Pfizer's approval pathway for its meningococcal B vaccine just got shorter. On Thursday, the FDA designated the candidate, dubbed rLP2086, as a breakthrough therapy, which will speed its trip through the regulatory process--and put it in a head-to-head battle with Novartis' Bexsero.
Pfizer picked up the FDA's breakthrough therapy designation for an in-development vaccine against meningococcal disease, a common cause of meningitis, lighting the path for an accelerated approval as the drugmaker looks to expand its vaccine portfolio beyond the blockbuster Prevnar 13.
How much is a pharma company's brand worth? More than $4 billion, if that pharma company is Pfizer. It's the most valuable pharma brand in the U.S., according to Brandirectory's latest iteration of the Billion Dollar Brands Club. For a company that's among the biggest prescription drug marketers in the world, that might not be so surprising.
With Lipitor already over the patent cliff, Pfizer has been working hard to hang onto exclusivity for its famed erectile dysfunction drug, Viagra. In its latest bid to block generic competition, Pfizer has sued Indian drugmaker Torrent Pharmaceuticals for patent infringement.
When Bristol-Myers Squibb and Pfizer launched their new anticoagulant, Eliquis, early last year, Wall Street analysts predicted it would be a $3-billion-a-year blockbuster. After more than a year of struggling to reach that goal, the companies got some good news late Friday, when the FDA approved the drug to reduce the risk of blood clots in the legs and lungs following hip or knee replacement surgery.
Promising data could spell a new recommendation for Pfizer's Prevnar 13 pneumococcal vaccine in older adults, adding up to $1 billion in global sales. But some of Prevnar 13's sales will ride on Pfizer's marketing success with the 65-and-over crowd--which has proven a tough nut to crack for competitor Merck.
Pfizer's Prevnar 13 vaccine slashed the number of pneumonia cases in older adults, according to details from a new study that could add up to $1 billion to its global sales.
One of Pfizer's top-selling products is suddenly vulnerable to generic competition 18 months earlier than expected. A U.S. court nixed a key Celebrex patent, putting the pain drug up for a sales fight in May. And generics makers Mylan and Actavis are promising to launch their versions as soon as Pfizer's monopoly expires.
Last month Pfizer presented positive headline results from its massive Prevnar 13 trial, but the release was light on the details that could shape whether the data leads to an expanded recommendation. Now Pfizer has published a closer look at the data, and not everyone likes what they see.
The FDA's new guidelines for pill design may be the stick driving drugmakers to consider medication errors when blueprinting their drugs. But there's a carrot, too. With new tablet technologies, companies have more freedom to build their brands by making their pills distinctive.