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Merck
NEWS

Merck Reports P-III (MK-8591A-052 & MK-8591A-051) Trial Data of Doravirine + Islatravir (DOR/ISL) for HIV-1 Infection in Adults

Shots:Merck has reported 2 P-III (MK-8591A-052 & MK-8591A-051) trial data assessing DOR/ISL (100mg/0.25mg, QD, PO) in HIV-1 infected adults; MAA submission to begin by mid-2025   MK-8591A-052 assessed it vs BIC/FTC/TAF (50mg/200mg/25mg) in adults (n=513), meeting its 1EP with 1.5% subjects on DOR/ISL having a viral load ≥50 copies/mL vs 0.6% at 48wks. It…
March 13, 2025

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Merck
NEWS

Merck Reports P-III (MK-8591A-052 & MK-8591A-051) Trial Data of Doravirine + Islatravir (DOR/ISL) for HIV-1 Infection in Adults

Shots:Merck has reported 2 P-III (MK-8591A-052 & MK-8591A-051) trial data assessing DOR/ISL (100mg/0.25mg, QD, PO) in HIV-1 infected adults; MAA submission to begin by mid-2025 MK-8591A-052 assessed it vs BIC/FTC/TAF (50mg/200mg/25mg) in adults (n=513), meeting its 1EP with 1.5% subjects on DOR/ISL having a viral load ≥50 copies/mL vs 0.6% at 48wks. It…
March 13, 2025

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Kelun Biotech
NEWS

China’s NMPA Approves Kelun-Biotech’s Sacituzumab Tirumotecan (sac-TMT) for EGFR-mutant NSCLC

Shots:China’s NMPA has approved label expansion of sacituzumab tirumotecan (SKB264/MK-2870) to locally advanced or metastatic (LA/M) EGFRm NSCLC following disease progression on EGFR-TKI therapy or Pt-based Ct Approval was based on OptiTROP-Lung03 trial assessing sac-TMT alone (5mg/kg, IV, Q2W) vs docetaxel in mentioned pts, where it demonstrated improved ORR, PFS & OS sac-TMT is…
March 11, 2025

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Merck
NEWS

Merck Reports the US FDA’s sBLA Acceptance of Neoadjuvant Keytruda with Priority Review for Locally Advanced Head and Neck Squamous Cell Carcinoma (LA-HNSCC)

Shots:The US FDA has accepted sBLA & granted priority review to neoadj. Keytruda followed by adj. Keytruda + SoC radiotherapy ± cisplatin & then as a single agent to treat operable LA-HNSCC (PDUFA: Jun 23, 2025) sBLA was based on P-III (KEYNOTE-689) trial data assessing neoadj. Keytruda (200mg, IV, Q3W × 2 cycles), followed by…
February 26, 2025

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Merck
NEWS

Merck Receives the EC’s Approval for Welireg (Belzutifan) for Von Hippel-Lindau (VHL) Disease-Associated Tumors and Previously Treated Renal Cell Carcinoma

Shots:The EC has approved Welireg for VHL-related localized RCC, CNS hemangioblastomas, or pNET unsuitable for localized procedures and advanced ccRCC post-PD-1/PD-L1 inhibitors or VEGF therapies progression across EU member states, as well as Iceland, Liechtenstein & Norway Approval for VHL-related tumors was based on P-II (LITESPARK-004) study (n=61), showing ORR of 49% (all…
February 19, 2025

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Merck
NEWS

Merck Initiates P-III (waveLINE-010) Trial of Zilovertamab Vedotin to Treat Previously Untreated Diffuse Large B-Cell Lymphoma (DLBCL)

Shots:Merck initiated P-III (waveLINE-010) trial to assess zilovertamab vedotin (ROR1- ADC) + R-CHP (Rituximab, cyclophosphamide, doxorubicin & prednisone) vs R-CHOP (R-CHP + vincristine) to treat pts with previously untreated DLBCL; global enrolment is ongoing Trial will enrol ~1,046 pts to assess PFS as the 1EP, with 2EPs incl. OS, event-free survival, duration of…
February 7, 2025

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MERCK
NEWS

Merck Receives CHMP’s Positive Opinion for Capvaxive (Pneumococcal 21-valent Conjugate Vaccine) for Invasive Pneumococcal Disease (IPD)

Shots:The CHMP has recommended Capvaxive for active immunization against invasive disease & pneumonia caused by Streptococcus pneumoniae in adults (≥18yrs.), with the EC’s decision expected in Q2’25 for EU, Iceland, Liechtenstein and Norway. Ongoing regulatory review in Japan, plus multiple filings are underway Opinion was backed by P-III (STRIDE-3) data, assessing Capvaxive vs PCV20…
February 3, 2025

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