Reviva Pharmaceuticals Holdings said on Monday its lead experimental drug to treat adults with schizophrenia helped reduce disease symptoms in a late-stage study.
Treatment with the drug candidate, acquired as part of the purchase of U.S. biotech firm Chinook for up to $3.5 billion, resulted in a meaningful improvement in proteinuria in patients suffering from IgA nephropathy when compared to placebo, the Swiss drugmaker said in a statement.
Pfizer , which dominated COVID vaccine sales, now finds itself looking up at GSK , whose rival new respiratory syncytial virus (RSV) vaccine has surged to an early lead since the shots launched this summer.
The company stated that its cancer drug Jemperli when combined with chemotherapy, met the primary goal of overall survival in patients with advanced or recurrent endometrial cancer in a late-stage trial.
Pharmacovigilance translations must be done carefully, as the accuracy of translated documents has a direct impact on information evaluation and patient health and well-being. However, with volumes of non-English source documents increasing, the speed at which these translations are completed is also crucial, as any delays in communication can lead to serious consequences, such as harm to patients, legal liability, and missed regulatory deadlines for adverse event reporting.
The company’s stock plunged on Friday, wiping 20 billion euros ($21 billion) off its market value, after it abandoned its 2025 profit target under a plan to list its consumer healthcare business to focus on its core innovative drugs business.
The agency’s staff reviewers said it was not clear if the limited donor cells used for assessment were adequate to evaluate the potential safety risks of the therapy.
The company’s blockbuster cancer asset Keytruda brought in more than $6.3 billion in the third quarter, a 17% increase from the same period last year, while bolstering its antibody-drug conjugate portfolio.
Santhera Pharmaceuticals and partner Catalyst Pharmaceuticals got the FDA’s greenlight for their Duchenne muscular dystrophy drug Agamree, which is expected to launch in the first quarter of 2024.
The safety panel reviewed data from Novo’s popular diabetes drug Ozempic and weight loss treatment Wegovy, which contain the same active ingredient, semaglutide.
