Industry News

Ultragenyx to seek accelerated approval for rare disease gene therapy

Ultragenyx moved one step closer to establishing a new surrogate biomarker for accelerated approval in rare disease gene therapies. The biotech said Wednesday it will seek accelerated approval for its Sanfilippo syndrome type A gene therapy after the FDA appeared...

Who’s Paying for Million-Dollar Gene Therapies?

When Orchard Therapeutics announced the $4.25 million price tag in March for its newly approved rare disease gene therapy Lenmeldy, it became the most expensive on the market. But since 2019, the FDA has approved five others that cost more than $2 million. Some...

Aurigene Pharmaceutical Services Opens Biologics Facility

Aurigene Pharmaceutical Services Limited, a Dr. Reddy’s Laboratories Limited company, inaugurated its biologics facility spread across 70,000 square feet in Genome Valley, a bio cluster located in Hyderabad, India. The facility is designed to serve customers with...

CordenPharma, Certest Partner on Ionizable Lipids in LNP Formulation

CordenPharma, a global CDMO in the manufacture of Drug Substances (APIs) for complex modalities (such as peptides, GalNAc, lipids, etc.), Lipid NanoParticles (LNPs) containing xRNA / xDNA, and injectable Drug Products, and Certest, a Spanish company focused on...

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