Tesaro's Zejula, or niraparib, has received FDA approval as a maintenance treatment for adults with recurrent epithelial ovarian, fallopian tube or primary peritoneal cancer whose tumors have shrunk completely or in part because of platinum-based chemotherapy. The approval was based on a clinical study in which Zejula showed higher median progression-free survival of patients with BRCA mutation compared with placebo.
There have been a host of recent breakthroughs that offer hope for the visually impaired. Advancements include a smartwatch from Dot Watch that relays smartphone notifications using Braille and retinal prosthetics from eSight that could restore sight. Meanwhile, University of California at San Diego engineers have collaborated with the startup Nanovision Biosciences to create nanotechnology and wireless electronics for an advanced retinal prosthesis. A person in Los Angeles became the first person to receive an FDA-approved corneal cross-linking procedure to prevent blindness as a result of keratoconus. Read the story.
TB Alliance has agreed to a licensing deal with Medicines Patent Pool to clinically develop sutezolid, an antibiotic drug candidate being developed as a treatment for patients with extensively drug-resistant tuberculosis. John Hopkins University granted MPP sublicensing rights for sutezolid.
Ionis Pharmaceuticals subsidiary Akcea Therapeutics aims to generate as much as $100 million in an initial public offering. The proceeds will be used to complete a late-stage trial of the firm's lead candidate, volanesorsen, which is intended to treat partial lipodystrophy and familial chylomicronemia syndrome, and to fund midstage studies of other drug candidates.
Sonny Perdue, President Donald Trump's nominee for secretary of the US Department of Agriculture, said at last week's confirmation hearing that he will support economic development in rural communities, work to remove trade barriers, expand market opportunities for farmers and promote biobased and other value-added products. Sen. Joe Donnelly, D-Ind., said he will support Perdue's nomination.
Neste said it supported Sweden's draft law proposals for continuing the tax exemption for high-blend biofuels and reducing the emission mandate for traffic fuels. "Sweden is showing worldwide leadership with its ambitious goal to reduce carbon emissions from its transport sector by 70% by 2030," Neste's Kaisa Hietala said.
Eagle's new-drug application for Ryanodex, or dantrolene sodium, has been accepted for priority review by the FDA as a treatment for patients with exertional heatstroke. The application was backed by clinical data showing the increased efficacy and safety of Ryanodex when added to body cooling in patients with EHS compared with body cooling alone.
A supplemental new drug application has been submitted by Synergy Pharmaceuticals to the FDA for expanded use of Trulance, or plecanatide, as a treatment for adult patients who have irritable bowel syndrome with constipation. Trulance was approved in January to treat chronic idiopathic constipation in adults.
Pfizer's oral Janus kinase inhibitor Xeljanz, or tofacitinib citrate, has been approved by the European Commission for use as a combination treatment with methotrexate in adult patients with moderate to severe forms of rheumatoid arthritis who have responded inadequately to, or who are intolerant to, disease-modifying anti-rheumatic drugs. The regulator approved monotherapy use of Xeljanz if methotrexate cannot be used.
A voluntary recall was issued by Lakes Farm Raised Catfish affecting 1,695 pounds of catfish after Food Safety and Inspection Service inspectors found volatile levels of the antifungal agent dye malachite green and a reduction of it, leucomalachite green, in samples. The affected items, which were packed in 15-pound cardboard boxes and produced from March 14-17 of this year, bear the establishment number "EST. 48150" and were distributed to retail and institutional locations in Tennessee and Mississippi.
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