CALGARY, Oct. 20, 2015 /PRNewswire/ – Oncolytics Biotech Inc. (“Oncolytics”) (TSX:ONC, NASDAQ:ONCY) today announced that, following submission to the U.S. Food and Drug Administration (“FDA”) for review, the Investigational New Drug Application containing the protocol titled “A Phase Ib study of pembrolizumab (KEYTRUDA®) in combination with REOLYSIN® (pelareorep) and chemotherapy in patients with advanced pancreatic adenocarcinoma” is now active. read more
Mundipharma: New Study Provides Insights into Potential Treatment of Severe Pain in Parkinson’s Disease with Prolonged-Release Oxycodone/Naloxone
CAMBRIDGE, England–(BUSINESS WIRE)–A study published today in The Lancet Neurology has provided important insights into the analgesic effects of prolonged-release oxycodone/naloxone (OXN PR) for Parkinson’s disease patients with chronic, severe pain.1 The primary endpoint of improved average 24-hour pain scores with OXN PR versus placebo at week 16 was not met (p=0.058), however assessments at other time points as well as secondary endpoint data indicate some potentially positive treatment effects with OXN PR.1 read more
First Patient Enrolled in the SMILE Study, Sensible Medical Innovation’s Randomized Controlled Trial (RCT) Designed to Measure ReDS™ Technology Impact on Heart Failure Rehospitalizations
Sensible Medical Innovations, focused on the commercialization of a non-invasive thoracic fluid status monitor based on ReDS™ medical radar technology, today announced enrollment of the first patient in the SMILE study. SMILE is designed as a prospective, randomized, controlled, multi-center trial and is expected to enroll approximately 380 patients in 35 centers in the US. Its primary efficacy endpoint is the rate of recurrent Heart Failure re-hospitalization during the entire follow-up period of ReDS-guided fluid management. Additional endpoints include clinical outcomes and healthcare economics assessment. The first patient was enrolled at Ohio State University in Columbus Ohio by Dr. Rami Kawash, site principal investigator.
Chronix Biomedical: First Patient in the World Shows Utility of Brand New Cancer Test
LONDON–(BUSINESS WIRE)–A huge breakthrough in increasing the accuracy of cancer screening tests has been made. The method currently used has extremely poor accuracy. The new test developed by British, German and American scientists has a 91% accuracy, is expected to become the new norm and save many more lives as a result.
Addyi™ (Flibanserin), First-Ever Medical Treatment For Acquired, Generalized HSDD In Premenopausal Women, Now Available
RALEIGH, N.C., Oct. 19, 2015 /PRNewswire/ — Sprout Pharmaceuticals, Inc. (Sprout), a division of Valeant Pharmaceuticals North America LLC, announced today that Addyi, a once-daily, non-hormonal pill for the treatment of acquired, generalized hypoactive sexual desire disorder (HSDD) in premenopausal women, is now available in the United States through certified physicians and pharmacies. Addyi was approved by the U.S. Food and Drug Administration (FDA) on August 18, 2015. read more
BOSTON, Oct. 20, 2015 /PRNewswire/ — Juniper Pharmaceuticals, Inc. (Nasdaq: JNP) (“Juniper” or the “Company”), a women’s health specialty pharmaceutical company, announced that its common stock will begin trading on the Nasdaq Global Select Market, effective at market open today. The Company’s symbol (JNP) will remain the same. read more
Asterias Biotherapeutics to Begin Dose Escalation in the SCiStar Phase 1/2a Clinical Trial of AST-OPC1 for Complete Cervical Spinal Cord Injury
MENLO PARK, Calif., Oct. 20, 2015 /PRNewswire/ — Asterias Biotherapeutics, Inc. (NYSE MKT: AST), a biotechnology company focused on the emerging field of regenerative medicine, today announced that its Data Monitoring Committee has reviewed the initial safety data from all three patients in the first cohort and has recommended dose escalation to the second cohort. Recruitment for the second cohort will begin immediately, with a planned enrollment of five patients who will each receive 10 million cells of AST-OPC1 (oligodendrocyte progenitor cells). read more
Check-Cap Announces New Data Demonstrating Safety and Detection of Polyps in Clinical Study Evaluating Preparation-Free Colorectal Cancer Screening Capsule
ISFIYA, Israel, Oct. 20, 2015 /PRNewswire/ — Check-Cap Ltd. (Nasdaq: CHEK, CHEKW), a clinical stage medical diagnostics company engaged in the development of an ingestible capsule for preparation-free, colorectal cancer screening, today announced new data demonstrating safety and polyp detection from a clinical study evaluating the company’s non-invasive system for preparation-free examination of the colon. Results will be presented at the American College of Gastroenterology (ACG) Annual Scientific Meeting taking place October 16-21, 2015 and the United European Gastroenterology Week (UEGW) taking place October 24-28, 2015. read more