Biotronik said today that its Orsiro drug-eluting stent beat Abbott‘s (NYSE:ABT) Xience DES in a trial comparing the target lesion failure rates of both devices. The data, which were presented at the European Society of Cardiology’s ESC Congress and published by The Lancet, showed a 6.2% TLF rate at 12-months for patients treated with Orsiro compared […]
FDA intervenes after stem cell center offers unproven treatment to cancer patients
The FDA is cracking down on stem cell clinics that administer unproven and potentially dangerous treatments to patients, citing a California-based clinic that the regulatory watchdog said was treating cancer patients with the smallpox vaccine. Last week, the U.S. Marshals Service seized five vials of a vaccine that is reserved only for people at high […]
Xarelto, aspirin combo reduces risk of cardiovascular events in pivotal Ph3 trial
Johnson & Johnson (NYSE:JNJ) subsidiary Janssen touted data today from a pivotal Phase III trial showing that Xarelto plus aspirin reduced the risk of major cardiovascular events in patients with stable coronary and peripheral artery disease compared to aspirin alone. Treatment with Xarelto twice per day and aspirin once-daily cut the risk of major cardiovascular events […]
Bard lands new indication for its drug-coated balloon
C. R. Bard(NYSE:BCR) said today that its Lutonix 035 drug-coated balloon PTA catheter won premarket approval from the FDA and is available in the U.S. The company’s Lutonix 035 device is the first drug-coated balloon approved in end-stage renal disease patients with stenotic lesions in dialysis arteriovenous fistulae. Bard’s DCB is also approved to treat […]
Tandem Diabetes wins FDA nod for insulin pump with Dexcom’s CGM
Tandem Diabetes Care (NSDQ:TNDM) said today that the FDA approved its t:slim X2 insulin pump with Dexcom‘s (NSDQ:DXCM) G5 mobile continuous glucose monitor. The regulatory win makes the device the first sensor-augmented insulin pump cleared to let users make treatment decisions without pricking their finger, the company touted. The San Diego, Calif.-based company said that the […]
Gilead expands into cell therapy with $11.9B Kite Pharma purchase
Taking a plunge into the cell therapy arena, Gilead Sciences (NSDQ:GILD) said today that it has inked an $11.9 billion deal to acquire Kite Pharma (NSDQ:KITE). The deal, which was unanimously approved by both companies’ boards, is slated to close in the fourth quarter of this year. Gilead said it plans to pay $180 in cash […]
One Drop touts effects of diabetes management mobile app
One Drop touted data today from a retrospective study of people with Type I and Type II diabetes using its mobile diabetes management app. The data, which were published yesterday in JMIR Diabetes, showed that people using the One Drop mobile app had a 1.1% to 1.3% absolute reduction in A1C in 4 months. The app […]
‘Body-on-a-chip’ device screens human heart cells for drug toxicity
Researchers at Kyoto University‘s Institute for Integrated Cell-Material Sciences have developed a ‘body-on-a-chip’ device that can evaluate the side-effects of drugs on human cells, according to a study published today in the Royal Society of Chemistry Advances. The device was used to test the toxicity of doxorubicin, a cancer-killing drug, on human heart cells. The researchers […]
FDA clears Nordisk’s Victoza as only Type II diabetes drug to cut cardio risks
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 […]
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 […]