BioSpace News Archive

FDA

FDA to Review Supplemental Biologics License Application for Praluent® (alirocumab)Injection as Potential Treatment to Reduce Major Adverse Cardiovascular Events

Last month, FDA also approved Praluent label update for some patients currently requiring LDL apheresis therapy

September 12, 2018
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13 min read
Business

Biohaven Appoints Bob Repella to Board of Directors

Biohaven Pharmaceutical Holding Company Ltd. (NYSE: BHVN) today announced the appointment of Robert (Bob) Repella to its Board of Directors.

September 12, 2018
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4 min read
Business

Systech Announces Partnership with FarmaTrust to Deliver Foolproof Pharmaceutical Blockchain Solution

Revolutionary solution provides authentic, safe and connected products throughout the pharmaceutical supply chain

September 12, 2018
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2 min read
Pharm Country

AACR Releases Annual Cancer Progress Report

Strong bipartisan commitment from Congress to invest in biomedical science is fueling innovation in cancer research leading to advances in prevention and treatment

September 12, 2018
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6 min read
Lone Star Bio

ApoCell Expands Immuno-Oncology Biomarker Services to Develop Liquid Biopsy and Tumor Tissue Tests using the PerkinElmer Vectra Polaris Platform

Enhanced capabilities are designed to advance immuno-therapy candidates from pre-clinical discovery through Phase III clinical trials using smaller samples of both tumor biopsies and liquid biopsies to generate data required for assessing drug efficacy.

September 12, 2018
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3 min read
Business

Pall Corporation and Aetos Biologics Partner to Deliver Integrated, Off-the-Shelf Biosimilar Manufacturing Solutions

The companies will collaborate to offer biosimilar manufacturing solutions to the global biosimilars market.

September 12, 2018
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2 min read
Deals

Evolent Health to Acquire New Century Health, Expanding its Specialty Care Management Capabilities

The addition of New Century Health provides significant depth in managing high-cost specialty care for providers and payers

September 12, 2018
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9 min read
Policy

Exact Imaging Announces Health Canada Approval for its FusionVu™ Application for Micro-Ultrasound/MRI Fusion

ExactVu™ micro-ultrasound platform - - now with FusionVu -- enables the highest real-time resolution for targeted prostate imaging and biopsy

September 12, 2018
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2 min read
Deals

Intrexon Announces Transfer of Stock Listing to Nasdaq

Ticker symbol to remain “XON”

September 12, 2018
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2 min read
FDA

FDA Grants Priority Review to Merck’s Application for KEYTRUDA® (pembrolizumab) Monotherapy for First-Line Treatment of Locally Advanced or Metastatic Non-Small Cell Lung Cancer in Patients Whose Tumors Express PD-L1 (TPS ≥1%)

Application Based on Overall Survival Data from Pivotal Phase 3 KEYNOTE-042 Trial

September 12, 2018
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24 min read