Urigen Pharmaceuticals, Inc.
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Latest From Urigen Pharmaceuticals, Inc.
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.
Finance Watch: Earnings Season Brings Job Cuts, Even At Big Pharma
Restructuring Edition: Even big pharma companies are not immune from workforce reductions. BMS and Sanofi joined that ranks of Evotec, CureVac and BenevolentAI in cutting jobs. Also, Vaxxinity will de-list and Hepion winds down its NASH trial, among other strategic updates.
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