NicOx.... in attesa di..... (2 lettori)
- Creatore Discussione DickSIM
- Data di Inizio
furo
Forumer attivo
viralic
Forumer storico
intanto MG è rimasto al timone contro le vostre pedate e cacciatepovero koglionazzo
succate
bello vedervi annaspare con le azioni in portafoglio ed il pensiero che a condurre l'investimento è colui che odiate
Doc....ma non capisci che dicendo queste frasi per rispondere a guly o a Zohar offendi tutti quelli che ci hanno messo soldi spesso sudati e che ora si trovano con un pugno di mosche in mano ( per ora) non sapendo se e quando si recupererà i soldi investiti ( almeno quelli, perchè il guadagno possiamo anche scordarcelo).........per favore, per rispetto a tutti noi..dacci un taglio e parliamo solo di quello che Nicox potrà fare nel prossimo futuro..ipotesi, news, illazioni....ma attenendoci al titolo non al personale del singolo forumers....Thank you !!!
DickSIM
Prima o poi....ci becco!
Doc....ma non capisci che dicendo queste frasi per rispondere a guly o a Zohar offendi tutti quelli che ci hanno messo soldi spesso sudati e che ora si trovano con un pugno di mosche in mano ( per ora) non sapendo se e quando si recupererà i soldi investiti ( almeno quelli, perchè il guadagno possiamo anche scordarcelo).........per favore, per rispetto a tutti noi..dacci un taglio e parliamo solo di quello che Nicox potrà fare nel prossimo futuro..ipotesi, news, illazioni....ma attenendoci al titolo non al personale del singolo forumers....Thank you !!!
concordo e jumbojetto con vic.... doc sfogati se e quando ci sarà da sfogarsi...fino ad allora post costruttivi e non di becera denigrazione... anche perchè tanto ormai le litanie in un senso e nell'altro sono STRA RISAPUTE. grazie.guly
Forumer storico
guarda io ti dico solo questo:
1. io continuero' ad esprimere i miei pareri su questo forum a prescindere da tutto e da tutti.sia che abbia o non abbia piu' le azioni in quanto ho gia' spiegato i motivi.
2. di quello che dicono certe persone (due esattamente) non me ne frega piu' niente e come vedi neanche rispondo piu' alle loro provocazioni(a uno da sempre ad un altro da piu' breve tempo)
3.tu puoi pensare e dire quello che vuoi nei miei confronti (sempre entro i limiti consentiti dalla buona creanza)e comunque hai sempre la possibilita'(se ti do'fastidio) di mettermi nella lista ignora oppure (come faccio io per quelli che non mi interessano piu')non mi prendere in considerazione,sorvola i miei post (che poi sono sempre meno visto l'interesse che va scemando sul titolo).e come fai con me fai con gli altri che ti disturbano.ignorali o fattici sopra una risata (metaforica).io faccio cosi nei confronti di chi ti ho sopra indicato.nei tuoi confronti non ho motivo di essere contrariato anche se mi hai definito in quel modo,ti posso anche capire.un saluto cordiale
Ultima modifica:
simis
Encoxé à fond
Novartis doit aussi revoir sa copie ...
Comme pour NicOx le panel a dit non mais est enthousiasmé ...
Novartis International AG / FDA panel endorses efficacy but not safety of Novartis drug ACZ885 for gouty arthritis; did not support approval in proposed indication . Processed and transmitted by Thomson Reuters ONE. The issuer is solely responsible for the content of this announcement.
Advisory committee strongly endorsed the efficacy of ACZ885 (canakinumab)
Committee voted against approval of ACZ885 for proposed indication; potential identified for use in more narrow patient population
Gouty arthritis is a chronic and progressive inflammatory disease of the joints characterized by recurrent attacks of severe pain[1], lasting a week or more[2]
Basel, June 21, 2011 - An advisory committee of the Food and Drug Administration (FDA) today voted in favor of the overall efficacy but not the overall safety of ACZ885 (canakinumab) to treat gouty arthritis attacks in patients who cannot obtain adequate relief with non-steroidal anti-inflammatory drugs (NSAIDs) or colchicine. Committee members raised the potential for use in a more narrow population of gouty arthritis patients.
ACZ885, a fully human monoclonal antibody that neutralizes interleukin-1 beta (IL-1 beta)[3], would represent the first new class of therapies in nearly half a century to treat the pain and inflammation of gouty arthritis. Excessive production of IL-1 beta is believed to play a major role in many inflammatory diseases, including gouty arthritis[4].
