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.
Thank you, U.S. patent office. Pfizer ($PFE) won an extra 18 months of exclusivity for its pain drug Celebrex, in the form of a reissued patent that doesn't expire till the end of 2015. That means a cool couple of billion in extra sales.
Disgruntled Pfizer ($PFE) investors are accusing the company of a cover-up. In documents filed in a securities-fraud lawsuit, the investor group says Pfizer trashed some records and denied the existence of others--and it's calling for sanctions against company officials in response, Bloomberg reports.
A new front has opened up against Pfizer in its fight to defend itself against shareholders that claim that it was not upfront about the dangers of pain drugs Celebrex and Bextra to patients and--by extension--to shareholders.
Two weeks before some high-profile shareholder allegations were scheduled to hit court, Pfizer ($PFE) agreed to pay $164 million to settle. The investor class action had claimed Pfizer misrepresented Celebrex trial data to make its pain pill appear safer than its rivals.
Pfizer just can't get rid of the specter of fen-phen. Fifteen years after the diet drug was removed from the market over serious health concerns, litigation lingers and the drugmaker's move to kill that off fell short yesterday.
While drug labels get lots of FDA attention, drug information sheets have gotten very little--until now. With the blessing of the FDA, three of pharma's biggest companies are testing a new one-page sheet that was expressly created so that patients would read and benefit from it, rather than just cover the bases.
Could biomarkers tailor the use of pain drugs? Scientists at the University of Pennsylvania hope to determine whether common painkillers such as Celebrex and Aleve can be used more effectively by identifying patients most likely to benefit--and least likely to suffer serious side effects.
Scouting thousands of pages of unsealed documents gathered in the securities fraud case prepared against Pfizer, The New York Times reveals some embarrassing anecdotes from the pharma giant's internal records on Celebrex.
More than a decade after it was learned that Pfizer and Pharmacia "massaged" study data to show their arthritis drug Celebrex in a better light, new memos released in a lawsuit are serving up a reminder of how that episode played out, like pushing the research community to reconsider how studies are released and published.