FDA sets review date for Bydureon
SAN DIEGO — The Food and Drug Administration has acknowledged the resubmission of an investigational Type 2 diabetes drug made by Amylin Pharmaceuticals, Eli Lilly and Alkermes.
The FDA has set a Jan. 28, 2012 deadline for its review of Bydureon (exenatide extended-release for injectable suspension). The drug, which first was submitted to the FDA in May 2009, was declined by the regulatory agency on two occasions; the drug makers received complete response letters in March 2010 and October 2010. Bydureon, however, received marketing authorization in the European Union in June.
"If approved, we believe Bydureon will be an important new option for type 2 diabetes patients, as the first once-weekly treatment available in the U.S.," Amylin SVP research and development Christian Weyer said. "We will continue to work with the FDA through this stage of the review process."
APhA picks new president-elect, trustees
WASHINGTON — The American Pharmacists Association has elected Steven Simenson as its president for the 2012-2013 term, the group said.
Simenson, president and managing partner of Goodrich Pharmacy, a six-store chain based in Ramsey, Minn., will succeed Jenelle Sobotka; he also was elected to a second term on the APhA’s board of trustees. Daniel Hussar of Philadelphia was elected as honorary president for 2012-2013.
In addition, the APhA elected two new members to its board of trustees: Jean-Venable Goode, of Richmond, Va.; and Daniel Buffington, of Tampa, Fla. They will serve three-year terms and will be installed at the APhA’s annual meeting in New Orleans next March, the group said.
Ahh Bra makes debut in Walgreens
NEW YORK — The Rhonda Shear’s Ahh Bra has been launched into Walgreens in a single pack for $19.99, featuring the essential black and nude color scheme in sizes medium through extra large, Shear Enterprises announced recently.
The Ahh Bra utilizes seamless technology and the latest fabrications to mold to fit without the prodding, poking and bulge of an underwire. Comfortable enough to wear day or night, no woman should be without one or several in her lingerie drawer, the company said.
Shear may be best known for her role as a host of the USA Network’s 1980s/’90s weekend comedy show, "USA Up All Night." From 1991 to 1998 she hosted in-studio and on-location segments, replacing comedian Caroline Schlitt. Shear also has been featured in Playboy.