United States

FDA approves Symbiomix Therapeutics’ Solosec for bacterial vaginosis

Monday, September 18, 2017

Symbiomix Therapeutics announced the FDA has approved Solosec (secnidazole) 2g oral granules for the treatment of bacterial vaginosis (BV) in adult women. Solosec is a potent, next-generation, 5-nitroimidazole antibiotic with enhanced pharmacokinetic properties that enable delivery in a single dose that’s been shown to be efficacious and well tolerated. Solosec is the first and only single-dose oral therapy for BV, the most common gynecologic infection in the U.S.

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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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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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Abbott addresses pacemaker hacking fears

Tuesday, September 5, 2017

On August 23, 2017, the FDA approved a firmware update that is now available and is intended as a recall, specifically a corrective action, to reduce the risk of patient harm due to potential exploitation of cybersecurity vulnerabilities for certain Abbott (formerly St. Jude Medical) pacemakers. “Firmware” is a specific type of software embedded in the hardware of a medical device (e.g. a component in the pacemaker).

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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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