FDA Grants Bristol-Myers Squibb & AbbVie’s Elotuzumab Breakthrough Status

US regulatory body, the Food and Drug Administration (FDA), have granted breakthrough therapy status to Bristol-Myers Squibb and AbbVie’s elotuzumab to treat multiple myeloma (MM). The designation has been granted by the FDA for elotuzumab’s use with lenalidomide and dexamethasone in patients who have previously received one or more therapies to treat multiple myeloma. Elotuzumab

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NICE Draft Guidance Rejects Bayer’s Xofigo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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Germany to Review Price of Eisai’s Fycompa

Epilepsy patients in Germany may gain access to Eisai’s drug, Fycompa, again after Germany’s Federal Joint Committee agreed to take another look at the drug’s pricing. Last year, Eisai announced that they would be withdrawing Fycompa (perampanel) from the German market as opposed to selling the epilepsy drug at the price approved by the Germany’s

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Merck’s Vorapaxar Receives Backing from FDA Advisors

Advisors for the US regulatory body, the FDA, have given strong support for the approval of Merck & Co’s bloodthinner drug, vorapaxar. The US regulatory agency’s Cardiovascular and Renal Drugs Advisory Committee yesterday voted 10-1 in favour of vorapaxar being allowed onto the US market as an adjunctive treatment for cutting atherothrombotic events in patients

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FDA Grants Priority Review for Genzyme’s Cerdelga

US regulatory body, the Food and Drug Administration (FDA), have announced that they will be undertaking an accelerated a review of Sanofi’s Genzyme unit’s Gaucher disease drug, Cerdelga (eliglustat), having granted a six-month priority review for the application. Gaucher disease is a genetic disorder where lipids build up in cells and certain organs, causing problems

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Auxilium Pharmaceuticals’ Xiaflex Approved by FDA

The US Food and Drug Administration (FDA) announced on Friday that they have approved Auxilium Pharmaceuticals’ Xiaflex to treat Peyronie’s disease, which causes painful, curved erections in men. Xiaflex (collagenase clostridium histolyticum) is the first FDA-approved non-surgical treatment option for men with Peyronie’s disease, who have a plaque in the penis that results in curvature

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NICE Requests Further Information on Genzyme’s Lemtrada

The regulatory body for the NHS in England and Wales has requested additional information from Genzyme prior to making a decision on the submission of Lemtrada. The National Institute for Health and Care Excellence (NICE) are currently unlikely to recommend the use of Genzyme’s Lemtrada (alemtuzumab) for relapsing, remitting multiple sclerosis, as a result of

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