Current medical news from today, including FDA’s draft rules for approving biosimilars, mobile health’s integration into insurance, and healthcare social media makes clinical trials easier.

Shire (NASDAQ:SHPGY) has reached an agreement with U.S. regulators in the long-running saga over its low blood pressure drug, ProAmatine, that rests on the drug generating positive results in two clinical trials, or else face a withdrawal of its new drug application.The compromise was agreed to with the U.S. Food and Drug Administration’s Center for [...]

Shire (NASDAQ: SHPGY) has secured approval from U.S. regulators for a drug to manage symptoms of Attention Deficit and Hyperactivity Disorder in adults.Vyvanse has been approved as a maintenance treatment for ADHD. This new approval adds to the indication for Vyvanse as a treatment for ADHD in patients 6 years old and older, according to [...]

Under a preliminary deal announced Wednesday, medical device user fees paid to the U.S. Food and Drug Administration are going to more than double in the next five years.That might not sit well with some medical device makers who have long complained that over the years the agency has become too unpredictable and slow in [...]

SCROLL BELOW FOR UPDATESUser fees have been a bone of contention between the medical device industry and the U.S. Food and Drug Administration, and negotiations have dragged on for a year.var page_count = “off”; if (typeof OAS_rdl == “undefined”) {document.write(“”); page_count = “on”;}var MMI_ClickURL = [...]

How does an agency like the U.S. Food and Drug Administration balance its mandate to safeguard public health and protect confidential business information simultaneously?That delicate balance has come under the spotlight in a whistle-blower lawsuitagainst the agency brought by six current and former employees who charge that the FDA was secretly monitoring their personal email [...]

Ranbaxy‘s generic pharmaceuticals business in the U.S. has been suspended until it can correct violations at its factories in India and the United States that triggered a federal injunction.Under the terms of a settlement reached with the U.S. Department of Justice, which described its investigation of the company as “groundbreaking,” the company is to bring [...]

A gel to treat a precancerous skin condition has been approved by the U.S. Food and Drug Administration.Picato gel, produced by LEO Pharma is applied to the skin to treat actinic keratosis, a skin condition caused by overexposure to the sun. The condition produces dry, scaly patches or lesions that form on the outermost layer [...]

Invacare (NYSE:IVC) plans to move production of a line of manual wheelchairs to Mexico from Ohio, as the home health products company is in the midst of negotiating a legal settlement with the FDA over issues with wheelchair production in the Elyria, Ohio, plant.The Cleveland-area company will shift production of its Solara line of manual [...]

The regulatory process for reviewing medical devices in Europe is coming under fire after a controversy over leaking breast implants made in France.That’s a big deal for U.S. medical device companies, who frequently praise the European regulatory system as faster, less burdensome and more supportive of technological innovation. Many in the device industry would like [...]