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Top stories summarized by our editors
9/20/2021

Kroger issued a recall of 16-ounce bags of Kroger-branded kale due to possible listeria contamination. The recall affects Kroger stores in seven states: Ohio, Georgia, Alabama, South Carolina, Kentucky, Tennessee and Virginia.

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Food Safety News
9/20/2021

AstraZeneca and Daiichi Sankyo released data from a comparative study assessing their antibody drug conjugate Enhertu, or fam-trastuzumab deruxtecan-nxki, in late-stage breast cancer. Data showed Enhertu lowered the risk of death or disease progression by 72%, compared with Roche's Kadcyla, or trastuzumab emtansine, in patients with HER2-positive metastatic breast cancer. Enhertu posted an overall response rate of 79.7%, compared with 34.2% for Kadcyla.

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Roche
9/20/2021

The Defense Logistics Agency has given a one-year contract worth about $119.5 million to Abbott for over-the-counter antigen test kits.

9/20/2021

Arnot Health and Medline have entered a prime vendor partnership worth $40 million. "Working with Medline allows us to leverage their entire scope of expertise in the areas of supply chain logistics and clinical solutions, as well as their proactive hands-on approach, to ultimately help improve our operating performance," said Arnot Health's system director of supply chain, Susan Houghtelling.

9/20/2021

A Series B financing round has raised $55 million for Francis Medical. The funds will be used for the development and to obtain 510(k) clearance for its water vapor energy technology that is used to treat prostate cancer.

9/20/2021

A study in the Journal of Diabetes and Its Complications found a significant link between breath ketone analyzer measurements and elevated blood ketone monitoring results in non-fasting adults with type 1 diabetes, but not in children. This highlights the potential of breath ketone analyzers as a noninvasive method for screening ketosis among adults at high risk for ketosis, said researcher Halis Kaan Akturk.

9/20/2021

European regulators have given CE mark certification to Microbio for its InfectID-COVID-19 tests.

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FDAnews
9/20/2021

Gynesonics has received FDA approval for its next-generation Sonata System 2.2 that is used during radiofrequency ablation of fibroids.

9/20/2021

The FDA has given 510(k) marketing clearance to MedCAD for its AccuPlate patient-specific plates that are used during mandibular reconstructive surgery.

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FDAnews
9/20/2021

Jacobus Pharmaceutical announced a voluntary recall of three lots of Ruzurgi 10-milligram tablets, its treatment for Lambert-Eaton myasthenic syndrome, due to potential contamination with mold, yeast and aerobic bacteria. Separately, a mix-up of diluent has prompted Azurity Pharmaceuticals to recall Firvanq, Vancomycin 50 milligram/milliliter kit, which is used to treat enterocolitis and Clostridium difficile-associated diarrhea.

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Azurity, Azurity Pharmaceuticals