18:47 , Nov 17, 2017 |  BC Week In Review  |  Clinical News

Lupin's Solosec meets in Phase III for bacterial vaginosis

In September, Symbiomix Therapeutics LLC -- now part of Lupin Ltd. (NSE:LUPIN; BSE:500257) -- reported data from the Phase III SYM-1219-301 trial in 189 women with bacterial vaginosis showing that 2 g oral Solosec secnidazole...
19:48 , Oct 13, 2017 |  BC Week In Review  |  Company News

Lupin gets newly approved drug in Symbiomix deal

Lupin Ltd. (NSE:LUPIN; BSE:500257) said it acquired anti-infectives company Symbiomix Therapeutics LLC (Newark, N.J.). The deal gives the Indian pharma rights to Solosec secnidazole, which FDA approved last month to treat bacterial vaginosis. Symbiomix shareholders received...
00:34 , Oct 13, 2017 |  BC Week In Review  |  Clinical News

FDA approves Symbiomix's Solosec for bacterial vaginosis

FDA approved an NDA from Symbiomix Therapeutics LLC (Newark, N.J.) for Solosec secnidazole to treat bacterial vaginosis. Solosec is a granule formulation of a next-generation, 5-nitroimidazole antibiotic. The product has Fast Track and Qualified Infectious Disease...
23:23 , Oct 11, 2017 |  BC Extra  |  Company News

Lupin gets newly approved drug in Symbiomix deal

Lupin Ltd. (NSE:LUPIN; BSE:500257) said it acquired anti-infectives company Symbiomix Therapeutics LLC (Newark, N.J.). The deal gives the Indian pharma rights to Solosec secnidazole, which FDA approved last month to treat bacterial vaginosis. Symbiomix shareholders received...
00:55 , Mar 29, 2017 |  BC Week In Review  |  Clinical News

Solosec regulatory update

FDA accepted and granted Priority Review to an NDA from Symbiomix for Solosec secnidazole to treat bacterial vaginosis. The PDUFA date is Sept. 17. Solosec has met the primary endpoints in a Phase III trial...
17:53 , Mar 23, 2017 |  BC Extra  |  Company News

Priority Review for Symbiomix's Solosec

Symbiomix Therapeutics LLC (Newark, N.J.) said FDA accepted and granted Priority Review to an NDA for Solosec secnidazole to treat bacterial vaginosis. Its PDUFA date is Sept. 17. Solosec has met the primary endpoints in a...
23:54 , Feb 24, 2017 |  BC Extra  |  Company News

Management Tracks

Celgene Corp. (NASDAQ:CELG) said President and COO Jacqualyn Fouse will retire on June 30. Scott Smith will succeed Fouse effective April 1. He is president of global inflammation and immunology. Terrie Curran will be promoted...
02:44 , Jan 25, 2017 |  BC Week In Review  |  Clinical News

Solosec regulatory update

Symbiomix submitted an NDA to FDA for Solosec secnidazole to treat bacterial vaginosis. The product is an oral granule formulation of a next-generation, 5-nitroimidazole antibiotic and has Fast Track and Qualified Infectious Disease Product (QIDP)...
07:00 , Aug 22, 2016 |  BC Week In Review  |  Clinical News

Secnidazole: Phase III data

The double-blind, U.S. Phase III Study 301 in 189 patients ages >=12 with infrequent or recurrent bacterial vaginosis showed that a single dose of 2 g oral Solosec met the primary endpoint of improving clinical...
07:00 , Aug 17, 2016 |  BC Extra  |  Company News

Management tracks

Rare disease company Wave Life Sciences Ltd. (NASDAQ:WVE) hired Keith Regnante as CFO. He was VP of finance at Shire plc (LSE:SHP; NASDAQ:SHPG). Infectious disease company Symbiomix Therapeutics LLC (Newark, N.J.) named Taunia Markvicka chief...