Rival drugmakers Merck KGaA and Pfizer are putting their cash and expertise into a new effort to better understand lupus, tapping the Broad Institute for a Big Data approach to help map out the disease and light the way for future drug candidates.
AstraZeneca has been pulling out all the stops in trying to preserve blockbuster Nexium's revenues for as long as it can. Now, the FDA has approved an over-the-counter version of the drug--but thanks to a 2012 agreement, those sales are on their way to Pfizer.
Thanks to genomic sequencing, some heart-healthy mutants and billions of dollars spent on R&D, rival drug developers are bearing down on a promising new way of treating the scourge of high cholesterol. And with the first FDA applications likely coming in the next year, the nascent field's trailblazers are vying for the top spot with blockbuster aspirations.
The combination of genomics and bioinformatics expertise now needed for target validation has led drugmakers to look outside their walls for skills, with Pfizer teaming with the Broad Institute on such a project. Now GlaxoSmithKline has set up its own initiative and called for its Big Pharma peers to get involved.
Pfizer says the Phase IIb study for its closely-watched PCSK9 cholesterol drug bococizumab (RN316) scored the primary endpoint on all doses, which should help steer a massive Phase III program that started out last fall with 22,000 patients.
Time is running out before generics descend on Nexium, the stomach drug that rakes in nearly $4 billion a year for AstraZeneca. And in an effort to conserve sales, the British drugmaker is going where it's gone once before: a direct-to-patient delivery program it hopes will keep customers in its grasp.
Pfizer said its targeted cancer drug Xalkori trounced chemotherapy in a trial of previously untreated patients with a particular type of lung cancer. The study showed for the first time that up-front treatment with Xalkori staves off cancer growth better than other treatments in patients whose tumors test positive for ALK-gene abnormalities.
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.