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...

6:43 PM Nov 09, 2018

Alkermes adcomm reveals SPCD paradox

Disagreement between FDA and Alkermes plc on how the data were analyzed took center stage at the panel meeting on the depression drug ALKS 5461. But the meeting also flushed out a chicken-and-egg...


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4:55 PM Nov 16, 2018

Tesaro stock rebounds on takeout report

Tesaro Inc. (NASDAQ:TSRO) declined to comment on a report of a potential sale that drove the company's...

4:55 PM Nov 16, 2018

Centrexion steps back from IPO amid volatile market

A decision by pain company Centrexion Therapeutics Corp. (Boston, Mass.) to not move forward with its...

4:18 PM Nov 16, 2018

Spotlight co-founder uses CRISPR screen to ID T cell regulator genes for cancer

Spotlight Therapeutics Inc. (Hayward, Calif.) co-founder Alexander Marson and colleagues at University of...

4:10 PM Nov 16, 2018

Adcetris gets speedy label expansion under FDA real-time pilot

FDA approved a label expansion for Adcetris brentuximab vedotin less than two weeks after Seattle Genetics...

4:06 PM Nov 16, 2018

Novartis joins call asking FDA to stop biosimilar trash-talkers

Novartis AG (NYSE:NVS; SIX:NOVN) joined Pfizer Inc. (NYSE:PFE) in asking FDA to stop campaigns from...

4:03 PM Nov 16, 2018

Postmarketing study delays increase, but Gottlieb hopeful on progress

Despite a slight slip in numbers for on-schedule postmarketing studies, FDA Commissioner Scott Gottlieb...

3:22 PM Nov 16, 2018

Alphamab Oncology raises more than $100M series A

Immuno-oncology company Alphamab Oncology (Suzhou, China) raised over $100 million in a series A round to...

3:19 PM Nov 16, 2018

As Finance chair, Grassley will become gatekeeper of biopharma bills

Sen. Chuck Grassley (R-Iowa) said he will opt to serve as chairman of the Senate Finance Committee for the...

2:54 PM Nov 16, 2018

Pfizer to increase list price of 41 drugs

Pfizer Inc. (NYSE:PFE) said it plans to increase the list price for 41 medicines, effective Jan. 15. Last...

2:19 PM Nov 16, 2018

CHMP backs first all-oral sleeping sickness treatment, extensions for Blincyto, Opdivo-Yervoy combo

EMA's CHMP recommended a basket of approvals and label extensions on Friday, including the first all-oral...

1:52 PM Nov 16, 2018

Chi-Med down on fruquintinib OS miss in third-line NSCLC

Hutchison China MediTech Ltd. (LSE:HCM; NASDAQ:HCM) said third-line treatment with fruquintinib missed the...

12:42 PM Nov 16, 2018

Imfinzi fails again in MYSTIC trial for first-line NSCLC

In another strike against tremelimumab, AstraZeneca plc (LSE:AZN; NYSE:AZN) said the anti-CTLA-4 mAb in...

5:23 AM Nov 16, 2018

Preventing DNA repair blocks inflammation

In Science, researchers at Karolinska Institute and colleagues reported a new approach to treat...

4:26 PM Nov 15, 2018

Arena licenses ralinepag to United, moves S1PR1 agonist to center stage

United Therapeutics Corp. (NASDAQ:UTHR) licensed exclusive, worldwide rights to pulmonary arterial...

4:14 PM Nov 15, 2018

Patients: Trust and transparency key to using social media, apps to gather data

Members of an FDA committee agreed that social media and digital technologies could help companies and the...

4:13 PM Nov 15, 2018

V-Bio, Gimv lead €37M Camel-IDS series A

Camelid-derived antibody company Camel-IDS N.V. (Brussels, Belgium) raised €37 million ($41.7 million)...

4:10 PM Nov 15, 2018

U.K. biopharma stocks weather the Brexit storm

U.K. biopharma stocks held steady Thursday despite the turmoil caused by Brexit negotiations, while the...

4:01 PM Nov 15, 2018

NICE backs Novartis' Kymriah in acute lymphoblastic leukemia

U.K.'s NICE recommended in final guidance CAR T therapy Kymriah tisagenlecleucel from Novartis AG (NYSE:...

3:59 PM Nov 15, 2018

Cell-free DNA could identify likely Rubraca responders

Cell-free DNA analysis of BRCA reversion mutations could go beyond tissue-based diagnostics to help...

3:23 PM Nov 15, 2018

Boehringer, Epizyme to develop small molecules against epigenetic cancer targets

Boehringer Ingelheim GmbH (Ingelheim, Germany) partnered with Epizyme Inc. (NASDAQ:EPZM) to develop small...

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