"We continue to believe in the benefits of ACZ885 for this painful and debilitating disease and will work closely with the FDA to identify the right patient population who will benefit from this therapy," said Trevor Mundel, MD, Global Head of Development at Novartis Pharmaceuticals. "We are encouraged by the committee's enthusiasm and robust discussion and remain committed to addressing the needs of people with gouty arthritis."
The committee's recommendation will be considered by the FDA in its review of the supplemental biologics license application (sBLA) that Novartis submitted for ACZ885. The FDA has the option of seeking the advice of its advisory committees when it is reviewing a new drug approval, although it is not obliged to follow the recommendations.
The recommendation by the committee was based on the results of two pivotal Phase III trials in patients with gouty arthritis. The studies showed patients treated with ACZ885 experienced superior pain relief at 72 hours and a significant reduction in the risk of new attacks over six months, compared to patients treated with the injectable steroid, triamcinolone acetonide (TA)[5].
Gouty arthritis is the most common form of inflammatory arthritis in adults[6]. Chronic and progressive, the disease is characterized by recurrent attacks in the joints[1]. These attacks occur when the body has a strong inflammatory response to uric acid crystals forming in the affected joint, typically of the toe, foot, ankle, or knee[1],[7]. The intense inflammatory response associated with these attacks may cause severe pain and debilitating symptoms that can last a week or more[1],[2],[7].
About ACZ885 Phase III Studies
The committee reviewed results of two pivotal Phase III studies in which the efficacy of ACZ885 150 mg over 24 weeks was studied in more than 450 gouty arthritis patients. Both trials used an internationally recognized pain scale to measure differences in pain 72 hours after treatment. Patients treated with ACZ885 had a significantly lower mean pain score - a 49.1 millimeter (mm) decrease from baseline - resulting in a statistically significant and clinically meaningful 10.7 mm difference (p<0.0001) compared to TA 40 mg[5]. Patients receiving ACZ885 also experienced a significant reduction in the relative risk of suffering a new gouty arthritis attack within 24 weeks, by 56%, compared to patients receiving TA (p<0.0001)[5]. Importantly, only 28% of patients treated with ACZ885 experienced new attacks over 24 weeks compared to 49% treated with TA[5].
ACZ885 was generally well tolerated in the two studies, with most adverse events being mild to moderate in severity[5]. Across both studies, 69.6% of patients had adverse events (AEs) with ACZ885 vs. 57% with TA[5]. Serious events (SAEs) were reported by 18 patients treated with ACZ885 vs. nine patients on TA[5]. None of the SAEs were considered by clinical investigators to be related to study medication[5].
About Gouty Arthritis
Gouty arthritis, commonly referred to as gout, is a painful and debilitating inflammatory disease that affects up to 8.3 million Americans[1],[6],[7]. The most common form of inflammatory arthritis in adults, gouty arthritis is estimated to be five times more prevalent than rheumatoid arthritis in the US[8],[9].
Treatments currently available to manage the pain and inflammation of gouty arthritis attacks, such as NSAIDs or colchicine, may be inadequate or inappropriate in patients who have certain coexisting medical problems[2],[10],[11]. As a result, there is a significant unmet medical need among individuals with gouty arthritis. In the US, over 95% of gouty arthritis patients or those with high levels of uric acid (hyperuricemia) have at least one coexisting disease[12].
About ACZ885
Regulatory filings for the use of ACZ885 in gouty arthritis patients with limited treatment options were submitted in the EU in 2010 and in the US, Canada and Switzerland in the first quarter of 2011. ACZ885 is being assessed by the FDA with a priority review voucher (PRV), which expedites review time from 10 to six months. A decision is expected in the third quarter of 2011.
Under the brand name Ilaris®, ACZ885 is approved in more than 45 countries, including the EU, US and Switzerland for the treatment of adults and children as young as four with Cryopyrin-Associated Periodic Syndromes (CAPS), a rare, lifelong, inflammatory disorder with debilitating symptoms[3]. ACZ885 is also being studied in other diseases in which IL-1 beta plays a key role in causing inflammation, such as Systemic Juvenile Idiopathic Arthritis (SJIA), cardiovascular disease and diabetes. Not all potential patients with these diseases would be eligible for treatment with ACZ885, if approved.
Comme pour NicOx le panel a dit non mais est enthousiasmé ...
Novartis International AG / FDA panel endorses efficacy but not safety of Novartis drug ACZ885 for gouty arthritis; did not support approval in proposed indication . Processed and transmitted by Thomson Reuters ONE. The issuer is solely responsible for the content of this announcement.
