Skip to content Skip to footer
Subscribe Now
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

Read more

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

Read more

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

Read more

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

Read more

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

Read more

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

Read more

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

Read more

Load more

Sign Up to Our Newsletter

Be the first to know the latest updates

[mc4wp_form id="13387" element_id="style-1"]