FDA approves KarmelSonix’s home asthma assessment device
KarmelSonix, a developer and marketer of asthmatic and pulmonary devices, has received Food and Drug Administration approval for its device, the WIM-PC.
KarmelSonix specializes in the analysis of sounds emitted from the body (specifically, wheezing) heard in asthmatic patients. The device consists of a sensor attached to the patient’s neck and chest near the windpipe, and a computerized system that analyzes the sounds and determines whether the sounds indicate a life threatening situation requiring the sufferer to be admitted to hospital, or whether the condition can treated at home or at a clinic.
The Australian-traded company is a merger of Karmel Medical and PulmaSonix. Founded in 1996 under the name Karmel Medical, the company has raised $8 million and it even received FDA approval for its device (a previous generation of the WIM-PC), but the company’s inability to market the product proved more difficult than anticipated. Karmel Medical eventually merged the company with an Australian shell called PulmaSonix, and a third company.
KarmelSonix recently raised $6 million (US$5.3 million) on the Australian Stock Exchange at around 17 cents per share in U.S. dollars.
Eisai announces new hires and appointments
WOODCLIFF LAKE, N.J. Eisai Inc., the U.S. subsidiary of Eisai Co., today announced new hires and appointments within the company, which produces such drugs as the acid-reflux medication Aciphex and Aricept, which is used to treat mild, moderate and severe Alzheimer’s disease.
Sunitha Ramamurthy has joined Eisai Corporation of North America as compliance director of Research and Development. Christine Drobot has joined the company as counsel for Employment and Research and Development. Barbara Sudovar has joined Eisai Inc. as director of U.S. Market Research.
Steven Brown has been promoted to director of Marketing Finance and will be responsible for financial reporting and business planning of product line P&Ls. Prior to this promotion, Steven was associate director of Marketing Finance for two years and marketing finance manager on the Aricept brand for two years. Terry Paluga has been promoted to specialty district manager where she will oversee the Baltimore Specialty District.
Study shows Zocor could increase incidence of sleep disorders
WHITEHOUSE STATION, N.J. A new study showed that patients on the cholesterol drug Zocor were three times as likely to suffer from insomnia than those who took another cholesterol drug Pravachol and those taking a placebo, according to Bloomberg.com.
Insomnia is listed as a possible side effect for all cholesterol-lowering drugs. Merck spokesman Ron Rogers said the company found no significant effects on sleep in its own insomnia studies comparing Zocor with pravastatin, the generic of Pravachol and a placebo. Nor did the company see sleep disruption as a side effect in two other studies testing the drug’s effectiveness in thousands of patients.
The National Institutes of Health, in Bethesda, Maryland, funded the study. Zocor was the world’s second-best-selling cholesterol pill, behind Pfizer’s Lipitor, before it lost patent protection in June 2006.