22:45 , May 14, 2019 |  BC Extra  |  Politics & Policy

Mylan calls for streamlined interchangeable insulin pathway

A streamlined approach to interchangeable insulins will help to eliminate burdensome requirements that are hindering the therapies’ development, according to a Mylan executive. Abhijit Barve, head of global clinical research at Mylan N.V. (NASDAQ:MYL), said...
20:14 , Mar 29, 2019 |  BC Week In Review  |  Clinical News

Opko's diabetes therapy meets in Phase IIb

Opko said OPK88003 met the primary endpoint in a Phase IIb trial to treat adult Type II diabetics who had inadequate glucose control with metformin and/or diet and exercise. Opko Health Inc. (NASDAQ:OPK; Tel Aviv:OPK)...
03:03 , Feb 15, 2019 |  BC Innovations  |  Tools & Techniques

Heartening predictors in diabetes

New biomarkers of cardiovascular risk could relieve a decade-old bottleneck for diabetes drug development, but validating them will require companies to invest in strategic trial designs, and public and private stakeholders to pool thinking. As...
22:54 , Nov 9, 2018 |  BioCentury  |  Product Development

Cashing out CVOT

Whether or how much diabetes companies will save by dropping postmarket cardiovascular outcomes trials, if FDA follows the advice of its advisory committee, could boil down to what target they are pursuing and whether they...
23:29 , Sep 17, 2018 |  BC Extra  |  Politics & Policy

FDA to re-examine diabetes CVOT requirements

FDA is reconsidering its policy to require pre- and postmarket cardiovascular outcomes trials for diabetes drugs, and plans to hold an Oct. 24-25 meeting of its Endocrinologic and Metabolic Drugs Advisory Committee to discuss existing...
03:13 , Aug 17, 2018 |  BC Week In Review  |  Clinical News

Amgen's Repatha lowers LDL-C in Phase III for dyslipidemia in Type II diabetics

Amgen Inc. (NASDAQ:AMGN) reported in June that Repatha evolocumab met the co-primary endpoints in the Phase III BANTING trial to treat hypercholesterolemia or mixed dyslipidemia in Type II diabetics taking the maximum tolerated dose of...
19:53 , Jul 13, 2018 |  BC Week In Review  |  Clinical News

Ironwood reports Phase IIb data of praliciguat to treat diabetes with hypertension

Ironwood Pharmaceuticals Inc. (NASDAQ:IRWD) reported data from 26 diabetic patients with hypertension in a Phase IIa study showing that compared with placebo praliciguat (IW-1973) reduced blood pressure (6.3 vs. 1.5 mmHg), fasting glucose levels (32.5...
19:27 , Jul 13, 2018 |  BC Week In Review  |  Clinical News

Xeris' G-Pen increases plasma glucose in Phase III pediatric hypoglycemia

Xeris Pharmaceuticals Inc. (NASDAQ:XERS) said its G-Pen glucagon injection rescue pen significantly increased mean plasma glucose levels within 30 minutes by at least 25 mg/dL in all patients in a Phase III trial to treat...
19:25 , Jul 13, 2018 |  BC Week In Review  |  Clinical News

Xeris' G-Pen similar to standard kit in Phase III hypoglycemia

Xeris Pharmaceuticals Inc. (NASDAQ:XERS) said its G-Pen glucagon injection rescue pen had comparable efficacy to a standard glucagon emergency kit in a double-blind, crossover Phase III trial to treat severe hypoglycemia in adult Type I...
16:44 , Jul 6, 2018 |  BC Week In Review  |  Clinical News

AZ's MEDI0382 reduces glucose and body weight in Phase IIa for Type II diabetes

AstraZeneca plc (LSE:AZN; NYSE:AZN) and its MedImmune LLC unit said once-daily 200 µg subcutaneous MEDI0382 significantly reduced glucose area under the curve (AUC) from 0-4 hours after a Mixed Meal Tolerance Test (MMTT) (32.8% vs....