• Boehringer Ingelheim GmbH, of Ingelheim, Germany, and Eli Lilly and Co., of Indianapolis, reported data from a pooled analysis of 17 trials testing linagliptin in people with Type II diabetes and self-reported previous/current liver and biliary disease, with results showing linagliptin demonstrated a statistically significant placebo-adjusted reduction in HbA1c of 0.52 and 0.62 percent in patients with and without hepatobiliary disorders, respectively, from baseline to 24 weeks.
• Alvogen Pharma US Inc., of Pine Brook, N.J., said it finalized a transaction with Shionogi & Co. Ltd., of Osaka, Japan, acquiring the exclusive rights to commercialize Naprelan (naproxen sodium) controlled-release tablets in the U.S.
• Biocryst Pharmaceuticals Inc., of Research Triangle Park, N.C., said it dosed the first subject in OPuS-1 (Oral ProphylaxiS-1), a Phase IIa trial testing orally administered BCX4161 in patients with hereditary angioedema.
• Quest Pharmatech Inc., of Edmonton, Alberta, said it continued an exclusive license agreement with Stanford University to develop and market anti-MUC1 IgE technology for the treatment of cancer.
Abstracts of the data that are to be presented at the American Society of Hematology’s annual meeting next month were released Thursday. And the biggest market response to trial data involved Geron Corp’s myelofibrosis drug Imetelstat.
On the heels of better-than-expected third quarter sales for idiopathic pulmonary fibrosis (IPF) drug Esbriet (pirfenidone) in Europe, Intermune Inc. priced a public offering to raise $84.5 million to help fund additional studies of Esbriet, including the pivotal trial needed for U.S. approval of the drug and studies to expand its use in IPF and other indications.
• Supernus Pharmaceuticals Inc., of Rockville, Md., said that in a single-blind, randomized-sequence, crossover study in healthy adults, Trokendi (SPN-538), produced more consistent plasma concentrations of topiramate compared to topiramate.
What could be the first chapter in a sequel to the Jumpstart Our Business Startups (JOBS) Act was unveiled Wednesday with the hope that it soon will become a congressional best-seller that will stimulate investment in groundbreaking R&D.
The FDA’s partial clinical hold on CUDC-427 because of a cancer patient’s death from liver failure overshadowed third-quarter earnings for Curis Inc., which is analyzing possible causes.
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