Cirrus’ ClearEars can relieve glue ear
COLD SPRING HARBOR, N.Y. Cirrus Healthcare Products recently announced the launch of ClearEars, earplugs that contain a polymer to draw water from the ears after water activities. Consumers with glue ear, a condition in which thick, sticky fluid collects behind the eardrum, discovered that ClearEars helps to alleviate this condition, the company said.
Glue ear is common in children but also may affect adults. Left untreated, glue ear can cause temporary hearing loss and may affect a child’s behavior and educational process. Adults with glue ear also find it difficult to use regular earplugs to reduce noise or for water protection while swimming. Consumers with glue ear have reported that soft and comfortable ClearEars may be used while sleeping to reduce noise and also alleviate the moist, sticky glue ear feeling.
Arena, Eisai receive complete response letter for lorcaserin
SAN DIEGO The Food and Drug Administration declined to approve a regulatory approval application from Arena Pharmaceuticals and Eisai for a drug to treat obesity, the two companies said Saturday.
The FDA issued a complete response letter for the drug lorcaserin, designed for weight management and weight loss in patients who are overweight or obese and have at least one co-morbid condition. The FDA issues a complete response letter when it finishes reviewing an approval application, but issues remain that preclude final approval.
The FDA told the companies that it found problems regarding tumors in the mammary glands of rats receiving the drug and issues surrounding the efficacy of the drug in some patients.
“This is an important step for us toward the FDA’s approval of lorcaserin,” Arena president and CEO Jack Lief said. “While the complete response letter provides us with recommendations from the agency, we intend to meet with the FDA to obtain further clarity on the approval path and timeline.”
CHPA names Melville its new president
WASHINGTON —Scott Melville has been named the new president of the Consumer Healthcare Products Association, succeeding Linda Suydam, who is retiring after eight years with CHPA. The news becomes official Nov. 1.
Prior to the announcement, Melville served as SVP government affairs and general counsel for the Healthcare Distribution Management Association. Before joining HDMA, Melville was as an attorney and head of government relations for Cephalon. A veteran facilitator, familiar with health care and the vital role over-the-counter medicines and natural products play in today’s healthcare system, Melville also is a former staffer for Rep. Jerry Lewis, R-Calif.
At CHPA, Melville will have an opportunity to bring all of his decades of experience as a healthcare sector advocate to bear. With healthcare reform on the line and millions of baby boomers hitting their 60s, CHPA chairman Christopher DeWolf said that Melville’s “experience in public policy, coalition building and working with government officials and key stakeholders will be invaluable in guiding the industry through the rapidly changing healthcare environment.”