- Policy
- Reimb for Paxlovid still pending amid COVID-19 resurgence
- by Lee, Tak-Sun Aug 12, 2024 05:55am
- As the COVID-19 treatment supply becomes an ongoing issue amid a virus resurgence, clinical practices are frustrated by delayed reimbursement coverage of 'Paxlovid (nirmatrelvir&8231;ritonavir, Pfizer Korea).' The drug reimbursement application for Paxlovid was submitted to the Health Insurance Review and Assessment Service (HIRA) in ear
- 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
- 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
- Policy
- Approval of abortion drugs at a halt in KOR
- by Lee, Jeong-Hwan Jul 31, 2024 05:52am
- The Ministry of Food and Drug Safety has gained attention for stating that the Criminal Code and the Mother and Child Health Act must be amended before the approval of abortion drugs in Korea. The process of gaining marketing authorization for abortion drugs that the pharmaceutical companies applied for has been at a halt for 4 years, as
- Policy
- GSK receives administrative disposition in KOR
- by Lee, Hye-Kyung Jul 30, 2024 05:51am
- The global pharmaceutical company GlaxoSmithKline (GSK) has received administrative dispositions for failing to report changes to the specifications of the main ingredient of its active pharmaceutical ingredient and for issues relating to the drug containers. The Ministry of Food and Drug Safety recently imposed a fine of KRW 52.2 million
- Policy
- Daewoong secures generic Xigduo through a transfer
- by Lee, Tak-Sun Jul 29, 2024 05:48am
- Daewoong Pharmaceutical has secured a generic version of the diabetes treatment Xigduo XR Tab (metformin hydrochloride/dapagliflozin propanediol hydrate) through a transfer and acquisition deal. The drug will be covered by reimbursement and introduced to the market in August. With the addition of generic Xigduo XR Tab, Daewoong Pharmaceuti
- Policy
- P3T for new insomnia drug will be conducted in KOR
- by Lee, Hye-Kyung Jul 29, 2024 05:47am
- The Swiss biotechnology company Idorsia will conduct a Phase III clinical trial in Korea for ACT-541468 (daridorexant), its new drug candidate for insomnia. The Ministry of Food and Drug Safety (MFDS) approved Nxera Pharma Korea's application for a "multicenter, randomized, double-blind, placebo-controlled, parallel-group, Phase III clin
- Policy
- KDCA "Will secure budget for domestic mRNA vaccine dev."
- by Lee, Jeong-Hwan Jul 26, 2024 05:47am
- The Korea Disease Control and Prevention Agency (KDCA) announced that they will focus on securing national budget to develop Korea-made mRNA vaccines and secure platforms, supporting up to phase 3 trials. Its vision is to secure domestic mRNA technology based on Japan's case. Japan designated companies that could develop domestic vaccine
- Policy
- Will Rinvoq’s pediatric indication be expanded in KOR?
- by Lee, Hye-Kyung Jul 26, 2024 05:47am
- AbbVie Korea will conduct a clinical trial in Korea to expand the indication of its atopic dermatitis drug Rinvoq (upadacitinib) to children aged 2 to 12 years old. On the 24th, the Ministry of Food and Drug Safety (MFDS) approved AbbVie’s application to initiate a Phase III, open-label, blinded trial (START UP) to compare the safety and
