The U.S. FDA’s accelerated approval of Vanrafia (atrasentan) from Novartis AG for primary immunoglobulin A nephropathy (IgAN) is the company’s second approval for the indication in the past year and a half. The nod also came without a required safety program through a black box warning.
Top-line data from the second and third parts of Edgewise Therapeutics Inc.’s four-part phase II Cirrus-HCM study in hypertrophic cardiomyopathy (HCM) has produced more positive data. There was however less enthusiasm for the results than there had been in September for the first batch of data.
Despite missing the primary endpoint in a phase III study of solriamfetol in major depressive disorder, Axsome Therapeutics Inc. still sees a path to another phase III study. It’s a path some analysts and investors are concerned about, though its precision-medicine approach got plenty of nods of approval.
Relacorilant, a cortisol modulator from Corcept Therapeutics Inc., produced new and strong phase III results in treating platinum-resistant ovarian cancer. The company also has relacorilant in studies that could eventually lead to approval in other indications. In the near term, though, the positive data led to the company’s stock (NASDAQ:CORT) closing 109% higher at $114.22 per share on March 31.
Milestone Pharmaceuticals Inc.’s heart rhythm-restoring calcium channel blocker for paroxysmal supraventricular tachycardia (PSVT) has yet another obstacle in its way.
Building upon its already impressive obesity drug portfolio, Novo Nordisk A/S has licensed a triple agonist of the receptors for GLP-1, GIP and glucagon from United Biotechnology Co. Ltd. China-based United is getting $200 million up front and the chance to earn up to $1.8 billion in milestone payments. United Biotechnology retains the rights to subcutaneously administered UBT-251, which is in the early stages of development for treating obesity, type 2 diabetes and other diseases, in China, Hong Kong, Macau and Taiwan while Bagsværd, Denmark-headquartered Novo get exclusive rights to develop, manufacture and commercialize the triple agonist receptor across the rest of the world.
In a deal that could reach nearly $2 billion, Jiangsu Hengrui Pharmaceuticals Co. Ltd. has licensed a small molecule for treating cardiovascular disease to Merck & Co. Inc., dropping the China-based company into a space with lots of competitors in varying stages of development.
The U.S. FDA’s approval of Telix Pharmaceuticals Ltd.’s kit for preparing prostate-specific membrane antigen-PET imaging for prostate cancer widens the opportunities for patients who live far away from large hospitals. The FDA’s nod for the imaging agent, TLX007-CDx, now branded as Gozellix, has a long shelf life and needs less equipment and preparation compared to some other agents.
Building upon its already impressive obesity drug portfolio, Novo Nordisk A/S has licensed a triple agonist of the receptors for GLP-1, GIP and glucagon from United Biotechnology Co. Ltd. China-based United is getting $200 million up front and the chance to earn up to $1.8 billion in milestone payments. United Biotechnology retains the rights to subcutaneously administered UBT-251, which is in the early stages of development for treating obesity, type 2 diabetes and other diseases, in China, Hong Kong, Macau and Taiwan while Bagsværd, Denmark-headquartered Novo get exclusive rights to develop, manufacture and commercialize the triple agonist receptor across the rest of the world.
The U.S. FDA’s approval of Telix Pharmaceuticals Ltd.’s kit for preparing prostate-specific membrane antigen-PET imaging for prostate cancer widens the opportunities for patients who live far away from large hospitals. The FDA’s nod for the imaging agent, TLX007-CDx, now branded as Gozellix, has a long shelf life and needs less equipment and preparation compared to some other agents.