Dewpoint Therapeutics has formed a research and development partnership with Novo Nordisk for identifying drug candidates to treat insulin resistance and diabetic complications. Dewpoint’s discovery platform related to biomolecular condensates will be used to identify the drug candidates. The collaboration will enable combination of Novo Nordisk’s expertise … [Read more...]
FDA grants fast track status to Prestige’s PBP1510 for pancreatic cancer
The US Food and Drug Administration has granted fast track designation to Prestige Biopharma’s PBP1510 (Ulenistamab) to treat unresectable or metastatic pancreatic adenocarcinoma (PDAC). PBP1510 will mainly act on a tumour-specific protein called pancreatic adenocarcinoma upregulated factor (PAUF), which is overexpressed in most pancreatic cancer … [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...]