1. Generics Bulletin

Outlook Pulls Bevacizumab BLA As Filing Falls Short

Plans To Submit Revised US Application With FDA In Q3

 
• By Dean Rudge

Pinning its hopes on its proposed bevacizumab product for ophthalmic indications, Outlook Therapeutics has been told to give more information to the US FDA ahead of an approval. However, one analyst remained upbeat for the company’s prospects.

Eye
Is an ophthalmic bevacizumab coming soon? • Source: Shutterstock: Prostock-studio

Outlook Therapeutics’ plans to repurpose bevacizumab for the treatment of wet age-related macular degeneration have been dealt a setback, with the US Food and Drug Administration telling the firm that it requires additional information to complete filing of the company’s biologics license application.

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More from Regulation

Sandoz Slims Down Pembrolizumab Trial As Regulators Streamline Requirements

 
• By Dave Wallace

As Sandoz continues development of its planned pembrolizumab biosimilar rival to Keytruda, the company has revealed plans to slim down its Phase III trial amid the latest moves from regulators towards streamlining clinical study requirements for biosimilar registration.

Rage Against The Machine: Generics CEOs Slam Systemic Problems In The US

 
• By Dave Wallace

During the “CEOs Unplugged” panel at the AAM’s annual conference in February, leaders from Sandoz, Lupin and Amneal discussed the various ways in which the US framework is making life difficult for generics and biosimilars.

US FDA Shows Support For Generic Drug User Fee Goals Amid Cutbacks

 
• By Michael McCaughan

The FDA struck an upbeat tone during its annual Generic Drugs Forum despite an unprecedented period of cutbacks and disruptions and reiterated a desire to continue meeting user fee goals.

OGD’s Policy Office Cut To Have ‘Profound’ Impact On New Generic Approvals, Warns Former FDA Head Gottlieb

 
• By Urtė Fultinavičiūtė

The elimination of the policy division at the Office of Generic Drugs, tariffs, the Section 232 investigation, and a new executive order to promote lower drug prices seem to both cause and purport to solve the same problem: supply chain disruption.

More from Policy & Regulation