BioSpace News Archive

FDA

Ipsen Announces U.S. FDA Approval for Newly Designed Pre-Filled Syringe for Somatuline® Depot (lanreotide)

Ipsen Biopharmaceuticals, an affiliate of Ipsen (Euronext: IPN; ADR: IPSEY), announced today that the United States Food and Drug Administration (FDA) has approved a new pre-filled syringe for Somatuline® Depot (lanreotide).

June 24, 2019
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13 min read
Deals

ArQule Announces Commencement of Proposed Public Offering of Common Stock - June 24, 2019

ArQule, Inc. announced that it has commenced an underwritten public offering, subject to market and other conditions, to issue and sell shares of its common stock.

June 24, 2019
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4 min read
Business

Sensyne Health, Evotec, OSI and the University of Oxford create new partnership called LAB10x to accelerate data-driven drug discovery powered by AI

LAB10x aims to accelerate the commercialisation of the next generation of digital therapeutics and data-driven drug discovery from clinical artificial intelligence research and digital health innovations at the University of Oxford

June 24, 2019
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10 min read
Drug Development

MaaT Pharma Completes Third Positive DSMB Assessment Setting High Safety Standard for Human Intestinal Microbiome Whole Ecosystem-Based Therapeutics

Independent Data Safety Monitoring Board (DSMB) confirms continuation of Phase II HERACLES study in acute GvHD with no safety concerns occurring within the study

June 24, 2019
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5 min read
Drug Development

FDA Grants Orphan Drug Designation to XW Laboratories’ XWL-008 for the Treatment of Patients with Narcolepsy

XW Laboratories Inc. announced that the U.S. Food and Drug Administration has granted Orphan Drug Designation to the company’s lead proprietary compound XWL-008 for the treatment of patients with narcolepsy.

June 24, 2019
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2 min read
Policy

/R E P E A T -- Notice to Media - Minister of Health to visit the Greater Toronto Area/

The Honourable Ginette Petitpas Taylor, federal Minister of Health, will visit Toronto and Brampton to deliver health-related announcements.

June 24, 2019
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1 min read
Drug Development

Mallinckrodt Achieves 50 Percent Enrollment for Phase 2B Trial Investigating the Use of Acthar® Gel (Repository Corticotropin Injection) in Amyotrophic Lateral Sclerosis (ALS)

Mallinckrodt plc, confirmed it has achieved 50 percent patient enrollment in the company’s Phase 2B study designed to assess the efficacy and safety of Acthar® Gel as an investigational treatment for amyotrophic lateral sclerosis.

June 24, 2019
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10 min read
Biotech Bay

Veeva Vault Safety Now Available

Veeva delivers a modern cloud application for the management of adverse events

June 24, 2019
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3 min read
Business

Ingenico Improves Patient Safety with Solutions for Healthcare Settings Leveraging Antimicrobial Product Protection

Ingenico Group (Euronext: FR0000125346 - ING), the global leader in seamless payment, announced the introduction of the industry’s first payment solutions with antimicrobial product protection.

June 24, 2019
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3 min read
Bio NC

Phitonex Launches NovaFluor Dyes Enabling High Resolution Biology for Single Cell Analysis

New Dyes and Platform Provide a Transformative Leap in Fluorescence by Design to Enable Research

June 24, 2019
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2 min read