European Medicines Agency

NEW YORK (GenomeWeb) – If AstraZeneca's PARP inhibitor olaparib is granted market approval by European and US healthcare authorities in the coming months, it would enable Myriad Genetics to begin marketing BRACAnalysis as a companion test for the first time.

NEW YORK (GenomeWeb) – Myriad Genetics announced today that it has established a European laboratory that will offer its Tumor BRACAnalysis CDx test to guide treatment with PARP inhibitors, namely AstraZeneca's olaparib.

EMA Approves Roche/Genentech's Perjeta
Roche has garnered approval from the European Medicines Agency for its HER2-positive metastatic breast cancer drug Perjeta.

The European Commission has granted conditional marketing authorization to Pfizer's Xalkori (crizotinib), a personalized treatment for non-small cell lung cancer.

Originally published Jan. 30.
The European Medicines Agency is seeking stakeholder input on how best to use pharmacogenomics data to advance personalized medicines.

Specifically, the designation is for the use of the drug against familial amyloidotic polyneuropathy, one of the predominant forms of the disease, Alnylam said.

The provisions for the EU orphan designation provide incentives to companies developing orphan drugs, including the potential for up to 10 years of market exclusivity and various fee reductions for certain regulatory activities, Quark said.

At a meeting hosted by the Partners HealthCare Center for Personalized Genetic Medicine last month, the events leading up to the re-labeling for colorectal cancer drugs Vectibix and Erbitux sparked discussion among participants about what Amgen and Bristol-Myers Squibb/ImClone knew about the drugs and when.

The US Food and Drug Administration has new guidelines that enable some gene and cell therapies to undergo expedited review, according to the New York Times.

Using gene drives to control invasive species might be too risky, an initial advocate of the approach says.

In Science this week: intellectual property experts argue patent battles such as the one over CRISPR are wasteful, and more.

Researchers have grown tumors in 3D cell cultures to better understand cancer, the Economist reports.