KIRKLAND, QC, Nov. 8, 2024 /CNW/ - Merck (NYSE: MRK), known as MSD outside of the United States and Canada, announced that Canada's Drug Agency (CDA) has recommended WINREVAIR® (sotatercept) for reimbursement in combination with standard pulmonary arterial hypertension (PAH) therapy, for the treatment of adults with World Health Organization [WHO] Group 1 PAH and Functional Class (FC) II or III.

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NEW YORK, Oct. 3, 2024 /PRNewswire/ -- Pharmaceutical companies are demonstrating innovation by not only developing new drugs but also exploring combination therapies and repurposing existing drugs to address unmet medical needs. This strategic approach holds promise for providing hope to millions of patients suffering from historically challenging diseases. Alzheimer's disease (AD) for example, has become a focal point of this innovation, with recent U.S. Food and Drug Administration (FDA) approvals of Leqembi and Kisunla — although these treatments only slow cognitive decline rather than improve cognitive function. New uses for approved glucagon-like peptide-1 (GLP-1) and phosphodiesterase 5 (PDE5) inhibitor drugs show promise in treating Alzheimer's, with companies such as Annovis Bio Inc. (NYSE: ANVS) (profile) leading the way with treatments ready for late-stage clinical trials. Beyond Alzheimer's, the pharmaceutical industry is experiencing a surge of innovation across various disease areas. Major players, including Johnson & Johnson (NYSE: JNJ), Novartis (NYSE: NVS), Merck & Co. Inc. (NYSE: MRK) and GSK plc (NYSE: GSK) are at the forefront of medical innovation, tackling previously intractable diseases.

KIRKLAND, QC, Sept. 12, 2024 /CNW/ - Merck (NYSE: MRK), known as MSD outside the United States and Canada, announced that Health Canada has granted approval of KEYTRUDA® (pembrolizumab), Merck's anti-PD-1 therapy, as a monotherapy for the treatment of adult and pediatric patients with unresectable or metastatic microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) solid tumours, as determined by a validated test, that have progressed following prior treatment and who have no satisfactory alternative treatment options. This approval is based on the results from Phase II KEYNOTE-158, KEYNOTE-164, and KEYNOTE-051 trials, and includes data from 504 patients across more than 30 cancer types.

Approved indications include the treatment of adult patients with von Hippel-Lindau (VHL) disease for associated non-metastatic renal cell carcinoma (RCC), central nervous system (CNS) hemangioblastomas, or non-metastatic pancreatic neuroendocrine tumours (pNET), not requiring immediate surgery

KIRKLAND, QC, Sept. 5, 2024 /CNW/ - Merck (NYSE: MRK), known as MSD outside of the United States and Canada, announced that it has successfully completed negotiations with the pan-Canadian Pharmaceutical Alliance (pCPA) for WELIREG® (belzutifan) on August 30th. The pCPA negotiates on behalf of the provinces, territories, and federal drug programs, serving as a critical step in bringing WELIREG® closer to public reimbursement.

KIRKLAND, QC, Sept. 4, 2024 /CNW/ - Merck (NYSE: MRK), known as MSD outside of the United States and Canada, announced that WINREVAIR® (sotatercept) is now authorized for use in Canada in combination with standard pulmonary arterial hypertension (PAH) therapy, for the treatment of adults with World Health Organization [WHO] Group 1 PAH and Functional Class (FC) II or III.

Sotatercept is the first activin signaling inhibitor therapy for PAH in Canada. This represents a new class of therapy that works by improving the balance between pro-proliferative and anti-proliferative signaling to modulate vascular proliferation in PAH patients.

Approval is based on the Phase 3 KEYNOTE-A39 Trial 

KIRKLAND, QC, Aug. 22, 2024 /CNW/ - Merck (NYSE: MRK), known as MSD outside the United States and Canada, announced that Health Canada has granted approval of KEYTRUDA® (pembrolizumab), Merck's anti-PD-1 therapy, in combination with enfortumab vedotin, an antibody-drug conjugate, for the treatment of adult patients with unresectable locally advanced or metastatic urothelial cancer (mUC) with no prior systemic therapy for mUC. This approval is based on the results from the Phase 3 KEYNOTE-A39 trial (also known as EV-302), which demonstrated statistically significant improvements in overall survival (OS) and progression-free survival (PFS) versus platinum-based chemotherapy.