The U.S. FDA granted breakthrough device designation to CG Bio Co. Ltd.’s spine implantation device, Novosis putty, making it the first bone substitute material developed in South Korea to gain the agency’s priority support. Novosis putty, successor to CG Bio’s first generation Novosis Ortho, combines a bone-forming protein called recombinant human bone morphogenetic protein 2 (rhBMP-2; Nebotermin) with ceramic scaffolds to accelerate bone growth.
As South Korea awaits potential changes to drug pricing policies for generics and novel ultra-expensive therapies like Novartis AG’s Kymriah (tisagenclecleucel), the domestic pharmaceutical industry is proactively voicing concerns about some policies that could do more harm than good.
With Aeon Biopharma Inc. listing on the New York Stock Exchange (NYSE) on July 24, South Korea’s Daewoong Pharmaceutical Co. Ltd. is seeking new territory for its beleaguered botulinum toxin (BTX) product, Nabota (Jeuveau or ABP-450 in the U.S). Aeon’s move is expected help expand Nabota beyond aesthetic treatment to include medical conditions such as episodic migraines, cervical dystonia and post-traumatic stress disorder (PTSD).
Daewoong Pharmaceutical Co. Ltd. has out-licensed its phase I-ready autoimmune disease candidate, DWP-213388, to new spinout company Vitalli Bio in a deal worth up to $477 million.
Daewoong Pharmaceutical Co. Ltd. has out-licensed its phase I-ready autoimmune disease candidate, DWP-213388, to new spinout company Vitalli Bio in a deal worth up to $477 million.
Daewoong Pharmaceutical Ltd. has out-licensed greater China rights for its idiopathic pulmonary fibrosis (IPF) candidate, bersiporocin (DWN-2088), to CS Pharmaceuticals Ltd. in a deal worth up to $336 million. Bersiporocin is a prolyl-tRNA synthetase inhibitor being developed by Daewoong for IPF and potentially other fibrotic indications.
HONG KONG – Incheon, South Korea-based Celltrion Inc. has gleaned positive results in a small early stage trial for its anti-COVID-19 monoclonal antibody CT-P59. The results were presented at the Korean Society of Infectious Diseases’ 2020 fall conference, which took place on Nov. 5.