Aziridines

 UroGen Pharma Reports Second Quarter 2021 Financial Results and Recent Corporate Developments

Retrieved on: 
Wednesday, August 4, 2021

The U.S. FDA previously granted Orphan Drug, Fast Track, and Breakthrough Therapy Designations to Jelmyto for the treatment of LG-UTUC.

Key Points: 
  • The U.S. FDA previously granted Orphan Drug, Fast Track, and Breakthrough Therapy Designations to Jelmyto for the treatment of LG-UTUC.
  • You should not receive JELMYTO if you have a hole or tear (perforation) of your bladder or upper urinary tract.
  • Tell your healthcare provider right away if you become pregnant or think you may be pregnant during treatment with JELMYTO.
  • JELMYTO and UroGen are registered trademarks of UroGen Pharma, Ltd.
    View source version on businesswire.com: https://www.businesswire.com/news/home/20210804005328/en/

UroGen Pharma Announces License and Supply Agreement with Neopharm to Pursue Regulatory Approval and Commercialization for Jelmyto® in Israel

Retrieved on: 
Wednesday, July 28, 2021

We are proud to be the first company outside the US to have started the regulatory approval and commercialization process for Jelmyto, demonstrating Israel's importance in geographic expansion.

Key Points: 
  • We are proud to be the first company outside the US to have started the regulatory approval and commercialization process for Jelmyto, demonstrating Israel's importance in geographic expansion.
  • I am confident that our well-established expertise and heritage of collaboration with innovative biopharmaceutical companies will make Jelmyto a success in Israel.
  • UroGen is committed to bringing the promise of Jelmyto to as many patients as possible, as quickly as feasible.
  • JELMYTO and UroGen are registered trademarks of UroGen Pharma, Ltd.
    View source version on businesswire.com: https://www.businesswire.com/news/home/20210728005968/en/

UroGen Pharma Reports First Quarter 2021 Financial Results and Recent Corporate Developments

Retrieved on: 
Thursday, May 13, 2021

The U.S. FDA previously granted Orphan Drug, Fast Track, and Breakthrough Therapy Designations to Jelmyto for the treatment of LG-UTUC.

Key Points: 
  • The U.S. FDA previously granted Orphan Drug, Fast Track, and Breakthrough Therapy Designations to Jelmyto for the treatment of LG-UTUC.
  • It is important that you receive all 6 doses of JELMYTO according to your healthcare provider\xe2\x80\x99s instructions.
  • If you miss any appointments, call your healthcare provider as soon as possible to reschedule your appointment.
  • UroGen has developed RTGelTM reverse-thermal hydrogel, a proprietary sustained release, hydrogel-based platform technology that has the potential to improve therapeutic profiles of existing drugs.

UroGen Pharma Reports Fourth Quarter and Full Year 2020 Financial Results and Recent Corporate Developments

Retrieved on: 
Thursday, March 18, 2021

The U.S. FDA previously granted Orphan Drug, Fast Track, and Breakthrough Therapy Designations to Jelmyto for the treatment of LG-UTUC.

Key Points: 
  • The U.S. FDA previously granted Orphan Drug, Fast Track, and Breakthrough Therapy Designations to Jelmyto for the treatment of LG-UTUC.
  • On April 15, 2020, the FDA approved Jelmyto, making it the first drug approved for the treatment of LG-UTUC in adult patients.
  • You should not receive JELMYTO if you have a hole or tear (perforation) of your bladder or upper urinary tract.
  • Tell your healthcare provider right away if you become pregnant or think you may be pregnant during treatment with JELMYTO.

Complete and Durable Responses Observed in OPTIMA II Phase 2b Final Results for UGN-102 in Patients with Low-Grade Intermediate Risk Non-Muscle Invasive Bladder Cancer

Retrieved on: 
Tuesday, November 17, 2020

As previously reported, 65% (41/63) of patients receiving UGN-102 achieved a complete response (CR) three months after the start of therapy.

Key Points: 
  • As previously reported, 65% (41/63) of patients receiving UGN-102 achieved a complete response (CR) three months after the start of therapy.
  • The Company expects to initiate a Phase 3 study evaluating UGN-102 versus current standard of care by the end of the year.
  • The current approach to treating patients diagnosed with low-grade intermediate risk non-muscle invasive bladder cancer is surgery.
  • UGN-102 (mitomycin) for intravesical solution is an investigational drug formulation of mitomycin in Phase 2b development for the treatment of low-grade intermediate risk non-muscle invasive bladder cancer.

UroGen Pharma Reports Third Quarter 2020 Financial Results and Recent Corporate Developments

Retrieved on: 
Monday, November 9, 2020

The U.S. FDA previously granted Orphan Drug, Fast Track, and Breakthrough Therapy Designations to Jelmyto for the treatment of LG-UTUC.

Key Points: 
  • The U.S. FDA previously granted Orphan Drug, Fast Track, and Breakthrough Therapy Designations to Jelmyto for the treatment of LG-UTUC.
  • On April 15, 2020, the FDA approved Jelmyto, making it the first drug approved for the treatment of LG-UTUC in adult patients.
  • Urothelial cancer is the ninth most common cancer globally and the eighth most lethal neoplasm in men in the U.S.
  • Our primary focus is on the health and well-being of patients, caregivers, and UroGen employees at this critical juncture.

