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NEWS

Astellas Secures the CHMP Positive Opinion for Perioperative Padcev + Keytruda in MIBC Patients

Shots: The CHMP has recommended Padcev (enfortumab vedotin) + Keytruda for neoadj. & adj. treatment for pts with resectable muscle-invasive bladder cancer (MIBC); if approved, authorization would be valid in all 30 EEA states Opinion was supported by the P-III (EV-304/KEYNOTE-B15) trial assessing neoadj. Padcev + Keytruda, followed by surgery & then adj. Keytruda + Padcev vs neoadj.…
1 day ago

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NEWS

Cipla Partners with Qilu Pharmaceutical to Commercialize QL2107 (Biosimilar, Keytruda) in the US

Shots: Invagen Pharmaceuticals, a wholly owned subsidiary of Cipla, has entered into a strategic partnership with Qilu Pharmaceutical for the exclusive licensing & supply of QL2107, a biosimilar version of Keytruda (pembrolizumab), for the US As per the deal, Qilu will handle product development, regulatory registration & supply, while Cipla USA will commercialize the asset across the…
September 4, 2026

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NEWS

Merck and Moderna Report the INTerpath-001 Trial Data on Intismeran Autogene + Keytruda for Completely Resected Stage IIB-IV Melanoma

Shots: Merck & Moderna have reported the P-III (INTerpath-001) trial data assessing adj. intismeran autogene (1mg, Q3W for 9 doses) + Keytruda (400mg, Q6W up to 9 cycles) vs Keytruda alone in 1,137 pts with high-risk (stage IIB-IV) resected cutaneous melanoma Intismeran plus Keytruda as adj. therapy showed improvements in RFS (1EP) and DMFS (2EP)…
August 19, 2026

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NEWS

Summit Therapeutics Initiates P-II/III (HARMONi-GU1) Trial of Ivonescimab + Enfortumab Vedotin in Bladder Cancer

Shots: Summit has initiated P-II/III (HARMONi-GU1) trial of ivonescimab + enfortumab vedotin (EV) against Keytruda + EV as first-line treatment of locally advanced or metastatic urothelial (bladder) cancer The global, multi-regional trial will enroll ~800 pts through P-III, with site activations beginning later this year. P-II will determine the recommended P-III dose of ivonescimab in…
August 5, 2026

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TOP 20

Top 20 R&D Spending Biopharma Companies of 2026 

Shots:   Merck & Co., Roche, and Johnson & Johnson emerged as the leading pharmaceutical companies by R&D expenditure in 2025, investing $15.78B, $15.49B, and $14.66B, respectively. Continued investments in late-stage clinical programs, pipeline expansion, advanced technologies, and strategic business development reinforced their commitment to driving pharmaceutical innovation  Global biopharmaceutical R&D investment continues to accelerate as…
July 31, 2026

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Kelun Biotech
NEWS

Kelun-Biotech Reports P-III Trial Findings on sac-TMT + Keytruda for 1L PD-L1-Negative Non-Squamous NSCLC

Shots: Kelun-Biotech has reported P-III (OptiTROP-Lung06) trial data assessing sacituzumab tirumotecan (sac-TMT/SKB264/MK-2870) + Keytruda vs CT + Keytruda as the 1L treatment for PD-L1-negative locally advanced or metastatic non-squamous NSCLC (TPS <1%) IDMC has concluded that the trial met its 1EP of improved PFS at interim analysis vs Keytruda + pemetrexed & Pt-based CT, plus…
July 15, 2026

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NEWS

Merck, Astellas and Pfizer Report the US FDA Approval of Perioperative Padcev + Keytruda for Cisplatin-Eligible MIBC Patients

Shots: The US FDA has approved Padcev (enfortumab vedotin) + Keytruda/Keytruda Qlex for neoadj. & adj. treatment for pts with muscle-invasive bladder cancer (MIBC), regardless of cisplatin eligibility Approval was supported by the P-III (EV-304/KEYNOTE-B15) trial assessing neoadj. Padcev + Keytruda, followed by surgery & then adj. Keytruda + Padcev vs neoadj. SoC + surgery in cisplatin-eligible MIBC…
July 13, 2026

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