- Policy
- 4th PVA negotiations complete for Prolia
- by Lee, Tak-Sun Aug 8, 2024 09:25am
- The government completed price-volume agreement (PVA) negotiations for Prolia Prefilled Syringe (denosumab), the leading product in the domestic osteoporosis treatment market, with Amgen Korea. Whether the drug’s price will be adjusted for the 4th time under the PVA is gaining attention. According to industry sources on the 4th, Amgen
- Policy
- Topiramate XR generics may be released soon
- by Lee, Tak-Sun Aug 8, 2024 09:24am
- Generic companies have applied for approval of new follow-on drugs of 'Qudexy XR Cap,’ an extended-release topiramate formulation used for epilepsy, to the Ministry of Food and Drug Safety. The follow-on drugs that applied for approval this time are film-coated tablet formulations rather than capsule formulations, and whether the gener
- Company
- RSV vaccine market for children is expected to be big
- by Hwang, Byung-woo Aug 8, 2024 09:24am
- As Sanofi is set to launch its injectable antibody drug to prevent respiratory syncytial virus (RSV) lower respiratory tract disease for the first time in South Korea, the company begins marketing. The company aims to raise awareness of RSV disease to promote vaccination. Sanofi has strategized a top-down approach, starting with labor and de
- Company
- Celltrion presents clinical results of Prolia biosimilar
- by Hwang, Byung-woo Aug 8, 2024 09:24am
- Celltrion announced on August 6th that it has published the global Phase 3 clinical trial results evaluating the efficacy and safety of CT-P41, a biosimilar referencing the osteoporosis drug Prolia (ingredient: denosumab). The Phase 3 study compared the safety profile, including the efficacy, pharmacodynamics, pharmacokinetics, and immuno
- Company
- Qalsody receives orphan drug designation in Korea
- by Eo, Yun-Ho Aug 8, 2024 09:24am
- ‘Qalsody (tofersen),’ a new drug for Lou Gehrig's disease, was designated as an orphan drug in Korea. The Ministry of Food and Drug Safety (MFDS) recently announced the designation through an orphan drug designation notice. More specifically, the drug is indicated for amyotrophic lateral sclerosis (Lou Gehrig's disease) associated wi
- Opinion
- [Reporter's View] govt's foreign drug price comparisons
- by Kim, Jin-Gu Aug 8, 2024 09:24am
- The pharmaceutical industry's concerns grow over the government's plan to reevaluate foreign drug price comparisons. The government has established a policy to reduce domestic drug prices by comparing them to those in 'A8 countries (United States·Japan·Germany·France·Italy·Switzerland·Canada).' As the policy is set to be effective,
- Policy
- Price-Volume Agreement negotiations to be finalized soon
- by Lee, Tak-Sun Aug 8, 2024 09:24am
- The ‘Type C’ price-volume agreement (PVA) negotiations are expected to be completed next week. When the negotiations are complete, the insurance price ceiling of the subject items is expected to be adjusted from September after passing the Health Insurance Policy Review Committee review this month. According to the industry sources on
- Company
- Vaxneuvance increases presence in NIP mkt
- by Hwang, Byung-woo Aug 8, 2024 09:24am
- MSD Korea is accelerating its efforts to capture the national immunization program (NIP) market by touting the high immunogenicity of Vaxneuvance. The vaccine has already been rapidly introduced to general hospitals and clinics upon its launch, and the company is highlighting the vaccine’s clinical benefits to gain a competitive advantage.
- Company
- Electronic drugs show potential to conquering Alzheimer's
- by Son, Hyung-Min Aug 8, 2024 09:24am
- The Korean pharmaceutical bio industry is making a bid into the electronic drug market for Alzheimer's disease. Recently, Remed unveiled the results of its transcranial magnetic stimulation (TMS) therapy that demonstrated an effect in treating Alzheimer's disease. AriBio, which is developing a new drug for Alzheimer's disease, is developing an e
- Company
- Tepezza receives orphan drug designation in Korea
- by Eo, Yun-Ho Aug 6, 2024 09:16am
- Tepezza (teprotumumab), a targeted treatment for thyroid eye disease (TED), has been designated as an orphan drug in Korea. The Ministry of Food and Drug Safety (MFDS) recently announced the designation through an orphan drug designation notification. Specifically, Tepezza is indicated for the treatment of adult patients with moderate-
