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.

Sometimes genetic tests give inconclusive results and provide little reassurance to patients, the Associated Press reports.

Vox wonders whether gene-editing crops will be viewed similarly as genetically modified organisms of if people will give them a try.

In Science this week: research regulation and reporting requirement reform, and more.

With H3Africa, Charles Rotimi has been working to bolster the representation of African participants and African researchers in genomics, Newsweek reports.