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…

ByDipanshu DixitAugust 12, 2025

NEWS

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…

ByRidhi RastogiJuly 22, 2025

NEWS

Merck Advances MK-8527 in P-III (EXPrESSIVE) Trials to Prevent HIV in Individuals at Risk

Shots: Merck has initiated P-III (EXPrESSIVE-11) trial to evaluate MK-8527 (QM) vs FTC/TDF for HIV PrEP in ~4,390 individuals at higher risk across 16 countries (enrolment from Aug 2025), & will begin the P-III (EXPrESSIVE-10) trial in ~4,580 women (16-30yrs.) in sub-Saharan Africa, with enrolment starting in the next few mos. Decision to initiate P-III…

ByDipanshu DixitJuly 15, 2025

NEWS

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…

ByDipanshu DixitJuly 11, 2025

NEWS

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…

ByRidhi RastogiJuly 10, 2025

NEWS

Merck Reports the Data from P-III (HYPERION) Study of WINREVAIR (sotatercept-csrk) in Adults with Recently Diagnosed PAH

Shots : The P-III (HYPERION) study evaluating Winrevair vs PBO (both in combination with background therapy) in recently diagnosed adults (N=320, >18) with PAH (WHO Group 1) functional class (FC) II or III at intermediate or high risk of disease progression The study met its 1EP of TTCW measured by the first confirmed morbidity or…

ByPrince GiriJune 24, 2025

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…

ByRidhi RastogiJune 19, 2025

NEWS

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

Shots: The US FDA has approved neoadj. Keytruda followed by adj. Keytruda + SoC radiotherapy (RT) ± cisplatin & then as a single agent to treat operable LA-HNSCC based on P-III (KEYNOTE-689) trial Trial assessed neoadj. Keytruda (200mg, IV, Q3W × 2 cycles), followed by adj. Keytruda (15 cycles) + SoC RT ± cisplatin vs…

ByRidhi RastogiJune 16, 2025

NEWS

The US FDA Approves Merck’s ENFLONSIA for RSV Prevention in Infants

Shots : Merck’s ENFLONSIA has been approved by the US FDA to prevent RSV lower respiratory tract disease in newborns and infants entering their first RSV season, offering protection for up to 5mos. with a single 105mg dose, regardless of weight The approval was supported by the P-IIb/III (CLEVER) study of ENFLONSIA that demonstrated reduced…

ByDipanshu DixitJune 10, 2025

NEWS

Merck Reports P-II (WILLOW) Trial Data of Enpatoran for Cutaneous Lupus Erythematosus (CLE) and Systemic Lupus Erythematosus (SLE)

Shots: The P-II (WILLOW) basket trial assessed enpatoran (25, 50 &100mg, BID, PO) vs PBO + SoC in 2 Arms, where Arm 1 has SLE & CLE pts with active lupus rash & Arm 2 has active SLE pts. Discussions with health authorities on a global P-III program are underway Arm 1 met its 1EP,…

ByRidhi RastogiMay 22, 2025

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

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

Merck Advances MK-8527 in P-III (EXPrESSIVE) Trials to Prevent HIV in Individuals at Risk

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

Merck to Acquire Verona Pharma for ~$10B

Merck Reports the Data from P-III (HYPERION) Study of WINREVAIR (sotatercept-csrk) in Adults with Recently Diagnosed PAH

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

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

The US FDA Approves Merck’s ENFLONSIA for RSV Prevention in Infants

Merck Reports P-II (WILLOW) Trial Data of Enpatoran for Cutaneous Lupus Erythematosus (CLE) and Systemic Lupus Erythematosus (SLE)

Contact US

FOLLOW US