BioSpace News Archive

Policy

China FDA Grants Liquid Biopsy Approval to AmoyDx Super-ARMS EGFR Mutation Test

Amoy Diagnostics announced that CFDA approved its Super-ARMS EGFR Mutation Test for use with plasma samples, as a companion diagnostic for NSCLC therapy with EGFR-TKIs on January 19.

January 22, 2018
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2 min read
BioAxial Granted U.S. Patent Covering ‘Black Fluorophore’ Technology

This patent consolidates BioAxial’s patent portfolio, which already comprises ten patent families.

January 22, 2018
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3 min read
Pharm Country

Athenex Announces Proposed Offering of Common Stock

In addition, Athenex intends to grant the underwriters a 30-day option to purchase up to an additional 645,000 shares of common stock at the public offering price.

January 22, 2018
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3 min read
Pharm Country

CluePoints Launches Risk-Based Monitoring Starter Pack to Drive Regulatory Compliance

The starter pack has been developed following CluePoints’ extensive market and industry research to better understand the challenges faced by clinical development organizations and CROs since the introduction of the ICH E6 (R2) addendum.

January 22, 2018
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3 min read
BioCapital

Shimadzu’s LabSolutions Insight Software for LC/MS/MS and GC/MS Provides Powerful Data Mining and Analytics Capabilities

With intuitive operation and a new advanced peak detection algorithm, this software supports review-by-exception to improve the speed and efficiency of multi-analyte data analysis.

January 22, 2018
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2 min read
BioMidwest

Myriad Applauds New Consensus Statement From International Expert Panel On Screening Recommendations for Hereditary Prostate Cancer

The consensus recommendations point to the need for routine obtainment of family history information and hereditary cancer counselling for men with prostate cancer seen by either a urologist or oncologist.

January 22, 2018
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6 min read
Drug Development

Athenex Announces Encouraging Results of the First Cohort of Phase I Clinical Trial of Oraxol and CYRAMZA (Ramucirumab) Comvric Cancer

A previously completed Phase II clinical trial of Oraxol in the second-line treatment of gastric cancer patients showed an encouraging overall median survival of 10.7 months.

January 22, 2018
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5 min read
Business

Invetech Announces Senior Management Appointment

Invetech has announced the appointment of David Kneen as VP, Cell Therapy.

January 22, 2018
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2 min read
Biotech Beach

Medeor Therapeutics Awarded $18.8M From the California Institute for Regenerative Medicine

The award is to support a Phase 3 clinical trial to evaluate the safety and efficacy of MDR-101.

January 22, 2018
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3 min read
ProMIS Neurosciences Issues Response to Recent Market Activity

At the request of IIROC, ProMis Neurosciences wishes to confirm that it is not aware of any material, undisclosed information related to the Company that would account for the recent increase in the market price and level of trading volume of its ordinary shares.

January 22, 2018
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2 min read