Vonoprazan, Tapinarof, and Tirzepatide: FDA Novel Drug Approvals in May 2022
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Several multi-million dollar acquisitions or license agreements took place in November 2023 for hot drug targets, with assets from selective PARP1 inhibitors to GLP1R agonists, and others. This recent news roundup highlights the notable acquisitions by pharma companies for rights to molecules in a range of different indications, with illustrative patent examples for undisclosed structures.
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Billion-Dollar Molecules: Etavopivat, an Allosteric PKR Kinase Activator for Sickle Cell Disease Abstract. Novo Nordisk has acquired Forma Therapeutics for $1.1B for its primary investigational drug, etavopivat. Etavopivat, a past Molecule of the Month , is an oral, once-daily allosteric activator of pyruvate kinase-R (PKR), which is [...]
2023 Novel Large Molecule FDA Drug Approvals
Recently, we summarized the novel small molecule drug approvals of 2023 (34/55). The remaining 21 molecular entities approved were large molecules like proteins and oligonucleotides, accounting for nearly 38% of the total approvals. Notably, seven of these large molecules have earned the prestigious Breakthrough Therapy designation, relative to the two small molecules that share this recognition. A summary of approvals for large molecule drugs, accompanied by links to FDA labels and additional information pertaining to the drug's discovery and originators, appears here.
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There continue to be opportunities for another KRAS(G12C) inhibitor to prove itself best-in-class.
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Gadopiclenol: Reducing Gadolinium Retention Risks Through Coordination Chemistry
While gadolinium-based MRI contrast agents (GBCAs) are important for enhancing MRI and MRA imaging, several studies have shown that gadolinium can be retained in the brain and body for months to years after GBCA injection, prompting the FDA to issue box warnings to the drug class. Gadopiclenol, the ninth approved GBCA, was designed to enable use of a lower gadolinium dose than other agents. This highlight reviews how it works and why it’s notable.
