Genzyme receives FDA request

Genzyme (Cambridge, Massachusetts) said it has received a letter from the FDA requesting additional analyses and data regarding the marketing application for Synvisc-One in the U.S. The company now expects that approval of the next-generation Synvisc (hylan G-F 20) to be delayed in the U.S. until at least the second half of 2008.

Synvisc-One is a single treatment of Synvisc that is intended to provide up to six months of pain relief from osteoarthritis of the knee.

ACP issues new COPD guidelines

Chronic obstructive pulmonary disease (COPD) is a slowly progressive lung disease involving the airways and lung tissue, resulting in gradual loss of lung function, typically as a result of smoking. The symptoms of COPD range from chronic cough and wheezing to more severe symptoms such as shortness of breath and significant activity limitation.

Now America’s largest medical specialty organization, the American College of Physicians (ACP; Philadelphia), is issuing new guidelines for treatment of this condition that affects more than 5% of the U.S. adult population.

The new guidelines recommend that doctors use spirometry, a simple test that measures lung function, only on patients who exhibit symptoms such as chronic coughing and wheezing to more severe symptoms like shortness of breath, poor exercise tolerance, and signs of fatigue.

There is no substantial evidence that picking up the disease early by spirometry actually changes the overall natural course of the disease, the ACP said.

SCA signs with Galleria Tower

Surgical Care Affiliates (SCA; Birmingham) has signed a lease with the Galleria Tower to house its home office operations and expects to move into the new space during the first quarter of 2008. SCA is the surgical services company created by HealthSouth’s sale of its surgery division to TPG in June 2007.

“We are very pleased with our decision to move to the Galleria Tower,” said Mike Snow, SCA president/CEO. “Once we complete the build-out, it will provide us with the space we need to accommodate SCA’s future growth as one of the nation’s largest providers of specialty surgical services.”

SCA provides specialty surgical services.