Urigen Pharmaceuticals, Inc.
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Latest From Urigen Pharmaceuticals, Inc.
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.
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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