01:58 , Jun 29, 2019 |  BioCentury  |  Finance

Biotech backs down in 2Q19

In a reversal from 1Q19, biotech stocks across all market cap tiers fell in the second quarter, leading to a total loss of $22.3 billion. However, the year-to-date change in market cap remains well in...
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...
00:43 , Jun 11, 2019 |  BC Extra  |  Clinical News

Provention could use data from diabetes consortia to bring teplizumab to market faster

Results from a Phase II study showing Provention’s anti-CD3 mAb teplizumab delayed the onset of Type I diabetes in high-risk individuals raised the possibility of a faster path to market than the biotech’s Phase III...
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...