In May, the FDA approved Roche's diagnostic test for its cancer drug Tarceva, saying it was the first approved to detect EGFR mutations, and today the FDA today approved a new targeted lung cancer drug from Boehringer Ingelheim and its companion test that can detect the same mutation.
In the bid to propel personalized medicine into everyday use, Biodesix may have hit pay dirt. The company's recently concluded Phase III trial appears to show that its lung cancer blood diagnostic successfully predicts treatment outcomes for two different therapies.
Along with its partner, Astellas, Roche has won FDA approval for a new, first-line use for its lung cancer drug Tarceva in patients whose cancers test positive for specific mutations of the EGFR gene. Roche also got the nod for a diagnostic test to identify eligible patients.
Did Roche ($RHHBY) bungle tens of thousands of adverse-event reports? European regulators aim to find out. The European Medicines Agency says it has started an "infringement procedure" against the Swiss drugmaker, to probe allegations that it dragged its feet on reporting potential side effects.
With its lead drug ponatinib on track to a likely approval in the U.S. and Europe, Ariad Pharmaceuticals ($ARIA) moved center stage at ESMO 2012 over the weekend with an early-stage cancer drug that produced some impressive results among a small population of non-small cell lung cancer patients.
Two lung cancer drugs developed by Roche and AstraZeneca, along with other related synthetic compounds, successfully reversed Alzheimer's-like memory loss in fruit fly and mouse trials. The finding comes from research that spanned the globe, involving neuroscientists in the U.S. and China.
Bayer lost its bid to stop generic Nexavar in its tracks. An Indian patent board denied the drugmaker's petition to stay a compulsory license granted to generics maker Natco Pharma. That means Natco's much-cheaper version of the cancer treatment can stay on the market, at least for now.
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.
Nexavar plus Tarceva did not equate to improved survival for liver cancer patients in a new trial. But that doesn't mean Nexavar is losing its edge.
Indian genericsmaker Natco Pharma, having knocked off Bayer's cancer drug Nexavar with a compulsory license, says it is lining up the targets it wants to shoot at next.