Gov. Napolitano honors C-Path with Arizona innovation award
TUSCON, Ariz. Arizona governor Janet Napolitano presented an Arizona Innovation Award to The Critical Path Institute (C-Path) for its approach to speeding the development of safe, innovative medical products for patients.
C-Path?s ability to collaborate with the FDA and industry regulators (in addition to using academia) has given way to new methods and more efficient pathways for developing safe, innovative medicines, diagnostic tests and devices.
“I am pleased that C-Path chose to open its doors here in Arizona, and commend this organization for its dedication to expediting the process of bringing medical technologies to market,” said Governor Napolitano. “C-Path is truly deserving of this Arizona Innovation Award.”
Headquartered in Tucson, Arizona with offices in Rockville, Md., C-Path was established in 2005 as a publicly funded, nonprofit research and education institute to serve as a trusted third party for collaborations between scientists and others from government, industry and academia. C-Path’s mission is to help implement the FDA’s Critical Path Initiative by developing faster, safer and smarter pathways to new medical products.
FDA approves label changes for Accutane and its generics
The Food and Drug Administration has approved label changes to Roche’s acne medication Accutane and its generic isotretinoin, manufactured by Barr Laboratories, Genpharm/Mylan Pharmaceuticals and Ranbaxy Laboratories.
The label changes were made to improve the management of the iPledge pregnancy risk management program. Pregnant women are not allowed to take the medication due to risk of birth defects.
Roche, who proposed the changes, said they are intended to enhance the flexibility of the iPledge program, reduce interruptions in treatment and reduce the burden on patients, prescribers and pharmacies, thereby making the program more consistent with the way prescribers function.
The changes are planned to go into effect on Dec. 2.
FDA approves Ixempra for breast cancer
WASHINGTON The Food and Drug Administration has approved Bristol-Myers Squibb’s Ixempra monotherapy for the treatment of patients with metastatic or locally advanced breast cancer whose tumors are resistant or refractory to anthracyclines, taxanes and capecitabine.
The FDA has also granted approval of Ixempra in combination with capecitabine for the treatment of patients with metastatic or locally advanced breast cancer resistant to an anthracycline and a taxane or whose cancer is taxane-resistant and for whom further anthracycline therapy is contraindicated.
BMS anticipates Ixempra will be available soon.