FDA approves Merck’s new antibacterial drug applications

The FDA has accepted two new antibacterial drug applications from Merck & Co, both of which have received Priority Review. The first is for the company’s combination of relebactam, an investigational beta-lactamase inhibitor, with imipenem/cilastatin (MK-7655A, IMI/REL), for the treatment of complicated urinary tract infections (cUTI) and complicated intra-abdominal infections (cIAI) caused by certain susceptible

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US regulatory body grants Merck & co’s Keytruda priority review

FDA has accepted Merck & Co’s anti-PD-1 therapy, Keytruda,  in combination with Eli Lilly’s pemetrexed and platinum chemotherapy as a first-line treatment for patients with metastatic nonsquamous non-small cell lung cancer (NSCLC). The regulators has also granted Priority Review to this application. This supplemental application is based on overall survival and progression-free survival (PFS) data

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MSD’s Bladder cancer treatment, Keytruda approved in EU following superior survival rates

Merck Sharp & Dohme’s Keytruda has received approval in Europe for metastatic urothelial carcinoma allowing it to catch up with its immunotherapy rivals. Although, while BMS’ Opdivo and Roche’s Tecentriq beat MSD to approval in Europe earlier this year, Keytruda is the first treatment to show superior overall survival when compared to using chemotherapy in

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Merck and Pfizer receive FDA Breakthrough Therapy designation for Avelumab

Merck and Pfizer today announced that the FDA) has granted avelumab, an investigational fully human anti-PD-L1 IgG1 monoclonal antibody, Breakthrough Therapy designation for the treatment of patients with metastatic Merkel cell carcinoma (MCC) that have progressed after at least one previous chemotherapy regimen. Breakthrough Therapy designation is designed to accelerate the development and review of

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Merck & Co Submit Pembrolizumab to EU Regulators

Merck & Co yesterday announced that they have submitted pembrolizumab, to the European regulatory body, the European Medicines Agency. The company confirmed that the European Medicines Agency (EMA) has accepted the marketing authorisation application for review of Merck & Co’s investigational anti-PD-1 antibody for the treatment of advanced melanoma. The drug has demonstrated positive results

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