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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FDA approves SK Biopharma’s seizure drug

FDA has given Arvelle Therapeutics’ Xcopri the go-ahead for partial-onset seizures in adults. The emerging company, which is part of a subsidiary of SK Biopharmaceuticals, announced that it has also licensed exclusive rights to develop and commercialise the drug in Europe, with intent to file a Marketing Authorisation Application (MAA) in the first half of

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