The FDA this month warned Valeant Pharmaceuticals (NYSE:VRX) on violations found during inspections of its Rochester, N.Y., plant last summer. The federal safety watchdog, in a Nov. 3 warning letter posted online today, wrote that inspections from Aug. 23 through Sept. 1 turned up problems with its small-particle aerosol generator, the SPAG-2 device, and a high-precision compound and dispensing […]
Regulatory/Compliance
Sernova, CTI ink regulatory deal for Cell Pouch System
Sernova said it inked a regulatory deal with CTI Clinical Trial and Consulting Services to further the clinical development and IND application for its Cell Pouch drug delivery system. The London, Ontario-based company’s Cell Pouch is an implantable device that acts as an environment within the body to store therapeutic cells for patients with chronic diseases. Cincinnati-based […]
aTyr Pharma wins FDA fast track for muscular dystrophy therapy
aTyr Pharma (NSDQ:LIFE) said today that its candidate Resolaris was granted fast track designation by the FDA for the treatment of facioscapulohumeral muscular dystrophy, making it the 1st therapeutic candidate to receive the designation for the rare form of muscular dystrophy. Resolaris is derived from a naturally occurring protein released by human skeletal muscle cells. aTyr is […]
Medtronic secures Health Canada license for MiniMed 630G system
Medtronic (NYSE:MDT) subsidiary Medtronic Canada said today that it landed a license with Health Canada for its MiniMed 630G insulin pump system for patients with diabetes mellitus. The Fridley, Minn.-based company said it interviewed more than 1,000 diabetes patients to better understand the features they look for in an insulin pump. The final product has a […]
Keystone Nano wins orphan designation for ceramide liver cancer treatment
Keystone Nano said today that its ceramide nanoliposome won orphan drug status from the FDA for the treatment of liver cancer. The designation provides the company with a window of market exclusivity after product approval. The State College, Penn.-based company touted its nanoliposome delivery system as being able to load both water-loving and water-hating compounds and […]
FDA approves Genentech’s Lucentis pre-filled ranibizumab syringe
Genentech, a member of the Roche group (PINK:RHHBY), said today that it won FDA clearance for its Lucentis (ranibizumab injection) pre-filled syringes. The anti-VEGF medicine is FDA-approved to treat wet age-related macular degeneration and macular edema after retinal vein occlusion. The pre-filled syringe enables physicians to eliminate steps in preparation and administration process, the company […]
Mylan settles EpiPen pricing probe with $465m
Mylan (NSDQ:MYL) last week agreed to pay $465 million to settle claims that it underpaid Medicaid for its EpiPen auto-injector by misclassifying the device as a generic. Last week, the Centers for Medicare & Medicaid Services said it spent $797 million on the emergency allergy treatment between 2011 and 2015, including rebates. The Canonsburg, Pa.-based company has […]
FDA approves Bayer’s Kyleena IUD
Bayer (ETR:BAYN) said yesterday that it won FDA approval for its hormonal contraceptive device, Kyleena, to prevent pregnancy for up to 5 years. The German company said the long-acting reversible contraceptive (LARC) is due to hit the market next month. LARCs are an increasingly popular form of birth control, including intrauterine devices like Kyleena. Bayer’s […]
OrthoSera wins CE Mark for hypACT regenerative osteoarthritis device
Orthobiologics company OrthoSera GmbH said today it won CE Mark approval in the European Union for its hypACT system designed to aid in regenerating osteoarthritic bone. The Austrian company’s hypACT device is designed to deliver its hyperacute, platelet rich plasma serum to aid in regeneration for patients with osteoarthritis and other degenerative diseases. “After the […]
FDA draft guidance on 510(k)s omits combination devices
Combination medical devices which bring together device components and drugs or biological products into a single unit are missing from new draft guidance from the FDA. The guidance, released last week, covered recommendations for manufacturers on when to submit 510(k) applications for modifications to devices currently on the market, replacing guidance that was 19 years […]
