Press Releases

Press Releases

ARIAD Pharmaceuticals, Inc. announced it has completed the rolling submission of the New Drug Application (NDA) for its investigational anaplastic lymphoma kinase (ALK) inhibitor, brigatinib, to the U.S. Food and Drug Administration (FDA). ARIAD is seeking U.S. marketing approval of brigatinib for patients with metastatic ALK-positive (ALK+) non-small cell lung…

Press Releases

Karyopharm Therapeutics Inc., a clinical-stage pharmaceutical company, today announced it will provide an overview of top-line results from its Phase 2b STORM study and the planned development path for selinexor (KPT-330) in multiple myeloma (MM) on Tuesday, September 6, 2016, followed by a conference call on Tuesday, September 6, 2016…

Press Releases

Tonix Pharmaceuticals Holding Corp., which is developing next-generation medicines for fibromyalgia and post-traumatic stress disorder (PTSD), announced today that it has received the final meeting minutes from the U.S. Food and Drug Administration (FDA) from an  End-of-Phase 2/Pre-Phase 3 meeting.  These minutes confirmed the FDA’s acceptance of Tonix’s proposed Phase…

Press Releases

Teva Pharmaceutical Industries Ltd. announced today that it will host a conference call and live webcast along with a slide presentation on Friday, September 9, 2016 at 8:00 a.m. ET to communicate an overview of the future prospects of Teva Generics business following the close of the Actavis generics deal.…

Press Releases

PaxVax, a fully integrated specialty vaccine company committed to developing and commercializing innovative vaccines against infectious diseases, today announced that the company has entered into a marketing and distribution agreement with Seqirus. Under the terms of this agreement, PaxVax will market, sell and distribute two of Seqirus’ influenza vaccine products…

Press Releases

EUROPEAN SOCIETY OF CARDIOLOGY CONGRESS 2016 -- Study sponsor CardioCell LLC, a global biotechnology company that uses allogeneic stem cells for cardiovascular indications, announces data from its Phase IIa clinical trial "Safety and Efficacy of Intravenous Infusion of Ischemia-Tolerant Allogeneic Mesenchymal Stem Cells in Patients With Non-ischemic Cardiomyopathy" at the…

Press Releases

Shionogi & Co., Ltd. (hereafter "Shionogi") reported clinical and non-clinical data for S-033188, a cap-dependent endonuclease inhibitor targeting influenza. In a Phase 2 proof-of-concept study, one-day, single oral dose of S-033188 demonstrated favorable safety and efficacy results that support moving forward into a global Phase 3 program. These results were…

Press Releases

BirchBioMed Inc. announced today that a unique and ground-breaking topical treatment developed by University of British Columbia (UBC) researchers to prevent scarring has completed a Health Canada approved Phase I trial. The double-blind and placebo-controlled clinical study involving 40 healthy volunteers demonstrates the safety of topically applying FS2 cream at…

Press Releases

Armetheon, Inc., a specialty pharmaceutical company developing novel small molecule drugs for cardiovascular diseases, today announced results from its Phase 1 clinical trial evaluating the effect of severe chronic kidney disease on the pharmacokinetics (PK) of tecarfarin, Armetheon's lead candidate, and of warfarin, the current standard of care in anticoagulation.…

Press Releases

Highland Therapeutics Inc. announced that its wholly owned subsidiary, Ironshore Pharmaceuticals & Development, Inc. (“Ironshore”), has initiated enrollment in a Phase 2 study of HLD100, which is currently under development as a new amphetamine-based treatment option for patients with Attention Deficit/Hyperactivity Disorder (ADHD). Utilizing Ironshore’s proprietary delayed-release and extended-release technology,…