Clinical Intelligence

Alkermes initiates ALKS 5461 NDA for major depressive disorder

Tuesday, August 22, 2017

Alkermes announced the initiation of its rolling submission of a New Drug Application (NDA) to the FDA, seeking marketing approval of ALKS 5461, a once-daily, oral investigational medicine with a novel mechanism of action, for the adjunctive treatment of major depressive disorder (MDD). The company expects to complete the submission of the NDA for this Fast Track designated medicine by year-end 2017.

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FDA approves Ironwood’s Duzallo for hyperuricemia related to gout

Tuesday, August 22, 2017

Ironwood Pharmaceuticals announced Duzallo was approved by the FDA as a once-daily oral treatment for hyperuricemia associated with gout in patients who have not achieved target serum uric acid (sUA) levels with a medically appropriate daily dose of allopurinol alone. Duzallo is not recommended for the treatment of asymptomatic hyperuricemia. Ironwood expects Duzallo to be commercially available early in the fourth quarter of 2017.

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BioLineRx plans phase III BL-8040 registrational study of stem cell mobilization

Tuesday, August 22, 2017

BioLineRx, a clinical-stage biopharmaceutical company focused on oncology and immunology, announced the filing of regulatory submissions required to commence a randomized, controlled phase III registrational trial of BL-8040 for the mobilization of hematopoietic stem cells for autologous transplantation in patients with multiple myeloma. The trial, named GENESIS, is expected to commence by the end of 2017, following receipt of regulatory approvals.

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Ophthotech announces results from third phase III trial of Fovist in Wet AMD

Tuesday, August 15, 2017

Ophthotech announced that the pre-specified primary endpoint of mean change in visual acuity at 12 months was not achieved in its phase III clinical trial investigating the superiority of Fovista (pegpleranib) anti-PDGF therapy in combination with Eylea (aflibercept) or Avastin (bevacizumab) anti-VEGF therapy compared to Eylea or Avastin monotherapy for the treatment of wet age-related macular degeneration (AMD). The addition of 1.5mg of Fovista to an Eylea or Avastin regimen did not result in benefit as measured by the mean change in visual acuity at the 12-month time point.

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Gilead announces FDA priority review designation for fixed-dose treatment of HIV

Friday, August 11, 2017

Gilead Sciences, Inc. has announced that the U.S. Food and Drug Administration (FDA) has granted priority review for the company’s New Drug Application (NDA) for an investigational, fixed-dose combination of bictegravir (50mg) (BIC), a novel investigational integrase strand transfer inhibitor (INSTI) and emtricitabine/tenofovir alafenamide (200/25mg) (FTC/TAF), a dual-NRTI backbone, for the treatment of HIV-1 infection. Gilead filed the NDA for BIC/FTC/TAF with a Priority Review voucher on June 12, 2017, and the FDA has set a target action date under the Prescription Drug User Fee Act (PDUFA) of February 12, 2018.

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