Bayer HealthCare has confirmed that they have begun a Phase II clinical trial of riociguat for the treatment of diffuse cutaneous systemic sclerosis (dcSSc). Systemic sclerosis is a rare multisystem, autoimmune disease that results in the overproduction and abnormal growth of collagen, which causes fibrosis of the skin and internal organs. dcSSc is one of
The European Commission have given marketing authorisation to use Nexavar, oral multi-kinase inhibitor, to treat the most common form of thyroid cancer, expanding the approved uses for the drug. Nexavar, which has previously received regulatory approval for advanced kidney and liver cancers, has now been approved for the treatment of metastatic differentiated thyroid carcinoma (DTC)
The National Institute for Health and Care Excellence (NICE) today published draft regulatory guidance rejecting Bayer’s Xofigo for patients with prostate cancer. Xofigo has been submitted to the regulatory body to treat patients with hormone relapsed prostate cancer, symptomatic bone metastases and no known visceral metastases. Clinical trials have demonstrated that Xofigo can significantly improve
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).
In final draft guidance, the NICE (National Institute for Health and Clinical Excellence) announced that they are recommending the use of Bayer’s xarelto (rivaroxaban) to treat deep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
