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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UK allows NHS use of Gilead’s remdesivir for Coronavirus patients

The UK medicines regulator has cleared early access to Gilead Sciences’ coronavirus drug remdesivir for people hospitalised with severe coronavirus infection, although supplies will initially be limited. MHRA has approved the drug under the Early Access to Medicines Scheme (EAMS), used to speed up access to unlicensed drugs for life-threatening or seriously debilitating conditions. The

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Novartis gain EU approval for SMA gene therapy

AveXis, Novartis’ gene therapy division, announced that it has been given European approval for Zolgensma, (onasemnogene abeparvovec), the only gene therapy for spinal muscular atrophy (SMA). Specifically, the European Commission has granted conditional approval for Zolgensma for the treatment of patients with 5q SMA with a bi-allelic mutation in the SMN1 gene and a clinical

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NICE recommends new thrombocytopenia in chronic liver disease treatment

NICE has announced its final draft guidance recommending avatrombopag for routine use on the NHS in England and Wales for the treatment of thrombocytopenia in chronic liver disease patients who require surgery. Avatrombopag has been shown to elevate platelet levels for longer periods than platelet transfusions. The recommendation provides patients with a new treatment option

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EMA and FDA both accept application filing of Novartis’ RMS treatment

FDA and EMA have accepted its Supplemental Biologics License Application (sBLA) and Marketing Authorisation Application (MAA), for ofatumumab, formerly known as OMB157. The fully human anti-CD20 monoclonal antibody, indicated for the treatment of relapsing forms of multiple sclerosis (RMS) in adults, is a novel B-cell therapy that delivers sustained efficacy with a favourable safety profile.

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