BioSpace News Archive

Policy

/R E P E A T -- Notice to the media - Health Canada officials to hold a media technical briefing on medical devices/

Officials from Health Canada will hold a technical briefing to provide information on the Action Plan on Medical Devices.

December 20, 2018
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1 min read
Molecule Discovery by University of Birmingham Scientists Holds Promise for Gene Therapies for Psoriasis

Scientists at the University of Birmingham, UK, have discovered a protein that could hold the key to novel gene therapies for skin problems including psoriasis - a common, chronic skin disease that affects over 100 million people worldwide.

December 20, 2018
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3 min read
Deals

Heritage Portfolio Company EPTAM Announces Add-On Acquisition of Relius Medical

Acquisition of Relius Provides EPTAM with Precision Metals Machining Capabilities

December 20, 2018
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2 min read
Business

Frelii Appoints Seasoned Expert as New Board Member to Support Growth & Expand Strategic Positioning

Frelii Inc. announced the appointment of Leslie M. Norris to its Board of Directors (the “Board”), effective December 12, 2018.

December 20, 2018
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4 min read
Policy

Federal Street Acquisition Corp. Amends Terms of Merger Agreement With Agiliti Health and Enters Into Subscription Agreement With Affiliate of Thomas H. Lee Partners, L.P.

Federal Street Acquisition Corp.

December 20, 2018
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9 min read
Policy

BD Completes Molecular Portfolio for GI Infection With New Viral Panel

BD MAX™ Enteric Viral Panel Receives 510(k) Clearance from U.S. Food and Drug Administration

December 20, 2018
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4 min read
Policy

FDA Accepts HETLIOZ® (tasimelteon) Supplemental New Drug Application for Review in the Treatment of Jet Lag Disorder

Vanda Pharmaceuticals Inc. today announced that the U.S. Food and Drug Administration (FDA) has accepted the filing of Vanda’s Supplemental New Drug Application for HETLIOZ® (tasimelteon) for the treatment of jet lag disorder.

December 20, 2018
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3 min read
Deals

Verastem Oncology Added to the NASDAQ Biotechnology Index®

Verastem, Inc. today announced that it has been selected for addition to the NASDAQ Biotechnology Index® (NASDAQ: NBI). Verastem Oncology’s addition to the NBI will become effective prior to market open on Monday, December 24, 2018.

December 20, 2018
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2 min read
Contextual Genomics Launches Improved FIND ITTM Assay and New FOLLOW ITTM Assay

Contextual Genomics Inc.announces that it has completed development of two new products: (i) an improved version of its FIND ITTM hotspot panel for detection of genomic mutations in solid tumour cancers, and (ii) its FOLLOW ITTM hotspot panel for detection of the same genomic mutations in blood plasma.

December 20, 2018
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4 min read
Drug Development

Deciphera Pharmaceuticals Initiates Pivotal Phase 3 Clinical Study of Ripretinib (DCC-2618) in Second-line Patients with Gastrointestinal Stromal Tumors (“INTRIGUE” Study)

The Efficacy and Tolerability Profile of Ripretinib Will Be Compared to Sunitinib in Second-line GIST Patients Regardless of KIT or PDGFRα Mutational Status

December 20, 2018
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8 min read