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Merck has scored US Food and Drug Administration (FDA) approval for its next-generation pneumonia vaccine Vaxneuvance that covers 15 different strains of the pneumococcal bacteria that causes the infection. Both next-gen shots offer enhanced protection against bacteria that can cause pneumonia, blood infections and meningitis.
An investigational orally delivered biologic drug, LMN-201 is a cocktail of four therapeutic proteins that act synergistically to neutralise the C difficile bacterium and the toxin. The company has already received FDAapproval for a Phase II/III trial, which will begin to enrol 375 participants at sites across the US during 2023.
Anthrax is a rare, yet severe disease caused by the bacterium B. The bacteria usually enter the body through wounds, but infection can also occur through contaminated meat or inhalation of spores. One such vaccine is BioThrax which was also developed by Emergent BioSolutions and gained FDA clearance back in 1970.
Under the terms of the new deal, Nestle’s Health Sciences unit will pay Seres another $125 million if the FDAapproves the drug – called SER-109 – and is also line for up to $225 million in commercial milestones tied to sales targets. Nestle and Seres have been working together on the microbiome project since 2016, focusing on C.
The company says that these four serotypes represent roughly 10–15% of bacteria causing pneumococcal disease in adults. While the first pneumococcal polysaccharide vaccine was approved in the US in 1977, the first conjugate shot Prevnar was greenlighted only in 2000.
Paxlovid was first authorized under the FDA Emergency Use Authorization in December 2021 ; however, it has received FDAapproval on May 25, 2023. pneumoniae serotypes) replaced the company’s first pneumococcal conjugate vaccine Prevnar (PCV7, approved by the FDA in February 2000) in a February 2010 FDAapproval.
Several saliva-based tests also received FDAapprovals and authorizations, making sample collection easier and less invasive compared with traditional nasopharyngeal swabbing. Charpentier demonstrated that the CRISPR/Cas system functions to provide adaptive immunity against foreign DNA in prokaryotes such as bacteria and archaea.
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