22:35 , Jul 19, 2019 |  BioCentury  |  Regulation

A half step forward for heart failure as FDA guidance leaves key question unanswered

A draft FDA guidance for heart failure endpoints could spark investment and accelerate development of cardiovascular therapies. But companies still don’t have a clear sense of when and whether they’ll need to gather mortality data...
01:48 , Jul 13, 2019 |  BioCentury  |  Product Development

Moving Beyond a Buzzword: How small- to mid-sized biotechs can adopt patient centricity in oncology trials

A major benefit of integrating the patient voice into clinical trials is the ability to speed enrollment, yet few companies take advantage of this due to the perception that it is too costly and time-consuming....
00:19 , Jul 12, 2019 |  BC Extra  |  Clinical News

Amyloid hypothesis takes first hit in an Alzheimer’s prevention setting

With Novartis and Amgen’s decision to halt a pair of trials in presymptomatic Alzheimer’s patients Thursday, what was widely considered the only setting left for the amyloid hypothesis in the disease took a blow. Amyloid-lowering...
00:27 , Jul 11, 2019 |  BC Extra  |  Company News

July 10 Company Quick Takes: I-Mab licenses MacroGenics mAb; plus Mirati-Novartis, Jazz-Redx, Sanofi, Horizon and more

I-Mab gains China rights to enoblituzumab I-Mab Biopharma (Shanghai, China) gained exclusive rights to enoblituzumab from MacroGenics Inc. (NASDAQ:MGNX) in China, Hong Kong, Macao and Taiwan for $15 million up front. MacroGenics is eligible for...
21:21 , Jun 14, 2019 |  BioCentury  |  Product Development

Despite senior management shake-up, Novartis’ pipeline is primed to deliver

A string of departures at Novartis AG and strategic shifts by new CEO Vasant Narasimhan have produced a fairly thorough makeover of the executive committee he inherited in 2018. The team gains a pipeline that...
12:00 , May 21, 2019 |  BC Extra  |  Financial News

Sequoia leads digital therapeutics company Biofourmis' $35M round

Biofourmis raised $35 million in a series B round to develop its AI-powered digital therapeutics platform for improving patient outcomes. The platform uses AI, drug intervention, wearable sensors and a smartphone app to remotely monitor...
20:15 , May 10, 2019 |  BC Extra  |  Financial News

New Eisai venture arm to focus on digital tech, dementia, cancer

As Eisai looks to digital technologies for dementia drug discovery, the Japanese pharma’s newly launched venture arm has made its first investment and backed Tokyo-based digital healthcare company Allm. Eisai Co. Ltd. (Tokyo:4523) said the...
01:42 , May 4, 2019 |  BioCentury  |  Product Development

How the amyloid hypothesis holds its grip

By now, two things are clear about the amyloid hypothesis of Alzheimer’s disease: one is that the amyloid peptide is somehow involved; the other is that it’s a terrible target. β amyloid has had an...
01:39 , May 4, 2019 |  BioCentury  |  Product Development

Amyloid: how did we get here and what can we learn?

Unlike any other theory in drug development, the amyloid hypothesis of Alzheimer’s disease has maintained an almost cult-like following, despite two decades littered with a long line of late-stage failures and not a single success....
18:10 , May 2, 2019 |  BioCentury  |  Politics, Policy & Law

Gottlieb: How a cultural shift is transforming FDA’s drug reviews

A decade ago, the FDA secured new tools, resources, and authorities to implement a watershed change in how the agency approached the drug review process. The novel framework turned on a more active approach to...