Merck KGaA's early-stage M7824, being developed to treat patients with biliary tract cancer, has received orphan drug designation from the FDA.
Pear Therapeutics has secured clearance from the FDA to market its reSET-O mobile app for use in increasing retention of individuals receiving outpatient opioid abuse treatment. The app, which is a cognitive behavioral therapy designed to be used under the supervision of a health care professional in addition to other therapies, can be downloaded by patients after receiving a prescription.
Thermo Fisher Scientific's QMS Plazomicin Immunoassay, designed to help clinicians determine appropriate plazomicin doses in recommended patient populations, has received clearance from the FDA. Developed in collaboration with Achaogen, the immunoassay measures plazomicin in human plasma using automated clinical chemistry analyzers.
The CDC issued a public reminder for the holiday season not to eat raw cookie dough because some ingredients can harbor E. coli or raise the risk of salmonella poisoning. The warning was extended to include other raw products, such as dough or batter for tortillas, biscuits, pizza, pancakes or crafts made with raw flour.
A list of 38 punishments, including patent denials and inability to access expedited review of patent applications, has been released by China's National Development and Reform Commission for use by government institutions such as the country's National Medical Products Administration to protect against intellectual property theft and fraud. Preventive measures include increased daily supervision and more frequent and extensive spot checks conducted by relevant agencies.
The Coalition for Epidemic Preparedness Innovations and researchers from the UK's Imperial College London will collaborate on developing a synthetic vaccine platform using synthetic self-amplifying RNA that can be customized for various pathogens, including Ebola, Zika, Marburg and rabies. The coalition will invest up to $8.4 million for the project.
Children and teens with bipolar disorder given lithium treatment who continued receiving lithium had a lower hazard ratio of discontinuing treatment after 28 weeks, compared with those who took placebo as maintenance treatment, according to a study in the Journal of the American Academy of Child & Adolescent Psychiatry. Researchers also found that 15 of 17 youths who continued lithium had one or more adverse events, compared with nine of 14 of those who received placebo, while weight gain was similar between both groups.
Shanghai Junshi Biosciences filed an initial public offering in Hong Kong aiming to raise up to $414 million. Hong Kong recently allowed biotech companies with no revenue or profit to list on the stock market.
A Newton Prize worth $250,000 was awarded to developers of drought-tolerant biotech beans, Caspar Chater and Alejandra Covarrubias.
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