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Astellas Drug Acquired in $5.9B Deal Wins FDA Approval in Vision-Loss Disorder

MedCity News

Izervay, a drug developed by Astellas Pharma subsidiary Iveric Bio, is now the second approved therapy for the degenerative vision-loss disorder geographic atrophy. The regulatory decision comes as safety concerns emerge around the first therapy for the disease, an Apellis Pharmaceuticals product.

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Getting ahead of regulatory changes around PFAS in pharmaceutical packaging

Clarivate

With the introduction of a new CMC Intelligence entitlement to address post-approval changes, Clarivate now covers a broader range of the lifecycle of pharmaceutical products. Future research could focus on developing PFAS-free packaging materials that meet regulatory standards without compromising safety.

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Practical advice for Early Scientific Advice (ESA) in HTA submissions

pharmaphorum

In recent years, the biopharma market has become progressively complex. As a result, payers are feeling increased pressure to make the right decisions based on the perceived value of each product. HTA agencies can assist biopharma companies at the early stages of development to ensure they are meeting the expectations of payers.