When Al Robichaud got his start as a medicinal chemist in 1991, he knew that discovering and developing drugs meant shouldering some level of risk. But around 2011, it became clear that the process for developing brain drugs was too costly and risky for major pharmaceutical companies to justify pursuing, as companies including Novartis (NYSE:NVS), GlaxoSmithKline (NYSE:GSK), […]
Neurological
Sunovion looks to molecular clues, patient preferences to inform drug development
From discovery to commercial launch, drug development often takes years. New tools available to the industry, like the use of biomarkers and patient-reported outcomes, promise to help inform and speed up the process. “Being able to pick out the appropriate patients using the appropriate biomarkers and establishing a relationship between on-target pharmacology and any safety […]
Impel NeuroPharma readies trial for intranasal drug-device migraine treatment
Impel NeuroPharma said today that the FDA gave it the green light to proceed with its Phase III clinical trial of INP104 – a drug delivered by Impel’s intranasal delivery device for the treatment of acute migraine. The company expects to start enrolling patients in the pivotal trial in the second half of this year. […]
Cerebral Therapeutics raises $3m for epilepsy drug-device therapy
Cerebral Therapeutics closed a $3 million Series A financing round this week to support the development of its drug-device therapy designed for patients with refractory epilepsy. The Aurora, Co.-based company’s product uses an implanted, refillable catheter system to deliver a continuous, intracerebroventricular dose of an anti-epileptic drug – valproic acid. Investors that contributed to Cerebral […]
FDA to review Sunovion’s apomorphine sublingual film for Parkinson’s disease
Sunovion Pharmaceuticals said today that the FDA accepted its new drug application for a sublingual film designed to treat motor fluctuations in people living with Parkinson’s disease. The U.S. regulatory agency is slated to make a decision regarding Sunovion’s application by January 29. The company’s product is a fast-acting therapy based on a novel formulation […]
Medtech stories we missed this week: June 8, 2018
From Royal Philips receiving FDA clearance to NeuroPace launching its epilepsy treatment device, here are seven medtech stories we missed this week but thought were still worth mentioning. 1. FDA clears Philips’s Ingenia Elition 3.0T MR scanner Royal Philips announced in a June 5 press releasethat it has received FDA 510(k) clearance for its Ingenia Elition […]
EMA committee recommends approval for migraine prevention drug
Novartis (NYSE:NVS) said today that a committee for the European Medicines Agency has recommended that the regulatory agency approve Aimovig, a self-administered drug designed to prevent migraines in adults who have at least four migraine days each month. The drug is the first of a new class of medicines, called CGRP inhibitors. It’s a monoclonal antibody […]
Denali acquires F-star Gamma and its antibody tech to help drugs cross the blood-brain barrier
Privately-held biopharma F-star said today that its partner, Denali Therapeutics (NSDQ:DNLI), chose to exercise its option to buy F-Star Gamma in a deal valued at approximately $471 million. The two companies first inked a collaboration in August 2016 to develop antibody technologies that help drugs cross the blood-brain barrier. “When you give an antibody via IV […]
FDA launches medical device innovation challenge to combat opioid crisis
The U.S. FDA today announced that it has launched an innovation challenge to encourage the development of medical devices to help reduce the country’s opioid abuse crisis. The hope is that the challenge will result in new medtech including digital health technologies and diagnostic tests to help detect, treat and prevent addiction, according to FDA. Go […]
MIT researchers send drug-ferrying nanoparticles across the blood-brain barrier
Researchers at the Massachusetts Institute of Technology demonstrated in an animal study that nanoparticles shuttling two different cancer drugs could effectively cross the blood-brain barrier and target tumor cells. The team of scientists evaluated the drug combination in mice that had gliobastoma – an aggressive form of brain cancer that is notoriously hard to treat. […]