Novartis
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Some have wondered why the agency has hit back at Novartis so hard when the data in question didn’t have any effect on the eventual outcomes of the product’s effectiveness and safety.
In a brief announcement, AveXis said the Kaspar brothers have not been involved in any operations at AveXis since early May, seemingly ahead of the U.S. Food and Drug Administration’s approval of Zolgensma.
Pharming Group N.V. announced it has entered into a development collaboration and license agreement with Novartis to develop and commercialize CDZ173, a small molecule phosphoinositide 3-kinase delta (PI3Kẟ) inhibitor being developed by Novartis to treat patients with Activated Phosphoinositide 3-kinase Delta Syndrome.
Sandoz’ biosimilar to Enbrel was approved in 2016 by the FDA but has remained off the market due to the patent protection surrounding Amgen’s blockbuster rheumatoid arthritis treatment.
Despite the data concerns, the U.S. Food and Drug Administration said it believes the gene therapy should remain on the market. Novartis said it stands behind the safety and efficacy of the therapy.
Every week brings news of clinical trials, ranging from launches, first-patient dosing, full enrollment, interim data or final data. Here’s a look at some of the clinical trial news from last week.
Novartis announced that its Phase III MONALEESA-3 clinical trial of Kisqali (ribociclib) hit its key secondary endpoint, overall survival, in a pre-planned interim analysis.
We embarked upon the landmark Phase III PARAGON-HF trial to determine whether sacubitril/valsartan could have a meaningful impact on the treatment of HFpEF, as it does in the treatment of heart failure with reduced ejection fraction,” stated John McMurray, professor of Medical Cardiology at University of Glasgow and PARAGON-HF Executive Committee Co-Chair.
Novartis Chief Executive Officer Vas Narasimhan is excited about the company’s progress through the first half of 2019 and expects that momentum to continue with a “catalyst-rich” second half of the year.
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