Stayhealthy gets license from Health Canada
MONROVIA, Calif. — Regulators in Canada have given a maker of health kiosks the green light to start marketing its products there.
Stayhealthy said Health Canada’s Medical Devices Bureau had granted it a license to sell its HealthCenter Kiosk, models 650 and 650-C. The kiosks measure blood pressure, heart rate, total body weight, body-mass index, total body composition and vision and can incorporate data on blood glucose.
"With Health Canada’s approval of our clinical-grade HealthCenters, final negotiations can proceed with several key prospective partnerships, which have been ongoing," Stayhealth CEO John Collins said. "We are pleased to expand our products and services into the Canadian market, which has similar challenges and opportunities as the United States."
Gilead’s Complera approved for HIV patients already on stable drug regimens
FOSTER CITY, Calif. — The Food and Drug Administration has approved an HIV pill made by Gilead Sciences for patients who are switching from other therapy regimens, the company said.
Gilead said the FDA approved its single-pill regimen, Complera (emtricitabine; rilpivirine; tenofovir disoproxil fumarate) for use in adult patients who have suppressed their infections on stable antiretroviral regimens and are replacing their current regimens. The FDA originally approved the drug in 2011.
"Complera is an effective single-pill therapy with a demonstrated safety profile and has rapidly become an important option for appropriate HIV patients who are initiating antiretroviral treatment," Community Research Initiative of New England research director and Complera clinical trial investigator Calvin Cohen said in a statement on behalf of Gilead.
Shire extends expiration date for offer to buy ViroPharma
DUBLIN — Drug maker Shire is extending the deadline for its offer to buy Exton, Pa.-based ViroPharma for $4.2 billion, Shire said Friday.
The company said it had extended the expiration date of its tender offer for ViroPharma until Jan. 9. The offer had previously been planned to expire on Thursday. Shire announced the $50-per-share offer last month.
As of 6 p.m. Thursday, about 50.2 million of ViroPharma’s shares, or 76% of the total shares of the company, had been put up for sale in connection with the offer, Shire said. ViroPharma develops treatments for rare diseases, including Cinryze (C1 esterase inhibitor [human]) for hereditary angioedema.