FDA declines to approve GSK vaccine
PHILADELPHIA — The Food and Drug Administration has declined to approve a vaccine developed by GlaxoSmithKline, the drug maker said.
GSK said it received a complete response letter from the FDA for MenHibrix (Hib-MenCY-TT), a vaccine for toddlers ages 6 weeks to 15 months against infection by Neisseria meningitides serogroups C and Y and Haemophilus influenza type b, also known as Hib. The FDA issues a complete response letter when it has finished reviewing an approval application for a drug or vaccine, but questions remain that preclude final approval; the company applying can resubmit once it has addressed the FDA’s questions.
The London-based company said this was the second complete response letter it had received from the FDA with regard to MenHibrix, though it did not specify which issues the agency had raised.
Roche receives FDA approval for new blood-sugar test strips
BASEL, Switzerland — Roche has received approval from the Food and Drug Administration for its new generation of blood-glucose test strips.
Roche said that its Accu-Chek Aviva Plus test strips are maltose-independent test strips that are designed to prevent the interference of maltose on blood-sugar readings, which can occur in rare cases when drugs containing or metabolizing to maltose are parenterally administered.
The Accu-Chek Aviva Plus test strip is cleared for patient self-monitoring of blood glucose and can be used with the Accu-Chek Aviva system.
“We are very pleased to announce that our new product for self-monitoring of blood glucose will also be available for people with diabetes in the U.S.,” Roche Diagnostics COO Daniel O’ Day said. “With its advanced technology and chemistry it is designed to support patients to manage their condition more effectively. This clearance is a significant milestone for our organization — one that will position us well for the clearance of other products in our pipeline.”
Biogen Idec appoints EVP global commercial operations
WESTON, Mass. — Biogen Idec has appointed Tony Kingsley as its new EVP global commercial operations.
Kingsley, who will transition to his new role Nov. 7, will oversee development and execution of Biogen Idec’s global commercial business strategies. In his current role as SVP U.S. commercial operations, a capacity he has served in since January 2010, he is responsible for all U.S. commercial functions, including marketing, sales, market access, patient services, training and sales operations.
Kingsley will report to Biogen Idec CEO George Scangos.