The Food and Drug Administration (FDA) have given approval to the new long-term contraceptive, Skyla, Bayer announced yesterday. Regulators in the USA have given the green light to Skyla, a low-dose levonorgestrel-releasing intrauterine system (IUS). The small, flexible plastic T-shaped device, which contains 13.5 mg of the progestin hormone, is positioned in the uterus for
European regulators have approved Bayer’s new long-term contraceptive, Jaydess, which offers women the opportunity to prevent pregnancy for up to three years. The German organisation confirmed that they have successfully completed the European registration procedure for their new low-dose levonorgestrel-releasing intrauterine system (IUS).
Bayer and Onyx Pharmaceuticals have announced that US regulators have approved Stivarga for the treatment of metastatic colorectal cancer. Yesterday, the Food and Drug Administration (FDA) approved Stivarga (regorafenib) for the medication of patients with mCRC who have been previously been treated with currently available therapies. The green light for the oral multi-kinase inhibitor is
In final draft guidance, the NICE (National Institute for Health and Clinical Excellence) announced that they are recommending the use of Bayer’s xarelto (rivaroxaban) to treat deep vein thrombosis (DVT) and avoid recurrent DVT and pulmonary embolism (PE) in adults diagnosed with acute deep vein thrombosis. The new draft endorsement shadows the delivery of additional
Bayer’s chief executive, Marijn Dekkers (pictured), has expressed concern around the pricing squeeze being placed on innovative pharmaceutical groups, whose efforts, he believes, are greatly under-appreciated by society. Speaking at Bayer’s annual press conference in Leverkusen, Dr Dekkers commented that it is “crucial to have an environment that views innovation as something desirable and values
Bayer has provided more information about their recently-halted late-stage trial of their colorectal cancer drug, regorafenib, which shows that the drug improved overall survival by 29%, meeting its primary endpoint. In October, the Phase III CORRECT (Colorectal cancer treated with regorafenib or placebo after failure of standard therapy) trial, which contained 760 patients with metastatic
Bayer and Johnson & Johnson suffered a setback ahead of an advisory committee meeting on the use of their Xarelto blood thinner to prevent stroke in atrial fibrillation, after the US Food and Drug Administration said it would not recommend approval. Documents released by the FDA ahead of the Cardiovascular and Renal Drugs advisory committee
Bayer HealthCare announced yesterday that its affiliate, MEDRAD, Inc. has acquired Pathway Medical Technologies, Inc. With this acquisition, Bayer HealthCare is strengthening its MEDRAD Interventional business by expanding its presence in the field of vascular intervention technologies. Pathway Medical Technologies is a leader in mechanical atherectomy in the field of vascular intervention. The company’s products
