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NEWS

Mabwell Reports First Patient Dosing in P-I Trial of Bulumtatug Fuvedotin for Triple-Negative Breast Cancer (TNBC) in the US

Shots: Mabwell has dosed its first patient with Bulumtatug Fuvedotin (BFv or 9MW2821) in P-I trial for the treatment of TNBC pts Trial will assess safety & efficacy of BFv in TNBC pts previously treated with a taxane & an ADC with a topoisomerase inhibitor payload, measuring ORR as the 1EP Bulumtatug Fuvedotin, a Nectin-4–targeting…
August 13, 2025

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NEWS

Junshi Biosciences Reports the NMPA’s sNDA Acceptance of Toripalimab + Disitamab Vedotin for Urothelial Carcinoma

Shots:                                                                                                                                                                  China’s NMPA has accepted sNDA of toripalimab + disitamab vedotin for the treatment of HER2+ locally advanced or metastatic urothelial carcinoma (LA/M UC) sNDA was backed by P-III (RC48-C016) trial assessing toripalimab + disitamab vedotin vs gemcitabine + cisplatin/carboplatin across 74 centres in systemic-treatment-naïve Chinese pts with HER2+ LA/M UC Toripalimab is an anti-PD-1…
August 12, 2025

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Viewpoints_Ahsan Arozullah
VIEWPOINTS

Astellas at ASCO 2024: Ahsan Arozullah in an Illuminating Dialogue Exchange with PharmaShots

Shots:  At ASCO 2024, Astellas Pharma presented 16 abstracts across several types of cancers with unmet medical needs  Today at PharmaShots, we have Ahsan Arozullah Sr. VP, Head of Oncology Development, shedding light on the advancement Astellas’ oncology portfolio for urothelial carcinoma, gastric cancer, and prostate cancer  Ahsan talks about the presented results from studies…
September 16, 2024

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Bristol Myers Squibb
NEWS

BMS’ Opdivo Plus Cisplatin and Gemcitabine Gain EC’s Approval for Treating Urothelial Carcinoma 

    Shots:  The EC has approved Opdivo + cisplatin & gemcitabine as 1L treatment of unresectable or metastatic urothelial carcinoma (UC) adults, valid across the whole EU along with Iceland, Liechtenstein & Norway, based on the P-III (CheckMate -901) study  The P-III (CheckMate -901) study assessed Opdivo + Yervoy or Opdivo + cisplatin & gemcitabine…
May 29, 2024

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BMS
NEWS

BMS Receives the CHMP’s Positive Opinion for Opdivo (Nivolumab) as a 1L Treatment of Urothelial Carcinoma 

Shots:  The CHMP has granted positive opinion to Opdivo + CT (cisplatin & gemcitabine) as 1L treatment of metastatic or unresectable urothelial carcinoma adults (n=608). The decision is anticipated in Jun 2024   The opinion was based on a sub-study of the P-III (CheckMate–901), assessing Opdivo (360mg, Q3W, 6 cycles) + CT (cisplatin & gemcitabine) followed…
April 26, 2024

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New Drug Designations - November 2023
INSIGHTS+

New Drug Designations – November 2023

Shots:  PharmaShots' designation report provides a concise overview of several drugs and their designations by the US FDA, EMA and China. This month’s report includes 3 biological drugs, 12 small molecules, 13 cell and gene therapies, 1 peptide, 3 exosome-based therapy and 4 devices  Atsena Therapeutics’ capsid AAV.SPR gene therapy, focused on the treatment of Leber congenital…
December 27, 2023

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