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.
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.
The New Jersey-based player had filed its BLA for its proposed Lytenava (bevacizumab-vikg) asset in March this year. It envisions...
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Japanese generics giant Sawai appears to be turning a corner, but the impact of National Health Insurance pricing revisions continues to hold the firm – and the rest of the country’s generics industry – back.
Following on from its recently announced US licensing deal with Amneal over its Xolair biosimilar, Kashiv has finished patient recruitment for a trial for the omalizumab candidate, paving the way for submissions.
After US President Joe Biden launched a review of the country’s API supply chain, the task force has reported back with key vulnerabilities that contribute to drug shortages and supply risks during a global public health emergency. According to the report, the lack of geographic diversity and dependence on foreign nations and anti-competitive actions by foreign nations are key areas of concern.
Japanese generics giant Sawai appears to be turning a corner, but the impact of National Health Insurance pricing revisions continues to hold the firm – and the rest of the country’s generics industry – back.
A fresh executive order from US president Joe Biden calls for short-term and long-term study, broad consultation, and co-ordination with allies on the domestic supply chain.
