Aid workers are seeking approval to use three experimental drugs to treat patients found positive for Ebola in the Democratic Republic of Congo: ZMapp, favipiravir and GS-5734, which were also administered to West Africa's patients during the Ebola outbreak from 2014 to 2016. Testing these drugs will involve doing research during the outbreak, which is something that needs to be done and has gained acceptance, said Daniel Bausch, director of the London-based UK Public Health Rapid Support Team.
Results from two AstraZeneca Phase III trials published in the New England Journal of Medicine demonstrated the clinical efficacy of using the anti-inflammatory Symbicort Turbuhaler, or budesonide/formoterol fumarate dihydrate, as needed for mild asthma relief compared with two other current reliever therapies. Symbicort taken as needed showed a 64% decrease in asthma exacerbations compared with a short-acting beta-2 agonist.
The FDA urged health providers to detail dolutegravir's benefits and risks to women of childbearing age with HIV, administer pregnancy testing before medication initiation and consider other antiretroviral drugs, while the European Medicines Agency advised that the drug shouldn't be prescribed for those who are trying to get pregnant, after preliminary study data showed higher odds of neural tube defects among infants whose mothers took dolutegravir. Both agencies said women taking the drug should use contraception but shouldn't stop treatment before physician consultation.
Pious Lion recalled an undisclosed amount of kratom products after the company received a report of illness allegedly related to its product, and then state testing revealed the presence of salmonella. Included in the recall were Pious Lion Pure Premium Potent Limited Release Pink Bali and Pious Lion Pure Premium Potent White Maeng DA, Bright Uplifting Energy, which were sold online and via phone.
A prostatic urethral lift procedure using the UroLift system from Teleflex unit NeoTract was recommended by the American Urological Association as a standard-of-care treatment for benign prostatic hyperplasia-related lower urinary tract symptoms. The minimally invasive system uses tiny devices to push aside enlarged prostate tissue to reopen the lower urinary tract, allowing patients to avoid invasive surgery.
The FDA granted MED-EL USA approval for its Rondo 2 cochlear implant audio processor with wireless charging. The device, designed for people with hearing loss, has a battery life of 18 hours with an advanced wireless charging option and can connect to televisions and cellphones with the use of intelligent wireless accessories, as well as to Bluetooth neckloops and hearing induction loops.
A Class I recall was issued by the FDA for 529 units of Medtronic's MindFrame Capture LP revascularization device because of delivery wire separation or breakage during use, which could pose risks for complications such as additional stroke symptoms, vessel blockage, bleeding or death. Meanwhile, Medtronic has recommended caution on the use of its N'Vision clinician programmer with neurostimulation devices after the release by the Department of Homeland Security warning about the programmer's cyber vulnerabilities.
HistoIndex and CymaBay Therapeutics agreed to work together to assess the efficacy of seladelpar in a Phase IIb study of 175 subjects with biopsy-confirmed nonalcoholic steatohepatitis using HistoIndex's Genesis 200 multiphoton digital pathology system.
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