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Lead Product(s): Enzalutamide
Therapeutic Area: Oncology Product Name: Xtandi
Highest Development Status: Phase III Product Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable March 29, 2021
Details:
If approved by the European Commission, enzalutamide will be the only oral therapy for the treatment of metastatic hormone-sensitive prostate cancer in addition to non-metastatic and metastatic castration-resistant prostate cancer.
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Lead Product(s): Enfortumab vedotin-ejfv
Therapeutic Area: Oncology Product Name: Padcev
Highest Development Status: Approved Product Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable March 11, 2021
Details:
If approved, enfortumab vedotin would be the first antibody-drug conjugate (ADC) available in Japan for people living with this form of urothelial cancer.
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Lead Product(s): Fezolinetant
Therapeutic Area: Obstetrics/Gynecology (Women’s Health) Product Name: ESN364
Highest Development Status: Phase III Product Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable February 19, 2021
Details:
The SKYLIGHT 1 and SKYLIGHT 2 pivotal Phase III trials reached all co-primary endpoints, showing a significant reduction in the incidence and severity of mild to extreme VMS from baseline to week 4 and week 12 for women taking fezolinetant 30 and 45 mg once-daily.
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Lead Product(s): Enfortumab vedotin-ejfv
Therapeutic Area: Oncology Product Name: Padcev
Highest Development Status: Approved Product Type: Large molecule
Partner/Sponsor/Collaborator: Seagen
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable February 18, 2021
Details:
The sBLA for regular approval of PADCEV in the U.S. is supported by data from the global EV-301 phase 3 confirmatory trial, which compared PADCEV to chemotherapy in metastatic urothelial cancer, previously treated with platinum-based chemotherapy and a PD-1/L1 inhibitor.
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Lead Product(s): Mirabegron
Therapeutic Area: Urology Product Name: Myrbetriq
Highest Development Status: Phase III Product Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable January 06, 2021
Details:
The NDA and sNDA were based on findings from a Phase 3 pivotal study that evaluated the efficacy, safety, tolerability and pharmacokinetics of mirabegron in children and adolescents with NDO and using clean intermittent catheterization.
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