BioSpace News Archive

FDA

Asepticys™ Files 510k Submission with U.S. FDA seeking Marketing Clearance for Novel TriFlect™ Disinfection Technology Following Successful Completion of Clinical Trial Requirements

Asepticys LLC, a leading innovator and developer of anti-infective pharmaceutical and consumer healthcare products, today announced the successful completion of multi-site human clinical trials for Asepticys’ novel contact lens care solution containing TriFlect™ technology, and the submission of its 510k application to the U.S. Food and Drug Administration.

April 8, 2019
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2 min read
Business

Ascentage Pharma Announces Clinical Collaboration with Junshi Bioscience to Evaluate the Combination of APG-1387 and Toripalimab in Treating Cancers

Ascentage Pharma announced that it has entered into a strategic collaboration with Shanghai Junshi Biosciences Co., Ltd. to explore the synergies of Ascentage’s Inhibitor of Apoptosis Proteins (IAP) inhibitor APG-1387, and Junshi Biosciences’ anti-PD-1 therapy toripalimab in clinical trials in solid and hematological tumors in China.

April 8, 2019
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4 min read
Pharm Country

BD Unveils Platelet Quality Control Media to Help Reduce the Incidence of Sepsis in Patients Requiring Platelet Transfusion

BD BACTEC™ Platelet Quality Control Media is cleared by the U.S. Food and Drug Administration and CE-IVD marked for platelet testing

April 8, 2019
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4 min read
Biotech Bay

Bruker Announces World’s First Superconducting 1.1 Gigahertz Magnet for High-Resolution NMR in Structural Biology

Homogeneous 25.9 Tesla Standard-bore NMR Magnet Sets New World Record

April 8, 2019
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6 min read
Pharm Country

Evolution announces the formal launch of blulava

An innovation lab committed to delivering solutions that enhance the performance of brands and businesses

April 8, 2019
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1 min read
Drug Development

Regeneron and Alnylam Announce Broad Collaboration to Discover, Develop and Commercialize RNAi Therapeutics Focused on Ocular and Central Nervous System (CNS) Diseases

Companies to also jointly advance select number of preclinical disease programs with targets expressed in the liver and treatments for C5 complement-mediated diseases

April 8, 2019
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16 min read
Biotech Bay

Audentes Therapeutics Announces Expansion of AAV Technology Platform and Pipeline with New Development Programs for Duchenne Muscular Dystrophy and Myotonic Dystrophy

Platform expansion combines the delivery power of AAV with the precision tools of antisense oligonucleotides to develop best-in-class treatments for Duchenne muscular dystrophy (DMD) and myotonic dystrophy type 1 (DM1)

April 8, 2019
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10 min read
Genetown

Tetraphase Pharmaceuticals to Present Data at the 29th European Congress of Clinical Microbiology and Infectious Diseases

Tetraphase Pharmaceuticals, Inc. announced five data presentations at the 29th European Congress of Clinical Microbiology and Infectious Diseases, taking place April 13-16 in Amsterdam, Netherlands.

April 8, 2019
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4 min read
Business

Alnylam and Regeneron Announce Broad Collaboration to Discover, Develop and Commercialize RNAi Therapeutics Focused on Ocular and Central Nervous System (CNS) Diseases

Companies to Also Jointly Advance Select Number of Preclinical Disease Programs with Targets Expressed in the Liver and Treatments for C5 Complement-Mediated Diseases

April 8, 2019
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16 min read
Pharm Country

GenScript Launches Beta Testing Program for New Precision Mutant Library Services

Advanced semiconductor-based platform offers diverse libraries with complete coverage of only desired variants

April 8, 2019
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3 min read