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. […]
With groundbreaking approval, Amgen launches new class of medicine for migraine patients
Amgen (NSDQ:AMGN) won FDA approval this week for its once-monthly Aimovig injection designed to prevent the onset of migraines in adults. The drug is the first of its kind – a molecule that blocks the receptor for a protein that is linked to migraine pain, the calcitronin gene-related peptide. Other major pharmaceutical companies like Eli Lilly (NYSE:LLY) […]
J&J’s Janssen touts Ph3 data for antidepressant nasal spray
Johnson & Johnson‘s (NYSE:JNJ) Janssen revealed data today from two Phase III trials of its investigational esketamine nasal spray in patients with treatment-resistant depression. The Titusville, N.J.-based company said that if approved by the FDA, esketamine would represent one of the first new approaches designed to treat refractory major depressive disorder in the last 50 […]
In reversal, FDA accepts Alkermes’ depression drug for review
In an about-face, the FDA reportedly agreed to review a new drug application for Alkermes‘ (NSDQ:ALKS) depression drug just weeks after the agency said it would only do so if the company conducted additional trials. Alkermes’ once-daily oral medication is a fixed dose combination of buprenorphine and samidorphan, designed for patients with major depressive disorder […]
Study: PET imaging agent could help predict depression drug’s efficacy
Researchers have identified a positron emission tomography imaging agent that could identify the patients that are more likely to benefit from a drug designed to treat major depressive disorder, according to a study published this month in The Journal of Nuclear Medicine. The C-DASB tracer targets a protein, 5-HTT, found in the part of a person’s […]
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