BC Week In Review | Dec 2, 2016
Company News

Inisync sales and marketing update

Takeda launched Inisync alogliptin/metformin in Japan to treat Type II diabetes. The recommended dose is a once-daily tablet consisting of 25 mg of alogliptin benzoate and 500 mg of metformin. The National Health Insurance (NHI)...
BC Week In Review | Oct 17, 2016
Clinical News

Kazano regulatory update

Japan approved an NDA from Takeda for Inisync alogliptin/metformin to treat Type II diabetes. The fixed-dose combination of alogliptin and metformin is approved as Kazano in the U.S. and as Vipdomet in the EU for...
BC Extra | Jun 10, 2015
Clinical News

Merck reports data from Januvia CVOT

Merck & Co. Inc. (NYSE:MRK) reported results from the TECOS cardiovascular outcomes trial (CVOT) of Januvia sitagliptin , which Merck had previously said met the study's primary endpoint of non-inferiority vs. placebo in time to first...
BC Extra | Apr 29, 2015
Company News

Merck's Januvia meets in CV outcomes trial

Merck & Co. Inc. (NYSE:MRK) said the TECOS cardiovascular outcomes trial (CVOT) of Januvia sitagliptin met the primary endpoint of non-inferiority vs. placebo in time to first CV event. The results add to the evidence...
BioCentury | Apr 27, 2015
Regulation

CVOT crossroads

As data begin to trickle in from the wave of cardiovascular outcomes trials mandated in the wake of the Avandia rosiglitazone debacle, patients, physicians and some of FDA's own advisory committee members think the agency...
BC Week In Review | Apr 20, 2015
Clinical News

Nesina alogliptin regulatory update

FDA’s Endocrinologic and Metabolic Drugs Advisory Committee recommended that the agency add language about potential risks of heart failure to the labels of 2 dipeptidyl peptidase-4 ( DPP-4 ; CD26 ) inhibitors to treat diabetes -- Onglyza...
BC Week In Review | Apr 20, 2015
Clinical News

Onglyza saxagliptin regulatory update

FDA’s Endocrinologic and Metabolic Drugs Advisory Committee recommended that the agency add language about potential risks of heart failure to the labels of 2 dipeptidyl peptidase-4 ( DPP-4 ; CD26 ) inhibitors to treat diabetes -- Onglyza...
BC Extra | Apr 15, 2015
Company News

FDA panel backs label changes to DPP-4 inhibitors

FDA's Endocrinologic and Metabolic Drugs Advisory Committee recommended on Tuesday that the agency add language about potential risks of heart failure to the labels of two DPP-4 inhibitors to treat diabetes -- Onglyza saxagliptin from...
BC Extra | Apr 10, 2015
Top Story

FDA committee to discuss CV risks of DPP-4s

FDA's Endocrinologic and Metabolic Drugs Advisory Committee will meet on April 14 to discuss results from two CV outcomes trials of dipeptidyl peptidase-4 ( DPP-4 ) inhibitors marketed by AstraZeneca plc (LSE:AZN; NYSE:AZN) and Takeda Pharmaceutical Co....
BioCentury | Jan 12, 2015
Finance

Buyside view XXIII: Milestones galore

Stephen Hansen, Associate Editor and Jennifer Rhodes, Staff Writer   Buyside view XXIII The maturation of the biotech sector over the past few years finds fund managers focusing on a slew of clinical milestones and...
Items per page:
1 - 10 of 115