02:08 , Jul 26, 2017 |  BC Extra  |  Company News

Lilly stretches Olumiant timeline, updates cancer strategy

Eli Lilly and Co. (NYSE:LLY) reported 2Q17 earnings and said it would delay its plans to resubmit an NDA for Olumiant baricitinib beyond 2017. The company also said it would narrow its oncology focus to...
22:48 , Feb 8, 2017 |  BC Week In Review  |  Clinical News

Tadalafil PharmFilm regulatory update

MonoSol said FDA accepted for review an NDA for Tadalafil Oral Soluble Film (OSF) to treat erectile dysfunction (ED). The PDUFA date is Sept. 18. The product is a film formulation of tadalafil, a phosphodiesterase-5...
01:22 , Feb 1, 2017 |  BC Extra  |  Company News

Lilly rides recent launches to quarterly, annual growth

In its 4Q16 and full-year earnings report, Eli Lilly and Co. (NYSE:LLY) said quarterly and annual revenue growth was driven primarily by sales volume increases tied to several drugs including Trulicity dulaglutide, Cyramza ramucirumab, Jardiance...
01:44 , Dec 30, 2016 |  BC Week In Review  |  Company News

Lilly joins cTAP consortium

The Collaborative Trajectory Analysis Project (cTAP) said Eli Lilly has joined the consortium. The group, which includes scientists, drug companies, patient advocacy organizations and clinical centers, is collaborating to advance treatments for Duchenne muscular dystrophy...
00:10 , Dec 22, 2016 |  BC Extra  |  Company News

Lilly joins DMD consortium

The Collaborative Trajectory Analysis Project (cTAP) said Eli Lilly and Co. (NYSE:LLY) has joined the consortium. The group, which includes scientists, drug companies, patient advocacy organizations and clinical centers, is collaborating to advance treatments for...
21:49 , Dec 2, 2016 |  BC Week In Review  |  Company News

Lilly, IntelGenx deal

Eli Lilly granted IntelGenx rights to U.S. Patent No. 6,943,166, which covers dosing of Lilly’s tadalafil. IntelGenx says the deal will allow it to commercialize its Tadalafil ED Versafilm in the U.S. before the expiration...
11:43 , Dec 1, 2016 |  BC Week In Review  |  Clinical News

Tadalafil PharmFilm regulatory update

MonoSol submitted an NDA to FDA for Tadalafil PharmFilm to treat erectile dysfunction (ED). The product is a film formulation of tadalafil, a phosphodiesterase-5 (PDE-5) inhibitor. MonoSol Rx LLC, Warren, N.J.  Product: Tadalafil PharmFilm  Business: Genitourinary  ...
07:00 , Oct 24, 2016 |  BioCentury  |  Strategy

Lilly’s history lesson

  Eli Lilly and Co. President and CEO-in-waiting David Ricks will inherit a well-stocked pipeline, seven drugs less than three years old and a much-improved growth trajectory. To maintain momentum, he’ll have to execute on the...
07:00 , Apr 4, 2016 |  BioCentury  |  Finance

1Q approvals

1Q approvals CompanyApprovalAlexion Pharmaceuticals Inc. (NASDAQ:ALXN)Japan approves Kanuma sebelipase alfa to treat lysosomal acid lipase deficiency (LAL-D)Amgen Inc. (NASDAQ:AMGN)Japan approves Repatha evolocumab to treat familial hypercholesterolemia or hypercholesterolemia in patients at high risk of cardiovascular events...
08:00 , Feb 15, 2016 |  BC Week In Review  |  Clinical News

Tadalafil: Phase III data

A double-blind, international Phase III trial in about 330 patients ages 7-14 with DMD showed that once-daily oral tadalafil missed the primary endpoint of improving 6MWD from baseline to week 48 vs. placebo. Tadalafil also...