Clinical Intelligence

FDA grants Fast Track to Pluristem’s PLX-PAD for critical limb ischemia

Monday, September 18, 2017

Pluristem Therapeutics, a developer of placenta-based cell therapy products, announced that the FDA has granted Fast Track Designation to the company’s ongoing phase III study of PLX-PAD cells for the treatment of Critical Limb Ischemia (CLI) in patients ineligible for revascularization. The FDA’s Fast Track Designation is a process designed to facilitate the development and expedite the review of drugs to treat serious conditions and unmet medical needs. With Fast Track Designation, there is an increased possibility for a priority review by the FDA of PLX-PAD cells for the treatment of CLI.

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Quest for patient centricity drives Greenphire and mProve payment technology partnership

Monday, September 18, 2017

With an estimated three billion smart phones now in use worldwide, clinical researchers and support companies are working to catch up with how patients want to participate in clinical trials. This powerful mobile trend is very much at the heart of a recent announcement by Greenphire and mProve Health. The two companies are joining forces to allow clinical trial patients real-time mobile access via their cell phones for a range of support functions. This includes the ability to be paid by trial sponsors electronically and make travel arrangements.

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GSK announces phase III results of mepolizumab for eosinophilic COPD

Wednesday, September 13, 2017

GlaxoSmithKline announced the publication of full results from the phase III studies for mepolizumab in chronic obstructive pulmonary disease (COPD). Data from the investigational clinical development program showed that treating eosinophilic COPD patients with the biologic medicine, mepolizumab, in addition to maximal guideline-recommended therapy, reduced exacerbations in these difficult-to-treat patients. Based on the full data, discussions with external experts and the recognized unmet medical need in this patient population, regulatory filings are planned for 2017. Mepolizumab is not approved for use anywhere in the world for COPD.

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Teva’s Trisenox receives Priority Review for promyelocytic leukemia

Wednesday, September 13, 2017

Teva Pharmaceutical Industries announced the FDA has accepted for review the company’s supplemental New Drug Application (sNDA) for the use of Trisenox (arsenic trioxide) injection in combination with all-trans retinoic acid (ATRA) for induction of remission and consolidation in patients with newly diagnosed low or intermediate risk acute promyelocytic leukemia (APL) whose APL is characterized by the presence of the t(15;17) translocation or PML/RAR-alpha gene expression.

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FDA halts two multiple myeloma Keytruda trials

Tuesday, September 5, 2017

Based on data from two recently halted clinical trials, the FDA is issuing this statement to inform the public, healthcare professionals and oncology clinical investigators about the risks associated with the use of Keytruda (pembrolizumab) in combination with dexamethasone and an immunomodulatory agent (lenalidomide or pomalidomide) for the treatment of patients with multiple myeloma. Keytruda (pembrolizumab) is not approved for treatment of multiple myeloma.

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ProQR’s QRX-421 for Usher syndrome receives FDA/EMA Orphan Designation

Tuesday, September 5, 2017

ProQR Therapeutics announced that investigational drug QRX-421 for Usher syndrome has received orphan drug designation (ODD) from the FDA and EMA. This marks the third drug candidate in the company’s ophthalmology pipeline and the fourth drug in the broader pipeline to receive ODD from the FDA and EMA. QR-421 is a first-in-class investigational RNA-based oligonucleotide designed to address the underlying cause of Usher syndrome due to mutations in exon 13 of the USH2A gene. Usher syndrome is the leading cause of combined deafness and blindness. 

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