Matrix expands licensing agreement with Gilead for HIV/AIDS therapies
PITTSBURGH — Mylan subsidiary Matrix Labs has expanded its licensing agreement with Gilead Sciences.
Under the new terms, Mylan said that Matrix has the rights to produce and market generic versions of three Gilead HIV/AIDS therapies — elvitegravir, an investigational integrase inhibitor; cobicistat, an investigational antiretroviral boosting agent; and the “quad,” a once-daily, single-tablet combination of four separate Gilead medicines — if and when the drugs receive regulatory approval.
“Every patient living with HIV/AIDS has a right to treatment,” Mylan president Heather Bresch said. “Matrix has made a significant contribution to dramatically lowering the cost of HIV/AIDS medicines, and we are now focused on expanding access to high-quality treatment to more people who need it. We are pleased to expand our collaboration with Gilead as it will enable more individuals living with HIV/AIDS in resource-limited countries to access the newest innovative medicines.”
Graceway receives regulatory approval for Zyclara
BRISTOL, Tenn. — The Food and Drug Administration has approved a drug made by Graceway Pharmaceuticals for actinic keratoses, Graceway said.
The agency approved Zyclara (imiquimod) cream in the 2.5% strength for AK, a precancerous lesion that affects about 10 million Americans and can develop into skin cancer later on.
“The addition of a 2.5% formulation of Zyclara cream will provide healthcare practitioners greater flexibility when prescribing imiquimod therapy for patients with actinic keratoses,” New York University Medical Center dermatology professor and former American Academy of Dermatology president Darrell Rigel said. “The lower concentration offers greater tolerability while maintaining the efficacy that has been long associated with imiquimod.”
Six drug makers OKed to produce flu vaccines
SILVER SPRING, Md. — The Food and Drug Administration has approved a new influenza vaccine formulation for the 2011-2012 flu season, the agency said Monday.
The FDA said six manufacturers are licensed to produce vaccines. These include GlaxoSmithKline Biologicals, manufacturing Fluarix; CSL Limited, manufacturing Afluria; ID Biomedical, manufacturing FluLaval; MedImmune Vaccines, manufacturing FluMist; Novartis Vaccines and Diagnostics, manufacturing Fluvirin; and Sanofi Pasteur, manufacturing Fluzone.
“Vaccines to prevent seasonal influenza have a long and successful track record of safety and effectiveness in the United States,” FDA Center for Biologics Evaluation and Research director Karen Midthun said. “It is important to get vaccinated every year, even if the strains in the vaccine do not change because the protection received the previous year will diminish over time and may be too low to provide protection into the next year.”