Bayer Starts Phase II Clinical Trial of Riociguat

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

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Bayer and Onyx’s Nexavar Receives European Regulatory Approval for Thyroid Cancer

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)

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NICE Draft Guidance Rejects Bayer’s Xofigo

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

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Bayer’s Skyla Receives FDA Approval

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

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Bayer’s Jaydess Approved in Europe

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).

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Bayer and Onyx’s Cancer Drug Approved by FDA

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

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Pharmaceutical Industry Is Unappreciated By Society

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

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Bayer To Submit Regorafenib After Positive Survival Statistics

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

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