Topic:

Regulatory

Latest Headlines

Latest Headlines

Biosensors Japan's PhIII trial of drug eluting has enrolled patients

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 starts study of world's tiniest pediatric mechanical heart valve

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.

FDA puts off Mylan's Nexium generic, giving Teva's version free rein

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.

Competition to J&J's Remicade looms in U.S. as biosimilar conquers new markets

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 plans universal healthcare blending public and private hospitals

SINGAPORE-- Singapore plans to offer a version of universal healthcare that builds on catastrophic insurance mandatory under the country's Central Provident fund.

FDA regulatory oversight apparent in failed knee replacement procedure, experts say

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.

FDA clears first stroke stent system to go in via the neck from startup Silk Road

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.

FDA letter takes issue with Micro Labs' data practices

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.

Guinea approves Fujifilm's Avigan to treat early Ebola cases

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 boasts new Lucentis approval for retinal damage in diabetes

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.