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 drug […]
Regulatory/Compliance
FDA | Recalls | 510(k) | Pre-Market Approvals | MDSAP | Clinical Trials
Z-Medica wins FDA de novo nod for QuickClot Control+
Hemostatic device developer Z-Medica said today it won FDA de novo clearance for its QuickClot Control+, now indicated for temporary control of internal organ space bleeding for patients displaying Class III or Class IV bleeding. The Wallingford, Conn.-based company touted its QuickClot Control+ as the 1st and only non-absorbable hemostatic dressing with clearance for internal organ […]
Cosmetics dev Bellus Medical wins CE Mark for SkinPen
Bellus Medical said today it won CE Mark approval for its SkinPen microneedling cartridge, with clearance to treat surgical scars. The microneedling device uses collagen induction therapy to treat cosmetic conditions, the Addison, Texas-based company said. A rollout is planned in Europe during this year. “Receiving the CE Mark represents a significant milestone for Bellus […]
Oramed to meet with FDA about late-stage clinical program for oral insulin capsule
Oramed Pharmaceuticals (NSDQ:ORMP) said today that the FDA scheduled an end-of-phase II meeting with the Jerusalem-based company for August 31. Oramed is developing an oral insulin capsule for the treatment of Type II diabetes. The company’s Phase IIb trial met primary and secondary endpoints, since the insulin capsule lowered patients’ blood sugar relative to a placebo. […]
Stryker wins FDA 510(k) for MultiGen 2 RF generator
Stryker (NYSE:SYK) said today it won FDA 510(k) clearance for its MultiGen 2 radiofrequency energy generator designed for RF ablation procedures. The newly cleared MultiGen 2 generator is designed with double the industry standard for power to achieve its target temperature faster with fewer errors and increased reliability and efficiency, the Kalamazoo, Mich.-based company said. “The […]
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 a […]
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. Get […]
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 […]
FDA clears Medtronic’s CoreValve Evolut TAVR in intermediate risk patients
Medtronic (NYSE:MDT) said today it won expanded FDA approval for its CoreValve Evolut transcather aortic valve replacement platform, now indicated for patients with symptomatic severe aortic stenosis who are at an intermediate risk for open heart surgery. The Fridley, Minn.-based company said that patients at intermediate risk for open-heart surgery have a mortality risk of greater than […]
Masimo wins CE Mark for Rainbow Super DCI-mini sensor
Masimo (NSDQ:MASI) said today it won CE Mark approval in the European Union for its Rainbow Super DCI-mini sensor designed as a reusable spot-check sensor with multiple physiologic measurements. The Irvine, Calif.-based company said that the newly cleared, reusable sensor includes for the 1st time the ability to measure total hemoglobin, carboxyhemoglobin, methemoglobin and arterial oxygen […]
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 plug, Dextenza, […]