Reva Medical (ASX:RVA) announced today that the company’s Fantom Encore bioresorbable vascular scaffold was used for the first time in Switzerland. The sirolimus-eluting device, which is made from Reva’s proprietary Tyrocore polymer, features a 95-micron strut profile and x-ray visibility. “Reva’s Tyrocore polymer makes Fantom Encore the most advanced bioresorbable scaffold with x-ray visibility and the […]
Pharmaceuticals
Convexity Scientific launches pocket-sized nebulizer
Convexity Scientific announced today that the company launched its Flyp nebulizer for patients with asthma and chronic obstructive pulmonary disease. The handheld, pocket-sized device was approved by the FDA in May last year. Convexity’s nebulizer includes a vibrating internal disk that produces an inhaled aerosol mist to deliver medication deep into patients’ lungs. The device […]
Milestone Scientific wins Health Canada license for epidural drug-delivery system
Health Canada issued a medical device license to Milestone Scientific (NYSE:MLSS) this week for the company’s CompuFlo Epidural computer-controlled anesthesia system. The Livingston, N.J.-based company developed CompuFlo Epidural to use dynamic pressure sensing to help anesthesiologists correctly identify the epidural space and reduce complications in real-time. The system also has 510(k) clearance in the U.S. “Receiving […]
Sanofi’s high-capacity insulin pen wins FDA nod
Sanofi (NYSE:SNY) reported today that its Toujeo Max SoloStar high-capacity insulin pen won FDA approval and will be available in the third quarter of this year. The new device holds 900 units of long-acting insulin and delivers 160 units/mL of Toujeo insulin glargine in each injection, the insulin-maker touted. “This new high capacity pen has a […]
This new technology could help surgeons clear out leftover cancer cells
In some instances, as many as 30% of patients need repeat surgeries get rid of cancerous cells initially left behind. The team from Lumicell wants to change that — and improve outcomes for cancer patients. [Image by MDO art director Matthew Claney] After his wife died of breast cancer in 2003, David Lee stepped away from […]
Kala Pharmaceuticals posts Q4 earnings miss
Shares in Kala Pharmaceuticals (NSDQ:KALA) tumbled -14% yesterday after the biopharma company missed expectations on Wall Street with its fourth-quarter and full-year results. The Waltham, Mass.-based company posted a net loss of -$11.3 million, or -46¢ per share, for the 3 months ended Dec. 31, for bottom-line loss of -34.5% compared with the same period last year. […]
FDA approves label update to Novo Nordisk’s Tresiba diabetes drug
The FDA approved Novo Nordisk‘s (NYSE:NVO) request to include heart health data on the label of its Tresiba insulin degludec product. The Danish insulin-maker evaluated its Type II diabetes drug in a 7,637-patient trial, assessing the therapy for cardiovascular safety compared to insulin glargine. Novo Nordisk’s Devote trial met its primary endpoint after Tresiba demonstrated […]
Acorda seeks EU approval for inhaled Parkinson’s disease drug
Acorda Therapeutics (NSDQ:ACOR) submitted a marketing authorization application to the European Medicines Agency for its inhaled Parkinson’s disease therapy, Inbrija, according to the Ardsley, N.Y.-based company. The investigational drug is designed to treat people with Parkinson’s disease who are experiencing “off” periods, or a re-emergence of symptoms. Acorda’s marketing application for Inbrija includes data from a […]
FDA aims to curb ingredient list for drug compounders
The FDA issued draft guidance last week designed to limit the list of pharmaceutical ingredients that drug compounding pharmacies can use to manufacture drugs in bulk that do not undergo the agency’s traditional approval process. The move comes in the wake of a deadly 2012 fungal meningitis outbreak that originated from contaminated drugs made in […]
EU committee backs dosing changes for Bristol-Myers Squibb’s immunotherapy
A committee for the European Union’s pharmaceutical regulatory agency backed changes to the dosing schedule for Bristol-Myers Squibb‘s (NYSE:BMY) Opdivo cancer drug, the company touted today. The Committee for Medicinal Products for Human Use recommended that the European Commission approve a dosing schedule of 480-mg infused over 60 minutes every four weeks as an option […]