The rapid change to the latest versions of Pfizer Inc./BioNTech SE’s Comirnaty and Moderna, Inc.’s Spikevax vaccines against SARS-CoV-2 illustrates the likelihood that they will maintain their leading market positions for vaccines to prevent COVID-19, given the “plug-and-play” properties of messenger RNA vaccines that allow much more rapid development than their traditional counterparts.
New COVID-19 Vaccines Shipping Soon, After Rapid Pivot To Address New Strain
Pfizer/BioNTech and Moderna rapidly adapted Comirnaty and Spikevax for the 2024-2025 season to address the KP.2 variant after the US FDA had advised them to target JN.1 in June.
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The company is planning to launch oxylanthanum carbonate for chronic kidney disease patients on dialysis with hyperphosphatemia.
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After a long wait for patients, Vykat has become the first drug approved for Prader-Willi syndrome symptoms, opening the market up for Soleno and future challengers.
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The US FDA approved Blujepa for the treatment of uncomplicated urinary tract infections, marking the first new mechanism of action for the infection in more than 30 years.
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Novartis US president Victor Bultó talked to Scrip about the company’s efforts to reach patients with rare kidney diseases who are candidates for Fabhalta.
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The highlights of recent comments and insights from industry executives on the key issues covered in Scrip.
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RemeGen is planning to complete enrolment in the global Phase III RemeMG study with telitacicept in generalized myasthenia gravis by the end of 2025 or early 2026. The Chinese firm has already sidelined two other global Phase III trials with the molecule to prioritize the indication.
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Private Company Edition: The latest group of drug developers to announce venture capital financings is remarkable for its geographic diversity, from Character Biosciences’ $93m series B round in the US to Augustine’s $85m series B in Belgium to a $29.2m series C for Aculys in Japan.