Court rules Teva’s GERD generic does not infringe on branded drug
JERUSALEM A generic version of a gastroesophageal reflux disease drug that dissolves in the mouth doesn’t infringe on the patent for the branded version, a U.S. appeals court has ruled.
Teva Pharmaceutical Industries announced Friday that the U.S. Court of Appeals for the Federal Circuit affirmed a Nov. 10, 2009 District Court ruling that its version of Takeda’s Prevacid SoluTab (lansoprazole) does not infringe U.S. Patent No. 5,464,632.
Teva’s regulatory approval application for the drug is awaiting final approval from the Food and Drug Administration. The branded version has annual sales of approximately $513 million, according to IMS Health.
FDA approves Ampyra
ROCKVILLE, Md. The Food and Drug Administration has approved a new drug for improving walking ability in adults with multiple sclerosis, the agency announced Friday.
The FDA approved Acorda Therapeutics’ Ampyra (dalfampridine) extended-release tablets, designed to be administered in daily 10-mg doses. The agency’s approval was based on clinical trials that showed patients treated with the drug had faster walking speeds than those who received placebo. Ireland-based Elan will manufacture the drug using its technology platform, while Acorda will market it in the United States. Biogen Idec will market it in other countries.
“Trouble with walking is one of the most debilitating problems people with MS face,” FDA Center for Drug Evaluation and Research Division of Neurology Products director Russell Katz said.
Cascade Health Solutions opens Primary Care Clinic
EUGENE, Ore. Cascade Health Solutions, a local nonprofit healthcare provider, is opening here on Feb. 1 a membership-based primary care clinic that will be staffed by a full-time nurse practitioner to treat members.
Unlike other retail medical clinics, the Primary Care Clinic will serve as a medical “home” for ongoing healthcare needs.
According to Cascade Health Solutions, the clinic will offer membership-based primary medical care to individuals and families who lack health insurance or who only have catastrophic coverage. The basic month-to-month membership cost is $45 for individuals; families of four or more enrolling together pay $40 per person each month. There is no enrollment fee to join and members will pay $20 per visit.
Membership will be initially limited to 750 members and will then grow to 2,500 in the first year.
Services include routine checkups, office visits, health education and counseling as well as treatment for such chronic illnesses as diabetes and high blood pressure. There are no caps for chronic conditions. Patients can visit the clinic as often as desired provided they pay their monthly membership costs and the $20 office visit fee for each visit. Preventive, birth control and mental health services are also available to members.
A variety of diagnostic tests also are available as part of the office-visit fee of $20, including throat cultures, PAP smears, and other standard tests and screenings.