The FDA issued a warning today that the strong magnetic fields used in an MRI exam can affect implantable infusion pumps. The federal watchdog has received reports of serious adverse events, including patient death, associated with using an infusion pump in an MR environment. The reports claim that some patients have experienced inaccurate medication dosing […]
Food & Drug Administration (FDA)
Neurelis closes Series B for intranasal diazepam spray
Neurelis, Inc. said today that it closed a Series B financing round, led by HBM Healthcare Investments. Other investors included LYZZ Capital, which previously led a Series A funding round for the company. Neurelis will use the funds to complete clinical trials for its intranasal diazepam spray and prepare a new drug application to submit […]
Keystone Nano wins FDA nod for nanoliposome cancer treatment
Keystone Nano said today that the FDA approved its investigational new drug application for the ceramide nanoliposome as a treatment for solid tumors. The company will launch a phase I trial at 3 sites to evaluate safe dosing levels and the product’s efficacy as a cancer therapy. Ceramide is a lipid that has demonstrated efficacy in […]
Neurelis wins fast track designation from FDA for intranasal diazepam spray
Neurelis, Inc. said today that it won fast track designation from the FDA for its intranasal diazepam spray. The nasal formulation of diazepam, which is being developed for pediatric and adult epilepsy patients who experience repititive or cluster seizures, is in the final stage of clinical development, according to Neurelis. The company expects to submit […]
Ocular Therapeutix touts data from phase III trial of Dextenza
Ocular Therapeutix (NSDQ:OCUL) touted interim data today from its phase III trial of Dextenza for the treatment of post-surgical ocular inflammation and pain. The bioresorbable intracanalicular hydrogel plug is designed to release drugs at the ocular surface for up to 30 days. The company announced last month that Dextenza met the trial’s 2 primary efficacy endpoints: […]
FDA accepts Allergan’s new drug application for Liletta contraception device
Allergan (NYSE:AGN) and the global nonprofit women’s health company Medicines360 said today that the FDA accepted its supplemental New Drug Application for the Liletta contraception device. The companies are asking the federal watchdog to extend the system’s duration of use from 3 years to 4 years. Liletta is a levonorgestrel-releasing intrauterine system that is placed […]
Primatene Mist Inhaler rejected by FDA
Amphastar Pharmaceuticals (NSDQ:AMPH) said this week that the FDA denied its subsidiary’s new drug application for the latest version of its Primatene Mist epinephrine inhaler. The complete response letter from the federal watchdog told Amphastar’s subsidiary, Armstrong Pharmaceuticals, that the company needs to change the inhaler’s label and packaging. The FDA also recommended that the company […]
Biogen, Ionis win FDA approval for first spinal muscular atrophy drug
Biogen (NSDQ:BIIB) said last week that it won FDA approval for its spinal muscular atrophy treatment, Spinraza. The drug is the 1st treatment approved in the U.S. for spinal muscular atrophy, a progressive and often fatal genetic disease that causes muscle weakness in infants and toddlers. The FDA previously granted Biogen’s application fast track designation […]
Another warning for CareFusion’s Alaris drug pump
The U.K.’s Medicines & Healthcare Products Regulatory Agency issued a warning today for Carefusion‘s Alaris syringe drug pumps. The UK watchdog said that Alaris pumps with broken springs in the plunger assembly could accidentally release a single dose of medication if the pump also uses non-recommended syringes. “This problem comes about through a combination of using […]
21st Century Cures Act adds Hatch-Waxman rule to drug-device combos
Section 3038 of the 21st Century Cures Act applies Hatch-Waxman rules to certain drug-device combination products, addressing the regulatory pathway for devices that incorporate already approved drugs. The Hatch-Waxman Act, named for Sen. Orrin Hatch (R-Utah) and Rep. Henry Waxman (D-Calif.), was approved in 1984. It was designed to make it easier for generic drugs to enter […]
