Clinical Intelligence

Epizyme’s Tazemetostat granted FDA Orphan designation for malignant rhabdoid tumors

Tuesday, February 9, 2016

The FDA has granted Orphan Drug status to Epizyme’s first-in-class EZH2 inhibitor, tazemetostat, for the treatment of malignant rhabdoid tumors (MRTs). In December 2015, the company initiated a phase II study in adults and a phase I study in children with genetically defined tumors, including MRTs. Tazemetostat is also being investigated in an ongoing five-arm phase II study in patients with non-Hodgkin lymphoma.

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Spectrum Pharmaceuticals begins enrolling in SPI-2012 breast cancer trial

Thursday, February 4, 2016

Spectrum Pharmaceuticals, a biotechnology company with fully integrated commercial and drug development operations and a primary focus in hematology and oncology, has initiated the planned registrational trial for SPI-2012 (eflapegrastim), its novel, long-acting G-CSF. This trial will evaluate the safety and efficacy of SPI-2012 as a treatment for chemotherapy-induced neutropenia in patients with breast cancer, and will serve as the basis for the Biologics License Application (BLA) filing.

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Alkermes has positive phase III results for ALKS 5461 in major depressive disorder

Monday, January 25, 2016

Alkermes has announced preliminary topline results from FORWARD-3 and FORWARD-4, the first two of three phase III efficacy studies to read out from the comprehensive FORWARD pivotal program for ALKS 5461, a once-daily, oral investigational medicine with a novel mechanism of action for the adjunctive treatment of major depressive disorder (MDD) in patients who have an inadequate response to standard therapies for clinical depression. Neither of the two studies met the prespecified primary efficacy endpoint, which compared ALKS 5461 to placebo on the change from baseline on the Montgomery–Åsberg Depression Rating Scale (MADRS).

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vTv Therapeutics initiates phase II TTP273 diabetes trial

Monday, January 25, 2016

vTv Therapeutics, a clinical-stage biopharmaceutical company engaged in the discovery and development of new orally administered treatments for Alzheimer’s disease and diabetes, has announced the enrollment of the first patients in the company’s phase II LOGRA (aLlosteric Oral Glp1 Receptor Agonist) study, a randomized, double-blind, placebo-controlled, parallel group trial of TTP273. TTP273 is an oral, small molecule GLP-1R agonist with best-in-class potential.

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FDA Approves BOTOX for lower limb spasticity in adults

Monday, January 25, 2016

Allergan has announced that the FDA has approved BOTOX (onabotulinumtoxinA) for the treatment of lower limb spasticity in adult patients to decrease the severity of increased muscle stiffness in ankle and toe muscles. BOTOX is the first and only botulinum toxin product to be approved by the FDA to treat multiple muscle groups of the upper (elbow, wrist, fingers and thumb) and lower limbs that may be impacted by spasticity.

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Eisai’s Lenvatinib receives FDA Priority Review

Friday, January 22, 2016

Eisai has announced that the FDA has accepted for Priority Review the supplemental New Drug Application (sNDA) for lenvatinib for the potential treatment of patients with unresectable advanced or metastatic renal cell carcinoma (RCC) in combination with everolimus following one prior vascular endothelial growth factor (VEGF)-targeted therapy. The FDA had previously granted lenvatinib Breakthrough Therapy designation for this investigational indication. Breakthrough Therapy designation is reserved for drugs with preliminary clinical evidence that indicates the drug, alone or in combination, may demonstrate a substantial improvement over existing therapies for the treatment of a serious condition.

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