BioSpace News Archive

Drug Development

Chemomab Therapeutics Reports Positive Data from Secondary Analysis of Phase 2a Liver Fibrosis Trial in NASH Patients at EASL 2023

Chemomab Therapeutics Ltd. today reported topline results from secondary analyses of its Phase 2a liver fibrosis trial assessing CM-101, its first-in-class CCL24-neutralizing antibody, in patients with non-alcoholic steatohepatitis (NASH).

June 21, 2023
·
8 min read
Genetown

bluebird bio Announces FDA Priority Review of the Biologics License Application for lovotibeglogene autotemcel (lovo-cel) for Patients with Sickle Cell Disease (SCD) 12 years and Older with a History of Vaso-Occlusive Events

bluebird bio, Inc . (Nasdaq: BLUE) today announced that the U.S. Food and Drug Administration (FDA) has accepted the Biologics License Application (BLA) for lovotibeglogene autotemcel (lovo-cel) for priority review.

June 21, 2023
·
9 min read
ADAMA Receives Registration for Sierra®, the First Off-Patent, Self-Produced Saflufenacil-Based Product in Australia

ADAMA Ltd. announces the registration of Sierra®, its self-produced Saflufenacil-based herbicide formulation, the first off-patent product based on this active ingredient, in Australia.

June 21, 2023
·
2 min read
Cybin to Participate in the 2023 MAPS Psychedelic Science Conference

Cybin Inc. is pleased to announce that Doug Drysdale, Cybin’s Chief Executive Officer, and Allison House-Gecewicz, Cybin’s SVP of Clinical Operations, will be speaking at the Psychedelic Science 2023 Conference.

June 21, 2023
·
2 min read
Drug Development

Inhibikase Therapeutics Initiates Medical and Patient Awareness Campaign for its Phase 2 ‘201' Trial Evaluating IkT-148009 in Parkinson’s Disease

Inhibikase Therapeutics, Inc. today announced a physician and patient awareness campaign for its Phase 2 ‘201' program evaluating IkT-148009 as a potentially disease-modifying treatment of Parkinson’s disease.

June 21, 2023
·
4 min read
Pharm Country

Avantor® Launches Responsible Supplier Program

Avantor, Inc. announced the global launch of the company’s Responsible Supplier Program designed to help reduce environmental impact and accelerate sustainable practices across the supply chain.

June 21, 2023
·
3 min read
Bio NC

CMP Pharma, Inc Announces that Liqrev®, the First and Only Ready-made FDA-approved Liquid Suspension of Sildenafil is Now Available

CMP Pharma, Inc. announced today that Liqrev (Sildenafil) Oral Suspension, 10 mg/mL, the first and only FDA-approved ready-made oral liquid of sildenafil, is now available.

June 21, 2023
·
5 min read
Drug Development

DiaMedica Therapeutics Announces that the FDA Has Removed The Clinical Hold On DM199 Phase 2/3 Trial For Ischemic Stroke

DiaMedica Therapeutics Inc. announced today that the U.S. Food and Drug Administration (FDA) has removed the clinical hold placed on the investigational new drug application for its ReMEDy2 phase 2/3 clinical trial studying DM199 in the treatment of acute ischemic stroke (AIS) and that preparations are underway to resume the ReMEDy2 trial as soon as possible.

June 21, 2023
·
6 min read
Drug Development

AceLink Therapeutics Receives FDA Clearance to Initiate a Phase 2 Study of AL1211 in Patients with Fabry Disease

AceLink Therapeutics, Inc. today announced that it has received clearance from the U.S. Food and Drug Administration (FDA) to initiate a Phase 2 clinical trial of its lead program, AL1211.

June 21, 2023
·
5 min read
Pharm Country

CorMedix Inc. Announces FDA Acceptance of Resubmission of New Drug Application for DefenCath - June 21, 2023

CorMedix Inc. today announced that the resubmission of the New Drug Application (NDA) for DefenCath has been accepted for filing by the U.S. Food and Drug Administration (FDA).

June 21, 2023
·
4 min read