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.
BioNTech and Pfizer have joined forces to develop the former's mRNA-based influenza vaccines. Under the terms of the deal, BioNTech will receive upfront and near-term research payments totaling $120 million, plus milestone payments and royalties.
Scientists at the King Abdullah University of Science and Technology examined nitrogen oxide emissions from alcohol fuels such as ethanol and found that these fuels produce lower nitrogen oxide and greenhouse gas emissions compared with conventional fossil fuels.
AngioDynamics has paid an undisclosed amount for Surgical Specialties' BioSentry tract sealant system, which is designed for minimizing the occurrence of a common CT-guided percutaneous lung biopsy complication, pneumothorax, or collapsed lung.