BC Extra | Jun 14, 2019
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...
BC Extra | Apr 10, 2019
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...
BC Week In Review | Aug 3, 2018
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...
BC Week In Review | Feb 9, 2018
Company News

Intarcia terminates late-stage diabetes trials

Intarcia Therapeutics Inc. (Boston, Mass.) terminated two late-stage trials evaluating ITCA 650 in Type II diabetes, according to ClinicalTrials.gov. The company received a complete response letter from FDA in September for an NDA seeking approval...
BC Extra | Feb 2, 2018
Company News

Intarcia terminates Phase III diabetes trials

Intarcia Therapeutics Inc. (Boston, Mass.) terminated two late-stage trials earlier this week evaluating ITCA 650 in Type II diabetes, according to ClinicalTrials.gov. The company received a complete response letter from FDA in September for an...
BC Week In Review | Jan 4, 2016
Clinical News

Avandia rosiglitazone regulatory update

FDA removed the REMS for rosiglitazone-containing Type II diabetes drugs. The move comes 5 years after FDA issued the REMS warning of potential increased cardiovascular risk and 8 years after a meta-analysis first implicated GlaxoSmithKline’s...
BC Week In Review | Jun 8, 2015
Company News

GlaxoSmithKline sales and marketing update

The German Institute for Quality and Efficiency in Health Care (IQWiG) said Tanzeum albiglutide from GlaxoSmithKline in combination with metformin has a “hint of a minor added benefit” in patients with Type II diabetes vs....
BC Week In Review | Jun 23, 2014
Clinical News

Dulaglutide: Additional Phase III data

Additional data from the open-label, international Phase III AWARD-2 trial in 807 Type II diabetics on metformin and glimepiride showed that once-weekly 1.5 mg subcutaneous dulaglutide was superior to Lantus insulin glargine in reducing HbA1c...
BC Innovations | Mar 27, 2014
Distillery Therapeutics

Indication: Pulmonary disease

Indication Target/marker/pathway Summary Licensing status Publication and contact information Pulmonary disease Emphysema Peroxisome proliferation-activated receptor-g (PPARG; PPARg) Ex vivo and mouse studies suggest agonizing PPARg could help treat emphysema. In lung myeloid dendritic cells from...
BC Week In Review | Feb 3, 2014
Clinical News

Ertugliflozin: Phase III started

Pfizer disclosed in its 4Q13 earnings that it began a double-blind, placebo-controlled, U.S. Phase III trial to compare 5 and 15 mg oral ertugliflozin once daily plus metformin for 2 years vs. glimepiride plus metformin...
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