BioSpace News Archive

FDA

RemeGen Announces US FDA Clearance of IND Application to Initiate Phase II Clinical Trial in Urothelial Cancer

RemeGen today announced that the US Food and Drug Administration (FDA) has cleared an Investigational New Drug (IND) application to initiate its US-based Phase II clinical trial of RC48 (disit

April 29, 2020
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3 min read
Protagen Protein Services (PPS) expands capabilities for aggregate analytics to include dynamic light scattering (DLS)

Protein aggregation is a common challenge in the manufacturing of biological products. As one of the most sensitive techniques for the detection of aggregates, dynamic light scattering (DLS) provides a simple, fast and non-destructive testing method.

April 29, 2020
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5 min read
Pharm Country

Cancer Testing and Diagnosis Suffers Sharp Downturn, finds Diaceutics

Diaceutics PLC, (AIM: DXRX), the precision diagnostic commercialization company, today announces research results from its COVID-19 oncology tracker, which shows the impact of the crisis on cancer testing and diagnosis in the US

April 29, 2020
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5 min read
Business

BONESUPPORT Appoints Michael Roth as General Manager & Executive Vice President Commercial Operations North America

BONESUPPORT™, an emerging leader in orthobiologics for the management of bone injuries announces a change in its leadership team that will take place June 1, 2020.

April 29, 2020
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2 min read
Biotech Bay

Pear Therapeutics to Release Pear-004 to Help People Living with Schizophrenia During the COVID-19 Crisis

Pear Therapeutics, Inc., the leader in prescription digital therapeutics (PDTs), today announced that it is launching a limited distribution program for its product candidate, Pear-004, for people living with schizophrenia

April 29, 2020
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5 min read
Blue-Zone Technologies Ltd. Receives Drug Approval From Health Canada for Its Branded Generic DESFLURANE, USP.

Blue-Zone Technologies Ltd. (“Blue-Zone”) announces receipt from Health Canada of a Drug Identification Number (DIN) for DESFLURANE, USP, an important drug used for general anesthesia.

April 29, 2020
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3 min read
BioCapital

International Study Reports COVID-19 Outcomes in People With Cystic Fibrosis

Collaborative effort identifies 40 cases of COVID-19 across eight countries; outcomes for this high-risk population were reported in the Journal of Cystic Fibrosis

April 29, 2020
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4 min read
Business

Clinical Trial Begins to See if Convalescent Plasma Can Treat COVID-19

Montefiore and Albert Einstein College of Medicine Partner with NYU Langone Health to Determine if Blood from COVID-19 Survivors Can Aid Current COVID-19 Patients

April 29, 2020
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5 min read
Biotech Beach

Importance of Rapid Lyme Disease Testing To Be Discussed in Free Webinar Hosted by Industry-Leading Quidel Corporation

As America is painfully learning through the current coronavirus pandemic, reliable testing with quick and accurate results is the key to stopping a disease in its tracks and providing time-sensitive treatment to the afflicted.

April 29, 2020
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3 min read
Policy

Psychemedics Test for Cotinine (metabolite of Nicotine) Detection Cleared by FDAA New and Cost-Effective Tool to Detect and Deter Nicotine use

Psychemedics Corporation, the world leader and pioneer in detecting drugs of abuse using hair analysis, introduced the first FDA-cleared hair test for cotinine, the predominant metabolite for nicotine.

April 29, 2020
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3 min read