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 […]
GE plans ‘lab-in-a-box’ complex in Ireland
GE (NYSE:GE) reportedly plans to build 4 prefabricated drug factories in Cork, Ireland. The U.S.-based company said yesterday that it plans to put $167 million (€150 million) into a biopharmaceutical campus in County Cork, with construction slated to begin next year, according to Reuters. Both Pfizer (NYSE:PFE) and GE have prefab factories in China, designed 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 […]
Medical society backs drug-eluting sinus implants
The American Rhinologic Society today endorsed the use of drug-eluting implants in sinus cavities for patients following surgery. A successful sinus surgery depends on proper healing and avoiding inflammation, the society said in a press release. Drug-eluting implants can reduce nasal polyps and inflammation, which can decrease a patient’s use of oral medication, according to […]
Microchip mimics human cells for drug trials
A physics professor from the University of Texas in Dallas reportedly created a microchip that mimics human cells to study the effects of cancer-fighting drugs. Jason Slinker, who started working on the chip in 2007 as a postdoctoral researcher, in 2010 began collaborating with David Boothman, an oncology professor at the University of Texas Southwestern […]
Sanofi sues Merck over injected insulin
Sanofi Aventis (NYSE:SNY) said today that it filed a patent infringement lawsuit against Merck Sharp & Dohme Corp. (NYSE:MRK) over 10 U.S. patents related to its injected insulin device. The Paris-based company said it is seeking an injunction and damages from Merck for filing a new drug application with the FDA that challenged 10 of Sanofi’s […]
Sancilio withdraws $86m IPO for lipid-based drug delivery
Sancilio Pharmaceuticals last week withdrew its plans for an initial public offering it hoped would bring in $86 million for its Advanced Lipid Technology drug delivery platform. The Florida-based company registered the IPO in August 2015, but today requested that the SEC consent to its withdrawal, without giving a specific reason. The company’s drug delivery […]
Gore launches trial for Tag thoracic branch endoprosthesis
W.L. Gore & Assoc. said today that it enrolled the 1st patient in a pivotal study evaluating its Tag thoracic branch endoprosthesis as a treatment for lesions of the aortic branch and descending thoracic aorta. The Tag TBE is the 1st Gore device to win the FDA’s expedited access pathway designation and among the 1st medical devices […]
GE backs Injeq’s smart needle
Injeq, a resident at GE’s Health Innovation Village in Helsinki, created a smart needle that tells the user about surrounding tissue for safer liver biopsies and lumbar punctures. The Finnish company’s device looks like a standard hypodermic needle, but with an electrode attached to the tip. The needle measures changes in signal caused by contact […]
OptiNose touts Phase III data for exhaled breath drug delivery
OptiNose touted data from a pair of Phase III clinical trials proving the safety and efficacy of its exhaled breath drug delivery treatment for chronic rhinosinusitis patients with and without polyps. The company presented the data today at the American Rhinologic Society’s annual meeting in San Diego. Data from both trials showed limited adverse effects from […]
Sofregen lands $6.2m Series A
Sofregen Medical said yesterday that it landed a $6.2 million Series A round from Polaris Partners and other founding investors, bringing their total funding raised to more than $11 million. The Medford, Mass.-based company was founded in 2014 to advance silk-based medical technology developed at Tufts University and the University of Pittsburgh for soft tissue […]