Eight medicines set to receive EU approval from CHMP

The European Medicines Committee’s human medicines committee (CHMP) has backed approval of eight new medicines across a range of indications. Gilead’s remdesivir has been previously recommended for conditional approval for treatment of COVID-19 in adults and adolescents from 12 years of age with pneumonia who require supplemental oxygen. The drug is the first medicine against

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FDA announce new pilot program to communicate patient reported outcomes for cancer clinical trials

FDA has launched Project Patient Voice, an initiative of the FDA’s Oncology Center of Excellence (OCE). Through a new website, Project Patient Voice creates a consistent source of publicly available information describing patient-reported symptoms from cancer trials for marketed treatments. While this patient-reported data has historically been analysed by the FDA during the drug approval

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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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