Ocular Therapeutix (NSDQ:OCUL) said today that it submitted details of a manufacturing equipment change as an amendment to the new drug application resubmission for Dextenza, the company’s dexamethasone insert that is currently under review by the FDA. The FDA is slated to make a decision about the product’s regulatory approval by July 19. But the company recently […]
Drug-Device Combinations
Defymed reveals development of novel insulin delivery device
France-based medtech company Defymed said today that it’s developing a novel insulin delivery device which it hopes to bring to market by the end of 2020. The company’s device, ExOlin, uses a biocompatible membrane that is nonbiodegradable and permeable to insulin, according to Defymed. The insulin delivery device is designed to be implanted into a […]
Ocular Therapeutix faces more manufacturing problems as FDA decision deadline looms
Shares in Ocular Therapeutix (NSDQ:OCUL) fell last week after the company revealed that it received another letter from the FDA about issues spotted by the regulatory agency during a pre-approval inspection of a manufacturing plant. This isn’t the first time that the company has dealt with manufacturing issues. In July last year, the FDA denied approval for Ocular’s hydrogel […]
Resolute Onyx drug-eluting stent launches in Japan
Medtronic (NYSE:MDT) said this week that it’s Resolute Onyx drug-eluting stent will launch in Japan on July 10th. The device’s predecessor, Resolute Integrity, began selling in Japan in August 2012. The drug-eluting stent has a metallically dense, radiopaque inner core within the cobalt alloy wire to boost visibility for accurate placement, according to Medtronic. The stent […]
Capillary Biomedical takes aim at ‘the Achilles heel of diabetes’
Major players in the medical device realm are in a heated race to develop the first artificial pancreas to help patients with diabetes manage the chronic condition. Just last year, Medtronic (NYSE:MDT) won FDA approval for its MiniMed 670G hybrid-closed loop system. But while companies compete for the top spot in developing what could be a […]
Delcath raises $2m in Series B stock sale
Delcath Systems (NSDQ:DCTH) has raised $2 million after selling 2,360 shares of Series B preferred stock at $1,000 per share to unnamed institutional investors, according to a regulatory filing. The company wrote that it plans to use the proceeds for general corporate purposes. Delcath is developing a system for liver-directed high dose chemotherapy, which involves a […]
Novo Nordisk recalls cartridge holders in insulin delivery devices
Novo Nordisk (NYSE:NVO) launched a recall yesterday of insulin cartridge holders used in select batches of NovoPen Echo insulin delivery devices. The company said the cartridge holders could crack or break upon exposure to certain chemicals. Using a NovoPen Echo with a cracked or broken cartridge holder could result in the device delivering a lower dose […]
Aequus to launch trial for anti-nausea patch
Aequus Pharmaceuticals (CVE:AQS) said today that it won approval from Health Canada to launch a proof-of-concept trial to evaluate the bioavailability and safety of the company’s long-acting transdermal anti-nausea patch. The device is made up of a combination of pyridoxine and doxylamine. The traditional form is delivered orally up to 4 times per day. The […]
Novo Nordisk touts late-stage trial data for Tresiba insulin injection
Novo Nordisk (NYSE:NVO) touted data today from 2 Phase IIIb trials comparing Tresiba insulin degludec to insulin glargine in adults with Type I and Type II diabetes. The results were published in the Journal of the American Medical Association. The Switch trials are the 1st double-blinded insulin trials to compare the hypoglycemia rates and risks in patients […]
Ipsen wins approval for gastroenteropancreatic neuroendocrine tumor drug
Ipsen (EPA:IPN) said today that Teijin Pharma Ltd. won approval from the Japanese Ministry of Health, Labor and Welfare for Ipsen’s Somatuline as a therapy for gastroenteropancreatic neuroendocrine tumors. The subcutaneous drug was approved in Japan in 2012 for the treatment of acromegaly and pituitary gigantism. The latest approval was supported by Ipsen’s pivotal Phase III […]
