- Company to pursue comparative bioavailability regulatory route instead of clinical efficacy development route -

- NeuroDerm to add patients to its long-term safety trial -- Conference call and webcast today at 8:00 a.m. ET -

 

REHOVOT, Israel, Dec. 05, 2016  -- NeuroDerm Ltd. (NDRM), a clinical stage pharmaceutical company developing drugs for central nervous system (CNS) disorders, today announced that following its End-of-Phase 2 meeting with the United States Food and Drug Administration (FDA) in late October, the Company intends to pursue a comparative bioavailability regulatory path for the Company's lead product candidate ND0612 based on comparative pharmacokinetic (PK) data in place of data from Phase 3 clinical efficacy trials. The FDA also reaffirmed that long-term safety data from the Company’s ongoing BeyoND trial (trial 012) should be part of the eventual New Drug Application (NDA) submission.  ND0612 is the Company's continuous, subcutaneously delivered levodopa/carbidopa (LD/CD) proprietary liquid formulation for the treatment of Parkinson's disease. 

The study met its primary endpoint, demonstrating disease stabilization and safety, along with a dose-response

Newly released data show evidence of an overall survival benefit for patients treated with therapeutic dose of VB-111

 

TEL AVIV, Israel, Nov. 29, 2016 --  VBL Therapeutics (VBLT), today announced top-line results from its exploratory Phase 2 study of VB-111 (ofranergene obadenovec) in patients with advanced, differentiated thyroid cancer. As previously announced, this trial met its primary endpoint, which was defined as 25% progression-free survival at 6 months (PFS-6), in heavily-pretreated patients with late-stage disease. A dose-dependent response was seen, with 35% of patients reaching PFS-6 in the therapeutic dose cohort, versus 25% in a low-dose cohort. Given this positive clinical response, the Company continued to follow patients for overall survival (OS) data, which was not a primary endpoint. 

VANCOUVER, Nov. 28, 2016  - Neovasc Inc. ("Neovasc" or the "Company") (NASDAQ:NVCN - News) (TSX:NVC.TO - News) today announced it has received both regulatory and ethics committee approval to initiate the Tiara™ Transcatheter Mitral Valve Replacement Study (TIARA II) in Italy.   TIARA II is a 115 patient, non-randomized, prospective clinical study evaluating the safety and performance of the Tiara™ Transcatheter Mitral Valve with the Tiara™ Transapical Delivery System (Tiara™).

 

With these critical approvals now in place, it is expected that the first Italian TIARA II clinical study site will be initiated before year end, with first enrollment anticipated early in the new year.  Approvals in additional geographies are expected in the first quarter of 2017.

IV Meloxicam Achieves Primary Endpoint of Statistically Significant Reduction in SPID24 in Patients with Acute Postoperative Pain Following Abdominoplasty Surgery

Ten Secondary Endpoints Also Met

Company Estimates Filing US NDA in Summer 2017

 

MALVERN, Pa., Nov. 28, 2016  -- Recro Pharma, Inc. (REPH), a revenue generating specialty pharmaceutical company focused on products for hospital and ambulatory care settings, currently developing non-opioid products for the treatment of serious acute pain, today announced positive results from its second of two Phase III clinical trials evaluating intravenous (IV) meloxicam for the treatment of acute postoperative pain.  In this trial, IV meloxicam achieved the primary endpoint of a statistically significant difference in Summed Pain Intensity Difference (SPID) over the first 24 hours (SPID24), compared to placebo, in patients following abdominoplasty surgery. With the positive data from this study, the Company believes this completes the efficacy program for the IV meloxicam New Drug Application (NDA).