Advisory committee strongly endorsed the efficacy of ACZ885 (canakinumab)
Committee voted against approval of ACZ885 for proposed indication; potential identified for use in more narrow patient population
Gouty arthritis is a chronic and progressive inflammatory disease of the joints characterized by recurrent attacks of severe pain[1], lasting a week or more[2]
Basel, June 21, 2011 - An advisory committee of the Food and Drug Administration (FDA) today voted in favor of the overall efficacy but not the overall safety of ACZ885 (canakinumab) to treat gouty arthritis attacks in patients who cannot obtain adequate relief with non-steroidal anti-inflammatory drugs (NSAIDs) or colchicine. Committee members raised the potential for use in a more narrow population of gouty arthritis patients.
ACZ885, a fully human monoclonal antibody that neutralizes interleukin-1 beta (IL-1 beta)[3], would represent the first new class of therapies in nearly half a century to treat the pain and inflammation of gouty arthritis. Excessive production of IL-1 beta is believed to play a major role in many inflammatory diseases, including gouty arthritis[4].
"We continue to believe in the benefits of ACZ885 for this painful and debilitating disease and will work closely with the FDA to identify the right patient population who will benefit from this therapy," said Trevor Mundel, MD, Global Head of Development at Novartis Pharmaceuticals. "We are encouraged by the committee's enthusiasm and robust discussion and remain committed to addressing the needs of people with gouty arthritis."
The committee's recommendation will be considered by the FDA in its review of the supplemental biologics license application (sBLA) that Novartis submitted for ACZ885. The FDA has the option of seeking the advice of its advisory committees when it is reviewing a new drug approval, although it is not obliged to follow the recommendations.
The recommendation by the committee was based on the results of two pivotal Phase III trials in patients with gouty arthritis. The studies showed patients treated with ACZ885 experienced superior pain relief at 72 hours and a significant reduction in the risk of new attacks over six months, compared to patients treated with the injectable steroid, triamcinolone acetonide (TA)[5].
Gouty arthritis is the most common form of inflammatory arthritis in adults[6]. Chronic and progressive, the disease is characterized by recurrent attacks in the joints[1]. These attacks occur when the body has a strong inflammatory response to uric acid crystals forming in the affected joint, typically of the toe, foot, ankle, or knee[1],[7]. The intense inflammatory response associated with these attacks may cause severe pain and debilitating symptoms that can last a week or more[1],[2],[7].
About ACZ885 Phase III Studies
The committee reviewed results of two pivotal Phase III studies in which the efficacy of ACZ885 150 mg over 24 weeks was studied in more than 450 gouty arthritis patients. Both trials used an internationally recognized pain scale to measure differences in pain 72 hours after treatment. Patients treated with ACZ885 had a significantly lower mean pain score - a 49.1 millimeter (mm) decrease from baseline - resulting in a statistically significant and clinically meaningful 10.7 mm difference (p<0.0001) compared to TA 40 mg[5]. Patients receiving ACZ885 also experienced a significant reduction in the relative risk of suffering a new gouty arthritis attack within 24 weeks, by 56%, compared to patients receiving TA (p<0.0001)[5]. Importantly, only 28% of patients treated with ACZ885 experienced new attacks over 24 weeks compared to 49% treated with TA[5].
ACZ885 was generally well tolerated in the two studies, with most adverse events being mild to moderate in severity[5]. Across both studies, 69.6% of patients had adverse events (AEs) with ACZ885 vs. 57% with TA[5]. Serious events (SAEs) were reported by 18 patients treated with ACZ885 vs. nine patients on TA[5]. None of the SAEs were considered by clinical investigators to be related to study medication[5].
About Gouty Arthritis
Gouty arthritis, commonly referred to as gout, is a painful and debilitating inflammatory disease that affects up to 8.3 million Americans[1],[6],[7]. The most common form of inflammatory arthritis in adults, gouty arthritis is estimated to be five times more prevalent than rheumatoid arthritis in the US[8],[9].
Treatments currently available to manage the pain and inflammation of gouty arthritis attacks, such as NSAIDs or colchicine, may be inadequate or inappropriate in patients who have certain coexisting medical problems[2],[10],[11]. As a result, there is a significant unmet medical need among individuals with gouty arthritis. In the US, over 95% of gouty arthritis patients or those with high levels of uric acid (hyperuricemia) have at least one coexisting disease[12].
