The last of 140 patients have been enrolled in a trial of Singapore-based Biosensors International's clinical trial of its drug-coated stent, BioFreedom, according to a news release. The trial is being conducted in Japan by Leaders Free Japan patients at high risk of bleeding.
St. Jude Medical is starting a trial for a device that it hopes will be the smallest FDA-approved pediatric mechanical heart valve. The device is only 15 mm in diameter; that's roughly equivalent to the length of a staple.
Good news for Teva when it comes to Mylan's generic version of AstraZeneca's Nexium: It won't be around for a little while.
South Korea's Celltrion will start sales of Remsima, its biosimilar of Johnson & Johnson's Remicade (infliximab) in a dozen European countries in February, according to Joon Seok Kim of Celltrion Public Relations on Tuesday.
SINGAPORE-- Singapore plans to offer a version of universal healthcare that builds on catastrophic insurance mandatory under the country's Central Provident fund.
As lawmakers and industry groups call for increased regulation of medical devices, experts are pointing to a failed knee replacement surgery to illustrate the FDA's oversight.
The FDA has cleared the first system to reduce stroke risk that introduces a stent via the neck. The device, the Enroute Transcarotid Neuroprotection System from startup Silk Road, is expected to offer an option for patients whose vasculature is too convoluted to introduce a stent via the femoral artery in the groin.
Count another Indian API producer on the FDA's regulatory radar. Four months after issuing an import ban on products made at a Micro Labs plant in Bangalore, the agency outlined the violations last month.
SINGAPORE-- The head of Guinea's Ebola-response program wasted no time in announcing approval of broader use of Fujifilm's Avigan (favipiravir) influenza drug for treating early cases of Ebola in the West Africa nation.
Roche now has another approval under its belt for eye drug Lucentis. And it's in a market it can call its own: Lucentis is the first U.S.-approved treatment for diabetic retinopathy in patients with diabetic macular edema.