Thirty-one of 45 children's breakfast foods and cereals, such as granolas, oats and snack bars, had levels of glyphosate, a weed-killing chemical associated with cancer, exceeding what some consider to be safe levels for children, an Environmental Working Group report found. The report also showed that only two products didn't contain glyphosate.
Vertex Pharmaceuticals' Kalydeco, or ivacaftor, was approved by the FDA for pediatric patients age 12 months to younger than 2 years old with cystic fibrosis who have at least one mutation in the cystic fibrosis transmembrane conductance regulator gene that is responsive to the drug based on clinical and/or in vitro test data. The decision was backed by data from a late-stage trial, in which the drug showed a consistent safety profile to that seen in prior late-stage studies of older children and adults with CF.
Onspira Therapeutics' OSP-101, being developed as a treatment for post-lung transplant patients with bronchiolitis obliterans, received orphan drug designation from the FDA.
Health officials in the US are proposing to do away with special regulations pertaining to gene therapy experiments, and revisions will be implemented upon completion of a public comment period, NIH Director Francis Collins and FDA Commissioner Scott Gottlieb write in The New England Journal of Medicine. However, as more gene therapies are developed using gene-editing technology, "this is not the right time to be making any moves based on the idea that we know what the risks are," says Mildred Cho of the Stanford Center for Biomedical Ethics.
Invuity has announced the launch of its PhotonGuide Adapt system, which comes with retractors and a flexible illuminator for facilitating vaginal surgical procedures, such as vaginal hysterectomies and pelvic organ prolapse repairs. The system's waveguide, intended to conform to various retractor sizes and shapes, enables adjustment of illumination along the retractor's length.
China FDA granted priority review status to Correvio Pharma's Brinavess, or vernakalant hydrochloride, IV, indicated for the rapid conversion of recent onset atrial fibrillation. A late-stage trial assessed the drug in AF patients from Korea, Hong Kong, Taiwan and India, and is anticipated to show no difference in Brinavess' efficacy or safety across ethnicities.
The In.Pact Admiral drug-coated balloon has been released by Medtronic in Japan for use in treating peripheral artery disease in the upper leg. The device was approved last year by the Japanese Ministry of Health, Labor and Welfare based on results from a 100-patient trial, which showed the device demonstrated 93.9% primary patency at one year, higher than the 46.9% achieved with standard percutaneous transluminal angioplasty.
Updated preliminary data from Catalyst Biosciences' Phase II/III study assessing the efficacy and safety of MarzAA, or marzeptacog alfa (activated), a prophylactic factor VIIa variant for subcutaneous administration, were presented at the Hemophilia Drug Development Summit in Boston. MarzAA is being evaluated as a treatment for patients who have hemophilia A or B with inhibitors.
A new drug application was resubmitted to the FDA by Ortho Dermatologics for its plaque psoriasis lotion Duobrii. The submission included additional requested pharmacokinetic data.
Global life sciences and agriculture company Bayer's divested assets and businesses, which it was required to shed by global regulatory authorities to purchase Monsanto, have been acquired by multinational chemical company BASF for about $8.6 billion. The acquisition includes Bayer's seeds businesses, seed treatment products and several research projects involving herbicides and nematicides.
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