Mylan receives tentative approval for HIV/AIDS drug in developing countries
PITTSBURGH — The Food and Drug Administration has given tentative approval to a division of Mylan for a generic drug for treating HIV and AIDS in children in developing countries.
Mylan said Thursday that the FDA had tentatively approved Mylan Labs’ abacavir sulfate and lamivudine tablets in the 60 mg/30 mg strength. The drug is a generic version of Viiv Healthcare’s Epzicom and was approved under the President’s Emergency Plan for AIDS Relief. The drug will only be available for purchase in certain developing countries outside the United States.
"The approval of abacavir sulfate and lamivudine further supports Mylan’s mission to continue expanding access to high-quality medicine around the world, which is especially crucial for children living with HIV/AIDS," Mylan CEO Heather Bresch said. "This product combines two medications in one tablet, which may support treatment adherence in children as it reduces the pill burden often associated with complex antiretroviral regimens."
Mylan’s Tony Mauro elected as GPhA chairman
WASHINGTON — The president of one of the world’s largest generic drug manufacturers will serve as chairman of the Generic Pharmaceutical Association, the organization said Thursday.
The GPhA announced that it had elected Mylan president Tony Mauro as chairman. Mauro previously served as the organization’s vice chairman. "With growing populations, economic recessions and increasing healthcare costs, the need for widespread access to more affordable medicine has never been so great," Mauro said. "The generic pharmaceutical industry is stronger than it has ever been, and I see tremendous opportunities ahead for our association and for our industry."
Meanwhile, Sandoz president and CEO Don DeGolyer was elected vice chairman, while Momenta Pharmaceuticals president Craig Wheeler was reelected as secretary treasurer. Other board members include:
- Debra Barrett, SVP government and public affairs, Teva Pharmaceuticals;
- Carole Ben-Maimon, president of global pharmaceuticals, Impax Labs;
- Paul Bisaro, president and CEO, Watson Pharmaceuticals;
- Doug Boothe, president and CEO, Actavis;
- Chuck Caprariello, VP corporate communications and government affairs, Ranbaxy;
- Don DeGolyer, president and CEO, Sandoz;
- John Ducker, president and CEO, APP Pharmaceuticals;
- Jeffrey Glazer, CEO, Heritage Pharmaceuticals;
- David Klaum, SVP and GM, Fougera;
- Thomas Moore, president, U.S., Hospira; and
- Joseph Renner, president and CEO, Zydus Pharmaceuticals USA.
Mauro, DeGolyer, Wheeler, Barrett, Ben-Maimon, Bisaro, Boothe, Caprariello and Moore will serve on the GPhA executive committee.
Allscripts, MyCareTeam create integrated diabetes management system
LAS VEGAS — Allscripts and MyCareTeam have teamed up to launch an integrated diabetes management system, the companies announced at the Healthcare Information and Management Systems Society’s annual conference and exhibition.
The system combines Allscripts Enterprise Electronic Health Record and MyCareTeam’s MCT-Clinical for Diabetes software application, and enables patients and providers to collaborate to better manage diabetes between visits and in the officem the companies said. Specifically, patients use MyCareTeam’s application to regularly transmit their blood-glucose readings directly from their glucose meters, along with blood pressure, weight, vital signs, caloric intake and exercise to a database via the Internet. With the Allscripts integration, these data automatically connect to the Allscripts Enterprise EHR, and can create user-defined alerts that are routed to a diabetes educator, a care manager, a nurse, the patient’s primary care physician or, if serious enough, an endocrinologist.
UMass Memorial Health Care, the clinical partner of the University of Massachusetts Medical School, was the first hospital to use the integrated system, and a second implementation now is under way at University of South Florida Diabetes Center in Tampa, Fla.
"Nationally, diabetes affects 25.8 million people, an astonishing number. Managing a population of this size at the national level requires a truly connected community of health — one that both engages patients in self-management and uses remote health monitoring by a care team," said Glen Tullman, Allscripts CEO and Juvenile Diabetes Research Foundation board member. "At Allscripts, we are committed to an open technology platform that encourages innovative solutions, like this app from MyCareTeam, and drives better outcomes at a reduced cost."
"Caring for patients with chronic diseases is an ever-increasing burden to our healthcare system and a tremendous source of costs," MyCareTeam CEO Jim Mingle said. "Integrating the MyCareTeam clinical app with Allscripts Electronic Health Record was easy to do given their open platform and is already enabling providers and patients to communicate more effectively between — and avoid unnecessary — office visits."