- Policy
- AZ, novel PNH drug 'Voydeya' may soon receive KOR approval
- by Lee, Hye-Kyung May 23, 2024 05:48am
- First-in-class oral paroxysmal nocturnal hemoglobinuria (PNH) treatment will soon be approved in South Korea. According to the pharmaceutical industry on the 23rd, the Ministry of Food and Drug Safety (MFDS) completed the safety and efficacy review of AstraZeneca Korea’s 'Voydeya (danicopan)' for approval. Completing the safety and eff
- Company
- 'China approves new drugs after completing trials in China'
- by Lee, Tak-Sun May 23, 2024 05:48am
- China's drug approval authorities grant first-in-class drug approvals to drugs as soon as their multi-regional clinical trials (MRCTs) in China are complete, regardless of whether they are approved by the U.S. Food and Drug Administration (FDA) or other national drug regulatory agencies. Tigermed’s Senior Consultant Jessica Liu respond
- Company
- Clinical trial failures…novel PD drugs face challenges
- by Son, Hyung-Min May 23, 2024 05:48am
- Novel candidates for Parkinson’s disease that have gathered the industry’s attention are repeatedly failing to prove effectiveness in clinical trials. Bukwang Pharmaceutical was developing novel drugs for Parkinson’s disease but failed to prove its efficacy in Europe phase 2 clinical trials. D&D Pharmatech and Peptron also failed in phase
- Company
- Leclaza’s sales soar with reimbursement expansion
- by Chon, Seung-Hyun May 23, 2024 05:48am
- The sales of Yuhan Corp’s new anti-cancer drug 'Leclaza' have jumped significantly. Sales have more than tripled in one year since the drug has been granted reimbursement as a first-line treatment for lung cancer this year. Leclaza’s sales quickly reached the KRW 20 billion mark in quarterly sales, paving the way for the drug to achieve the KR
- Policy
- 4 Pharmas make bid into low-dose statin combo drug mkt
- by Lee, Tak-Sun May 22, 2024 05:47am
- The popularity of low-dose statin continues. Due to its lower risk of side effects than high-dose statins and a higher cholesterol-lowering effect when combined with ezetimibe than as monotherapy, domestic pharmaceutical companies have been busy launching low-dose statin combination products one after another. According to industry sourc
- Company
- Oral renal anemia drug meets reimb listing terms
- by Nho, Byung Chul May 22, 2024 05:47am
- An application for drug pricing has been filed for two items of renal anemia drugs that are equivalent in efficacy to conventional EPO injections but cost much less. New treatment options are expected to become available. According to industry sources, Mitsubishi Tanabe Pharma and JW Pharmaceutical have filed an application to the Heal
- Company
- MSD applies for Welireg’s reimbursement in Korea
- by Eo, Yun-Ho May 22, 2024 05:47am
- The rare anti-cancer drug ‘Welireg’is seeking insurance coverage in Korea. According to industry sources, MSD Korea recently submitted an application for the reimbursement of its oral hypoxia-inducible factor-2 alpha (HIF-2α) inhibitor Welireg (belzutifan). The drug is beginning its reimbursement voyage a year after its approval in Kor
- Company
- FDA approves Samsung and Biocon’s Eylea biosimilars
- by Son, Hyung-Min May 22, 2024 05:47am
- Samsung Bioepis’s Opuviz became the first Eylea biosimilar to be approved in the US. In particular, due to its interchangeability designation, Opuviz can be administered interchangeably with Eylea, increasing its chances of gaining an advantage in the market over its competitors. According to KoreaBIO on the 21st, the US FDA approved Sam
- Policy
- Forxiga to maintain upper limit price until Korean mkt exit
- by Lee, Tak-Sun May 22, 2024 05:47am
- Forxiga (dapagliflozin propanediol hydrate), an SGLT-2 class of diabetes treatment, will maintain its upper limit price until it leaves the South Korean market. It appears that AstraZeneca’s strategy for defending the upper limit price through the court’s suspension of execution has worked. The price-value agreement (PVA) negotiations,
- Company
- FDA approval delayed and retry…what’s 'Rivoceranib'?
- by Son, Hyung-Min May 21, 2024 05:56am
- HLB’s rivoceranib, which was expected to be an FDA-approved new drug candidate, failed to receive final approval. Although HLB confirmed that Rivoceranib combined with immunotherapy camrelizumab extended overall survival in the first-line treatment for liver cancer, they received request for supplementary documents. The current request f
