Article authored and contributed to PharmaLeaders by: Carlo Chatman, Power PR Cell and gene therapies are dominating the world of drug development. With the promise of significant breakthroughs in treatment of diabetes, cancer, and congenital conditions, it is no wonder that research and development is predicted to reach $232.5 billion by 2026, up from $186 billion in 2019 … [Read more...]
FDA grants fast track designation to Arrowhead Pharmaceuticals’ ARO-APOC3 to reduce triglycerides
The US Food and Drug Administration (FDA) has granted fast track designation to Arrowhead Pharmaceuticals’ ARO-APOC3 that helps to lower triglycerides in adult patients with familial chylomicronemia syndrome (FCS). Earlier, ARO-APOC3 received Orphan Drug designation from the FDA and the European Union. ARO-APOC3 is the firm’s investigational RNAi therapeutic … [Read more...]
Orion receives approval from Chinese NMPA for darolutamide
Orion has received approval from the Chinese National Medical Products Administration (NMPA) for darolutamide along with docetaxel to treat metastatic hormone-sensitive prostate cancer (mHSPC) patients. The oral androgen receptor inhibitor (ARi) darolutamide already received approval in China to treat non-metastatic castration-resistant prostate cancer … [Read more...]
Everest gets Chinese approval for Xerava to treat cIAI
Biopharmaceutical company Everest Medicines has received approval from China’s National Medical Products Administration (NMPA) for its new drug application (NDA) related to Xerava (eravacycline) to treat complicated intra-abdominal infections (cIAI) in adults. With this approval, the firm intends to introduce Xerava in the Chinese market in the third quarter … [Read more...]
Mediar Therapeutics announces $105m financing to advance fibrosis therapies
Biotechnology firm Mediar Therapeutics has announced a $105m financing, which includes a recent $85m Series A round. The Series A round was co-led by Novartis Venture Fund and Sofinnova Partners and has seen participation from Pfizer Ventures, Mission BioCapital, Gimv, Pureos, Bristol Myers Squibb, Eli Lilly & Company, Ono Venture Investment and Mass … [Read more...]