The FDA approved a new indication for Novo Nordisk‘s (NYSE:NVO) Victoza liraglutide injection, clearing it as the only Type II diabetes medication indicated to reduce the risk of cardiovascular diseases, like heart attack and stroke. The regulatory watchdog’s decision is based on results from Nordisk’s 9,300-patient Leader trial, which showed that Victoza significantly reduced the risk […]
Drug-Device Combinations
Federal judge dismisses faulty birth control suit against Merck
A Maine federal judge tossed out a woman’s lawsuit against Merck (NYSE:MRK), after she claimed that the company’s Nexplanon birth control implant allegedly failed to keep her from becoming pregnant. Kayla Doherty filed the suit in April 2015, seeking damages related to the costs of raising a child as a single mother and costs related to her […]
Titan wins FDA nod to study Parkinson’s implant
Titan Pharmaceuticals (NSDQ:TTNP) said today that the FDA cleared the investigational new drug application for its ropinirole implant designed to treat the symptoms of Parkinson’s disease. The Phase I/II trial, which is slated to enroll 20 patients with idiopathic Parkinson’s disease, will transition patients taking oral ropinirole to Titan’s ropinirole implant for three months of treatment, […]
Propeller Health, GSK expand collaboration for connected inhaler
Propeller Health and GlaxoSmithKline (NYSE:GSK) said today that the two companies are planning to commercialize GSK’s Ellipta inhaler with Propeller’s clip-on medication sensor and software platform. The companies first announced their partnership in 2015 and in November last year the pair won 510(k) clearance from the FDA to market the Propeller plaftform with the Ellipta dry powder inhaler. Get the […]
Tandem Diabetes launches t:lock connector for its insulin pumps
Tandem Diabetes Care (NSDQ:TNDM) said today that it launched the t:lock Connector for its insulin pump cartridges and infusion sets. The connector, which is produced and supplied by Unomedical, has a small inner cavity. San Diego-based Tandem said this feature reduces the amount of insulin used while filling an infusion set and lessens the time required […]
Bonti kicks off Ph2 trial for neurotoxin pain-reliever
Privately-held biotech Bonti said today that it launched the Lantern clinical program, evaluating its intramuscular neurotoxin injection as a non-opioid pain reliever. The first clinical trial, Lantern-1, is a Phase II study designed to assess the safety and efficacy of EB-001 in patients undergoing elective breast augmentation. Get the full story at our sister site, Drug Delivery […]
BTG helps fund immuno-oncology drug-device research programs
BTG (LON:BTG) and the Society of Interventional Oncology said today that it expanded its immuno-oncology/interventional oncology research grant program. The group launched a second round of funding, designed help evaluate minimally invasive, image-guided therapies that use the body’s own immune system to treat cancer. Get the full story at our sister site, Drug Delivery Business News.
Nanotech, immunotherapy combo vaccinates mouse against cancer
Researchers from Duke University combined an FDA-approved cancer immunotherapy with gold nanostars to boost the cancer-killing abilities of both therapies, according to a study published this week in Scientific Reports. The combination therapy cured two mice and vaccinated one against bladder cancer, the team reported. Get the full story at our sister site, Drug Delivery Business News.
Mylan inks $465m settlement with DOJ over EpiPen Medicaid classification
Mylan (NSDQ:MYL) said today that it inked a $465 million deal with U.S. Dept. of Justice to settle claims that it misclassified its EpiPen allergy auto-injector device with the Medicaid Drug Rebate Program. In October last year, The Centers for Medicare & Medicaid Services said that Mylan had been overcharging Medicaid for its EpiPen device for years, despite […]
Study: Drug-delivery micromotors treat bacterial infection in stomach
Researchers at the University of California San Deigo have successfully used tiny micromotors loaded with antibiotics to treat a bacterial infection in the stomachs of mice, according to a study published today in Nature Communications. The tiny drug-delivery vehicles are powered by gastric acid, pushing them through the stomach and releasing cargo in a specific region, based on […]
Glytec lands another 510(k) clearance for diabetes management software
Glytec said today that it won a fourth 510(k) clearance from the FDA for its insulin titration software, eGlycemic Management System featuring Glucommander. The latest FDA nod applies to product enhancements derived from user feedback, the Waltham, Mass.-based company said, including a streamlined transition of inpatients from IV to subcutaneous therapy and more robust workflow capabilities. […]