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Human Genes Biosimilars

Rothwell, Figg, Ernst & Manbeck, P.C.

Biogen and ViGeneron to Collaborate on Ophthalmic Gene Therapy Development

Earlier this week, Biogen and ViGeneron signed a global collaboration and licensing agreement to develop gene therapies for inherited eye diseases. The companies will use Munich-based ViGeneron’s proprietary adeno-associated...more

Proskauer - Minding Your Business

Orphan Drug Exclusivity for CRISPR/Cas-Based Therapeutics

The prospect of genetic engineering using CRISPR (clustered regularly interspaced short palindromic repeats) and CRISPR-associated nucleases (Cas) has long been hailed as a “revolutionary” development in medicine....more

Mintz - Health Care Viewpoints

FDA Releases Series of Gene Therapy Guidance Documents: From Drug Development to Postmarket Monitoring

In a highly anticipated step, which had been teased by agency leadership in their public appearances over the past several months, FDA released a series of draft guidance documents pertaining to the development and approval...more

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