About ACZ885
Regulatory filings for the use of ACZ885 in gouty arthritis patients with limited treatment options were submitted in the EU in 2010 and in the US, Canada and Switzerland in the first quarter of 2011. ACZ885 is being assessed by the FDA with a priority review voucher (PRV), which expedites review time from 10 to six months. A decision is expected in the third quarter of 2011.
Under the brand name Ilaris®, ACZ885 is approved in more than 45 countries, including the EU, US and Switzerland for the treatment of adults and children as young as four with Cryopyrin-Associated Periodic Syndromes (CAPS), a rare, lifelong, inflammatory disorder with debilitating symptoms[3]. ACZ885 is also being studied in other diseases in which IL-1 beta plays a key role in causing inflammation, such as Systemic Juvenile Idiopathic Arthritis (SJIA), cardiovascular disease and diabetes. Not all potential patients with these diseases would be eligible for treatment with ACZ885, if approved.
Ultima modifica:
doctor NO
NO nel DNA
eh si SIMIS
Pensa un pò!!!!!!!!!!!! Ma anche qui la colpa è dell'AD che guadagna più di Garufi!!!!!!!!!!!!!! E quindi non avendo preso le precauzioni stando al ragionamento di certuni va preso a pedate nel Kulo?????????????' Il y aura une renaissance de notre coxinelle. Il suffit d'attendre
Pensa un pò!!!!!!!!!!!! Ma anche qui la colpa è dell'AD che guadagna più di Garufi!!!!!!!!!!!!!! E quindi non avendo preso le precauzioni stando al ragionamento di certuni va preso a pedate nel Kulo?????????????'
Il y aura une renaissance de notre coxinelle. Il suffit d'attendre
doctor NO
NO nel DNA
vic vic!!!!!!!
tanto non aspetteranno il tempo che serve poichè non ne sono in grado Il DOC pensiero sul futuro della società lo conoscete, io ci credo al 100% e non è un'incidente di percorso a farmi cambiare idea. Io ho fatto da pesticida contro i parassiti noiosi che ogni giorno infestano il forum con cantilene da zanzara. Vedi Vic di Nicox al momento non c'è nulla di cui parlare ma solo aspettare e credimi che leggere il trio di sfigati che si mazzulano i cocones ogni giorno ripetendo la storia del pallonaro dei 500000 € al mese del titolo che non ha futuro ma che intendono mantenere le azioni nonostante tutto, sono una vera agonia Guarda cosa è successo a novartis !!!!!!!!!! Dimmi anche li la colpa è dell'AD!!!!!!!!!!!! Stoppate a furor di popolo le minkiate del trio ed io la smetterò di fare da FLIT
Con tutto quello che hanno detto contro il board il minimo che auguro a loro è quello che da nicox non ci cavino fuori un centDoc....ma non capisci che dicendo queste frasi per rispondere a guly o a Zohar offendi tutti quelli che ci hanno messo soldi spesso sudati e che ora si trovano con un pugno di mosche in mano ( per ora) non sapendo se e quando si recupererà i soldi investiti ( almeno quelli, perchè il guadagno possiamo anche scordarcelo).........per favore, per rispetto a tutti noi..dacci un taglio e parliamo solo di quello che Nicox potrà fare nel prossimo futuro..ipotesi, news, illazioni....ma attenendoci al titolo non al personale del singolo forumers....Thank you !!!
tanto non aspetteranno il tempo che serve poichè non ne sono in grado Il DOC pensiero sul futuro della società lo conoscete, io ci credo al 100% e non è un'incidente di percorso a farmi cambiare idea. Io ho fatto da pesticida contro i parassiti noiosi che ogni giorno infestano il forum con cantilene da zanzara. Vedi Vic di Nicox al momento non c'è nulla di cui parlare ma solo aspettare e credimi che leggere il trio di sfigati che si mazzulano i cocones ogni giorno ripetendo la storia del pallonaro dei 500000 € al mese del titolo che non ha futuro ma che intendono mantenere le azioni nonostante tutto, sono una vera agonia Guarda cosa è successo a novartis !!!!!!!!!! Dimmi anche li la colpa è dell'AD!!!!!!!!!!!! Stoppate a furor di popolo le minkiate del trio ed io la smetterò di fare da FLIT
doctor NO
NO nel DNA
domanda ai detrattori di Garufi. Visto il rifiuto del panel circa la molecola Novartis che sorte spetterebbe al AD e board della società visto il flop di approvazione? Non è che il problema sta in FDA che boccia tutto e non nelle strategie di chi spende milioni di $ per innovazione nel campo farmaceutico? Di questo passo fra 30 anni useremo gli stregoni per curarci.