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Featured

Analyst: Insulet’s drug-delivery biz a long-term growth driver

October 3, 2016 By Sarah Faulkner

Insulet

Insulet’s (NSDQ:PODD) drug-delivery business will be a long-term growth driver for the company by as much as 20% a year for the next few years, according to Leerink Partners analysts. Billerica, Mass.-based Insulet generates 86% of its revenue from its OmniPod insulin delivery device, according to Leerink. The OmniPod technology could be easily adapted to […]

Filed Under: Auto-injectors, Diabetes, Drug-Device Combinations, Featured Tagged With: Amgen, Insulet, SVB Leerink

Dicerna bails on EnCore lipid nanoparticle tumor delivery program

September 27, 2016 By Sarah Faulkner

Dicerna raises $70m, reels in losses for Q4

Dicerna Pharmaceuticals (NSDQ:DRNA) said yesterday that it plans to spike the development program for its lipid nanoparticle delivery system for solid tumors because its preliminary results don’t meet expectations. The Cambridge, Mass.-based company evaluated its lipid nanoparticle, DCR-MYC, in a pair of clinical trials – a Phase I study of patients with solid tumors, hematological […]

Filed Under: Clinical Trials, Drug-Device Combinations, Featured, Nanoparticles, Oncology Tagged With: Dicerna Pharmaceuticals

Mylan clarifies $104 profit on $600 EpiPens

September 27, 2016 By Sarah Faulkner

Mylan

Mylan (NSDQ:MYL) acknowledged that the $104 profit it reported to Congress included taxes, after the Wall Street Journal reported that the company applied the statutory U.S. tax rate of 37.5% to calculate its profits for testimony before the Senate, according to Reuters. “Without the tax-related reduction, Mylan’s profits on the EpiPen 2-pack would be closer […]

Filed Under: Auto-injectors, Drug-Device Combinations, Featured, Wall Street Beat Tagged With: Capitol Hill, Mylan

Parents question Mylan’s EpiPen school campaign

September 23, 2016 By Sarah Faulkner

Mylan

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 […]

Filed Under: Auto-injectors, Drug-Device Combinations, Featured, Food & Drug Administration (FDA), Pharmaceuticals Tagged With: Mylan

Magnetic bacteria holds promise for drug delivery in cancer therapies

September 23, 2016 By Sarah Faulkner

cancer-drug nanotransporters

Researchers from the Polytechnique Montreal NanoRobotics Laboratory showed that magnetic bacteria can be used as a vehicle for cancer-fighting drugs. The study, funded in part by the National Institute of Biomedical Imaging & Bioengineering, was published in the August 2016 issue of Nature Nanotechnology. Traditional drug-delivery techniques using nanoparticles have a hard time fully penetrating […]

Filed Under: Drug-Device Combinations, Featured, Oncology, Research & Development Tagged With: National Institute of Biomedical Imaging & Bioengineering, Polytechnique Montreal NanoRobotics Laboratory

Changing healthcare & clinical trials with patient monitoring tech

September 21, 2016 By Sarah Faulkner

Patient monitoring can be challenging, often relying on patients to self-report symptoms or describe how they’re feeling. But technology is changing that, making it easier for researchers to monitor patient adherence to a trial’s regimen and for doctors to personalize a patient’s treatment. At the FierceBiotech Drug Development Forum in Boston today, a panel took up the […]

Filed Under: Clinical Trials, Drug-Device Combinations, Featured, mHealth (Mobile Health) Tagged With: Biogen Idec, Propeller Health, Qualcomm

FDA approves clinical trial for QT Vascular’s Chocolate Touch DCB

September 20, 2016 By Sarah Faulkner

QT Vascular

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 […]

Filed Under: Clinical Trials, Drug-Device Combinations, Featured, Food & Drug Administration (FDA) Tagged With: AngioScore Inc., Peripheral Artery Disease, QT Vascular

FDA approves Bayer’s Kyleena IUD

September 20, 2016 By Sarah Faulkner

Bayer

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 […]

Filed Under: Drug-Device Combinations, Featured, Food & Drug Administration (FDA), Regulatory/Compliance, Women's Health Tagged With: Bayer HealthCare, Teva Pharmaceuticals

FDA approves 6-month endpoint in trial of Bard’s Lutonix 014 drug-coated balloon

September 20, 2016 By Brad Perriello

C.R. Bard

C.R. Bard (NYSE:BCR) said yesterday that the FDA approved a supplemental investigational device exemption to change the main 6-month endpoint in the clinical trial of a new version of its Lutonix drug-coated balloon in treating below-the-knee peripheral arterial disease. Murray Hill, N.J.-based Bard in October 2014 won pre-market approval from the FDA for the Lutonix 035 DCB for PAD lesions above the […]

Filed Under: Clinical Trials, Drug-Device Combinations, Featured Tagged With: C.R. Bard, Peripheral Artery Disease

Medical society backs drug-eluting sinus implants

September 19, 2016 By Sarah Faulkner

American Rhinologic Society

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 […]

Filed Under: Drug-Device Combinations, Featured, Otolaryngology Ear, Nose & Throat Tagged With: American Rhinologic Society, Intersect ENT Inc.

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