5:51 AM Nov 19, 2018

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...

7:21 PM Nov 16, 2018

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...

5:45 PM Nov 16, 2018

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...

2:55 PM Nov 15, 2018

Tempest takes PPAR alpha into cancer

Tempest Therapeutics Inc.’s first data from its preclinical PPARα program gave it the support it was looking for to repurpose the cardiovascular target for cancer.

2:43 PM Nov 15, 2018

Benchtop manufacturing gets smaller

MIT scientists continue to break new ground in benchtop manufacturing systems for biologics. Published in Nature Biotechnology last month, the latest advance from the institute centered on an...

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Latest News

4:34 PM Nov 20, 2018

Deal with Idorsia gives Santhera shot at second DMD candidate

In a deal that will make Idorsia Ltd. (SIX:IDIA) its largest shareholder, Santhera Pharmaceuticals Holding...

3:46 PM Nov 20, 2018

ICER to review peanut allergy therapies from Aimmune, DBV

The Institute for Clinical and Economic Review (ICER) will review peanut allergy therapies AR101 from...

3:35 PM Nov 20, 2018

Merck KGaA, Palantir team up to drive cancer research data sharing and integration

Merck KGaA (Xetra:MRK) and big data company Palantir Technologies (Palo Alto, Calif.) plan to create a JV...

2:28 PM Nov 20, 2018

FDA planning class-wide cancer companion diagnostic guidance

FDA plans to release guidance soon that will make it easier to get a cancer companion diagnostic approved...

2:05 PM Nov 20, 2018

Ascletis adds marketed HBV drug from Roche to Chinese portfolio

With one marketed HCV therapy in China and another under review, Ascletis Pharma Inc. (HKSE:1672) extended...

1:26 PM Nov 20, 2018

Sanders, Khanna propose compulsory licensing to reduce U.S. drug prices

Sen. Bernie Sanders (I-Vt.) announced Tuesday plans to introduce legislation that would impose compulsory...

12:57 PM Nov 20, 2018

Pear, Sandoz launch first FDA-approved digital therapeutic

Pear Therapeutics Inc. (Boston, Mass.) and Sandoz launched reSET, the first FDA-authorized prescription...

12:53 PM Nov 20, 2018

On heels of Sobi deal, Novimmune's emapalumab gets FDA approval

FDA approved Gamifant emapalumab-lzsg from Novimmune S.A. (Plan-les-Ouates, Switzerland), giving Novimmune...

11:44 AM Nov 20, 2018

U.K.'s MHRA to seek new CEO as Hudson steps down next fall

Ian Hudson said he will step down in September 2019 as CEO of the U.K.'s Medicines and Healthcare products...

11:13 AM Nov 20, 2018

REMS prep pushes back Sage's Zulresso timeline

Sage Therapeutics Inc. (NASDAQ:SAGE) anticipates a June 2019 launch of postpartum depression candidate...

3:06 AM Nov 20, 2018

Leo Pharma invests in PellePharm to develop rare skin disease therapy

Dermatology company Leo Pharma A/S (Ballerup, Denmark) gained an option to acquire PellePharm Inc. (Menlo...

4:53 PM Nov 19, 2018

Bavencio fails Phase III for ovarian cancer

Hopes for Merck KGaA (Xetra:MRK) and Pfizer Inc. (NYSE:PFE) to get ahead in the ovarian cancer space,...

4:39 PM Nov 19, 2018

Aimmune down on safety concerns for peanut allergy therapy

Aimmune Therapeutics Inc. (NASDAQ:AIMT) was off $3.33 (11%) to $26.29 on Monday after the New England...

3:52 PM Nov 19, 2018

Pediatric IBD workshop calls for innovative trial design

Participants at an FDA-sponsored workshop called on regulators and drug developers to minimize placebo...

3:44 PM Nov 19, 2018

Management tracks: Brickell, Genevant

Dermatology company Brickell Biotech Inc. (Boulder, Colo.) hired Robert Brown as CEO, effective Jan. 1. He...

3:15 PM Nov 19, 2018

Immunocore, Genentech team up to bring soluble TCR therapy into clinic

Despite losing at least five key executives this year, Immunocore Ltd. (Abingdon, U.K.) has teamed up with...

2:17 PM Nov 19, 2018

U.K. groups push for explicit language on medicines regulation post-Brexit

U.K. health and pharma groups are asking their country and the EU to explicitly make cooperation on...

12:22 PM Nov 19, 2018

Inflazome to bring inflammasome inhibitors to clinic with €40M series B

Inflazome Ltd. (Dublin, Ireland) raised €40 million ($45.7 million) in a series B round Monday, giving...

12:17 PM Nov 19, 2018

RNAi method targets placenta directly to treat preeclampsia

In a Nature Biotechnology study, researchers from University of Massachusetts Medical School and...

11:20 AM Nov 19, 2018

NASH company Genfit planning U.S. listing

As it prepares for a readout from a Phase III study of its lead candidate to treat non-alcoholic...

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