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Human Genome Sciences Benlysta Drug Approval for Lupus Patients

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Manage episode 151514514 series 1029942
Contenuto fornito da Archive. Tutti i contenuti dei podcast, inclusi episodi, grafica e descrizioni dei podcast, vengono caricati e forniti direttamente da Archive o dal partner della piattaforma podcast. Se ritieni che qualcuno stia utilizzando la tua opera protetta da copyright senza la tua autorizzazione, puoi seguire la procedura descritta qui https://it.player.fm/legal.
New Break through in Human Genome Sciences Benlysta drug approval for lupus patients. SMF will cover the pros and the cons of the HGSI new drug and benefits to humanity. We will take a look at one of the most positive developments in "biotechnology" in the past 50 years. We have highlighted HGSI and the longer term trends relative to the current drug developments. BENLYSTA is an investigational human monoclonal antibody drug. It is the first in a new class of drugs called BLyS-specific inhibitors that recognize and inhibit the biological activity of B-lymphocyte stimulator, or BLyS, which was discovered by HGS in 1996. We and GlaxoSmithKline (GSK) are developing BENLYSTA under a co-development and commercialization agreement entered into in 2006. In lupus, rheumatoid arthritis and certain other autoimmune diseases, elevated levels of BLyS are believed to contribute to the production of autoantibodies – antibodies that attack and destroy the body’s own healthy tissues.
BENLYSTA has successfully met its primary endpoint in two pivotal Phase 3 trials in seropositive patients with systemic lupus erythematosus (SLE). In June 2010, HGS and GSK submitted regulatory applications seeking approval to market BENLYSTA in the United States and Europe. The FDA has granted BENLYSTA a priority review designation with a Prescription Drug User Fee Act (PDUFA) target date of December 9, 2010 – so it is possible that BENLYSTA could receive regulatory approval in the United States before the end of 2010.
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5 episodi

Artwork
iconCondividi
 

Serie archiviate ("Feed non attivo" status)

When? This feed was archived on October 21, 2023 05:48 (5M ago). Last successful fetch was on September 28, 2019 01:48 (4+ y ago)

Why? Feed non attivo status. I nostri server non sono riusciti a recuperare un feed valido per un periodo prolungato.

What now? You might be able to find a more up-to-date version using the search function. This series will no longer be checked for updates. If you believe this to be in error, please check if the publisher's feed link below is valid and contact support to request the feed be restored or if you have any other concerns about this.

Manage episode 151514514 series 1029942
Contenuto fornito da Archive. Tutti i contenuti dei podcast, inclusi episodi, grafica e descrizioni dei podcast, vengono caricati e forniti direttamente da Archive o dal partner della piattaforma podcast. Se ritieni che qualcuno stia utilizzando la tua opera protetta da copyright senza la tua autorizzazione, puoi seguire la procedura descritta qui https://it.player.fm/legal.
New Break through in Human Genome Sciences Benlysta drug approval for lupus patients. SMF will cover the pros and the cons of the HGSI new drug and benefits to humanity. We will take a look at one of the most positive developments in "biotechnology" in the past 50 years. We have highlighted HGSI and the longer term trends relative to the current drug developments. BENLYSTA is an investigational human monoclonal antibody drug. It is the first in a new class of drugs called BLyS-specific inhibitors that recognize and inhibit the biological activity of B-lymphocyte stimulator, or BLyS, which was discovered by HGS in 1996. We and GlaxoSmithKline (GSK) are developing BENLYSTA under a co-development and commercialization agreement entered into in 2006. In lupus, rheumatoid arthritis and certain other autoimmune diseases, elevated levels of BLyS are believed to contribute to the production of autoantibodies – antibodies that attack and destroy the body’s own healthy tissues.
BENLYSTA has successfully met its primary endpoint in two pivotal Phase 3 trials in seropositive patients with systemic lupus erythematosus (SLE). In June 2010, HGS and GSK submitted regulatory applications seeking approval to market BENLYSTA in the United States and Europe. The FDA has granted BENLYSTA a priority review designation with a Prescription Drug User Fee Act (PDUFA) target date of December 9, 2010 – so it is possible that BENLYSTA could receive regulatory approval in the United States before the end of 2010.
  continue reading

5 episodi

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