United Therapeutics PAH drug wins approval
SILVER SPRING, Md. — The Food and Drug Administration has approved a new drug made by United Therapeutics for treating pulmonary arterial hypertension, the company said Monday.
The FDA approved Orenitram (treprostinil) extended-release tablets for treating certain PAH patients to improve exercise capacity. PAH is a disease in which abnormally high blood pressure in the arteries of the lungs causes the right side of the heart to work harder than normal, according to the National Library of Medicine.
"This approval marks the first time that the FDA has approved an orally administered prostacyclin analogue for any disease, and our fifth approval from the FDA for treatment of PAH, supporting our mission of providing a wider choice of PAH therapies for physicians and patients," United Therapeutics president and COO Roger Jeffs said. "We are grateful for the FDA’s thorough review and will continue to build clinical support for the use of Orenitram."
Tracey Rossi named Kinney Drugs’ 2013 Favorite Pharmacist of the Year
GOUVERNEUR, N.Y. — A Barre, Vt., pharmacist has been named Kinney Drugs’ top pharmacist, the regional chain announced Monday.
Kinney, which operates 99 stores in central and northern New York and adjacent areas of Vermont, named Tracey Rossi as its 2013 Favorite Pharmacist of the Year, based on customer votes from all of the chain’s stores.
"Tracey is a kind, caring, compassionate individual," Kinney Drugs stores president Jim Spencer said. "The relationship she has with her patients and the care she provides for them are her highest priorities. We truly appreciate Tracey’s nearly 30 years of service as a healthcare professional at Kinney Drugs."
Rossi will be honored at a reception later this month, while the company will donate $1,000 in her name to a charity of her choice.
"Tracey is a spectacular pharmacist who is revered by our customers," Barre, Vt., Kinney Drugs store manager Norm Robinson said. "She knows her patients by name and works hard to go beyond the everyday counseling to deliver outstanding customer service. Over the years, Tracey has truly become woven into the fabric of our community."
Amneal, Hanmi get favorable court ruling in esomeprazole strontium case
BRIDGEWATER, N.J. — A federal court decision paves the way for Amneal Pharmaceuticals and its South Korean partnering company to market a drug for treating gastroesophageal reflux disease, the companies said Monday.
Amneal Pharmaceuticals and Hanmi Pharmaceutical announced that the U.S. Court of Appeals for the Federal Circuit ruled in their favor in a patent infringement case brought by AstraZeneca. Amneal recently announced the launch of esomeprazole strontium delayed-release capsules, developed by Hanmi. AstraZeneca sued the companies, saying the drug infringed on its patent covering the drug Nexium (esomeprazole magnesium). However, the court ruled that AstraZeneca’s patent did not cover esomeprazole strontium.
"The appellate court adopted the position that Hanmi and Amneal advocated from the outset – specifically, that the Hanmi esomeprazole strontium product does not infringe the patents asserted by AstraZeneca," Amneal VP global intellectual property Kenneth Cappel said. "Moreover, Amneal’s recent launch will proceed free from the legal uncertainty that may have been perceived before last week’s favorable decision."