BioCentury | Jan 6, 2018
Finance

Burgeoning bellwethers

The miserable performance of large cap biotechs last quarter is likely to be a boon for small- and mid-cap players this year, in more ways than one. Buysiders spent most of 2017 focusing to a...
BioCentury | Nov 17, 2017
Clinical News

Lupin's Solosec meets in Phase III for bacterial vaginosis

...Solosec secnidazole met all primary and secondary endpoints vs. placebo. Later in September, FDA approved Solosec...
...next-generation 5-nitroimidazole antibiotic, to treat bacterial vaginosis (see BioCentury, Oct. 13 ). In the trial, Solosec...
...Lupin plans to launch Solosec by mid-2018. Lupin Ltd. (NSE:LUPIN; BSE:500257), Mumbai, India Product: Solosec secnidazole...
BioCentury | Oct 13, 2017
Clinical News

FDA approves Symbiomix's Solosec for bacterial vaginosis

...an NDA from Symbiomix Therapeutics LLC (Newark, N.J.) for Solosec secnidazole to treat bacterial vaginosis. Solosec...
...the U.S. Symbiomix Therapeutics LLC , Newark, N.J. Product: Solosec secnidazole (formerly SYM-1219) Business: Infectious Alicia Parker secnidazole Solosec Symbiomix...
BioCentury | Oct 13, 2017
Company News

Lupin gets newly approved drug in Symbiomix deal

...company Symbiomix Therapeutics LLC (Newark, N.J.). The deal gives the Indian pharma rights to Solosec secnidazole...
...for another $100 million in milestones, plus contingent payments. Lupin said it plans to launch Solosec...
...debt, in a series A round closed in 2015 (see BioCentury, May 11, 2015 ). Solosec...
BioCentury | Oct 11, 2017
Company News

Lupin gets newly approved drug in Symbiomix deal

...company Symbiomix Therapeutics LLC (Newark, N.J.). The deal gives the Indian pharma rights to Solosec secnidazole...
...for another $100 million in milestones, plus contingent payments. Lupin said it plans to launch Solosec...
...debt, in a series A round closed in 2015 (see BioCentury, May 11, 2015) . Solosec...
BioCentury | Mar 29, 2017
Clinical News

Solosec regulatory update

...from Symbiomix for Solosec secnidazole to treat bacterial vaginosis. The PDUFA date is Sept. 17. Solosec...
...approved, Symbiomix said the candidate would be the only single-dose oral therapy for the indication. Solosec...
...the U.S. Symbiomix Therapeutics LLC , Newark, N.J. Product: Solosec secnidazole (formerly SYM-1219) Business: Infectious Chris Lieu secnidazole Solosec Symbiomix...
BioCentury | Mar 23, 2017
Company News

Priority Review for Symbiomix's Solosec

...an NDA for Solosec secnidazole to treat bacterial vaginosis. Its PDUFA date is Sept. 17. Solosec...
...approved, Symbiomix said the candidate would be the only single-dose oral therapy for the indication. Solosec...
...antibiotic. It has Fast Track and Qualified Infectious Disease Product (QIDP) designations in the U.S. Chris Lieu Solosec Symbiomix...
BioCentury | Jan 25, 2017
Clinical News

Solosec regulatory update

...Symbiomix submitted an NDA to FDA for Solosec secnidazole to treat bacterial vaginosis. The product is...
...the U.S. Symbiomix Therapeutics LLC , Newark, N.J. Product: Solosec secnidazole (formerly SYM-1219) Business: Infectious Julian Zhu secnidazole Solosec Symbiomix...
BioCentury | Aug 22, 2016
Clinical News

Secnidazole: Phase III data

...with infrequent or recurrent bacterial vaginosis showed that a single dose of 2 g oral Solosec...
...potassium hydroxide “Whiff” test and clue cells of <20%, at days 21-30 vs. placebo (p<0.001). Solosec...
...meeting in Annapolis. Symbiomix Therapeutics LLC , Newark, N.J. Product: Secnidazole ( Solosec ) (formerly SYM-1219...
BioCentury | Sep 7, 2015
Clinical News

Secnidazole: Completed Phase III enrollment

...to SYM-1219 to treat bacterial vaginosis. Symbiomix Therapeutics LLC , Newark, N.J. Product: Secnidazole ( SYM-1219...
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