FDA approves Merck/MSD’s antibiotic drug for bacterial pneumonia

Merck/MSD has won an approval from the FDA for its Gram-negative antibiotic Recarbrio, as a treatment for hospital-acquired and ventilator-associated bacterial pneumonia. Recarbrio is a combination treatment comprised of imipenem, a carbapenem antibacterial, cilastatin, a renal dehydropeptidase inhibitor, and relebactam, a beta-lactamase inhibitor. Imipenem works to kill the bacteria associated with the infection while the other

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Merck receives approval for Alzheimer’s label claim for insomnia drug

Merck & Co/MSD has claimed FDA approval for a new use of its insomnia drug Belsomra, treating sleep disruption in people with mild-to-moderate Alzheimer’s disease. Belsomra (suvorexant) has been approved since 2014 for treating insomnia in the general population characterised by difficulties with falling or staying asleep, becoming the first in a new class of drugs targeting

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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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