16:24 , Feb 9, 2018 |  BC Week In Review  |  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...
23:40 , Feb 2, 2018 |  BC Extra  |  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...
08:00 , Jan 4, 2016 |  BC Week In Review  |  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...
07:00 , Jun 8, 2015 |  BC Week In Review  |  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...
07:00 , Jun 23, 2014 |  BC Week In Review  |  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...
07:00 , Mar 27, 2014 |  BC Innovations  |  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...
08:00 , Feb 3, 2014 |  BC Week In Review  |  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...
07:00 , Jul 15, 2013 |  BC Week In Review  |  Clinical News

Tradjenta: Phase III data

A double-blind, international Phase III trial of 235 Type II diabetes with moderate to severe renal impairment, defined as an estimated glomerular filtration rate (eGFR) of <60 mL/min/1.73 m2, showed that once-daily 5 mg oral...
07:00 , Jul 1, 2013 |  BC Week In Review  |  Clinical News

Albiglutide: Phase III data

The double-blind Phase III Harmony 5 trial in 657 Type II diabetics on a background of metformin and glimepiride showed that once-weekly subcutaneous 30 mg albiglutide met the primary endpoint of reducing HbA1c from baseline...
07:00 , Jul 1, 2013 |  BC Week In Review  |  Clinical News

Albiglutide: Phase III data

The double-blind, international Phase III Harmony 3 trial in 999 Type II diabetics who were inadequately controlled on metformin showed that once-weekly subcutaneous 30 mg albiglutide plus metformin met the primary endpoint of reducing HbA1c...