WALTHAM, Mass.-- Cerulean Pharma Inc. (CERU), a clinical-stage company developing nanoparticle-drug conjugates (NDCs), today announced that the U.S. Food and Drug Administration (FDA) granted Fast Track designation for Cerulean’s lead nanoparticle-drug conjugate, CRLX101, in combination with paclitaxel, for the treatment of platinum-resistant ovarian carcinoma, fallopian tube or primary peritoneal cancer.

 

“We appreciate the FDA’s acknowledgement of CRLX101’s potential in an area of significant unmet medical need,” said Christopher D. T. Guiffre, President and Chief Executive Officer of Cerulean. “We are encouraged by the profound treatment effect observed early in the ongoing clinical trial with the GOG Foundation, Inc. (GOG), and we look forward to working closely with the FDA as we endeavor to bring a new treatment option to women living with platinum-resistant ovarian cancer.”

Agreement provides BUNAVAIL with an opportunity to access a significant portion of more than 140,000 additional prescriptions annually

 

RALEIGH, N.C., July 11, 2016  BioDelivery Sciences International, Inc. (BDSI) announced it has signed an agreement with a significant managed care provider providing preferred access to BUNAVAIL® (buprenorphine and naloxone) buccal film (CIII) for the maintenance treatment of opioid dependence. 

 

As a result of the agreement, access to BUNAVAIL will be improved substantially from its current non-formulary position with this managed care plan to a preferred formulary position, while the current market leader is made non-preferred.  The other branded buprenorphine/naloxone product will share preferred status with BUNAVAIL.

Primary endpoint achieved with statistical significance at 60 hours maintained through 30 days

70% remission achieved at 60 hours of SAGE-547 treatment and maintained at 30-day follow-up

Company expects to pursue further development of SAGE-547 and SAGE-217 for PPD in a global clinical program

Conference call scheduled for 8:00 AM ET today

 

CAMBRIDGE, Mass.-- Sage Therapeutics (SAGE), a clinical-stage biopharmaceutical company developing novel medicines to treat life-altering central nervous system disorders, today announced positive top-line results from its Phase 2 clinical trial of SAGE-547 for the treatment of severe postpartum depression (PPD). SAGE-547 achieved the primary endpoint of a significant reduction in the HAM-D score compared to placebo at 60 hours (p=0.008). This represented a greater than 20 point mean reduction in the depression scores of the SAGE-547 group at the primary endpoint of 60 hours through trial completion with a greater than 12 point difference from placebo.

Improved clinical response seen for multiple symptoms associated with disease progression and overall survival, with notable lack of toxicity

Xilonix is the first antibody therapy to neutralize biological activity of interleukin-1 alpha (IL-1α), a potent anti-inflammatory signaling molecule known to promote the growth and spread of tumors

Xilonix granted accelerated review by the European Medicines Agency (EMA); an approval decision could come as early as fourth quarter 2016

 

AUSTIN, Texas, July 02, 2016 -- XBiotech Inc. (XBIT), developer of next-generation True Human™ antibody therapies, today presented positive results from a pivotal Phase III trial of Xilonix™, the company’s lead monoclonal (IgG1k) antibody immunotherapy for the treatment of advanced colorectal cancer (CRC). In the study, Xilonix-treated patients with advanced disease and multiple symptoms known to inversely correlate with overall survival experienced a 76% relative increase in clinical response rate (CRR), a novel measure of anti-cancer activity, after 8 weeks of therapy compared to placebo (33% vs. 19%, respectively; p=.0045).