Mylan's fixed-dose combination of dolutegravir, emtricitabine and tenofovir alafenamide pill received tentative approval from the FDA as a treatment for patients with HIV infection in developing countries.
Acorda Therapeutics' new-drug application for inhaled Inbrija, or levodopa, which is being developed to treat off periods in patients with Parkinson's disease who are currently on a carbidopa/levodopa regimen, was accepted by the FDA for review. The agency has set Oct. 5 as the PDUFA date.
Findings from a study reported in the Journal of Hepatology found that the drug Vesatolimod, or GS-9620, was well tolerated and safe to use in virally suppressed patients with chronic hepatitis B. The midstage study involved 162 patients from 23 international centers who received varying doses of Vesatolimod or placebo for 12 weeks.
The European Medicines Agency said doctors should stop prescribing Allergan's Esmya, or ulipristal acetate, for uterine fibroids pending a safety review of the drug. The investigation of the drug was initiated after reports of four cases of serious liver injury after Esmya use, including liver failure leading to transplants in three of the cases.
Three individuals who became ill from a salmonella outbreak linked to Fareway's chicken salad have filed civil suits in the US District Court for the Southern District of Iowa, seeking reimbursement for medical expenses and other costs from Fareway grocery stores. The outbreak numbers have already reached 115 cases of salmonella infection, in which 37 are confirmed with laboratory tests and 78 are probable cases.
A rule requiring medical device clinical trials conducted in foreign countries to flexibly comply with Good Clinical Practice standards has been finalized by the FDA. An accompanying guidance on ensuring compliance of US and non-US studies with the final rule and modified regulations was also released by the agency.
Corindus Vascular Robotics' CorPath GRX system was granted 510(k) clearance by the FDA for use in peripheral vascular intervention procedures. The system, which was previously cleared for use in percutaneous coronary interventions, can now be used for treating both coronary artery disease and peripheral artery disease.
Stick-on throat sensors have been developed by scientist John Rogers at Northwestern University in partnership with the Shirley Ryan AbilityLab to monitor the progress of patients who have had a stroke, particularly those with aphasia. The sensors, which are used with on-body sensors developed by Rogers' team for monitoring muscle movement and heart rhythm, evaluate patients' swallowing ability and detect unusual speech characteristics.
Takeda Pharmaceutical will develop and commercialize with Wave Life Sciences nucleic acid treatments indicated for central nervous system diseases. Under the terms of the deal, Wave receives an upfront payment of $170 million, and Takeda gets an option to co-develop and co-commercialize Wave's WVE-120101, WVE-120102 and WVE-3972-01, as well as for a preclinical program targeting ataxin 3 for the treatment of spinocerebellar ataxia type 3.
Orthotaxy, a French company that develops software-enabled surgery technologies, was acquired by Johnson & Johnson through its French affiliate Apsis for undisclosed terms. J&J is aiming to expand the application of Orthotaxy's early-stage robotic-assisted surgery technology for total and partial knee replacement to include other orthopedic surgeries and hopes to develop a solution that is cost-effective, easy to use and saves time in various care settings.
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