Janssen Submits XARELTO to US FDA

Janssen Research & Development announced earlier this week that they have submitted supplemental New Drug Applications (sNDAs) to the US FDA (Food and Drug Administration). Janssen are pursuing approval from the FDA for the use of XARELTO (rivaroxaban), an oral anticoagulant, to treat patients with deep vein thrombosis (DVT) or pulmonary embolism (PE) and prevention

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Amgen Requests Biosimilars Clinical Trial Clarification

Amgen, the world’s largest biotechnology company, have replied to the US FDA’s recent draft advice on biosimilars, noting that certain “changes and additional clarity are needed.” In February, the US Food and Drug Administration (FDA) presented three initial draft guidance documents on the regulation of biosimilars.  In response to these documents, Amgen commented “we appreciate

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Arena and Eisai Resubmit Lorcaserin to FDA

Arena Pharmaceuticals and partner Eisai are optimistic that regulators will approve their obesity drug, lorcaserin, after responding to a rejection issued by the US Food and Drug Administration in October 2010. Arena has submitted their response to the comprehensive reply letter from the Food and Drug Administration which cited a number of reasons for their

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FDA Approves Teva’s Generic Version of Lipitor

Generics major Teva Pharmaceutical Industries is set to enter the lucrative market created in the USA by the patent expiry on Pfizer’s Lipitor but not until Ranbaxy Laboratories’ 180-day exclusivity period runs out. The Israeli drugmaker noted that the US FDA (Food and Drug Administration) have granted tentative approval for their generic version of Lipitor,

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Intermezzo Finally Gains FDA Approval

Transcept Pharmaceuticals has finally secured the approval of regulators in the USA for their insomnia medication, Intermezzo. The US Food and Drug Administration (FDA) have approved Intermezzo (zolpidem) to treat insomnia characterised by middle-of-the-night waking followed by difficulty returning to sleep, which is a form of insomnia that is estimated to affect millions of adults

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FDA Approves Regeneron & EUSA Drugs

Regeneron Pharmaceuticals and EUSA Pharma have announced that US regulators have approved their blindness drug and leukaemia therapy, respectively. The US FDA (Food and Drug Administration) has given the okay to Regeneron’s Eylea, also known as VEGF Trap-Eye, for the treatment of patients with wet age-related Macular Degeneration at a recommended dose of 2 milligrams

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