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Latest From Oncopeptides AB
Project Orbis, 'Cluster' Calls Validate Global Regulators’ Drug Application Concerns
Regulators from the US, Canada, European Union, Switzerland and Japan talk about the benefits of global collaboration, and reasons why they might reach different decisions on the same drug, at the American Society of Clinical Oncology annual meeting.
Accelerated Approval: Withdrawing Gene Therapies Could Be Easier Than Small Molecules
The FDA would only withdraw a rare disease gene therapy for “pretty clear” reasons, such as when there is minimal benefit with extensive side effects. The one-and-done nature of administration also makes withdrawal easier, CBER Director Peter Marks says.
For BMS, Launching New Products Is The Start Of The Battle
Bristol Myers Squibb’s head of major markets, Monica Shaw, wants to improve access to lifesaving therapies. Payers and politicians must be persuaded to loosen their purse strings – and open their minds.
Fighting Accelerated Approval Withdrawal Hinders Other Sponsors' Applications, FDA’s Pazdur Says
Resource-intensive withdrawal process means FDA reviewers are not able to work on other drugs, Oncology Center of Excellence Director Richard Pazdur says, citing the ‘arduous’ withdrawal of Pepaxto. Pazdur also says no one should be surprised that the FDA has begun issuing complete response letters when confirmatory studies are not sufficiently advanced.
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