Clinical Intelligence

Trevena receives FDA Breakthrough Therapy for Oliceridine in pain

Tuesday, February 23, 2016

Trevena, a clinical stage biopharmaceutical company focused on the discovery and development of biased ligands targeting G protein coupled receptors, has announced the FDA granted Breakthrough Therapy designation to the company’s lead product candidate, intravenous oliceridine (TRV130), for the management of moderate-to-severe acute pain. Following two successful phase II studies, oliceridine is now in phase III development. The ATHENA-1 safety and tolerability study is ongoing, with pivotal studies expected to begin in the second quarter of 2016.

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Novaliq begins phase II dry eye trial

Friday, February 19, 2016

Novaliq, a pharmaceutical company with a disruptive drug delivery platform that transforms poorly soluble drugs into effective therapeutics for ophthalmology, has begun enrolling patients in a phase II clinical trial that will evaluate the safety, efficacy and tolerability of CyclASol for the treatment of moderate to severe dry eye disease (DED). CyclASol is a clear, preservative free ophthalmic solution of cyclosporine in SFA (semifluorinated alkanes).

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JHL Biotech to start biosimilar trial

Wednesday, February 17, 2016

JHL Biotech has received authorization from the U.K.s Medicines and Healthcare Products Regulatory Agency (MHRA) to begin clinical trials for JHL1101, a rituximab biosimilar developed and manufactured by its Taiwanese subsidiary to treat rheumatoid arthritis. JHL is the first company from the Greater China region to receive European approval for clinical trials of a monoclonal antibody biosimilar.

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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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