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Renaissance Pharma licenses Hu14.18 for neuroblastoma

Drug Discovery World

Renaissance Pharma has announced its first development programme focused on Hu14.18, a humanised anti-GD2 monoclonal antibody (mAb), licensed from St Jude Children’s Research Hospital for the treatment of newly diagnosed high-risk neuroblastoma. and three-year event-free (EFS) of 73.7%. A novel Phase II trial incorporating Hu14.18

Licensing 246
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Combination therapy recommended for NHS use for advanced biliary tract cancer 

Drug Discovery World

This means durvalumab was granted intellectual property (IP) and included in the Innovative Licensing and Access Pathway (ILAP), which aims to reduce the time it takes innovative treatments to be made available to NHS patients. Grade 3 or 4 treatment-related adverse events (AEs) were experienced by 60.9% 0.97, p=0.021). months to 12.9

Therapies 130
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The challenges and trends of cell & gene therapies 

Drug Discovery World

DDW Editor Reece Armstrong looks at the cell and gene therapy landscape, examining the challenges facing developers and the trends we can expect to see throughout the year. . There’s no doubt that cell and gene therapies present some of the most exciting opportunities for emerging drugs. million price point per dose.

Therapies 130
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Teva and Daiichi Sankyo found in breach of the UK ABPI Code

Drug Discovery World

This was compounded by a failure to include an adverse event reporting statement, for failing to include prescribing information for Ajovy and Copaxone, and for failing to certify the article.

Licensing 130
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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.

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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.

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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