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 […]
Food & Drug Administration (FDA)
FDA awards product development grants for rare diseases
The FDA said yesterday that it awarded 21 clinical trial research grants totaling more than $23 million over the next 4 years to stimulate product development for patients with rare diseases. The Orphan Products Clinical Trials Grants Program has awarded more than $370 million to fund more than 590 clinical studies since its creation in […]
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 […]
Parents question Mylan’s EpiPen school campaign
Three years ago, Mylan (NSDQ:MYL) began holding summits for food allergy bloggers to learn about its campaign to get its EpiPen epinephrine injector into schools. Many of the bloggers, mothers of children with serious allergies, were eager to help. Some, including Ruth LovettSmith, wrote thousands of posts, providing testimony that some legislators say convinced them […]
FDA approves clinical trial for QT Vascular’s Chocolate Touch DCB
QT Vascular said today that it won an investigational device exemption from the FDA for a pivotal study of its Chocolate Touch drug-coated balloon. The device won the CE Mark for treating peripheral artery disease in September 2015 and in July it won approval for treating coronary artery disease. The Singapore-based company is slated to […]
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 […]
Ablative Solutions wins FDA nod for Phase II chemical denervation trial
Ablative Solutions said today that the FDA approved a Phase II trial of its chemical denervation system for hypertension under its investigational new drug application. The trial, called Target-BP I, will evaluate the efficacy of Ablative’s Peregrine infusion ablation system, which uses ethanol to interrupt signals from sympathetic nerves in the renal artery to control […]
Teva plans competitor for Mylan’s EpiPen
Teva Pharmaceutical (NYSE:TEVA) said last week that it hopes to win U.S. approval for its version of Mylan‘s (NSDQ:MYL) EpiPen by late 2017 or early 2018. Mylan’s EpiPen holds an estimated 94% market share in the U.S.; an alternate device from Teva could threaten the product’s dominance. Teva’s application for its epinephrine injector has been […]
FDA request delays timeline for Sanofi’s iGlarLixi drug-device combo for diabetes
By Sarah Faulkner The FDA’s request for more data on the iGlarLixi drug-device combination for treating Type II diabetes pushed the timeline for a decision back 3 months, Sanofi (NYSE:SNY) and Zealand Pharma (CPH:ZEAL) said last week. Sanofi said August 19 that it submitted a new data package for iGlarLixi, an injection pen designed to […]
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 […]
