GILEAD SCIENCES 885823 (Seite 332)
eröffnet am 20.02.06 13:18:36 von
neuester Beitrag 13.02.24 21:17:08 von
neuester Beitrag 13.02.24 21:17:08 von
Beiträge: 3.632
ID: 1.041.671
ID: 1.041.671
Aufrufe heute: 0
Gesamt: 481.750
Gesamt: 481.750
Aktive User: 0
ISIN: US3755581036 · WKN: 885823 · Symbol: GILD
60,91
EUR
-0,28 %
-0,17 EUR
Letzter Kurs 02.05.24 Tradegate
Neuigkeiten
| Gilead Sciences Aktien jetzt im kostenlosen Demokonto handeln!Anzeige |
02.05.24 · Shareribs Anzeige |
30.04.24 · Business Wire (engl.)  |
30.04.24 · Shareribs Anzeige |
26.04.24 · Shareribs Anzeige |
Werte aus der Branche Pharmaindustrie
| Wertpapier | Kurs | Perf. % |
|---|---|---|
| 1,2000 | +471,16 | |
| 13,110 | +38,44 | |
| 1,8250 | +35,19 | |
| 1,2100 | +21,00 | |
| 27,50 | +19,57 |
| Wertpapier | Kurs | Perf. % |
|---|---|---|
| 40,23 | -12,54 | |
| 4,5001 | -13,46 | |
| 1,4500 | -18,08 | |
| 0,9378 | -18,55 | |
| 36,70 | -22,87 |
Beitrag zu dieser Diskussion schreiben
Feedback
So, heute folgte der zweite Streich:
FDA Advisory Committee Supports Approval of Gilead’s Once-Daily Quad Single Tablet Regimen for HIV
– Final FDA Decision On The Quad Anticipated Late Summer –
FOSTER CITY, Calif.--(BUSINESS WIRE)--May. 11, 2012-- Gilead Sciences, Inc. (Nasdaq: GILD) today announced that the Antiviral Drugs Advisory Committee of the U.S. Food and Drug Administration (FDA) has voted 13 to 1 in support of approval of the Quad, a complete single tablet regimen of elvitegravir, cobicistat, emtricitabine and tenofovir disoproxil fumarate, for the treatment of HIV-1 infection in treatment-naïve adults.
The recommendations of the Advisory Committee are not binding, but will be considered by FDA as the agency completes its review of Gilead’s New Drug Application (NDA) of the Quad. Gilead submitted the NDA on October 27, 2011 and FDA has set a target action date under the Prescription Drug User Fee Act (PDUFA) of August 27, 2012. Applications for marketing approval of the Quad are also pending in Australia, Canada and the European Union.
“With new government guidelines recommending that people diagnosed with HIV begin treatment early, it is important that we continue to simplify and improve HIV therapy,” said Andrew Cheng, MD, PhD, Senior Vice President, HIV Therapeutics and Development Operations, Gilead Sciences. “The Quad is the latest example of Gilead’s ongoing efforts to develop highly effective and well tolerated single tablet regimens for people living with HIV.”
The Quad NDA is supported by the positive results from two pivotal Phase 3 studies in which Quad met its primary objective of non-inferiority as compared to Atripla® (efavirenz 600 mg/emtricitabine 200 mg/tenofovir disoproxil fumarate 300 mg) (Study 102) and to a regimen containing ritonavir-boosted atazanavir plus Truvada® (Study 103). The NDA is also supported by Chemistry, Manufacturing and Controls (CMC) information on the individual components of the Quad and the co-formulated single tablet regimen.
In all studies, the Quad was well tolerated and most adverse events were mild to moderate. The most common adverse events observed were nausea, diarrhea, upper respiratory track infection and headache. Overall, there have been nearly 9 million patient years of experience with tenofovir-containing regimens.
About the Quad
The Quad contains four Gilead compounds in a complete once-daily, single tablet regimen: elvitegravir 150 mg; cobicistat 150 mg, a “boosting” agent that enables elvitegravir once-daily dosing; and Truvada (emtricitabine 200 mg/tenofovir disoproxil fumarate 300 mg).
Elvitegravir is a member of the integrase inhibitor class of antiretroviral compounds. Unlike other classes, integrase inhibitors interfere with HIV replication by blocking the ability of the virus to integrate into the genetic material of human cells. Elvitegravir was licensed by Gilead from Japan Tobacco Inc. (JT) in March 2005. Under the terms of Gilead’s agreement with JT, Gilead has exclusive rights to develop and commercialize elvitegravir in all countries of the world, excluding Japan, where JT retains rights.
