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7:24 AM, Feb 15, 2018  |  BC Extra | Politics & Policy

FDA signals enhanced focus on patient input with new neurological guidances

FDA demonstrated its commitment to an enhanced focus on incorporating patient input into its drug review programs Thursday with the release of new guidance documents to help researchers approach development of drugs to treat neurological...
6:00 AM, Feb 15, 2018  |  BC Extra | Financial News

Celularity unveils size of series A

Celularity Inc. (Warren, N.J.) revealed on Thursday that it has raised more than $250 million in series A funding and assets from Celgene Corp. (NASDAQ:CELG), three other biotechs and private investors. The cell therapy, regenerative...
5:14 PM, Feb 14, 2018  |  BC Extra | Company News

BMS, Nektar partner on NKTR-214 combos in $3.6B deal

Nektar Therapeutics (NASDAQ:NKTR) gained $8.34 (11%) to $84 on Wednesday after partnering with Bristol-Myers Squibb Co. (NYSE:BMY) to develop and commercialize Nektar's NKTR-214 in combination with BMS's anti-PD-1 mAb Opdivo nivolumab and Opdivo plus the...
4:43 PM, Feb 14, 2018  |  BC Extra | Company News

Teva jumps on Berkshire Hathaway investment

Teva Pharmaceutical Industries Ltd. (NYSE:TEVA; Tel Aviv:TEVA) gained $1.77 to $21.10 in after-hours trading on Wednesday after Berkshire Hathaway Inc. (NYSE:BRK-A; NYSE:BRK-B) disclosed a new stake in the generics company. In an SEC filing issued...
4:38 PM, Feb 14, 2018  |  BC Extra | Clinical News

Biogen slips on Phase III AD studies

Biogen Inc. (NASDAQ:BIIB) lost $20.91 to $296.08 on Wednesday after EVP and CMO Alfred Sandrock said the company will enroll a total of an additional 510 patients in the Phase III ENGAGE and EMERGE trials...
4:16 PM, Feb 14, 2018  |  BC Extra | Politics & Policy

House passes bill to extend SOX relief under JOBS Act

The House of Representatives passed a bill package on Wednesday that includes a provision known as the Fostering Innovation Act to extend for pre-revenue companies relief provided under the Jumpstart Our Business Startups Act. Enacted...
3:48 PM, Feb 14, 2018  |  BC Extra | Company News

March 7 ODAC meeting for Amgen's Blincyto

Amgen Inc. (NASDAQ:AMGN) said FDA’s Oncologic Drugs Advisory Committee will meet on March 7 to discuss an sBLA for Blincyto blinatumomab to treat minimal residual disease (MRD)-positive B cell precursor acute lymphoblastic leukemia (ALL). The...
3:46 PM, Feb 14, 2018  |  BC Extra | Clinical News

Tetraphase falls on Phase III cUTI miss

Tetraphase Pharmaceuticals Inc. (NASDAQ:TTPH) lost $3.28 (60%) to $2.15 on Wednesday after reporting that IV eravacycline (TP-434) missed the co-primary endpoints in the Phase III IGNITE3 trial to treat complicated urinary tract infections (cUTIs). The...
3:43 PM, Feb 14, 2018  |  BC Extra | Preclinical News

Three targets in the same brain region could alleviate depression

A Zhejiang University team published a pair of papers in Nature suggesting ketamine works by modulating the firing of neurons in the lateral habenula, a brain region that controls reward signaling. The studies point to...
3:14 PM, Feb 14, 2018  |  BC Extra | Preclinical News

TGFB inhibition could treat checkpoint inhibitor-resistant cancer

In two studies published in Nature, scientists uncovered the role of transforming growth factor (TGF) beta in the tumor microenvironment, and suggested that blocking TGF beta could help treat cancers resistant to checkpoint inhibitor therapies. In...

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