Statement From Eli Lilly and Company Regarding Stolen Company Products From Enfield, Connecticut Distribution Operations
INDIANAPOLIS, March 17, 2010 - Eli Lilly and Company (NYSE: LLY) today issued a statement and details regarding the stolen company products from its distribution operations in Enfield, Connecticut on Sunday, March 14.
Lilly is working with the U.S. Food and Drug Administration’s Office of Criminal Investigations (FDA), and other law enforcement officials, to recover cases of [...]
Study Shows Prevenar 13* Is Immunogenic In Young Children Previously Vaccinated With Prevenar*
NEW YORK – According to results from a Phase III safety and immunogenicity study presented today, Prevenar 13* (Pneumococcal polysaccharide conjugate vaccine, [13-valent, adsorbed]) was shown to be immunogenic and generally well tolerated in healthy young children who had received at least three prior doses of Prevenar* (Pneumococcal Saccharide Conjugated Vaccine, Adsorbed). These data were [...]
Exploratory trial shows no incremental benefit of aliskiren add-on therapy in improving changes to cardiac shape in heart attack patients
Basel, March 16, 2010 – The addition of the cardiovascular medicine aliskiren to standard therapy for patients recovering from a heart attack showed some positive effects in helping limit changes in the heart’s shape and function, but did not demonstrate a statistically significant benefit, according to new clinical trial results[1].
Data from the ASPIRE study (Aliskiren [...]
Intensive Lipitor Therapy Was Associated With Reduced Risk Of Cardiovascular Events In Two High-Risk Patient Groups
ATLANTA – Lipitor® (atorvastatin calcium) 80 mg was associated with a significantly reduced risk of major cardiovascular events compared with Lipitor 10 mg among patients with both coronary heart disease (CHD) and chronic kidney disease (CKD) who were obese or had metabolic syndrome. These data, from two sub-analyses of the Treating to New Targets (TNT) [...]
New Analysis Assesses Impact of Common Genetic Variation on Benefit of Antiplatelet Therapy
PARSIPPANY, N.J. and INDIANAPOLIS, March 15, 2010 - A new analysis of the TRITON-TIMI 38 study evaluated response rates in patients with a common genetic variant in the ABCB1 gene. Patients enrolled in the TRITON-TIMI 38 study were treated with dual antiplatelet therapy with either Plavix(R) (clopidogrel) plus aspirin or Effient(R) (prasugrel) plus aspirin and managed [...]
New Data From Second Phase Shows No Blood Clots, No Repeat Procedures and Very Low MACE in Patients Treated with Abbott’s Innovative Device
ATLANTA, March 15, 2010 - Abbott (NYSE: ABT) today announced positive 30-day results from the first 101 patients enrolled in the second phase of the ABSORB trial. Patients treated with Abbott’s bioresorbable vascular scaffold (BVS), under clinical investigation in Europe, demonstrated no cases of blood clots (thrombosis), no need for repeat procedures (ischemia-driven target lesion revascularization) [...]
Amylin, Lilly and Alkermes Receive Complete Response Letter From FDA for Exenatide Once Weekly Submission
SAN DIEGO, INDIANAPOLIS, and WALTHAM, Mass., March 15, 2010 - Amylin Pharmaceuticals, Inc. (Nasdaq: AMLN), Eli Lilly and Company (NYSE: LLY) and Alkermes, Inc. (Nasdaq: ALKS) today announced that the U.S. Food and Drug Administration (FDA) has issued a complete response letter regarding the New Drug Application (NDA) for BYDUREON(TM) (exenatide for extended-release injectable suspension).
In the [...]
Genentech Provides Update on Phase III Study of Avastin in Men With Late Stage Prostate Cancer
SOUTH SAN FRANCISCO, Calif.–(BUSINESS WIRE)–Genentech, Inc., a wholly owned member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), announced today the topline results of a Phase III trial led by the U.S. Cancer and Leukemia Group B (CALGB) and sponsored by the National Cancer Institute (NCI) investigating the use of Avastin® (bevacizumab) in combination [...]
Baxter Presents Clinical Efficacy Results from Phase III Study of Seasonal Flu Vaccine
DEERFIELD, Ill.–(BUSINESS WIRE)–Baxter International Inc. (NYSE:BAX), in conjunction with DynPort Vaccine Company LLC (DVC), a CSC Company (NYSE:CSC), today presented Phase III study data measuring the clinical efficacy for PREFLUCEL, a trivalent seasonal influenza candidate vaccine. PREFLUCEL is made using Baxter’s Vero cell culture platform and does not contain an adjuvant or preservatives. The data [...]
Bristol-Myers Squibb and AstraZeneca Announce the Commencement of the Saxagliptin Assessment of Vascular Outcomes Recorded in Patients with Diabetes Mellitus Trial (SAVOR-TIMI 53)
PRINCETON, N.J. & WILMINGTON, Del.–(BUSINESS WIRE)–Bristol-Myers Squibb Company (NYSE: BMY) and AstraZeneca (NYSE: AZN) today announced the commencement of the “Saxagliptin Assessment of Vascular Outcomes Recorded in Patients with Diabetes Mellitus” trial (SAVOR-TIMI 53), a multicenter, randomized, double-blind, placebo-controlled Phase 4 study, to evaluate treatment with ONGLYZA™ (saxagliptin), a dipeptidyl peptidase-4 (DPP4) inhibitor, in adult [...]
