00:11 , Jun 14, 2019 |  BC Extra  |  Clinical News

June 13 Clinical Quick Takes: Roche's Gazyva meets in Phase II for lupus; plus Boehringer/Lilly, Savara and more

Roche's Gazyva clears Phase II hurdle in lupus nephritis  Gazyva obinutuzumab from Roche (SIX:ROG; OTCQX:RHHBY) met the primary endpoint in the Phase II NOBILITY trial to treat lupus nephritis. Given in combination with standard of...
23:46 , Jun 4, 2019 |  BC Extra  |  Company News

June 4 Company Quick Takes: Lilly's Emgality gets expanded indication; plus Vimizim, Zerbaxa and more

Emgality gets U.S. approval for episodic cluster headaches  FDA approved Emgality galcanezumab-gnlm from Eli Lilly and Co. (NYSE:LLY) to treat episodic cluster headache in adults. The anti-CGRP mAb is already approved as a prophylaxis for...
19:43 , Apr 10, 2019 |  BC Extra  |  Clinical News

Aetion, Brigham and Women's partnerships will inform FDA RWE standards

FDA is expanding its real-world evidence partnership with Brigham and Women's Hospital and Aetion to use real-world evidence to predict clinical outcomes from trials. The results from this expansion should help the agency identify when...
16:38 , Aug 3, 2018 |  BC Week In Review  |  Clinical News

Boehringer, Lilly's Tradjenta meets in first CV outcomes trial

Boehringer Ingelheim GmbH (Ingelheim, Germany) and partner Eli Lilly and Co. (NYSE:LLY) said Tradjenta linagliptin met the primary endpoint of improving time to first occurrence of a major cardiovascular event (MACE), including CV death, non-fatal...
23:16 , Jul 21, 2017 |  BC Extra  |  Preclinical News

Researchers suggest inhibiting DPP-4 could help treat colitis

In a paper published in the Journal of Pharmacology and Experimental Therapeutics , researchers from the Medical University of Lodz and the University of Gdansk showed that inhibiting dipeptidyl peptidase-4 ( DPP-4 ; CD26) could...
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...
07:00 , Sep 26, 2016 |  BC Week In Review  |  Clinical News

Glyxambi empagliflozin/linagliptin regulatory update

EMA’s CHMP recommended approval of Glyxambi empagliflozin/linagliptin from Boehringer and Eli Lilly to treat Type II diabetes. The companies expect approval of the product by the European Commission in the “coming months.” The tablet combines...
07:00 , Sep 16, 2016 |  BC Extra  |  Company News

CHMP reverses on Ninlaro, also backs Lartruvo, Ibrance

EMA's CHMP recommended approval of three cancer medicines on Friday, including a reversal of opinion for multiple myeloma (MM) drug Ninlaro ixazomib from Takeda Pharmaceutical Co. Ltd. (Tokyo:4502). The committee recommended conditional approval of Ninlaro...
07:00 , Jun 6, 2016 |  BC Week In Review  |  Clinical News

Jentadueto XR linagliptin/metformin extended release regulatory update

FDA approved an NDA from Boehringer for Jentadueto XR linagliptin/metformin extended release as an adjunct to diet and exercise to improve glycemic control in adult Type II diabetics when treatment with both of Jentadueto XR’s...
00:01 , Aug 1, 2015 |  BC Extra  |  Top Story

Express Scripts unveils 2016 formulary

Pharmacy benefit manager Express Scripts Holding Co. (NASDAQ:ESRX) released a list of 73 therapies it will not cover in 2016. Diabetes drugs Onglyza saxagliptin and Kombiglyze XR from AstraZeneca plc (LSE:AZN; NYSE:AZN) were moved to...