Even as Novartis is fighting a long anticipated battle in India to protect the patent on its cancer drug Gleevec, another Swiss drugmaker must decide if it will appeal a ruling that it believes essentially ignored patent protections on its own cancer drug.
Shares of Amarin took a hit overnight after the company filed papers noting that the FDA had yet to decide whether its industrial-strength fish oil product Vascepa warranted approval as a new chemical entity, a classification that carries 5 years of marketing exclusivity with it.
Public Citizen has stepped up its fight against high-dose Aricept. The consumer advocacy group, which demanded last year that FDA pull the Eisai drug's 23 mg dose, sued the agency yesterday for action.
In the wrap-up of the European Society of Cardiology meeting in Munich, Reuters ' Ben Hirschler assessed the field in search of the next potential Lipitors in the pipeline--megablockbusters that will cost hundreds of millions of dollars to test in huge clinical trials--and came up with three big fields. Each of them has big caveats to consider.
Many companies have been caught off-guard by the extent to which generic competition has eaten away at their sales. Genentech says it managed to be caught off-guard by a lack of it.
Another quarter, another Lexapro blow for Lundbeck. The antidepressant, sold in the U.S. by Forest Laboratories, is suffering severely from generic competition. That suffering moves across the Atlantic to Lundbeck's Danish headquarters, forcing CEO Ulf Winberg to promise a turnaround.
Pfizer posted higher profits for the second quarter. That's the good news. The not-so-good is that sales dropped by 9%, thanks to increased competition for the newly off-patent Lipitor. The increase in profits came on the back of cost cuts across the company, including big reductions in R&D.
AstraZeneca's second-quarter results continue the generics-are-woe trend in Big Pharma. This time, it's the antipsychotic drug Seroquel doing most of the damage.
Without emerging markets, Japan and consumer heatlhcare, GlaxoSmithKline's second quarter earnings announcement would just be a sea of negative numbers. Thanks to positives in those three areas, overall sales were down just 2%. Europe and U.S. on the other hand, are in a world of hurt.
Leave it to a patent expiration to trigger musical chairs at the top of pharma sales rankings. Plavix is now the biggest-selling drug in the U.S., after stealing the crown from Pfizer's newly off-patent Lipitor, PM Live reports.