Clinical Intelligence

Tocagen receives FDA Breakthrough designation for glioma

Friday, February 24, 2017

Tocagen, a clinical-stage, cancer-selective gene therapy company, has announced the FDA granted Toca 511 & Toca FC Breakthrough Therapy designation for the treatment of patients with recurrent high grade glioma (HGG). Toca 511 & Toca FC is currently under evaluation in an international, randomized phase II/III clinical trial, which is designed to serve as a potential registrational study. The trial involves patients with first or second recurrence of glioblastoma or anaplastic astrocytoma who are undergoing resection. Enrollment in the phase II portion of the trial has completed and top-line results are anticipated in the first half of 2018.

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NIH respiratory syncytial virus vaccine enters clinical testing

Friday, February 24, 2017

A phase I clinical trial to test the safety and tolerability of an investigational vaccine against respiratory syncytial virus (RSV) has begun at the NIH Clinical Center in Bethesda, Maryland. The trial will also assess the vaccine’s ability to prompt an immune response in healthy adult participants. The investigational vaccine was developed by scientists at the National Institute of Allergy and Infectious Diseases (NIAID), part of NIH.

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FDA accepts Ocular’s NDA resubmission for DEXTENZA

Wednesday, February 22, 2017

Ocular Therapeutix, a biopharmaceutical company focused on the development and commercialization of innovative therapies for diseases and conditions of the eye, has announced that the company’s New Drug Application (NDA) resubmission for DEXTENZA (dexamethasone insert) 0.4mg for intracanalicular use, for the treatment of ocular pain occurring after ophthalmic surgery has been accepted as a filing for review by the FDA. DEXTENZA is a product candidate administered by a physician as a bioresorbable intracanalicular insert and designed for drug release to the ocular surface for up to 30 days.

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The CenterWatch Weekly, February 21, 2016

Tuesday, February 21, 2017

Regulatory uncertainties abound with presidential two-for-one order

The Trump administration seems to be serious about reducing the cost and burden of regulations. The question observers are asking is how those efforts will eventually shake out.
One the administration’s latest initiatives is an executive order signed by the President that would require federal agencies, such as the FDA, to eliminate two regulations for every new one it wants to issue. The order also mandates that the cost of a new regulation should be offset “to the extent permitted by law.”

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Ardelyx announces successful phase III trial of tenapanor for hyperphosphatemia

Thursday, February 16, 2017

Ardelyx, a clinical-stage company focused on enhancing the treatment of patients with cardiorenal and gastrointestinal (GI) diseases, has reported that the phase III clinical trial evaluating the efficacy and safety of tenapanor as a treatment for hyperphosphatemia in patients with end-stage renal disease (ESRD) who are on dialysis met its primary endpoint and was generally well-tolerated.

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Gilead releases Genvoya HIV-1 data

Thursday, February 16, 2017

Gilead Sciences announced 144-week data from two phase III studies (Studies 104 and 111) evaluating the safety and efficacy of Genvoya (elvitegravir 150mg, cobicistat 150mg, emtricitabine 200mg and tenofovir alafenamide 10mg) for the treatment of HIV-1 infection in treatment-naïve adults. Through week 144, Genvoya demonstrated significantly higher rates of virologic suppression compared to Gilead’s Stribild (elvitegravir 150mg, cobicistat 150mg, emtricitabine 200mg and tenofovir disoproxil fumarate 300mg), based on the%age of patients with HIV-1 RNA levels less than 50 copies/mL. Patients receiving Genvoya also demonstrated favorable renal and bone laboratory parameters compared to those treated with Stribild.

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