Tags : Meiji

Insights+ Key Biosimilars Events of December 2019

Biosimilars are developed to be highly similar versions of approved biologics in terms of safety, purity, and potency. Biosimilars are expected to be a cost-effective alternative to high-priced branded biologics, offering significant and much-needed cost savings to both payers and patients. Hence physicians are likely to adopt biosimilars “a reference product to biologics” possessing similar […]Read More

PharmaShots Weekly Snapshot (December 23-27, 2019)

1. Luye Pharma Reports Submission of NDA to the US FDA for LY03005 Published: Dec 26, 2019 | Tags: FDA, Luye Pharma, LY03005, NDA, reports, Submission, US 2. Immunomedics Reports the US FDA’s Acceptance of BLA for Sacituzumab Govitecan to Treat Metastatic Triple-Negative Breast Cancer Published: Dec 26, 2019 | Tags: Acceptance, BLA, FDA, Immunomedics, […]Read More

Kadmon and Meiji Collaborate to Form JV for the Development

Shots: Kadmon to receive ~$29M as development, regulatory & commercial milestones with royalties on sales of KD025 in Japan and certain other Asian countries The JV, named as Romeck Pharma has the HQ in Japan with shared oversight between Kadmon and Meiji KD025 is ROCK2 inhibitor with the potential to treat inflammatory and fibrotic diseases, […]Read More

Meiji and Dong-A Socio Initiate P-I Trial for DMB-3115 (biosimilar,

Shots: The P-I trial involves assessing of DMB-3115 vs reference products (US- and EU-marketed products under the name of Stelara) in healthy volunteers to evaluate its safety, PK and tolerability in Europe In 2011, Meiji and Dong-A signed a joint venture agreement on biosimilars to build DM Bio Limited in Incheon Free Economic Zone and […]Read More