A new study from the University of Eastern Finland shows that high serum omega-6 polyunsaturated fatty acid concentrations are linked to a significantly reduced risk of type 2 diabetes. The findings were published in the American Journal of Clinical Nutrition . read more
Pivotal Phase III Trial of enzalutamide Initiated in Metastatic Hormone Sensitive Prostate Cancer
PRNewswire/ — Astellas Pharma Inc. (TSE: 4503) and Medivation, Inc. (NASDAQ: MDVN) today announced that the ARCHES (AR Inhibition with ChemoHormonal Therapy in Men with MEtastatic Castrate Sensitive Prostate Cancer) Phase III registrational trial, which will evaluate the efficacy and safety of enzalutamide with androgen deprivation therapy (ADT) versus placebo with ADT in metastatic hormone sensitive prostate cancer (mHSPC) patients, has been initiated and the first patient has been randomized. read more
Egalet Announces ALERRT(SM) Study Demonstrated Egalet-002 Required Significantly More Effort to Manipulate than OxyContin
PRNewswire/ — Egalet Corporation (Nasdaq: EGLT) (“Egalet”), a fully integrated specialty pharmaceutical company focused on developing, manufacturing and marketing innovative treatments for pain and other conditions, today announced positive top-line results from a study using the ALERRT instrument. The study showed that Egalet-002, an abuse-deterrent, extended-release oxycodone product candidate which uses Egalet’s Guardian™ Technology, required significantly more effort to manipulate than OxyContin (oxycodone hydrochloride). The ALERRT instrument, which uses visual analog scales, is a tool developed by PinneyAssociates, Inc. to standardize how to quantify the level of effort required to manipulate an abuse-deterrent product candidate. The study was conducted in accordance with the U.S. Food and Drug Administration’s (FDA) final Guidance for Industry, Abuse-Deterrent Opioids — Evaluation and Labeling (April, 2015), which states that “testing should provide information sufficient to fully characterize the product’s abuse-deterrent properties, including the degree of effort required to bypass or defeat those properties
Peptonic Medical receives approval for its clinical Phase 2b study
Peptonic Medical AB (publ) (“the Company” or “Peptonic”) – a company developing pharmaceuticals based on oxytocin – today announced that it has received approval from the Swedish Medical Products Agency to start the planned Phase 2b study. Previously Peptonic has received approval from the Ethical Vetting Board. read more
Merrimack Announces Inclusion of ONIVYDE® (irinotecan liposome injection) as a Category 1 Treatment Option in the 2016 NCCN Guidelines for Pancreatic Adenocarcinoma
PRNewswire/ — Merrimack Pharmaceuticals, Inc. (Nasdaq: MACK) today announced the National Comprehensive Cancer Network (NCCN) has included ONIVYDE® (irinotecan liposome injection) in combination with fluorouracil (5-FU) and leucovorin in its 2016 Clinical Practice Guidelines in Oncology for pancreatic adenocarcinoma. The new guidelines recognize the ONIVYDE regimen as a category 1 second-line therapy for patients with metastatic adenocarcinoma of the pancreas who have previously been treated with gemcitabine-based therapy. A category 1 classification represents the highest level of evidence and uniform NCCN consensus that the intervention is appropriate. The new guidelines are published on read more
Cytori Update on Its U.S. Phase III Scleroderma Trial
Cytori Therapeutics, Inc. (NASDAQ: CYTX) today announced that its U.S. FDA approved Phase III STAR trial has enrolled and treated its 40th patient (50% of target enrollment). In addition, a pre-specified independent data monitoring committee review of safety data from the initial 20 patients has been conducted and the committee has recommended that the study continue as planned. read more
LCT Starts Phase IIb Clinical Trial of NTCELL for Parkinson’s Disease
SYDNEY & AUCKLAND, New Zealand–(BUSINESS WIRE)–Living Cell Technologies has received approval from the Auckland Hospital Research Review Committee for the Phase IIb clinical trial of NTCELL® for Parkinson’s disease. The New Zealand Minister of Health authorised the application to conduct the trial on 12 November 2015, and the Northern A Health and Disability Ethics Committee gave its approval on 3 February 2016. The initiation meeting with all those involved in the clinical trial has been held and patient recruitment is under way.
The Phase IIb trial follows the successful Phase I/IIa trial, which met the primary endpoint of safety and showed clinically and statistically significant efficacy data in patients with Parkinson’s disease one year after NTCELL treatment.
The Phase IIb trial aims to confirm the most effective dose of NTCELL, define any placebo component of the response and further identify the initial target Parkinson’s disease patient sub group.
If the trial is successful the company will apply for provisional consent to treat paying patients in New Zealand and launch NTCELL as the first disease modifying treatment for Parkinson’s disease, in 2017.
New Data with FoundationOne® Supports Clinical Utility and Improved Outcomes from Molecularly Matching Non-Small Cell Lung Can.–(BUSINESS WIRE)–Foundation Medicine, Inc. (NASDAQ:FMI) today announced the publication of two manuscripts that underscore the importance of integrating comprehensive genomic profiling with FoundationOne® into the management of patients with advanced lung cancer. Data from these studies demonstrate that comprehensive genomic profiling enabled identification of cancer-driving alterations that were or would have been missed by narrow, more limited hotspot testing. In both studies, researchers concluded that the discordant findings of the testing approaches underscore the fact that comprehensive genomic profiling consistently provides non-small cell lung cancer patients with more accurate and a broader range of treatment options, including clinical trials, versus narrow hotspot tests. cer Patients to Targeted Therapy read more
First affordable braille reader launched
The new Orbit braille reader was launched last night at the Annual International Technology & Persons with Disabilities Conference in San Diego, California.
The Orbit braille reader is the first ever affordable refreshable braille reader that is portable. Until now, braille displays cost on average around $3,000, putting them out of reach for many people – not just in Canada, but around the world. In contrast, the new Orbit braille reader will retail for under $400, providing an important new option for people who are blind or partially sighted to access literacy at an affordable cost. read more