Category - Developments

Tonix Pharmaceuticals Holding (NASDAQ:TNXP) said its Phase 3 AFFIRM study, designed to evaluate the safety and efficacy of TNX-102 SL in patients with fibromyalgia, did not achieve statistical significance in the...

Closely-held ASLAN Pharmaceuticals has licensed a novel immuno-oncology antibody, targeting RON (Recepteur d’Origine Nantais), from Singapore’s Agency for Science, Technology and Research (A*STAR). RON is a receptor...

Mesoblast (NASDAQ:MESO; ASX:MSB) appointed William Burns, a director, as vice chairman. In this role, Mr. Burns, a former CEO of Roche Pharmaceuticals from 2001 to 2009, will focus his considerable pharmaceutical...

Valeant Canada, a subsidiary of Valeant Pharmaceuticals International (NYSE, TSX: VRX), will commercialize Orexigen Therapeutics’ (NASDAQ:OREX) Contrave (naltrexone HCl / bupropion HCl extended release) in Canada. Under...

ARIAD Pharmaceuticals (NASDAQ:ARIA) has completed a rolling NDA submission to the FDA for its investigational anaplastic lymphoma kinase (ALK) inhibitor, brigatinib. ARIAD is seeking U.S. marketing approval of...

The FDA has granted orphan-drug status to Regenicin’s (OTC:RGIN) NovaDerm cultured skin substitute. In a statement, the company said it believes NovaDerm to be the only autologous cultured skin substitute prepared from...

IntelGenx (OTCQX:IGXT; TSX-V:IGX) has completed a pilot clinical study for montelukast VersaFilm that demonstrated a significantly improved pharmacokinetic profile against the reference product. Montelukast is a unique...

StemCells (NASDAQ:STEM) and closely-held Microbot Medical of Israel have entered into a definitive merger agreement, with plans to pursue the development of robotics-based medical devices for the treatment of...

Leerink reiterated its “outperform” rating on Aurinia Pharmaceuticals (NASDAQ:AUPH; TSX:AUP) after the reported top-line results with voclosporin in a Phase 2b clinical study in patients with active lupus nephritis...

IntelGenx (OTCQX:IGXT; TSX-V:IGX) has sold its royalty on future sales of Forfivo XL to SWK Holdings for $6-million. Forfivo XL (bupropion extended release) is the first 450-milligram bupropion hydrogen chloride tablet...