Industry News
Life Sciences
Top stories summarized by our editors
1/15/2021

The maker of Flo, a menstrual cycle tracking app, admitted no wrongdoing but agreed to a corrective action plan to settle Federal Trade Commission charges that it misled its 100 million users about keeping their personal data private. The FTC alleges the app shared private health information with third parties, including Facebook and Google, that provided marketing and analytics services, and that it did not limit how those companies could use the data.

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The Verge, ZDNet
1/15/2021

Four of the seven early career scientists to win Damon Runyon-Rachleff Innovation Awards are women, including three of the five first-time awardees and one of two stage-2 awardees. First-time awardees receive $400,000 over two years to support their research on cancer prevention, diagnosis or treatment, and stage-2 awardees receive a follow-on award of $400,000.

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Damon
1/15/2021

A Series A financing round has raised $100 million for Delfi Diagnostics. The funds will be used to expand its team of machine learning experts and cancer researchers as well as to validate its next-generation blood-based cancer test.

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Delfi Diagnostics
1/15/2021

Medtronic has started patient enrollment for its adaptive deep brain stimulation trial that will evaluate the efficacy and safety of aDBS in patients with Parkinson's disease.

1/15/2021

European regulators have given CE mark approval to Chembio Diagnostics for its DPP SARS-CoV-2 Antigen test and its DPP SARS-CoV-2 IgM/IgG test. The company has also entered a distribution deal for the UK and Ireland with Luas Diagnostics.

1/15/2021

The FDA has given emergency use authorization to PerkinElmer for its Nucleic Acid Detection Kit to test asymptomatic individuals.

1/15/2021

The FDA has given emergency use authorization to SML Genetree for its Ezplex SARS-CoV-2 G Kit.

1/15/2021

The FDA has given 510(k) marketing clearance to Hyperfine for its deep-learning image analysis software for use on the company's Swoop portable MRI system.

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FDAnews
1/15/2021

The FDA approved 53 novel drugs last year despite the pandemic, up from 48 approvals in 2019. Out of the approvals, 21 were considered first-in-class drugs while 31 were treatment for rare diseases.

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Regulatory Focus
1/15/2021

AstraZeneca, Sanofi and Eli Lilly and Co. filed separate lawsuits at different federal courts Tuesday seeking to toss an HHS advisory opinion that says pharmaceutical firms must offer 340B discounts on drugs dispensed at contract pharmacies. The statute for the 340B program "does not require manufacturers to recognize any contract pharmacies, much less unlimited contract pharmacies," AstraZeneca argued in its legal filing.

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FierceHealthcare