FDA approves crush-resistant painkiller by Endo
CHADDS FORD, Pa. — The Food and Drug Administration has approved a new formulation of a painkiller made by Endo Pharmaceuticals designed to thwart drug abuse, Endo said Monday.
Endo announced the FDA’s approval of a crush-resistant version of Opana ER (oxymorphone). Drug abusers often crush opioid pills in order to smoke, inhale or inject them. Endo developed the new formulation of the drug, scheduled for launch in 2012, using Grunenthal’s Intac technology. The new version will otherwise be identical to the old one.
"FDA’s approval of this new formulation of Opana ER is an important milestone for both the long-acting opioid category as well as Endo’s branded pharmaceutical portfolio," Endo EVP research and development and chief scientific officer Ivan Gergel said. "Patient safety is our top concern, and addressing appropriate use of opioids is a responsibility that we take very seriously."
Lilly names Harvard School of Public Health professor to board of directors
INDIANAPOLIS — Drug maker Eli Lilly has appointed Katherine Baicker to its board of directors, effective Dec. 12.
As a member of the board, Baicker — who is a professor of health economics in the department of health policy and management at the Harvard School of Public Health — will serve under interim election and will stand for election by Lilly shareholders at the company’s annual meeting in April 2012. As a member of the board, she also will serve on the public policy and compliance committee.
From 2005 to 2007, Baicker served as a Senate-confirmed member of the President’s Council of Economic Advisers, where she played a leading role in the development of health policy.
John Thievon named Dey Pharma president
PITTSBURGH — Mylan’s fully integrated specialty pharmaceutical business has a new leader.
The company said it appointed John Thievon as president of Dey Pharma. Prior to joining Dey Pharma, Thievon most recently served as MiddleBrook Pharmaceuticals president and CEO, where he built the company into a 450-person organization before its assets were acquired by Victory Pharma. Additionally, Thievon also worked as EVP commercial operations for Adams Respiratory Therapeutics, where he built the company’s marketing platform and led the launch of Mucinex, growing it to a $450 million brand before the company was sold to Reckitt Benckiser.
"I am extremely pleased to welcome John as our new leader of Mylan’s specialty business," Mylan president Heather Bresch said. "John’s extensive experience growing a branded pharmaceutical business from the ground up and proven track record launching highly successful pharmaceutical brands, like Mucinex, is invaluable as we continue to build on our specialty business. Dey has been and continues to be a very valuable asset and important growth driver for Mylan, evidenced by the strong performance of this business. John’s appointment demonstrates our continued commitment to invest in Dey and strengthen what we have in place in order to support the continued success of this business into the future."