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9:29 AM, Feb 20, 2018  |  BC Extra | Financial News

Arix, Fosun in China-focused deal

Life sciences investment firm Arix Bioscience plc (LSE:ARIX) partnered with Fosun International Ltd. (HKSE:656) to invest in and build newcos focused on the China market. The deal will give Arix access to investment opportunities in...
8:41 AM, Feb 20, 2018  |  BC Extra | Financial News

Taiwan Liposome planning NASDAQ listing

Taiwan Liposome Co. Ltd. (TPEx:4152) proposed to raise up to $50 million through the sale of ADSs in a NASDAQ listing underwritten by Cantor Fitzgerald, CLSA, H.C. Wainwright, Janney Montgomery Scott and Laidlaw. The company...
7:10 AM, Feb 20, 2018  |  BC Extra | Company News

Organ-on-chip company Emulate reveals new deals

Emulate Inc. (Cambridge, Mass.) announced partnerships with Roche (SIX:ROG; OTCQX:RHHBY) and Takeda Pharmaceutical Co. Ltd. (Tokyo:4502) on Tuesday, as well as an initiative with Cedars-Sinai Medical Center (Los Angeles, Calif.). The company's Organs-on-Chips are living, micro-engineered...
6:53 PM, Feb 16, 2018  |  BioCentury | Product Development

Necessary adjustment

Changing a pivotal trial’s primary endpoint analysis after the study is under way is usually not a good sign. So when Bristol-Myers Squibb Co. revealed top-line results from the CheckMate -227 trial in a biomarker-defined...
6:09 PM, Feb 16, 2018  |  BioCentury | Politics, Policy & Law

FDA’s bigger piggy bank

FDA plans to use a proposed record-setting funding boost to invest in projects it believes could lead to fundamental improvements in the way medical products are tested, reviewed and manufactured. The goal is to use...
4:42 PM, Feb 16, 2018  |  BC Extra | Preclinical News

Stem cell-based vaccine could give broad immunity against cancers

A Stanford University team published a paper in Cell Stem Cell showing a stem cell-based vaccine prevented tumor growth and reactivated the immune system in several cancer models. The therapy could grant broad immunity against...
4:27 PM, Feb 16, 2018  |  BC Extra | Company News

FDA grants EAP designation to Guardant's NGS-based liquid biopsy

Guardant Health Inc. (Redwood City, Calif.) said FDA granted Expedited Access Pathway (EAP) designation to its Guardant360 assay, a comprehensive next-generation sequencing (NGS)-based liquid biopsy test for advanced cancer. The company plans to submit a...
4:24 PM, Feb 16, 2018  |  BioCentury | Product Development

This year’s model

Companies are answering FDA’s push for model-informed dose optimization in cancer by modeling how tumors grow and how tumor kinetics relate to outcomes. The models can support dosing decisions and help companies make faster, better...
4:23 PM, Feb 16, 2018  |  BC Extra | Politics & Policy

FDA to hold patient meeting on opioid use disorder

FDA is asking individuals with opioid use disorder to testify at a public meeting April 17. The event is part of the agency's Patient Focused Drug Development (PFDD) initiative, which includes a series of public...
4:21 PM, Feb 16, 2018  |  BC Extra | Company News

FDA approves Imfinzi for NSCLC that has not progressed

FDA approved Imfinzi durvalumab from AstraZeneca plc (LSE:AZN; NYSE:AZN) to treat stage III unresectable non-small cell lung cancer that has not progressed following chemoradiation. The agency said this is the first drug approved for the...