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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...
4:20 PM, Feb 16, 2018  |  BC Extra | Financial News

Addex proposes CHF40M private placement

Addex Therapeutics Ltd. (SIX:ADXN) proposed Thursday to raise up to CHF40 million ($42.7 million) through the sale of 12.8 million shares at CHF3.43 in a private placement. The company said CHF30 million of the offering...
4:08 PM, Feb 16, 2018  |  BC Extra | Financial News

Alkermes hits high following IL-2 deal

Alkermes plc (NASDAQ:ALKS) hit a 52-week high of $71.22 on Friday on the heels of Wednesday's multibillion dollar deal between Nektar Therapeutics (NASDAQ:NKTR) and Bristol-Myers Squibb Co. (NYSE:BMY) involving NKTR-214. A note from Jefferies analyst...
4:05 PM, Feb 16, 2018  |  BC Week In Review | Financial News  |  Completed Offerings

Affimed raises $26.5M in follow-on

Cancer company Affimed N.V. (NASDAQ:AFMD) raised $26.5 million through the sale of 13.2 million shares at $2 in a follow-on underwritten by Jefferies and Wells Fargo. The figures include the sale of a 1.7 million...