Have a look at some interesting things happening with pharma and biotech in regulatory intelligence!
- FDA approved Tesaro’s PARP inhibitor, Zejula, as a maintenance therapy for recurrent ovarian cancer. The product was approved without a companion diagnostic and “is the only PARP inhibitor that has demonstrated a clinically meaningful increase in progression-free survival (PFS)”. (Endpoints)
- ArQule’s c-MET inhibitor tivantinib fails—again. The drug missed its primary endpoint in a phase 3 trial evaluating use for the treatment of liver cancer. The drug has previously been evaluated in numerous other cancers and this was the final indication being pursued. (FierceBiotech)
- FDA approved Roche’s Ocrevus (Ocrelizumab) for the treatment of primary progressive multiple sclerosis (PPMS). It is the first product approved for the severe form of the disease. (Reuters)
- Dupixent, a drug made by Regeneron and Sanofi, was approved for the treatment of a serious form of eczema. In an unusual move aimed at mitigating pricing scrutiny, the companies negotiated directly with insurers over the price in advance of the approval. (NYTimes)
- Artificial intelligence (AI) diagnoses depression. US researchers at the University of Texas at Austin have developed an artificial intelligence algorithm that can accurately predict depressive disorder in 75% of cases. (PharmaPhorum)