Eisai receives complete response letter for GERD treatment
WOODCLIFF LAKE, N.J. — The Food and Drug Administration declined to approve a drug made by Eisai for treating gastroesophageal reflux disease, Eisai said Tuesday.
The drug maker announced its receipt of a complete response letter from the agency for its application for rabeprazole sodium extended-release capsules, a proton-pump inhibitor for GERD. The FDA delivers a complete response letter when it has finished reviewing a regulatory approval application, but issues remain that preclude final approval of the drug.
Eisai did not specify what issues the FDA brought up in the letter, but said it would work with the agency to address them.
Long Island University’s pharmacy school celebrates 125th anniversary
NEW YORK — The pharmacy school of Long Island University is turning 125.
The university said Tuesday that the Arnold & Marie Schwarz College of Pharmacy and Health Sciences would celebrate its 125th anniversary with a series of events to showcase its history. A $12.5 million capital campaign focused on construction and renovation, scholarships and expansion of research and graduate education will coincide with the anniversary celebrations.
The school was founded in 1886 as the Brooklyn College of Pharmacy, and its alumni include former Roche president Herbert Conrad and Louis Lemberger, one of the scientists who discovered Eli Lilly’s antidepressant Prozac (fluoxetine hydrochloride).
“This significant anniversary comes at a pivotal moment in our college’s existence, as well as in our nation’s history,” college dean David Taft said. “There are dramatic changes occurring within this country’s healthcare system. So, while we take the opportunity to celebrate our longevity and our success, we will also look to position our institution for the future.”
Decision Resources: Bydureon could promote weight loss among patients
BURLINGTON, Mass. — Eli Lilly’s and Amylin Pharmaceuticals’ Type 2 diabetes drug, Bydureon, appears to work better at promoting weight loss than drugs made by Takeda and Merck, but it could face a challenger of its own.
Market research firm Decision Resources found that while Lilly’s and Amylin’s Bydureon (exenatide) was better able to promote weight loss among patients than Takeda’s Actos (pioglitazone hydrochloride) and Merck’s Januvia (sitagliptin), Bristol-Myers Squibb’s and AstraZeneca’s investigative drug dapagliflozin could challenge Bydureon in this aspect as well.
Decision Resources said the Type 2 diabetes market would experience strong growth over the next decade, increasing from $20.5 billion in 2009 to $36 billion in 2019 in the United States, United Kingdom, France, Germany, Italy, Spain and Japan.