FDA clarifies EUAs for COVID multi-analyte respiratory panels

The Agency added a new item to its questions and answers (Q&As) for laboratories and manufacturers of tests for SARS-CoV-2, the virus that causes COVID-19.  The new Q&A cites “the overlap in signs and symptoms between SARS-CoV-2 and other respiratory viral infections, including influenza.”  Multi-analyte panels for respiratory infections, noted the Agency, “are useful when … Read more

Drugmakers, FDA try to build public confidence in COVID vaccine decisions

November 17, 2020 The CEOs, who head vaccine front-runners AstraZeneca, Moderna and partners Pfizer and BioNTech, as well as GlaxoSmithKline, Johnson & Johnson (J&J), Merck, Novavax and Sanofi, also say they will put patient safety first and will “adhere to high scientific and ethical standards regarding the conduct of clinical trials and the rigor of … Read more

How Biden plans to change the US pandemic response

November 13, 2020 “The pandemic is getting significantly more worrisome all across the country,” Biden said on Friday.  “I want everyone to know on day one, we’re going to put our plan to control this virus into action.” There were dauntingly high new case numbers last week, and by the time Biden takes office January … Read more

National Survey Shows Encouraging Decline in Overall Youth E-Cigarette Use, Concerning Uptick in Use of Disposable Products

November 10, 2020 In September, the U.S. Food and Drug Administration, in partnership with the Centers for Disease Control and Prevention, released new data from the 2020 National Youth Tobacco Survey (NYTS), which show 1.8 million fewer U.S. youth are currently using e-cigarettes compared to 2019.  After two (2) years of disturbing increases in youth … Read more

Scripps study suggests wearables could predict COVID-19 infection

November 05, 2020 Could wearables be used to detect potential COVID-19 cases?  A group of researchers at the Scripps Research Translational Institute found that changes in sleep, activity levels and heart rate, paired with symptom data, could be used to identify COVID-19 cases.  Their results were published in Nature on Thursday. The idea behind the … Read more

Mojo Vision sees $51M round for its smart vision-improving contact lens

November 03, 2020 Led by New Enterprise Associates, the series B-1 round brings the company’s total funding to $159 million.  Additional backers included Gradient Ventures, Khosla Ventures, Liberty Global Ventures, Struck Capital, Dolby Family Ventures, Motorola Solutions Venture Capital, Fusion Fund, Intellectus Partners, KDDI Open Innovation Fund, Numbase Group, InFocus Capital Partners and others. The … Read more