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5:51 AM, Nov 19, 2018  |  BioCentury | Regulation

FDA to apply light touch to biopharma apps

Concerned that regulatory uncertainty is preventing biopharma companies from developing digital tools that could help patients manage their health, FDA plans to exempt a broad range of apps and other software from premarket review. In...
7:21 PM, Nov 16, 2018  |  BioCentury | Product Development

Betting Combos on Biomarkers

Despite lackluster monotherapy data at SITC from the latest tranche of immunotherapy candidates, drug developers are moving into combination trials with PD-1 and PD-L1 inhibitors based on biomarkers of pharmacodynamic activity. Results from the next...
7:17 PM, Nov 16, 2018  |  BioCentury | Product Development

Rethinking RECIST for immunotherapies

Momentum is growing for new tumor response criteria that better reflect the benefits of cancer immunotherapies, with FNIH, companies and FDA all pushing for validation of these criteria. At a Nov. 9 workshop co-hosted by...
6:00 PM, Nov 16, 2018  |  BioCentury | Emerging Company Profile

Sepset’s sepsis signature

Sepset Biosciences Inc.’s gene expression test detects an "endotoxin tolerance" signature that can diagnose sepsis as soon as patients appear in an emergency room, earlier than approved assays and thereby providing more time for antibiotics...
5:45 PM, Nov 16, 2018  |  BioCentury | Product Development

MyoKardia’s myosin mechanism deconvolution

With preclinical proof of concept that its lead candidate mavacamten acts via two distinct mechanisms to treat cardiomyopathy, MyoKardia Inc. is ready to accelerate a pipeline of preclinical programs that exploit the mechanisms separately for...
1:46 PM, Nov 16, 2018  |  BioCentury | Finance

SVB Leerink’s full suite

The planned $280 million acquisition of Leerink Partners by SVB Financial Group (NASDAQ:SIVB) is expected to provide biotechs with a new one stop shop for financial services. SVB, a commercial lender with a dedicated healthcare...
11:59 AM, Nov 16, 2018  |  BioCentury | Tools & Techniques

Benchtop manufacturing gets smaller

Publisher’s note: This story originally ran in the Nov. 15, 2018 issue of BioCentury Innovations, a comprehensive source of developments in translational research with knowledgeable perspectives on the key innovations, trends and opportunities in early...
7:08 AM, Nov 15, 2018  |  BioCentury | Politics, Policy & Law

Requiring Drug Prices in TV Ads Violates First Amendment

Drug companies, which have learned to live with advertisements calling out a litany of possible side effects for their drugs, may want to take a couple of aspirin. The recent announcement by CMS that it...
8:25 AM, Nov 13, 2018  |  BioCentury | Finance

Kymera’s degradation toolbox

As the protein degradation space continues to gain traction, Kymera Therapeutics LLC has attracted interest from investors to the tune of $65 million to bring its first program to the clinic. 6 Dimensions Capital, Bessemer...
3:33 AM, Nov 13, 2018  |  BioCentury | Finance

Playing in RNA

M Ventures, the strategic venture arm of Merck KGaA (Xetra:MRK), is adding another RNA company to its portfolio by leading a $30 million series A round for Ribometrix Inc. Fellow new investors Amgen Ventures, Pappas...

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