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BioWorld - Thursday, September 28, 2023
Home » Topics » Infection » Coronavirus

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Inside the Beltway: FDA/AAMI post-market risk paper invokes 'reasonable person' standard

Sep. 2, 2015
By Mark McCarty
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Other news to note

Aug. 5, 2015
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Otsuka Pharmaceuticals Co. Ltd., of Tokyo, and H. Lundbeck, A/S, of Valby, Denmark, said the FDA expanded the label of Abilify Maintena (aripiprazole) for extended-release injectable suspension to include a new injection site, the deltoid muscle of the arm. Healthcare providers will now have the option for either a gluteal or deltoid injection site for administering Abilify Maintena to patients with schizophrenia.
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Bench Press: BioWorld looks at translantional Medicine

Aug. 3, 2015
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The CONVERGE consortium has identified the first genetic risk loci for depression. Genetic risk factors for major depressive disorder have been surprisingly hard to pin down, with several major genomewide association studies coming up empty.
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Other news to note

July 29, 2015
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Georg-August-University Göttingen (UMG) and MRC Technology (MRCT), of London, signed an exclusive license to develop a therapy for neurodegenerative diseases based on antibody-targeting amyloid beta peptides.
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Bench Press: BioWorld looks at translational medicine

July 6, 2015
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Researchers from McGill University have shown that the immune system contribution to chronic pain differs in male and female mice. A large body of research suggests the hypersensitivity to normal stimuli, part of chronic pain, is due in part to immune cell signaling. Specifically, such signaling is from microglia to neurons.
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MERS: Not a Crisis Yet: As researchers work on drug candidates, Kinghawk reveals MERS diagnostic

June 15, 2015
By Cornelia Zou and T.V. Padma
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S. Korea, China on alert as researchers scramble to move drugs forward

June 15, 2015
By Cornelia Zou and T.V. Padma
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HONG KONG & NEW DELHI – Middle East respiratory syndrome (MERS) is in the spotlight across Asia, as researchers search for drugs to fight a virus many fear could be as devastating as SARS was in 2003.
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Other news to note

June 5, 2015
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Kineta Inc., of Seattle, presented preclinical in vitro and animal data at the Novel Antiviral Therapies for Influenza and Other Respiratory Viruses: Bench to Beside Conference in Austin, Texas, from a class of molecules discovered by Kineta and broadly inhibit influenza A and B, respiratory syncytial virus and coronavirus, which include Middle East respiratory syndrome.
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BioWorld's top 10: The biggest news makers and trending stories of 2014

Dec. 29, 2014
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To say that 2014 was a good year for the biopharma industry would be a radical understatement. The flourishing capital markets, the record-breaking number of companies successfully going public via initial public offerings and the validation of scientific breakthroughs that only a few years ago had been mere theories all made for a banner year for the sector.
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Other news to note

July 23, 2014
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Genentech Inc., of South San Francisco, a member of the Roche Group, said the FDA accepted its supplemental biologics license application (sBLA) and granted priority review for Avastin (bevacizumab) plus chemotherapy for the treatment of women with recurrent platinum-resistant ovarian cancer.
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