Days after Neos Therapeutics (NSDQ:NEOS) nabbed U.S. regulatory approval for its controlled-release formulation of methylphenidate, Shire (NSDQ:SHPG) said it won a nod from the FDA for its long-acting ADHD drug. The drug, Mydayis, is made up of the same active ingredient in Shire’s ADHD treatment Adderall XR – amphetamine – but it is designed to last up to […]
Neurological
Cleveland Clinic spinout Infuseon inks deal with OncoSynergy
Infuseon Therapeutics inked a deal this week with OncoSynergy to evaluate a glioblastoma therapeutic with the Cleveland Clinic spinout’s novel delivery device. The alliance hopes to demonstrate proof-of-concept that OncoSynergy’s candidate can be successfully delivered directly to a patient’s brain using the device in a Phase I glioblastoma trial. Infuseon’s Cleveland Multiport Catheter, which won […]
Controlled-release ADHD drug wins FDA approval
Neos Therapeutics (NSDQ:NEOS) won FDA approval yesterday for its controlled-release formulation of an old ADHD drug, methylphenidate. The company touts its product, Cotempla XR-ODT, as the 1st methylphenidate tablet designed to release medication over time instead of all at once. For years, children with ADHD have been treated with methylphenidate and amphetamines. But kids can sometimes […]
FDA clears IND for Cerveau’s tau imaging agent
Cerveau Technologies said today that the FDA cleared the investigational new drug application for its tau imaging agent. The company plans to work with pharmaceutical partners to evaluate the product’s use in positron emission tomography scans to assess neurofibrillary tangles in the brain. NFTs composed of aggregated tau protein are characteristic of certain neurodegenerative conditions like […]
Cleveland Clinic spinout Infuseon wins FDA nod for CNS drug delivery device
Cleveland Clinic spinout Infuseon Therapeutics said today that its novel central nervous system delivery device won 510(k) clearance from the FDA as a therapeutic delivery device. The company’s Cleveland Multiport Catheter, which won FDA clearance in March, was designed to effectively deliver therapeutics to the brain. Usually, the blood brain barrier prevents drugs delivered in […]
Novocure launches Optune, chemotherapy combo trial for glioblastoma
Novocure (NSDQ:NVCR) said today that the 1st patient was enrolled in a Phase II pilot trial evaluating Optune with bevacizumab, a chemotherapy, for patients with refractory recurrent glioblastoma. In recurrent GBM, Optune and bevacizumab are approved as monotherapies. Novocure’s consortium study is slated to evaluate the efficacy and safety of the Optune-chemo combo in patients […]
Living Cell Technologies NTCell meets primary endpoint in Phase I/IIa Parkinson’s trial
Living Cell Technologies (ASX:LCT) touted data today showing its NTCell cell therapy is safe 130 weeks after treatment in a Phase I/IIa Parkinson’s trial. The study’s primary endpoint was safety. The trial, which enrolled and treated 4 patients, involved implanting 40 NTCell capsules into 1 side of the brain. The company reported that treatment with […]
Inhaled Parkinson’s treatment improves motor function in Phase III
Shares in Acorda Therapeutics (NSDQ:ACOR) jumped this morning after the company reported that its inhaled Parkinson’s drug significantly improved motor function in a Phase III trial. The investigational drug is being studied as a therapy for people with Parkinson’s disease experiencing “off” periods, or a re-emergence of symptoms. The Phase III Span-Pd trial enrolled 339 patients with […]
Cingulate moves controlled-release ADHD drug to human testing
Cingulate Therapeutics said this week that it began a proof-of-concept trial for its controlled-release attention deficit/hyperactivity disorder drug. The 4-week clinical trial is being conducted by its development partner, Bio-Images Drug Delivery. The trial enrolled healthy volunteers to evaluate the pharmacokinetic behavior of CTX-1301, including the body’s absorption, distribution, metabolism and excretion of the drug. […]
Bayer wins FDA nod for connected MS auto-injector
Bayer (ETR:BAYN) said yesterday that the FDA approved a supplemental biologics license application for the BetaConnect Navigator and myBetaApp – software for its electronic BetaConnect auto-injector. The company’s BetaConnect auto-injector administers Betaseron for patients with relapsing-remitting multiple sclerosis. The newly-approved software allows patients to connect their device with the myBetaApp on their mobile device or computer […]