The Department of Justice will review a 2015 government patent related to the use of Gilead Sciences' Truvada for the prevention of HIV infection, an indication approved by the FDA in 2012. Gilead has rebuffed requests for royalty payments and says the patent is invalid.
La Jolla Pharmaceutical's LJPC-0118, being developed to treat patients with severe malaria, was granted breakthrough therapy designation by the FDA. The drug was shown to be superior to quinine in reducing mortality in patients with severe falciparum malaria infection in two clinical studies.
Knopp Biosciences' hypereosinophilic syndrome drug candidate dexpramipexole was given orphan drug status by the FDA. In a proof-of-concept study, two of seven evaluable patients reached minimally effective corticosteroid dose of 0 mg of prednisone, demonstrating dexpramipexole as a possible steroid-sparing drug.
The FDA has granted AliveCor 510(k) clearances for its KardiaMobile electrocardiogram device for use in detecting bradycardia and tachycardia. The device, which previously received clearance for detecting atrial fibrillation, can deliver information on the detected arrhythmias to physicians and patients and share results through the Apple Watch.
European regulators have granted Guerbet CE mark approval for its Drakon and SeQure microcatheters, which are designed for peripheral embolization procedures. SeQure helps reduce nontarget embolization risk by creating a fluid barrier while Drakon works in the same way but does not come with side slits.
Boston Scientific has released its LOTUS Edge mechanically expanded transcatheter aortic valve replacement system on a limited basis after receiving approval from the FDA.
Two draft guidances have been issued by Health Canada for clarification of proposed changes to its abbreviated new drug submission pathway for generic drugs. One draft guidance updates the "pharmaceutical equivalent" definition to allow certain differences in medicinal ingredients between the reference and the generic drug, and the other explains how generic drug sponsors can show safety, efficacy and quality of their product when it has the same active components but differs in medicinal ingredients versus the reference drug.
A triple-combination arm added to Arrowhead Pharmaceuticals' Phase I/II clinical trial assessing its candidate ARO-HBV as a treatment for chronic hepatitis B virus will combine the drug with two other agents to be chosen by Johnson & Johnson's Janssen Pharmaceuticals, its partner and licensee. The addition of the trial arm triggers a $25 million milestone payment from J&J and another $25 million payment upon initiation of the trial's second phase.
Biotech firm Sherlock Biosciences raised $31 million from a Series A round and plans to use the funding to develop diagnostics using CRISPR gene-editing technology. The aim is to create diagnostics that are faster and more economical for use in areas including infectious diseases, oncology and low-resource settings.
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