FDA panel recommends approval for Novartis Cushing’s disease drug
EAST HANOVER, N.J. — A Food and Drug Administration expert panel has voted unanimously in favor of approval for a Novartis drug for a rare endocrine disorder.
Novartis said the FDA’s Endocrinologic and Metabolic Drugs Advisory Committee voted to support approval for Signifor (i.e., pasireotide) for patients with Cushing’s disease who require medical therapeutic intervention. Cushing’s disease is a form of Cushing’s syndrome that affects one- to two-in-1 million people per year, and results from excessive amounts of the metabolic hormone cortisol — resulting in weight gain, severe fatigue, depression and anxiety and other symptoms.
"We are encouraged by today’s favorable advisory committee recommendation for pasireotide in Cushing’s disease and will work closely with the FDA as it completes its review of our application," Novartis Oncology president Herve Hoppenot said. "There is a significant unmet medical need for Cushing’s disease patients, and Novartis is committed to providing the endocrinology community with a novel therapeutic approach for this rare and debilitating endocrine disorder."
FDA advisory committee recommendations are not binding, and the FDA is not required to follow them when deciding whether to approve a drug, but usually does.
FDA accepts Merck application for insomnia drug
WHITEHOUSE STATION, N.J. — The Food and Drug Administration has accepted an application from Merck for an experimental drug for insomnia, the drug maker said Thursday.
Merck announced the the FDA’s acceptance of its regulatory filing for suvorexant, which the FDA’s Controlled Substances Staff will review while the agency is reviewing the application.
"The discovery and development of innovative medicines that help patients is our goal at Merck, and insomnia is a common disorder where patients are seeking new treatments," Merck Research Labs SVP and franchise head for neuroscience and ophthalmology Darryle Schoepp said. "Suvorexant is a novel mechanism for the treatment of insomnia, and the filing of suvorexant is a novel mechanism for the treatment of insomnia, and the filing of suvorexant is an example of Merck’s commitment to patients and to scientific excellence."
CVS/pharmacy expands role of two field executives, 37-year retail veteran announces retirement
WOONSOCKET, R.I. — CVS/pharmacy on Thursday expanded the role of two retail field executives as SVP operations Dennis Palmer, a 37-year retail veteran, announced his retirement.
Effective Nov. 5, Hanley Wheeler, SVP operations has assumed responsibility of CVS/pharmacy’s Western and Southwestern markets while continuing to have responsibility for the company’s retail operations in its Midwest and Southeast markets.
Assuming responsibility for CVS/pharmacy’s retail operations in the Northeast and Mid-Atlantic is Kevin Hourican, SVP operations, who joined the CVS/pharmacy in June 2012 from Macy’s.
A pharmacist by training, Wheeler began his career at CVS/pharmacy in 1994 as an area VP. Prior to joining CVS, he spent 13 years at Revco Drug, where he held various managerial positions across the company. During his tenure at CVS and among his many accomplishments, Wheeler played a key role in the successful conversion of the acquired Osco and Sav-on stores, and led CVS/pharmacy’s organic growth into Chicago, Southern California, Las Vegas and Phoenix, as well as its entry into Puerto Rico, the company’s first market outside of the 50 U.S. states.
Prior to joining CVS/pharmacy, Hourican served as Macy’s SVP and Mid-Atlantic regional director of stores. He also served as Macy’s SVP of direct-to-consumer logistics and worked for Sears from 1999 through 2006 in a series of increasingly responsible operational roles.
Palmer has served in his current role since 2006, when he entered the company through the Albertson’s Drug Division acquisition. He began his retail career in 1975 with American Stores and held positions of increasing scope and responsibility, including store, district, regional and corporate management for American Stores, Sav-On and Albertsons. He was a key player in American Stores’ integration of Jewel in the mid-1980s and subsequently served in executive roles in real estate, store strategy and planning and store operations, before being named SVP western operations for CVS/pharmacy in 2006.
During his tenure with CVS/pharmacy, Palmer was responsible for the Sav-On/Osco integration and the conversion of Longs Drugs stores, increasing profitability faster than any other acquisition. He also led the company’s entry into several new markets including New Mexico; Tulsa, Okla.; Omaha, Neb.; and Midland/Odessa, Texas.