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Novartis tries to rescue stalled inclisiran filing with FDA

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Novartis has tried to get its marketing application for high cholesterol therapy inclisiran in the US back on track, after the FDA rejected it last year, by changing the factory that makes the drug.

RNA 105
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Pfizer/BioNTech say COVID-19 vaccine could be approved in Europe by year-end

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Pfizer and BioNTech have filed their COVID-19 vaccine with the European medicines regulator, paving the way for a potential approval before the end of the year. The filing for a conditional marketing authorisation completed the rolling submission process that began on October 6.

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Novartis bags elusive US approval for cholesterol drug inclisiran

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The US regulator issued Novartis with a complete response letter (CRL) for inclisiran a year ago, citing “unresolved facility inspection-related conditions” at a third-party manufacturing site run by Corden Pharma near Milan, Italy. It will be launched in the US in January, said Novartis. It has a long way to go.

Drugs 105
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Sanofi, Sobi eye filings for once-weekly haemophilia A therapy

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Sanofi and Sobi’s haemophilia partnership has been under competitive pressure from new therapies like Roche’s antibody Hemlibra, so the two companies are hoping a new long-acting drug candidate can revitalise the franchise. The half life of the new drug – one of the main draws for Sanofi’s $11.6

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Gritstone bio trumpets first data for ‘multivariant’ COVID jab

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The results of the CORAL-BOOST are only in a few patients, but showed strong increases in neutralising antibody levels when Gritstone’s shot given as a booster after two doses of AstraZeneca’s Vaxzevria given as a primary course. “With new variants – like Omicron and B.1.640.2

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Pfizer begins US pilot delivery programme for COVID-19 vaccine

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Pfizer is poised to file the vaccine with the FDA in the coming days, seeking an Emergency Use Authorization (EUA) after gathering enough safety data required by the regulator. Both Pfizer and Moderna vaccines use synthetic messenger RNA to activate the immune system against the virus. Pfizer and BioNTech have a $1.95

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Cash round sets up trial of InteRNA’s microRNA for cancer

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InteRNA is focusing on the development of gene-silencing drugs based on microRNA, naturally occurring, non-coding strands of RNA that are thought to regulate gene expression in cells.

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