BioSpace News Archive

Drug Development

Innovative Trial Design may have Cost Lilly’s Donanemab Accelerated Approval

The FDA issued a complete response letter Thursday refusing accelerated approval for Eli Lilly’s Alzheimer’s disease candidate donanemab.

January 20, 2023
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2 min read
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Tristan Manalac
FDA

FDA Green Lights Astellas’ Trial for Pompe Disease Therapeutic

Thursday, Astellas announced that the FDA had lifted its clinical hold for the company’s experimental gene therapy trial for late-onset Pompe disease.

January 20, 2023
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2 min read
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Hayley Shasteen
FDA

Seagen Snags Accelerated Approval in Aggressive Colon Cancer

The FDA granted Seagen’s tyrosine kinase inhibitor Tukysa accelerated approval for an aggressive form of colorectal cancer Thursday.

January 20, 2023
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2 min read
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Kate Goodwin
Business

Weeks After Reverse Merger, Disc Expands Hematologic Pipeline

Disc Medicine inked an exclusive license agreement with Mabwell Therapeutics for the latter’s portfolio of monoclonal antibodies against the TMPRSS6 protein.

January 20, 2023
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2 min read
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Tristan Manalac
Policy

Astellas Announces Hold Lifted by FDA on FORTIS Clinical Trial of AT845 Investigational Treatment for Adult Patients with Late-Onset Pompe Disease

Astellas Pharma Inc. announced that the U.S. Food and Drug Administration has lifted the clinical hold on January 19th for the FORTIS Ph1/2 clinical trial evaluating the safety, tolerability and efficacy of investigational AT845 in adults with late-onset Pompe disease.

January 20, 2023
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6 min read
BioMidwest

Ryan Davies Conducts CEO Chat with Leading Biotech IP Expert

CancerVAX, Inc. announced that CEO Ryan Davies discussed how patents can be used to benefit companies undertaking early-stage development projects with Todd Kinard, a specialist in protecting biotech inventions.

January 20, 2023
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4 min read
Vitrolife AB (publ): Conference call Year-end report, 2022

Invitation to attend Vitrolife AB conference call regarding presentation of the Year-end report, 2022. The presentation will be held in English.

January 20, 2023
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1 min read
FDA

DualityBio Announces DB-1303 Granted Fast Track Designation by the U.S. Food and Drug Administration (FDA) for the Treatment of Advanced, Recurrent or Metastatic Endometrial Carcinoma with HER2 Overexpression

Duality Biologics announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation (FTD) to DB-1303 for the treatment of patients with advanced, recurrent or metastatic endometrial carcinoma with HER2 overexpression who have progressed on or after standard systemic treatment.

January 20, 2023
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4 min read
Dr. Reddy’s successfully completes full set of clinical studies of its rituximab biosimilar for filing in the U.S., Europe

Dr. Reddy’s Laboratories Ltd. announced that it has successfully completed the full set of clinical studies of its proposed rituximab biosimilar candidate, DRL_RI, for filing in highly regulated markets such as the United States, Europe and other regions.

January 20, 2023
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6 min read
Drug Development

Disc Medicine Announces Exclusive Licensing Agreement with Mabwell Therapeutics for Novel Anti-TMPRSS6 Monoclonal Antibodies to Modulate Iron Homeostasis

Disc Medicine, Inc. (NASDAQ:IRON) announced today that is has entered into an agreement with Mabwell Therapeutics to obtain an exclusive license to a portfolio of monoclonal antibodies targeting TMPRSS6 (Transmembrane Serine Protease 6, also known as Matriptase-2) including the phase 1-ready drug candidate MWTX-003.

January 20, 2023
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8 min read