BC Extra | Dec 31, 2019
Politics & Policy

China’s expanded list of drugs for centralized procurement comes with new rules

Following the nationwide expansion of China’s pilot program for centralized procurement of generics and off-patent originator drugs, Beijing is adding a second group of 33 drugs and unveiling new rules that could increase the number...
BioCentury | Oct 9, 2019
Politics, Policy & Law

Long-term data help two drugs sway ICER in drug price report

An analysis by the Institute for Clinical and Economic Review of price increases for some of the costliest drugs in the U.S. has found that seven of nine were not supported by new clinical evidence,...
BC Extra | Apr 8, 2019
Clinical News

United Therapeutics' esuberaprost fails Phase III in PAH

United Therapeutics discontinued development of esuberaprost after the compound failed to meet the primary endpoint in the Phase III BEAT trial to treat pulmonary arterial hypertension. Esuberaprost is a single isomer formulation of beraprost, a...
BC Extra | Jul 26, 2017
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...
BC Week In Review | Feb 8, 2017
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...
BC Extra | Feb 1, 2017
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...
BC Week In Review | Dec 30, 2016
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...
BC Extra | Dec 22, 2016
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...
BC Week In Review | Dec 2, 2016
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...
BC Week In Review | Dec 1, 2016
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:...
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