Denali Therapeutics (NSDQ:DNLI) has landed a strategic partnership with Takeda Pharmaceutical (TYO:4502) to develop and commercialize three of its product candidates for neurodegenerative diseases. The deal includes Denali’s preclinical Alzheimer’s projects, among other undisclosed candidates, which make use of the company’s antibody transport vehicles, or ATVs, to penetrate the blood-brain barrier. According to the terms of […]
Neurological
DelMar Pharma wins fast track status for glioblastoma drug
DelMar Pharmaceuticals (NSDQ:DMPI) said today that the FDA granted its lead product candidate, VAL-083, fast track status for approval as a therapy for recurrent glioblastoma. The designation applies to a Phase II trial with the University of Texas MD Anderson Cancer Center and a Phase III trial in patients whose disease has progressed after treatment with […]
7 medical devices combating the opioid crisis
Opioid-related deaths have become an epidemic in the U.S., garnering attention from the White House, the FDA and many other governmental bodies. From 2000 to 2014, nearly half a million Americans died from drug overdoses. In 2015, more than 50,000 people died from drug overdoses, and 33,000 were opioid-related. Prescription overdoses continue to cause more […]
Study: Novocure’s Optune, drug combo adds months to the lives of GBM patients
Novocure (NSDQ:NVCR) touted today the final analysis of a pivotal Phase III trial that evaluated Optune combined with temozolomide in newly-diagnosed glioblastoma patients. The analysis, published today in the Journal of the American Medical Association (JAMA), showed that Novocure’s Optune-temozolomide combo extended overall survival and progression-free survival by 37% compared to temozolomide alone. The drug-device therapy’s benefit […]
IntelGenx to reclaim global rights to oral thin-film migraine treatment
IntelGenx (CVE:IGX) is slated to regain exclusive global rights to develop and sell its Rizaport oral thin-film acute migraine treatment in January, according to a report from BioTuesdays. The company’s partner, RedHill Biopharma (NSDQ:RDHL), has decided to end its co-development and commercialization relationship with IntelGenx, the news site reported. “We were expecting RedHill’s decision because in recent […]
IntelGenx gets green light to launch Ph2 Alzheimer’s study in Canada
IntelGenx (CVE:IGX) said today that Health Canada approved its application to study its montelukast VersaFilm therapy in adults with mild to moderate Alzheimer’s disease. The Phase IIa proof-of-concept trial is slated to begin screening patients in the first quarter of next year. The 70-patient study is designed to evaluate the safety, feasibility, tolerability and efficacy […]
Acorda resubmits NDA for inhaled Parkinson’s disease therapy
Acorda Therapeutics (NSDQ:ACOR) said today that it resubmitted its new drug application for Inbrija, an inhaled therapy for people with Parkinson’s disease. The Ardsley, N.Y.-based company was dealt a setback in August when the FDA told Acorda that it wouldn’t review its application for Inbrija, a move that sent ACOR shares tumbling. The FDA’s refusal to […]
Novocure nabs reimbursement for Optune in Japan
Novocure (NSDQ:NVCR) shares were up this morning after the Japanese Ministry of Health, Labour and Welfare agreed to reimburse for Optune as a treatment for newly-diagnosed glioblastoma. The Optune device delivers low-intensity, intermediate frequency, alternating electric fields, called “Tumor Treating Fields,” to inhibit cancer cell replication. As a treatment for newly-diagnosed glioblastoma, Novocure combines its device with the […]
Medtech stories we missed this week: Nov. 17, 2017
From Skyline Medical’s joint venture to Lensar receiving FDA clearance and CE Mark, here are seven medtech stories we missed this week but thought were still worth mentioning. 1. Skyline Medical launches JV deal with Helomics Skyline Medical announced in a Nov. 15 press release that it has signed a joint venture agreement with Helomics. […]
FDA approves first pill with sensor to track ingestion
The FDA today approved Abilify MyCite, the first drug in the U.S. to have an ingestible sensor embedded within the pill that can track if the medication was taken. The drug-device combination product is indicated for the treatment of schizophrenia, acute treatment of manic and mixed episodes linked with bipolar I disorder and as an […]