UroGen Announces Positive Data from Pivotal OLYMPUS Trial Evaluating Jelmyto™ in Patients with Low-Grade Upper Tract Urothelial Cancer

Retrieved on: 
Friday, May 15, 2020

UroGen Pharma Ltd. (Nasdaq:URGN) today announced the presentation of positive data from the UGN-101 (Jelmyto (mitomycin) for pyelocalyceal solution) Phase 3 OLYMPUS trial in patients with low-grade upper tract urothelial cancer (LG-UTUC).

Key Points: 
  • UroGen Pharma Ltd. (Nasdaq:URGN) today announced the presentation of positive data from the UGN-101 (Jelmyto (mitomycin) for pyelocalyceal solution) Phase 3 OLYMPUS trial in patients with low-grade upper tract urothelial cancer (LG-UTUC).
  • OLYMPUS (Optimized DeLivery of Mitomycin for Primary UTUC Study) is an open-label, single-arm Phase 3 clinical trial of Jelmyto (mitomycin) for pyelocalyceal solution to evaluate the safety, tolerability and tumor ablative effect of Jelmyto in patients with low-grade upper tract urothelial cancer.
  • Jelmyto (mitomycin) for pyelocalyceal solution is a drug formulation of mitomycin for the treatment of low-grade upper tract urothelial cancer (LG-UTUC) in adult patients.
  • You should not receive JELMYTO if you have a hole or tear (perforation) of your bladder or upper urinary tract.

UroGen Announces Positive Interim Data from Phase 2b Study of UGN-102 in Patients with Low-Grade Intermediate Risk Non-Muscle Invasive Bladder Cancer

Retrieved on: 
Friday, April 3, 2020

UroGen Pharma Ltd. (Nasdaq:URGN) announced positive interim data analysis of UGN-102 (mitomycin) for intravesical solution in patients with low-grade intermediate risk non-muscle invasive bladder cancer (LG IR-NMIBC).

Key Points: 
  • UroGen Pharma Ltd. (Nasdaq:URGN) announced positive interim data analysis of UGN-102 (mitomycin) for intravesical solution in patients with low-grade intermediate risk non-muscle invasive bladder cancer (LG IR-NMIBC).
  • The Phase 2b OPTIMA II trial demonstrated a complete response (CR) rate at three months following onset of treatment of 65% (41/63 patients).
  • In this subset of patients, 31/32 patients (97%) and 17/20 patients (85%) remained free of disease at six and nine months follow-up, respectively.
  • UGN-102 (mitomycin) for intravesical solution is an investigational drug formulation of mitomycin in Phase 2b development for the treatment of low-grade non-muscle invasive bladder cancer (LG NMIBC).

Novadoz Pharmaceuticals Increases Presence in the Generic Oncology Market with an FDA Approval of Thiotepa 15mg &100mg Vials for Injection

Retrieved on: 
Friday, March 6, 2020

PISCATAWAY, N.J., March 6, 2020 /PRNewswire/ -- Novadoz Pharmaceuticals, the U.S based sales & marketing affiliate for MSN Labs, based in Hyderabad India, received FDA approval for their generic version of Thiotepa 15mg and 100mg vials for injection.

Key Points: 
  • PISCATAWAY, N.J., March 6, 2020 /PRNewswire/ -- Novadoz Pharmaceuticals, the U.S based sales & marketing affiliate for MSN Labs, based in Hyderabad India, received FDA approval for their generic version of Thiotepa 15mg and 100mg vials for injection.
  • The combined Thiotepa brand and generic sales are trending over $36.5mil during the previous 12 months according to recent published sales data.
  • Thiotepa for injection is indicated for treatment of adenocarcinoma of the breast or ovary.The recommended dose of Thiotepa for injection for treatment of adenocarcinoma of the breast or ovary is 0.3 to 0.4 mg/kg intravenously.
  • Seshu Akula, Novadoz President North America Generics, quotes, "MSN's approval for generic Thiotepa 15mg & 100mg vials for injection, increases the company's basket of specialty injectable products, moving forward our commitment to the generic oncology space.

Accord and ADIENNE Enter into Exclusive Distribution Agreement for TEPADINA®

Retrieved on: 
Monday, November 18, 2019

LONDON and LUGANO, Switzerland, Nov. 18, 2019 /PRNewswire/ --Accord Healthcare Limited ("Accord") and ADIENNE Pharma & Biotech S.A. ("ADIENNE") have entered into an exclusive licencing and distribution agreement for the commercialisation of TEPADINA(thiotepa) 15mg and 100mg lyophilized powder for injections.

Key Points: 
  • LONDON and LUGANO, Switzerland, Nov. 18, 2019 /PRNewswire/ --Accord Healthcare Limited ("Accord") and ADIENNE Pharma & Biotech S.A. ("ADIENNE") have entered into an exclusive licencing and distribution agreement for the commercialisation of TEPADINA(thiotepa) 15mg and 100mg lyophilized powder for injections.
  • ADIENNE is also working on a new delivery presentations for TEPADINA (thiotepa) and other oncology and cytotoxic drugs to improve and enhance the healthcare professional and patient experience.
  • The new delivery presentations for TEPADINA will be commercialized by Accord in Europe and India.
  • Accord will begin selling TEPADINA across select markets in the European region such as Italy, Spain, UK, Ireland, Benelux and Portugal.