Cobicistat is Gilead’s proprietary potent mechanism-based inhibitor of cytochrome P450 3A (CYP3A), an enzyme that metabolizes drugs in the body. Cobicistat acts only as a pharmacoenhancer and has no antiviral activity. In addition to studying the agent as part of the Quad, Gilead is also examining cobicistat’s potential in boosting commercially available HIV protease inhibitors.
The Quad, elvitegravir and cobicistat are investigational products and their safety and efficacy have not yet been established.
FDA Advisory Committee Supports Approval of Gilead’s Once-Daily Quad Single Tablet Regimen for HIV
– Final FDA Decision On The Quad Anticipated Late Summer –
FOSTER CITY, Calif.--(BUSINESS WIRE)--May. 11, 2012-- Gilead Sciences, Inc. (Nasdaq: GILD) today announced that the Antiviral Drugs Advisory Committee of the U.S. Food and Drug Administration (FDA) has voted 13 to 1 in support of approval of the Quad, a complete single tablet regimen of elvitegravir, cobicistat, emtricitabine and tenofovir disoproxil fumarate, for the treatment of HIV-1 infection in treatment-naïve adults.
The recommendations of the Advisory Committee are not binding, but will be considered by FDA as the agency completes its review of Gilead’s New Drug Application (NDA) of the Quad. Gilead submitted the NDA on October 27, 2011 and FDA has set a target action date under the Prescription Drug User Fee Act (PDUFA) of August 27, 2012. Applications for marketing approval of the Quad are also pending in Australia, Canada and the European Union.
“With new government guidelines recommending that people diagnosed with HIV begin treatment early, it is important that we continue to simplify and improve HIV therapy,” said Andrew Cheng, MD, PhD, Senior Vice President, HIV Therapeutics and Development Operations, Gilead Sciences. “The Quad is the latest example of Gilead’s ongoing efforts to develop highly effective and well tolerated single tablet regimens for people living with HIV.”
The Quad NDA is supported by the positive results from two pivotal Phase 3 studies in which Quad met its primary objective of non-inferiority as compared to Atripla® (efavirenz 600 mg/emtricitabine 200 mg/tenofovir disoproxil fumarate 300 mg) (Study 102) and to a regimen containing ritonavir-boosted atazanavir plus Truvada® (Study 103). The NDA is also supported by Chemistry, Manufacturing and Controls (CMC) information on the individual components of the Quad and the co-formulated single tablet regimen.
In all studies, the Quad was well tolerated and most adverse events were mild to moderate. The most common adverse events observed were nausea, diarrhea, upper respiratory track infection and headache. Overall, there have been nearly 9 million patient years of experience with tenofovir-containing regimens.
About the Quad
The Quad contains four Gilead compounds in a complete once-daily, single tablet regimen: elvitegravir 150 mg; cobicistat 150 mg, a “boosting” agent that enables elvitegravir once-daily dosing; and Truvada (emtricitabine 200 mg/tenofovir disoproxil fumarate 300 mg).
Elvitegravir is a member of the integrase inhibitor class of antiretroviral compounds. Unlike other classes, integrase inhibitors interfere with HIV replication by blocking the ability of the virus to integrate into the genetic material of human cells. Elvitegravir was licensed by Gilead from Japan Tobacco Inc. (JT) in March 2005. Under the terms of Gilead’s agreement with JT, Gilead has exclusive rights to develop and commercialize elvitegravir in all countries of the world, excluding Japan, where JT retains rights.
Cobicistat is Gilead’s proprietary potent mechanism-based inhibitor of cytochrome P450 3A (CYP3A), an enzyme that metabolizes drugs in the body. Cobicistat acts only as a pharmacoenhancer and has no antiviral activity. In addition to studying the agent as part of the Quad, Gilead is also examining cobicistat’s potential in boosting commercially available HIV protease inhibitors.
The Quad, elvitegravir and cobicistat are investigational products and their safety and efficacy have not yet been established.
Antwort auf Beitrag Nr.: 43.151.416 von Highjumper2 am 11.05.12 10:06:45Ja, es klingt so. Und "klingt so" ist die richtige Beschreibung. Die Sache ist hoch problematisch und man kann es nicht ausschließen, dass das alles am Ende mehr Schaden als Nutzen stiftet.
Trotzdem denke ich, dass die FDA der Empfehlung des Panel folgen wird.
