AstraZeneca (AZ) has been granted a priority review by the US Food and Drug Administration (FDA) for a new four-week, fixed-dose regimen of its PD-1 inhibitor Imfinzi. AZ have stated that if the new regimen is approved, Imfinzi could be administered intravenously every four weeks at a fixed dose of 1500mg in approved indications. This includes unresectable,
Janssen receives approval from the FDA for its Spravato CIII nasal spray, in combination with an oral antidepressant, to treat depressive symptoms in adults with major depressive disorder (MDD) with acute suicidal ideation or behaviour. The approval is based on two phase 3 clinical trials in which Spravato, plus comprehensive standard-of-care, demonstrated a significant and rapid
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
FDA has approved the first video game-based treatment for ADHD created by Akili. The video game, called EndeavorRx, has been years in development and is approved for children between the ages of eight and 12 with certain types of ADHD. The game is used in conjunction with other treatments such as clinician-directed therapy, medication and education to treat
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
AstraZeneca’s Brilinta has been cleared by US regulators to cut the risk of a first heart attack or stroke in high-risk patients with coronary artery disease (CAD). The decision was based on data from the Phase III THEMIS trial, which showed a significant 10% reduction in the primary composite endpoint of major adverse cardiovascular (CV)
Boehringer Ingelheim (BI) has gained another approval for its pulmonary fibrosis drug Ofev from the FDA, for targeting a wider spectrum of patients with interstitial lung disease (ILD). The FDA has approved Ofev for treating chronic fibrosing ILDs with a progressive phenotype, and Boehringer’s drug is the first to be registered in the US for
FDA has agreed to fast-track its regulatory review of Novartis’ capmatinib in a hard-to-treat form of lung cancer. Novartis said it has applied for capmatinib, developed in partnership with Incyte, to be marketed as a MET inhibitor for first line and previously treated patients with locally advanced or metastatic MET exon 14 skipping (METex14) mutated
BioIntelliSense has secured clearance from the FDA for its biosticker sensor for remote care. The sensor is an advanced body sensor which enables continuous monitoring of vital signs and insights. It helps clinician’s access data from patients at home and helps with detections of complications early. BioIntelliSense collaborated with UCHeatlth and its CARE Innovation Center
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
