AC-201 has shown the ability to inhibit the production and activity of caspase-1 and the cytokine Interleukin-1Beta (IL-1Beta) and to down-regulate IL-1Beta receptors. Inhibition of IL-1Beta signaling has
The company will assess the safety, tolerability, and pharmacokinetics of TNX-201 in a healthy volunteers trial scheduled to be completed before the end of 2014. IMH has a
The double-blind, randomized, placebo-controlled LUME-COLON 1 trial will evaluate the efficacy and safety of nintedanib plus best supportive care (BSC), versus placebo plus BSC, after previous treatment with
Apart from the EMA orphan designation status, the company has also received fast track designation by the US Food and Drug Administration (FDA) for Epidiolex to treat Dravet
Melanoma can be caused by abnormal changes or mutations in a cell protein called BRAF V600. The drug is recommended for people whose melanoma has spread or cannot
The prospective, randomized, double-blind, placebo controlled trial was carried out in the US under a US Food and Drug Administration (FDA) Investigational New Drug (IND) protocol. The trial
Around 80 patients will be enrolled in the trial across three sites including The University of Texas MD Anderson Cancer Center, the Sarah Cannon Research Institute and the
The approval allows the use of the Cook Pharmica manufacturing facility in Bloomington, Indiana for the production of bulk rHuPH20, the active ingredient used in Hylenex, and the
Xiaflex is approved in the US, EU, Canada and Australia to treat adult DC patients with a palpable cord. Dupuytren’s contracture is a progressive hand disease that can
LAL Deficiency is a serious, under-diagnosed disease with significant morbidity and early mortality. A rolling submission enables completed portions of the application to be submitted and reviewed on
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