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Latest From Oncopeptides AB
One In Five English HTAs Terminated Due To Company Non-Submissions And Withdrawals
Since 2019, 91 health technology assessments have been terminated by England’s NICE because companies withdrew their applications or did not submit evidence. In the first of this three-part article series, pharma firms share their reasons for opting out of the process.
Finance Watch: VC Mega-Rounds Ease Into Summer Slowdown
Private Company Edition: Venture capital investment has moved into a slower summer pace, or maybe just shifted to small- and medium-sized biopharma financings. In addition to Third Arc’s $165m series A round, Brenig raised a $65m series A and Confo’s series B totaled €60m ($65m).
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.
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