Same-Day BLA Filings Show Pfizer Has Gained Ground On Novartis In Meningitis B
This article was originally published in Pharmaceutical Approvals Monthly
Both companies have “breakthrough” therapy designations from FDA and both announced BLA filings on June 17, but Pfizer’s earlier completion of the rolling submission could give it an edge in the race to launch a meningitis B vaccine in the U.S.
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Pfizer, which saw 13% growth in its global vaccines business during the second quarter, pays $635 million to buy a pair of vaccines from Baxter. The meningitis and encephalitis vaccines, sold mainly in Europe, are expected to generate combined sales of about $300 million this year.
CDER Director Woodcock was quickly consulted about a manufacturing concern at a foreign site that emerged shortly before FDA’s target action date for Novartis’ ceritinib NDA as the agency strove to avoid delaying approval of the “breakthrough” lung cancer therapy.
The EU CHMP’s recommendation in favor of Novartis’ Meningitis B vaccine Bexsero is a positive turn for the company’s vaccines business, but with the division’s sales and profits languishing, some investors are wondering if Novartis should cut its losses and get out of the space.