October 12, 2021
FDLI SmartBrief
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Drugs & Biologics
Merck has filed an emergency use authorization request with the FDA for the oral antiviral drug molnupiravir as treatment for adults with mild to moderate COVID-19. A late-stage trial found that the drug reduced hospitalization and mortality by 50% among patients with mild to moderately severe COVID-19 and at least one risk factor.
Full Story: Reuters (10/11) 
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Judge rules class-action suits can proceed over Zantac
(Drew Angerer/Getty Images)
A federal judge has ruled that class-action lawsuits may proceed against GlaxoSmithKline, Boehringer Ingelheim, Sanofi and Pfizer over the potentially contaminated heartburn drug Zantac, or ranitidine. The lawsuits filed on behalf of Zantac consumers accused the firms of concealing the dangers and risks of the drug, which contains potential carcinogen N-nitrosodimethylamine.
Full Story: FDAnews (10/12),  Reuters (10/7) 
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The FDA has put a clinical hold on five clinical trials of Allogene Therapeutics' AlloCAR T chimeric antigen receptor T-cell therapies. The clinical hold follows a report from Allogene that a patient with follicular lymphoma showed evidence of chromosomal abnormality after receiving an infusion of Allogene's anti-CD19 CAR-T candidate ALLO-501A.
Full Story: Healio (free registration) (10/11),  FierceBiotech (10/8) 
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Medical Devices
The FDA has given emergency use authorization to PerkinElmer for its PKamp respiratory panel 1 assay. The assay is able to simultaneously test for influenza A, influenza B, SARS-CoV-2 and respiratory syncytial virus using anterior nasal swabs, mid-turbinate swabs and nasopharyngeal swabs.
Full Story: MassDevice (Boston) (10/7) 
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The FDA has given a second clearance to DreaMed for its Advisor Pro Al Clinical Decision Support System, an artificial intelligence-supported insulin management tool for people with type 2 diabetes. "DreaMed Advisor Pro greatly expands the access to the much-needed expert-level care to millions of people," said DreaMed Chief Science Officer Moshe Phillip in a statement.
Full Story: MobiHealthNews (10/7) 
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The FDA has given breakthrough device designation to Quanterix for its Simoa phospho-Tau 181 blood test, allowing it to be used to help in diagnostic evaluation of Alzheimer's disease. The test, a semiquantitative immunoassay, is designed to measure pTau-181 concentration in human serum and plasma.
Full Story: Seeking Alpha (free registration) (10/11) 
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European regulators have given CE mark certification to Medtronic for its Hugo robotic-assisted surgery system. The certification allows the modular, multi-quadrant platform to be used for gynecological and urological procedures.
Full Story: Medical Device Network (UK) (10/11) 
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Food & Dietary Supplements
The FDA has signed mutual reliance agreements with California, Florida, Utah and Wisconsin to streamline plans for addressing food-illness outbreaks, oversight and public safety. "We expect that as more states sign mutual reliance agreements, it will help reduce redundancy and duplication of effort, optimize the impact of our collective oversight, and allow us to build on the long-standing relationships that we have with our state regulatory partners," said Michael Rogers of the FDA's Office of Regulatory Affairs.
Full Story: Food Safety News (10/8) 
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The Food and Drug Administration found traces of E.coli in samples of romaine grown in Yuma County, Ariz., in February and March, according to a new report that's part of the FDA's Leafy Greens STEC Action Plan. The tests on 504 samples of the lettuce also looked for Salmonella, which was not detected.
Full Story: Food Safety News (10/8) 
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