- Policy
- HK inno.N starts developing a Lixiana generic
- by Lee, Hye-Kyung Apr 23, 2024 05:36am
- HK inno.N is joining the race to develop a generic version of the NOAC (novel oral anticoagulant) drug Lixiana (edoxaban). The Ministry of Food and Drug Safety recently approved clinical trials to evaluate the bioequivalence of the Lixiana generic ‘IN-G00002’ and IN-R00002 (Lixiana). The IN-G00002 bioequivalence trial will evaluate t
- Policy
- Atopic dermatitis drug Adtralza will be reimb in May
- by Lee, Jeong-Hwan Apr 22, 2024 05:45am
- Leo Pharma Korea’s atopic dermatitis treatment, Adtralza (tralokinumab), will be reimbursed from May 1 in Korea. The reimbursement standards for osteoporosis drugs will also be improved, and patients who show some improvement in bone mineral density will be able to continue receiving reimbursement. As such, JW Pharmaceuticals' iron injec
- Policy
- KMPG ‘We ask for the prompt reimbursement of Xpovio’
- by Kim, Jung-Ju Apr 22, 2024 05:45am
- Patients’ demand for the reimbursement listing of ‘Xpovio 20mg (selinexor),’ a new drug for multiple myeloma that was developed by the Chinese pharmaceutical company Antengene, is growing. The patients are claiming that they are becoming ‘medical poor’ due to the delay in the reimbursement of the only option available in the area. Xp
- Policy
- Will the 37th new drug in Korea receive approval?
- by Lee, Hye-Kyung Apr 22, 2024 05:45am
- The approval for the 37th new drug in Korea is approaching. According to industry sources on the 22th, the Ministry of Food and Drug Safety (MFDS) completed the safety and efficacy assessment of the three zastaprazan-containing products from Onconic Therapeutic, Jeil Healthscience, and Jeil Pharmaceutical. The completion of the safet
- Policy
- Reimb expansions of Keytruda have failed the 4th CDRC
- by Lee, Tak-Sun Apr 19, 2024 06:24am
- Keytruda’s reimbursement expansion item did not cross the Cancer Disease Review Committee (CDRC) threshold for the fourth time following its expansion in June last year. The analysis is that this attempt is particularly significant as all 15 indications were reviewed by the CDRC, and MSD’s financial contribution proposal was discussed f
- Policy
- Impurity detected in single-agent entacapones
- by Kang, Shin-Kook Apr 19, 2024 06:24am
- t has been confirmed that impurities have been detected in entacapone, a single-agent drug used to treat symptoms of Parkinson's disease. According to medical and pharmaceutical organizations on the 18th, the Ministry of Food and Drug Safety began reviewing safety measures, including setting necessary temporary permissible limits based
- Policy
- