The NCCN Oncology Research Program (ORP) was awarded a $2-million grant from Infinity Pharmaceuticals, Inc. to facilitate studies of duvelisib in the treatment of hematologic malignancies.
FORT WASHINGTON, PA — The National Comprehensive Cancer Network ® ( NCCN ® ) Oncology Research Program ( ORP ) has been awarded a $2-million grant from Infinity Pharmaceuticals, Inc. to evaluate the safety and effectiveness of duvelisib as a potential treatment for hematologic malignancies.
“NCCN ORP is pleased to be able to collaborate with Infinity in the study of duvelisib, a novel dual inhibitor of PI3K-delta and gamma. This targeted therapy has promising applications in hematologic malignancies and is of great interest to the investigators at NCCN Member Institutions,” said Robert C. Young, MD, Interim Vice President, NCCN ORP. read more
First Patient Treated with Medtronic Valiant TAAA Stent Graft System in Thoracoabdominal Aortic Aneurysm Study
Medtronic plc (NYSE:MDT), a global leader in medical technology, services and solutions and Sanford Health, one of the nation’s largest health care systems, today announced the first patient enrolled in a clinical study using the Medtronic Valiant® TAAA Stent Graft System for minimally invasive repair of thoracoabdominal aortic aneurysm. read more
Chugai’s ALK Inhibitor “Alecensa®” Trial Stopped Early for Benefit
TOKYO–(BUSINESS WIRE)–Chugai Pharmaceutical Co., Ltd. (TOKYO: 4519) announced that it received a recommendation by an independent data monitoring committee (IDMC) that the J-ALEX Study, a phase III study targeting ALK fusion gene positive non-small cell lung cancer (NSCLC) being conducted in Japan, should be stopped early as the study met its primary endpoint at a pre-planned interim analysis. The study showed that patients lived significantly longer without disease worsening (progression-free survival, PFS) when treated with Alecensa® compared to crizotinib. read more
Allena Pharmaceuticals Initiates Patient Treatment in Third Phase 2 Trial of ALLN-177 for Secondary Hyperoxaluria
NEWTON, Mass.–(BUSINESS WIRE)–Allena Pharmaceuticals, Inc., a specialty biopharmaceutical company focused on developing and commercializing innovative, non-systemic, oral protein therapeutics to treat metabolic and orphan diseases, today announced that patient treatment has commenced in its 28-day Phase 2 study of ALLN-177, an orally administered recombinant oxalate-degrading enzyme being developed for the management of hyperoxaluria and kidney stones. read more
Alkermes Announces Initiation of Second Phase 3 Study of ALKS 3831 for Schizophrenia
DUBLIN–(BUSINESS WIRE)–Alkermes plc (NASDAQ: ALKS) today announced the initiation of ENLIGHTEN-2, the second of two core phase 3 studies for ALKS 3831, an investigational, novel, oral atypical antipsychotic drug candidate designed to be a broad-spectrum treatment for schizophrenia. ENLIGHTEN-2 will evaluate the weight gain profile of ALKS 3831 in patients with schizophrenia over a six-month treatment period compared to olanzapine, an established atypical antipsychotic agent with proven efficacy but also metabolic liabilities, including significant weight gain. ALKS 3831 is designed to provide patients with the strong efficacy of olanzapine and a differentiated safety profile with favorable weight and metabolic properties. read more
Scleroderma Two Year Data to be Presented at the 4 Systemic Sclerosis World Congress
On Saturday, February 20, a session chaired by Dr. James Seibold and Professor Kazuhiko Takehara will focus on Emerging Therapies. Professor Guy Magalon from the Assistance Publique des Hôpitaux de Marseille (APHM) is scheduled to discuss two year data from the complete set of 12 patients treated in the SCLERADEC-I clinical study as part of a presentation entitled, “Treating Scleroderma of the Face and Hands with Fat and Stromal Vascular Fraction.” SCLERADEC-I (Principal Investigator: Professor Granel) is a French single center study aimed at measuring for the first time the safety, tolerability and potential efficacy of Cytori’s ECCS-50 locally injected in patients with hand disability due to scleroderma. ECCS – 50 was prepared in the Cell Therapy Department of APHM by the team of Professor Florence Sabatier in compliance with European regulations.
BD Receives FDA 510(k) Clearance for Diagnostic Device for HIV/AIDS
PRNewswire/ — BD (Becton, Dickinson and Company) (NYSE: BDX), a leading global medical technology company, today announced it has received U.S. Food and Drug Administration (FDA) 510(k) clearance for its BD FACSPresto™ system and BD FACSPresto™ CD4/Hb Cartridge.
The BD FACSPresto system is an automated multicolor fluorescent imaging cytometer and absorbance spectrometer that provides absolute and percentage results of CD4 T lymphocytes and hemoglobin (Hb) concentration in whole blood samples to manage HIV/AIDS patients. read more
Amarantus Receives Orphan Drug Designation From the US FDA for Eltoprazine in the Treatment of Parkinson’s Disease Levodopa-Induced Dyskinesia
SAN FRANCISCO, February 10, 2016 /PRNewswire/ —
Amarantus BioScience Holdings, Inc. (OTCQB: AMBS), a biotechnology company focused on developing products for Regenerative Medicine, Neurology and Orphan Diseases, today announced that it has received orphan drug designation from the US FDA for Eltoprazine in the treatment of Parkinson’s disease levodopa-induced dyskinesia (PD-LID). Amarantus published positive results from a Phase 2 initial proof-of-concept clinical study in February of 2015 in the journal Brain, and highlighted the publication of two independent peer-reviewed scientific publications describing the mechanism of action of eltoprazine for the treatment of PD LID in August of 2015 and December 2016.
LifeWatch™ Receives FDA Clearance for Its Continuous Vital Signs Monitoring Service
/PRNewswire/ — LifeWatch AG (SIX Swiss Exchange: LIFE), a leading developer and provider of medical solutions and remote diagnostic monitoring services in the digital health market, is pleased to announce that it has received FDA clearance for its continuous Vital Signs Monitoring Service.
The wireless, patch-based vital signs monitoring system makes vital signs monitoring faster, easier and more convenient for both, patients and medical staff. It will allow for early detection of vital sign changes thereby enabling faster interventions as well as increased nursing efﬁciency and higher patient satisfaction.