23:47 , Nov 12, 2018 |  BC Extra  |  Clinical News

AZ’s Farxiga reduces heart failure, but misses on CV events

AstraZeneca plc (LSE:AZN; NYSE:AZN) presented details of its 17,160-patient Phase III DECLARE-TIMI 58 cardiovascular outcomes trial (CVOT) showing that diabetes drug Farxiga dapagliflozin's primary CV benefit was limited to reducing hospitalizations due to heart failure....
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...
19:57 , Nov 2, 2018 |  BC Week In Review  |  Clinical News

FDA approves Janssen's Invokana to reduce MACE in Type II diabetics

The Janssen Pharmaceuticals Inc. unit of Johnson & Johnson (NYSE:JNJ) said FDA approved an sNDA for Invokana canagliflozin to reduce the risk of major adverse cardiovascular events (MACE) -- heart attack, stroke or death due...
16:15 , Jul 20, 2018 |  BC Week In Review  |  Clinical News

J&J planning submission for Invokana in CKD following Phase III readout

The Janssen Pharmaceuticals Inc. unit of Johnson & Johnson (NYSE:JNJ) said Invokana canagliflozin met the primary endpoint in the Phase III CREDENCE trial to treat chronic kidney disease in patients with Type II diabetes. A...
22:10 , Jul 16, 2018 |  BC Extra  |  Clinical News

J&J planning submission for Invokana in CKD

The Janssen Pharmaceuticals Inc. unit of Johnson & Johnson (NYSE:JNJ) said Invokana canagliflozin met the primary endpoint in the Phase III CREDENCE trial to treat chronic kidney disease in patients with Type II diabetes. A...
23:35 , Jan 31, 2018 |  BC Extra  |  Company News

Lilly falls on diabetes and animal health concerns

Despite 4Q17 figures that outperformed analyst expectations, Eli Lilly and Co. (NYSE:LLY) fell $4.64 to $81.45 on Wednesday after the pharma said it continues to see pricing pressure on its diabetes products. Lilly also reported...
21:44 , Oct 27, 2017 |  BC Week In Review  |  Clinical News

Janssen submits sNDA for Invokana

Johnson & Johnson (NYSE:JNJ) submitted an sNDA to FDA for Invokana canagliflozin (JNJ-28431754, TA-7284) to reduce the risk of major adverse cardiovascular events (MACE) in adult Type II diabetes patients at risk for or with...
19:58 , Sep 21, 2017 |  BC Innovations  |  Targets & Mechanisms

Appetite for GFRAL

Simultaneous publications from Eli Lilly and Co ., Johnson & Johnson and Novo Nordisk A/S identifying GFRAL as the receptor of the anti-obesity hormone GDF15 will undoubtedly accelerate therapeutic translation of the pathway. The race...
23:47 , Aug 17, 2017 |  BC Week In Review  |  Clinical News

Japan approves Mitsubishi's Canalia for Type II diabetes

Last month, Mitsubishi Tanabe Pharma Corp. (Tokyo:4508) and Daiichi Sankyo Co. Ltd. (Tokyo:4568) said Japan's Ministry of Health, Labor and Welfare (MHLW) approved Canalia teneligliptin/canagliflozin (MT-2412) to treat Type II diabetes. Canalia is an oral...
19:49 , Aug 4, 2017 |  BC Week In Review  |  Company News

CVS unveils changes to 2018 formulary

CVS Health Corp. (NYSE:CVS) will remove Gaucher's disease drug Elelyso taliglucerase alfa and diabetes drug Jardiance empagliflozin from its 2018 Standard Control Formulary . Elelyso from Pfizer Inc. (NYSE:PFE) and Protalix BioTherapeutics Inc. (NYSE-M:PLX; Tel...