Urigen Pharmaceuticals, Inc.
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Latest From Urigen Pharmaceuticals, Inc.
Finance Watch: A Year After Investors Denied Infinity Merger, MEI Considers Strategic Alternatives
Restructuring Edition: Financial market conditions are improving, but gains have not stopped some companies from cutting costs or shutting down. MEI may wind down if it does not identify another strategic alternative and Aslan has begun to liquidate, while others have cut jobs.
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.
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