Maryland-based TissueGene said today that Invossa, which it touts as the world’s first cell and gene therapy for degenerative arthritis, won approval from the Korea Ministry of Food and Drug Safety. Invossa is designed to treat osteoarthritis of the knee through a single intra-articular injection. Kolon Life Science (KSDQ:102940), TissueGene’s exclusive licensee for Asia, filed for a […]
Drug-Device Combinations
FDA rejects Ocular’s Dextenza for a second time
Ocular Therapeutix (NSDQ:OCUL) said today that the FDA rejected its resubmission of a new drug application for Dextenza. This is the second time that Ocular has received the FDA’s dreaded complete response letter for Dextenza. In July last year, the FDA denied approval for Ocular’s hydrogel plug after it discovered ‘deficiencies in manufacturing process and controls’ in a pre-new […]
Equashield seeks to automate hazardous drug handling: a Drug Delivery Business News podcast
Equashield’s Jason Dutcher chats with Drug Delivery Business News editor Sarah Faulkner about the company’s closed system transfer device and its latest move to automate hazardous drug compounding. Healthcare workers are often tasked with handling hazardous drugs, which give off harmful vapors. Exposure to these drugs has been linked to severe health risks, including infertility, […]
Trinseo launches polymer solutions for drug delivery devices
Trinseo (NYSE:TSE) said today that its consumer essential markets division now offers specialty engineered polymer solutions for medical device and pharmaceutical manufacturers to use in the production of drug delivery devices. The combination devices that can leverage Trinseo materials include auto-injectors, asthma inhalers, insulin pens, wearable devices and prefilled syringes, according to the Berwyn, Penn.-based […]
FDA accepts Axium’s orphan designation request for intranasal Truveta
Axium Pharmaceuticals said today that the FDA accepted its orphan designation request for the intranasal administration of lorazepam, Truveta, in the treatment of Lennox-Gastaut syndrome. The High Point, N.C.-based company is developing a novel intranasal administration device for new formulations of existing drugs. Axium said the device is designed to bring about rapid onset of […]
pSivida licenses European rights for Durasert to Alimera
pSivida (NSDQ:PSDV) said today that it restructured a deal with Alimera Sciences (NSDQ:ALIM) to grant Alimera rights to the Durasert three-year treatment for posterior segment uveitis in Europe, the Middle East and Africa. Alimera, which holds an exclusive license to pSivida’s intravitreal implant, Iluvien, plans to apply for a secondary indication for Iluvien for posterior segment uveitis. […]
Ocular seeks to extend regulatory timeline for Dextenza due to manufacturing concerns
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 […]
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 […]