Cleveland Clinic spinoff Juventas Therapeutics has successfully completed a phase 1 clinical trial of its regenerative medicine technology in heart failure patients. Cleveland-based Juventas’ technology, JVS-100, works by recruiting stem cells from the bone marrow to create new blood vessels. In addition to heart failure patients, the company is investigating the treatment of patients suffering […]
ReGen Biologics Inc. (PINK:RGBO) filed for Chapter 11 bankruptcy protection with the U.S. Bankruptcy Court for the District of Delaware. The embattled maker of the Menaflex knee implant said in regulatory filings that the bankruptcy petition includes the company’s wholly-owned subsidiary RBio Inc., but not its wholly-owned Swiss subsidiary, ReGen Biologics AG. The company will […]
In a webinar on April 16 at 1pm ET, Aneesh Chopra will moderate a discussion with executives from DocuSign, Velatura, and behavioral health providers on eConsent, health information exchange and compliance with the CMS Final Rule on interoperability.
ReGen Biologics Inc. (OTC:RGBO) is firing back at the Food & Drug Administration after the federal watchdog agency said last week that it plans to rescind a 510(k) clearance for ReGen’s controversial Menaflex knee implant. “For CDRH to arrive at the decision that the device has a new intended use four years after two senior […]
The Food & Drug Administration decided it was wrong to clear a knee implant made by ReGen Biologics Inc. (OTC:RGBO) in 2008, over-riding the objections of FDA reviewers. The rescission means Hackensack, New Jersey-based ReGen has to keep its Menaflex device off the market until it can prove its safety and effectiveness to the FDA's satisfaction.
Could Avandia be the drug industry’s ReGen? The New York Times reported Tuesday that for over a decade, GlaxoSmithKline hid the results of its own study that showed its diabetes drug Avandia “provided clear signs that it was riskier to the heart.” The Food and Drug Administration ultimately approved Avandia. But in 2007, a doctor […]
Merrill Goozner: "Until special interest lobbying is removed from every level of the health care decision-making process, all schemes at controlling costs are chimerical."
A specialty drug is a class of prescription medications used to treat complex, chronic or rare medical conditions. Although this classification was originally intended to define the treatment of rare, also termed “orphan” diseases, affecting fewer than 200,000 people in the US, more recently, specialty drugs have emerged as the cornerstone of treatment for chronic and complex diseases such as cancer, autoimmune conditions, diabetes, hepatitis C, and HIV/AIDS.