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Daiichi Sankyo and Merck Dose First Patient in P-III (HERTHENA-Breast04) Trial of Patritumab Deruxtecan to Treat HR+/HER2- Breast Cancer

Shots: The first patient is dosed in P-III (HERTHENA-Breast04) trial (n=~1000) of patritumab deruxtecan (HER3-DXd; 5.6mg/kg) vs CT/Enhertu for unresectable LA/M, HR+, HER2- breast cancer after progression on endocrine & CDK4/6 inhibitor therapy in either adjuvant or 1L metastatic settings HERTHENA-Breast04 was initiated based on findings from P-II (ICARUS-Breast01) & a P-I/II breast cancer study published…
August 28, 2025

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TOP 20

Top 20 R&D Spending Biopharma Companies of 2025  

Shots:  Research and Development (R&D) serves as the driving force behind groundbreaking therapeutic innovations, laying the foundation for advancements that transform patient health and overall well-being  The global Top 20 pharmaceutical leaders spent ~$180B in 2024, with Merck & Co. contributing the most with a whopping $17.93B, followed by Johnson & Johnson ($17.23B) and Roche…
August 21, 2025

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NEWS

Merck Receives Health Canada’s Approval for Perioperative Keytruda for Locally Advanced Head and Neck Squamous Cell Carcinoma (LA-HNSCC)

Shots: Health Canada has approved neoadj. Keytruda followed by adj. Keytruda + SoC radiotherapy (RT) ± cisplatin & then as a single agent to treat operable LA-HNSCC tumors expressing PD-L1 (CPS ≥1) Approval was based on P-III (KEYNOTE-689) trial assessing neoadj. Keytruda (200mg, IV, Q3W × 2 cycles), followed by adj. Keytruda (15 cycles) + SoC RT ±…
August 14, 2025

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NEWS

Merck and Pfizer Report Topline P-III (KEYNOTE-905) Trial Finding on Keytruda + Padcev to Treat Muscle-Invasive Bladder Cancer (MIBC)

Shots: The P-III (KEYNOTE-905/EV-303) trial randomized cisplatin-ineligible MIBC pts to Arm A (3 cycles of Keytruda + surgery with 14 subsequent cycles), Arm B (surgery alone), or Arm C (3 cycles of Keytruda + Padcev before surgery, followed 6 cycles of the combination, then 8 cycles of Keytruda alone) Arms C & B showed improved…
August 12, 2025

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Merck’s Keytruda Regimen Receives Health Canada’s Approval for FIGO 2014 Stage III-IVA Cervical Cancer

Shots: Health Canada has approved Keytruda + chemoradiotherapy (CRT) for the treatment of adults with FIGO 2014 Stage III-IVA cervical cancer Approval was based on P-III (KEYNOTE-A18/ ENGOT-cx11/GOG-3047) trial assessing Keytruda (200mg, IV, Q3W × 5 cycles) + CRT followed by Keytruda (400mg, IV, Q6W × 15 cycles) vs PBO + CRT in 1060 pts with…
July 22, 2025

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Merck NDA for Investigational HIV-1 Two-Drug Regimen DOR/ISL Accepted by US FDA

Shots: The US FDA accepted Merck’s NDA for once-daily oral doravirine/islatravir (DOR/ISL) for virologically suppressed HIV-1 adults; PDUFA target action date: Apr 28, 2026 DOR/ISL showed non-inferiority to bART in open-label P-III MK-8591A-051 and to BIC/FTC/TAF (50mg/200mg/25mg) in P-III MK-8591A-052 at Week 48; the safety profile was generally comparable in the P-III MK-8591A-051 study The…
July 11, 2025

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Merck to Acquire Verona Pharma for ~$10B

Shots: Merck has entered into a definitive agreement to acquire Verona Pharma incl. its asset Ohtuvayre (ensifentrine), expanding its cardio-pulmonary pipeline & portfolio As per the deal, Merck will acquire Verona Pharma for $107 per American Depository Share (ADS), each representing 8 ordinary Verona shares, for an aggregate of ~$10B; closing expected in Q4'25 Ohtuvayre…
July 10, 2025

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NEWS

Merck and Daiichi Sankyo Report First Patient Dosing with Ifinatamab DXd in P-III (IDeate-Prostate01) Trial for mCRPC

Shots: Merck & Daiichi Sankyo have dosed first pts with ifinatamab deruxtecan (I-DXd) in its P-III (IDeate-Prostate01) trial for metastatic castration-resistant prostate cancer (mCRPC), which was initiated based on positive P-I/II (IDeate-PanTumor01) trial data The P-III (IDeate-Prostate01) trial will evaluate I-DXd (12mg/kg) vs docetaxel (75mg/m²) plus corticosteroid in ~1440 mCRPC pts, who progressed during or after…
June 19, 2025

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