FDA approves Bydureon
SAN DIEGO — The Food and Drug Administration has approved a long-acting injected diabetes drug made by Amylin Pharmaceuticals and Alkermes, the two companies said.
The FDA approved Bydureon (exenatide), which the companies called the first once-weekly treatment for Type 2 diabetes. The drug will become available in February.
"With Bydureon, U.S. physicians can now choose a therapy that offers continuous blood sugar control in just one dose per week," University of North Carolina in Chapel Hill professor of medicine John Buse said in a statement on behalf of the companies. "New treatment options are essential for the millions of adults with Type 2 diabetes who continue to struggle to achieve optimal blood-sugar control."
Bydureon, an extended-release formulation of Byetta, was originally developed under an alliance between Amylin and Eli Lilly that started in 2002, but the two companies terminated the alliance in November 2011 after Lilly formed a diabetes partnership with Boehringer Ingelheim. The Lilly-BI partnership prompted a lawsuit from Amylin, though the companies agreed to settle it.
Biogen Idec appoints EVP human resources
WESTON, Mass. — Biogen Idec has appointed a former Lenovo executive to serve as its EVP human resources.
Kenneth DiPietro brings more than 30 years of experience in both human resources and organizational development, including broad cultural transformation and corporate re-engineering, to his new role at Biogen Idec. He will lead the development and execution of the company’s global human resources strategy, including talent management, talent acquisition, compensation and benefits, and global human resources operations and systems, Biogen Idec said. DiPietro — who joins the company from Lenovo, where he served as SVP human resources — will report to Biogen Idec CEO George Scangos.
“I am thrilled to welcome Kenneth DiPietro to Biogen Idec,” Scangos said. “Culture is what separates a good company from a great company, and in Ken, we have a proven leader who I’m confident will foster and build upon our culture of excellence as we enter a period of great opportunity for Biogen Idec.”
Lannett receives FDA approval for generic Microzide
PHILADELPHIA — Lannett announced that it has received approval from the Food and Drug Administration to market its version of a hypertension treatment.
The drug maker said its abbreviated new drug application for hydrochlorothiazide capsules in the 12.5-mg strength was approved. The drug is a generic version of Watson Pharmaceuticals’ Microzide capsules.
“We have received approvals for and launched a record number products thus far in fiscal 2012, following a lack of approvals last year,” Lannett president and CEO Arthur Bedrosian said. “Hydrochlorothiazide is an important addition to our offering and represents the eighth product approval (seven ANDAs and one NDA) we have received over the last seven months. We look forward to additional approvals over the next several months.”