11 documents

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20:46 , Oct 10, 2017 |  BC Innovations  |  Distillery Therapeutics

Neurology

INDICATION: Ataxia Cell culture studies suggest inhibiting NF-κB could help treat spinocerebellar ataxia type 17 (SCA17), which is caused by CAG/CAA repeat expansions in the TBP gene. In co-cultures of primary neurons and astrocytes from...
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08:00 , Dec 7, 2015 |  BC Week In Review  |  Clinical News

Careram regulatory update

Eisai and Toyama said Japan lifted the condition for approval of Careram/Kolbet iguratimod to treat rheumatoid arthritis. In June 2012, Japan approved the product on the condition that a “use-results survey” was conducted and efficacy...
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07:00 , Mar 12, 2012 |  BC Week In Review  |  Company News

Simcere sales and marketing update

Simcere disclosed in its 4Q11 earnings that during 1Q12 it launched Iremod iguratimod to treat rheumatoid arthritis (RA) in China. China's State Food and Drug Administration approved the oral cyclooxygenase-2 (COX-2) inhibitor last year (see...
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08:00 , Jan 9, 2012 |  BioCentury  |  Finance

PDUFAs produce yawns

Stephen Hansen Senior Writer  There are more than twice as many PDUFA dates this year than last - at least 40 vs. 17 - but only a handful of potential approvals are drumming up interest...
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07:00 , Oct 3, 2011 |  BioCentury  |  Finance

Few Cinderellas this time

Big caps suffered the least in a very ugly quarter. But that's not saying much: biotechs with market caps of more than $5 billion were still down 10% as a group in 3Q, while other...
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07:00 , Sep 5, 2011 |  BC Week In Review  |  Clinical News

Iguratimod regulatory update

Toyama and partner Eisai submitted a regulatory application to Japan's Ministry of Health, Labor and Welfare (MHLW) for iguratimod as an add-on therapy to treat rheumatoid arthritis (RA). The partners co-developed the DMARD that inhibits...
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00:03 , Sep 1, 2011 |  BC Extra  |  Company News

Toyama, Eisai seek iguratimod approval in Japan

Toyama Chemical Co. Ltd (Tokyo:4518) and partner Eisai Co. Ltd. (Tokyo:4523; Osaka:4523) submitted a regulatory application in Japan for iguratimod ( T-614 ) as add-on therapy to treat rheumatoid arthritis. The partners said the product...
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07:00 , Aug 29, 2011 |  BC Week In Review  |  Clinical News

Iremod iguratimod regulatory update

Simcere said China's State Food and Drug Administration approved Iremod iguratimod to treat rheumatoid arthritis (RA). Iremod selectively inhibits cyclooxygenase-2 (COX-2) and inhibits the production of IL-1, IL-6, IL-8 and TNF. Simcere said the compound...
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07:00 , Aug 29, 2011 |  BioCentury  |  Finance

Highlights of weekly biotech stock moves

Regulatory milestones Amgen Inc. (NASDAQ:AMGN) gained $2.10 to $54.08 last week after FDA assigned a PDUFA date of April 26, 2012, to an sBLA for Xgeva denosumab to prevent bone metastases in men with castration-resistant...
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23:37 , Aug 25, 2011 |  BC Extra  |  Company News

China approves Simcere's iguratimod for RA

Simcere Pharmaceutical Group (NYSE:SCR) said China's State Food and Drug Administration approved Iremod iguratimod to treat rheumatoid arthritis. Iremod selectively inhibits cyclooxygenase-2 (COX-2) and inhibits the production of IL-1, IL-6, IL-8 and TNF. Simcere said...
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