Hier einige Pro und Contra-Argumente bezüglich des präventiven Einsatzes von Truvada (das kein neuer Wirkstoff ist!):
http://www.businessweek.com/news/2012-05-10/gilead-s-pill-wi…
Trotzdem denke ich, dass die FDA der Empfehlung des Panel folgen wird.
Hier einige Pro und Contra-Argumente bezüglich des präventiven Einsatzes von Truvada (das kein neuer Wirkstoff ist!):
http://www.businessweek.com/news/2012-05-10/gilead-s-pill-wi…
Antwort auf Beitrag Nr.: 43.151.218 von SLGramann am 11.05.12 09:40:41klingt ja nachn einem Impfstoff gegen HIV-Ansteckung oder?
FDA Advisory Committee Supports Approval of Gilead’s Truvada® for Reducing the Risk of Acquiring HIV
FOSTER CITY, Calif.--(BUSINESS WIRE)--May. 10, 2012-- Gilead Sciences, Inc. (Nasdaq:GILD) today announced that the Antiviral Drugs Advisory Committee of the U.S. Food and Drug Administration (FDA) has voted to support approval of once-daily oral Truvada® (emtricitabine and tenofovir disoproxil fumarate) to reduce the risk of HIV-1 infection among uninfected adults, an HIV prevention strategy called pre-exposure prophylaxis or PrEP. If the FDA decides to approve Truvada for PrEP, it would be the first agent indicated for uninfected individuals to reduce their risk of acquiring HIV.
In response to questions posed to the committee, members voted 19 to 3 in favor of approval for Truvada for PrEP in men who have sex with men; 19 to 2 (with 1 abstaining) in support of use in HIV-uninfected partners in serodiscordant couples; and 12 to 8 (with 2 abstaining) in other individuals at risk for acquiring HIV through sexual activity.
The recommendations of the Advisory Committee are not binding, but will be considered by the FDA as the agency completes its six-month priority review of Gilead’s supplemental New Drug Application (sNDA) of Truvada for PrEP. Gilead submitted the sNDA on December 15, 2011 and the FDA has established a target review date under the Prescription Drug User Fee Act (PDUFA) of June 15, 2012.
--------------------
Wenn heute das Panel auch eine positive Empfehlung zu Quad abgibt, was ich hoffe und wovon ich auch ausgehe, hätte Gilead einiges getan, um sein HIV-Geschäft für die nächsten Jahre abzusichern.
Mal sehen, wie es heute Nacht wirklich ausgeht.
FOSTER CITY, Calif.--(BUSINESS WIRE)--May. 10, 2012-- Gilead Sciences, Inc. (Nasdaq:GILD) today announced that the Antiviral Drugs Advisory Committee of the U.S. Food and Drug Administration (FDA) has voted to support approval of once-daily oral Truvada® (emtricitabine and tenofovir disoproxil fumarate) to reduce the risk of HIV-1 infection among uninfected adults, an HIV prevention strategy called pre-exposure prophylaxis or PrEP. If the FDA decides to approve Truvada for PrEP, it would be the first agent indicated for uninfected individuals to reduce their risk of acquiring HIV.
In response to questions posed to the committee, members voted 19 to 3 in favor of approval for Truvada for PrEP in men who have sex with men; 19 to 2 (with 1 abstaining) in support of use in HIV-uninfected partners in serodiscordant couples; and 12 to 8 (with 2 abstaining) in other individuals at risk for acquiring HIV through sexual activity.
The recommendations of the Advisory Committee are not binding, but will be considered by the FDA as the agency completes its six-month priority review of Gilead’s supplemental New Drug Application (sNDA) of Truvada for PrEP. Gilead submitted the sNDA on December 15, 2011 and the FDA has established a target review date under the Prescription Drug User Fee Act (PDUFA) of June 15, 2012.
--------------------
Wenn heute das Panel auch eine positive Empfehlung zu Quad abgibt, was ich hoffe und wovon ich auch ausgehe, hätte Gilead einiges getan, um sein HIV-Geschäft für die nächsten Jahre abzusichern.
Mal sehen, wie es heute Nacht wirklich ausgeht.
Gilead Sciences stellt diese Woche auf europäischer Konferenz zu Lebererkrankungen neue Daten zu Hepatitis B und C vor
http://www.finanznachrichten.de/nachrichten-2012-04/23292253…
http://www.finanznachrichten.de/nachrichten-2012-04/23292253…
Trading Spotlight
Antwort auf Beitrag Nr.: 42.699.091 von geldspender am 04.02.12 10:53:09Habe ich was verpasst??
Gruß
Taxadvisor
Gruß
Taxadvisor
Durchsuchen
