Remove Events Remove Licensing Remove Therapies
article thumbnail

What FDA’s Newest Gene Therapy Approval Tells Us About Durability: How Long is Long Enough?

FDA Law Blog: Drug Discovery

Valentine — On November 22, 2022, FDA approved CSL Behring’s BLA for Hemgenix (etranacogene dezaparvovec), an AAV-based gene therapy for the treatment of adults with Hemophilia B who currently use Factor IX prophylaxis therapy, have current or historical life-threatening hemorrhage, or have repeated, serious spontaneous bleeding episodes.

Therapies 119
article thumbnail

AvantGen Announces Licensing of Its Anti-SARS-CoV-2 Antibodies to IGM Biosciences for COVID-19 Therapy Development

The Pharma Data

a San Diego-based biotechnology company with an array of technology platforms for antibody discovery and optimization, and novel NK and T cell engager generation, today announced licensing of a panel of its anti-SARS-CoV-2 antibody clones to IGM Biosciences for COVID-19 therapy development.

Insiders

Sign Up for our Newsletter

This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.

article thumbnail

Radioligand therapy pipeline with in-license for compounds targeting Fibroblast Activation Protein (FAP)

The Pharma Data

Novartis Oncology continues to reimagine cancer care through development of robust radioligand therapy portfolio. We continue to invest in radioligand therapy as one of the four unique platforms of Novartis Oncology. Broad expression of FAP demonstrated in tumors or in tumor stroma across many solid tumors 1 ,2 ,3.

article thumbnail

Kite Announces Yescarta® CAR T-cell Therapy Improved Event-Free Survival by 60% Over Chemotherapy Plus Stem Cell Transplant in Second-Line Relapsed or Refractory Large B-cell Lymphoma

The Pharma Data

With a median follow-up of two years, the study met the primary endpoint of event-free survival (EFS; hazard ratio 0.398, p <0.0001). Event-free survival is defined as time from randomization to disease progression, commencement of new lymphoma therapy, or death from any cause. This press release features multimedia.

article thumbnail

Gamida Cell Provides Regulatory Update on Biologics License Application for Omidubicel

The Pharma Data

Nasdaq: GMDA), an advanced cell therapy company committed to cures for blood cancers and serious hematologic diseases, today announced that the company conducted a Type B Meeting for omidubicel with the U.S. Omidubicel is an investigational therapy, and its safety and efficacy have not been established by the U.S. About Omidubicel.

article thumbnail

PharmaEngine, Inc. and Sentinel Oncology Limited Enter into an Exclusive Collaboration and License Agreement for SOL-578, a Chk1 inhibitor

The Pharma Data

TWO: 4162) announced today that it has entered into a Collaboration and License Agreement with UK-based Sentinel Oncology Limited for advancing the new drug development of SOL-578 , a Checkpoint Kinase 1 (Chk1) inhibitor, under which PharmaEngine will fund the IND enabling studies for SOL-578. TAIPEI , Dec. ” said Yufang Hu , Ph.D.,

article thumbnail

Quercis Pharma Licenses Key Patents for Thromboembolism Platform Across Cancer and COVID-19 Indications

The Pharma Data

The patents cover the inhibition of soluble P-selectin that helps to prevent and/or reduce thrombotic events. Quercis’ lead drug candidate acts as an antithrombotic with significantly lower risk of adverse events than existing therapies. ZUG, Switzerland , Jan. Terms of the agreement have not been disclosed.