug Applications (NDA) for cobicistat, a pharmacoenhancing or “boosting” agent that increases blood levels of the protease inhibitors atazanavir and darunavir ... [Published PharmaBiz - Apr 23 2014]
First reported Apr 21 2014 - Updated Apr 22 2014 - 1 reports

Gilead Sciences’ New Drug Applications for Cobicistat and Elvitegravir for HIV Therapy Accepted by U.S. FDA

FOSTER CITY, Calif.--(BUSINESS WIRE)--Gilead Sciences, Inc. (Nasdaq:GILD) today announced that the U.S. Food and Drug Administration (FDA) has accepted the company’s refiling of two New Drug Applications (NDA) for cobicistat, a pharmacoenhancing or “boosting” ... [Published Business Wire Health News - Apr 21 2014]

Quotes

...and Europe, underscoring the medical community's recognition of the benefits of this product," said John C Martin, PhD, Gilead's Chairman and CEO. "We look forward to making Sovaldi available in additional countries."
...to both patented pipeline and existing medicines," said Gregg Alton , Executive Vice President, Corporate and Medical Affairs for Gilead Sciences. "Our three-year collaboration has been very successful thus far. Countries eligible for generic competition for TDF, for example, have increased dramatically to the ultimate benefit of many national treatment programmes in key resource-limited countries."
"VIKING, an open-label, single-arm pilot study with 2 sequential cohorts of HIV-1-infected adults failing their current regimen with current or historic RAL treatment failure, evidence of RAL resistance at screening, and resistance in ≥1 other ART class [41]. The 50 mg once-daily dose of DTG was initially selected for evaluation in cohort I (n = 27); however, the suboptimal viral load response in some participants prompted an amendment to the protocol, and the dose was increased to 50 mg twice daily in cohort II (n = 24). The treatment phase for both cohorts involved a 10-day functional monotherapy period, where the participants were given DTG plus their currently failing ART (minus RAL), followed by a second phase from day 11 to 24 weeks where they were given DTG plus an investigator-selected OBR. In cohort I, it was suggested that participants have ≥1 active agent in the OBR, but it was mandated for cohort II. The primary efficacy endpoint was the proportion of participants on day 11 with a VL"
"Sovaldi has shown tremendous results, and it's the kind of medical innovation we need to sustain," the AHIP blog post states. "Unfortunately, the drug's maker … has priced it at an astronomical level that is not sustainable for consumers, innovation or society."

More Content

All (30) | News (22) | Reports (0) | Blogs (8) | Audio/Video (0) | Fact Sheets (0) | Press Releases (0)
sort by: Date | Relevance
Lack of Clinically Relevant Drug Interactions B... [Published National AIDS Treatment Advocacy Project - Jul 31 2014]
Week 144 Renal Safety of Elvitegravir/Cobicista... [Published National AIDS Treatment Advocacy Project - Jul 29 2014]
Elvitegravir/Cobicistat/Emtricitabine/Tenofovir... [Published National AIDS Treatment Advocacy Project - Jul 29 2014]
Gilead Sciences Posts 2Q 2014 Financial Results [Published Individual.com - Jul 28 2014]
Gilead beats forecasts as Sovaldi sales soar [Published Pharma Letter - Jul 24 2014]
Gilead Crushes Q2 Earnings Estimates as Sovaldi... [Published Yahoo! Finance - Jul 24 2014]
Medicines Patent Pool broadens collaboration wi... [Published Pharma Letter - Jul 24 2014]
Gilead's Sovaldi soars with sales of $3.48 billion [Published Pharma Times - Jul 24 2014]
MPP–Gilead agreement: Opportunity for Indian dr... [Published Hindu Business Line - Jul 24 2014]
The Medicines Patent Pool (MPP) Broadens Collab... [Published Wall Street Business Network - Jul 24 2014]
New Guidelines for Treatment of HIV Infection i... [Published PT Community - Jul 22 2014]
Dolutegravir: Clinical Efficacy and Role in HIV... [Published General Medicine eJournal - Jul 17 2014]
Dolutegravir: A Next-Generation Integrase Inhib... [Published National AIDS Treatment Advocacy Project - Jul 14 2014]
Gilead Sciences Has A Realistic Path To $100 [Published BioPortfolio - Jul 07 2014]
Gilead Sciences Has A Realistic Path To $100 [Published Seeking Alpha - Jul 07 2014]
ViiV Healthcare’s Triumeq for HIV Gets CHMP Nod [Published FDA News - Jul 04 2014]
Injectable PrEP studyseeks SF volunteers [Published Bay Area Reporter - Jul 03 2014]
Lauren Rudd: Merck, naysayers have yet to destr... [Published Northwestern - Jun 15 2014]
Human medicines European public assessment repo... [Published Pending EC decisions and European Public Assess ... - May 15 2014]
Human medicines European public assessment repo... [Published Pending EC decisions and European Public Assess ... - May 15 2014]
US FDA accepts Gilead’s NDA for cobicistat & el... [Published PharmaBiz - Apr 23 2014]
A Second Company Asks FDA to Reconsider Denial ... [Published FDA Law Blog - Apr 22 2014]
Gilead Sciences’ New Drug Applications for Cobi... [Published Business Wire Health News - Apr 21 2014]
FDA is Asked to Reconsider Denial of NCE Exclus... [Published FDA Law Blog - Apr 09 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]
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Human medicines European public assessment repo... [Published Pending EC decisions and European Public Assess ... - May 15 2014]
Human medicines European public assessment repo... [Published Pending EC decisions and European Public Assess ... - May 15 2014]
A Second Company Asks FDA to Reconsider Denial ... [Published FDA Law Blog - Apr 22 2014]
By Kurt R. Karst –The battle over New Chemical Entity (“NCE”) exclusivity for Fixed-Dose Combination (“FDC”) drugs continues to heat up.  In a recent Petition for Reconsideration and Petition for Stay (Docket No. FDA-2013-P-0119), Ferring Pharmaceuticals, ...
Gilead Sciences’ New Drug Applications for Cobi... [Published Business Wire Health News - Apr 21 2014]
FOSTER CITY, Calif.--(BUSINESS WIRE)--Gilead Sciences, Inc. (Nasdaq:GILD) today announced that the U.S. Food and Drug Administration (FDA) has accepted the company’s refiling of two New Drug Applications (NDA) for cobicistat, a pharmacoenhancing or “boosting” ...
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 ...
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