03:04 , Jun 30, 2018 |  BioCentury  |  Finance

Eyes on launches

The annual summer slowdown isn’t restricted to just the stock market this year, as the clinical catalyst calendar also appears to be on holiday in 3Q18. Buysiders are therefore turning their attention to a spate of...
15:03 , May 25, 2018 |  BC Week In Review  |  Clinical News

FDA accepts NDA for Cosmo's antibiotic

Cosmo Pharmaceuticals N.V. (SIX:COPN) said FDA accepted and granted Priority Review to an NDA for Aemcolo (Rifamycin SV MMX) to treat travelers’ diarrhea. The PDUFA date is Nov. 16. Aemcolo is a broad-spectrum, semisynthetic, oral non-absorbable...
20:21 , May 18, 2018 |  BC Extra  |  Company News

FDA accepts NDA for Cosmo's antibiotic

Cosmo Pharmaceuticals N.V. (SIX:COPN) said FDA accepted and granted Priority Review to an NDA for Aemcolo (Rifamycin SV MMX) to treat travelers’ diarrhea. The PDUFA date is Nov. 16. Aemcolo is a broad-spectrum, semisynthetic,...
21:06 , Apr 6, 2018 |  BioCentury  |  Finance

Smid-cap smorgasbord

While the biggest milestone of the second quarter came early and turned out to be a disappointment, investors still have plenty to look forward to in immuno-oncology. In addition, specialist investors’ current strategy of overweighting...
00:38 , Jan 6, 2018 |  BioCentury  |  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...
19:09 , Nov 17, 2017 |  BC Week In Review  |  Clinical News

Paion's remimazolam meets in Phase III trial for procedural sedation

Paion AG (Xetra:PA8) reported data from a Phase III trial in 431 patients undergoing bronchoscopy showing that procedural sedation with remimazolam (CNS 7056, ONO-2745) met the composite primary endpoint vs. both placebo and midazolam of...
00:33 , Oct 20, 2017 |  BC Week In Review  |  Clinical News

FDA accepts NDA for Cosmo's diagnostic

Cosmo Pharmaceuticals N.V. (SIX:COPN) said FDA accepted for review an NDA for Methylene Blue MMX (CB-17-01) to detect lesions, polyps and adenomas in the colon. Its PDUFA date is May 21, 2018. The candidate is an...
22:53 , May 26, 2017 |  BioCentury  |  Finance

Europe’s bellwether challenge

A healthy biotech ecosystem comprises a continuum from big pharma and bellwether biotechs at the top to private newcos at the bottom, with a mixture of liquidity events -- predominantly M&A -- to reward investors....
11:41 , Dec 1, 2016 |  BC Week In Review  |  Clinical News

LuMeBlue: Ph III data

Top-line data from a double-blind, international Phase III trial in about 1,270 patients undergoing a colonoscopy showed that oral LuMeBlue met the primary endpoint of improving the detection of adenomas vs. placebo. Cosmo Pharmaceuticals N.V. (SIX:COPN),...
07:00 , Oct 10, 2016 |  BC Week In Review  |  Company News

Cosmo, Shire autoimmune news

The Patent Trial and Appeal Board of the U.S. Patent and Trademark Office (PTO) upheld the validity of the only Orange Book-listed patent for ulcerative colitis drug Lialda mesalamine from Shire. PTAB evaluated an...