BC Extra | Nov 19, 2019
Company News

Nov. 18 Company Quick Takes: Eidos spikes on latest amyloidosis readout; plus Janssen, Pfizer, Tricida, BMS-Celgene

Eidos hits new peak on Phase II extension readout in amyloidosis  Eidos Therapeutics Inc. (NASDAQ:EIDX) shares climbed $8.47 (18%) to $55.02, touching an all-time intraday high of $55.25, after the company said results of a...
BC Innovations | Oct 3, 2019
Product Development

Kidney is the new liver: why kidney indications are coming into sharp focus

Interest in kidney diseases is mounting among investors, biotechs and pharmas at a rate reminiscent of the liver disease explosion almost a decade ago. The momentum is driven by improvements at both ends of the...
BC Extra | Jul 10, 2019
Politics & Policy

CMS’s new CKD payment models could be mixed bag for drug companies

A set of five different payment models announced by the Centers for Medicare & Medicaid Services for patients with chronic kidney disease or end-stage renal disease could be a boon for companies that have taken...
BC Extra | May 22, 2019
Company News

May 22 Company Quick Takes: Lilly adds warning to Verzenio's Japanese label; plus Janssen, a pair of China approvals and more

Lung disease warning for Lilly breast cancer drug in Japan  Eli Lilly and Co. (NYSE:LLY) told BioCentury it has updated the Japanese label of breast cancer drug Verzenio abemaciclib to include a warning for interstitial...
BC Extra | May 8, 2019
Company News

Gilead’s Goldfinch deal signals renewed optimism in kidney therapies

In the latest sign of that the kidney is regaining attention for drug developers, Gilead has tapped Goldfinch's drug discovery tools to co-develop therapies for diabetic kidney disease and orphan kidney diseases. Goldfinch Biopharma Inc....
BC Extra | Apr 15, 2019
Clinical News

Invokana reduces composite endpoint by 30% in Type II diabetics with CKD

After years of failures in the CKD space, two agents have now shown efficacy in the indication. The latest is Invokana canagliflozin from Janssen, which said Sunday that Invokana is the only drug in nearly...
BC Week In Review | Nov 16, 2018
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....
BC Extra | Nov 12, 2018
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....
BioCentury | Nov 9, 2018
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...
BC Week In Review | Nov 2, 2018
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...
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