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UroGen Pharma Says FDA Approves Plan For Rolling NDA Submission For UGN-102 From January 2024

RTTNews | hace 696

UroGen Pharma Says FDA Approves Plan For Rolling NDA Submission For UGN-102 From January 2024

(RTTNews) - Biotech company UroGen Pharma Ltd. (URGN) announced Tuesday that it has reached agreement with the U.S. Food and Drug Administration (FDA) on plans for submission of a New Drug Application (NDA) for UGN-102 (mitomycin) for intravesical solution.

The FDA indicated that the current clinical development plan for UGN-102, which includes evaluation of duration of complete response (CR) at 12 months from the pivotal ENVISION trial, will support submission of an NDA for the treatment of low-grade intermediate-risk non-muscle invasive bladder cancer (LG-IR-NMIBC).

The FDA also agreed that the UGN-102 NDA can utilize a rolling review, allowing for early submission of the Chemistry, Manufacturing and Controls (CMC) sections of the NDA, which is planned for January 2024.

If approved, UGN-102 has the potential to introduce a new non-surgical treatment paradigm for LG-IR-NMIBC, a subset of bladder cancer patients characterized by high recurrence rates and the need for multiple surgeries.

The UGN-102 clinical development plan centers around the Phase 3 ENVISION pivotal trial and is supported by robust clinical data from the ATLAS Phase 3 and OPTIMA Phase 2b trials.

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UroGen Pharma Files Patent Infringement Lawsuit Against Teva Pharma

UroGen Pharma Files Patent Infringement Lawsuit Against Teva Pharma

Biotech company UroGen Pharma Ltd. (URGN) announced Wednesday that it has filed a lawsuit in the U.S. District Court for the District of Delaware against Teva Pharmaceuticals, Inc., Teva Pharmaceuticals USA, Inc., and Teva Pharmaceutical Industries, Ltd. (TEVA), alleging infringement of U.S. Patent Numbers 9,040,074 and 9,950,069.

RTTNews | hace 513

German Unemployment Exceeds 3 Mln

German Unemployment Exceeds 3 Mln

Germany's unemployment exceeded the three million-mark for the first time in a decade in August as the prolonged period of subdued economic activity weighed on the labor market. The number of unemployed persons increased by 46,000 from the previous year to 3.025 million in August. However, unemployment fell by adjusted 9,000 compared to the previous month, while it was forecast to increase by 1

RTTNews | hace 30 minutos

U.S. PCE Price Index Increased In Line With Estimates In July

U.S. PCE Price Index Increased In Line With Estimates In July

Consumer prices in the U.S. increased in line with economist estimates in the month of July, according to closely watched data released by the Commerce Department on Friday.

RTTNews | hace 42 minutos

Slightly Weak Start Seen For U.S. Stocks; PCE Data In Focus

Slightly Weak Start Seen For U.S. Stocks; PCE Data In Focus

Lower U.S. futures point to a slightly negative start on Wall Street Friday morning.

RTTNews | hace 58 minutos

Lower Futures Pointing To Weak Start On Bay Street; Canadian GDP, US PCE Data In Focus

Lower Futures Pointing To Weak Start On Bay Street; Canadian GDP, US PCE Data In Focus

Lower Canadian and U.S. futures ahead of Canadian GDP data and U.S. personal consumption expenditure report, point to a weak start on Bay Street Friday morning.

RTTNews | hace 1h 36min

Pound Slides Against Majors

Pound Slides Against Majors

The British pound weakened against other major currencies in the European session on Friday, weighed down to a large extent by the weakness in the financial sector, amid reports of likely imposition of windfall tax on banks.

RTTNews | hace 1h 44min

FTSE 100 Weak Again, Looks Headed For Weekly Loss

FTSE 100 Weak Again, Looks Headed For Weekly Loss

U.K. stocks are trading lower on Friday, losing ground for a fourth straight session, weighed down to a large extent by the weakness in the financial sector, amid reports of likely imposition of windfall tax on banks.

RTTNews | hace 2h 16min

Pound Falls Against Majors

Pound Falls Against Majors

The British pound weakened against other major currencies in the European session on Friday.

RTTNews | hace 2h 23min

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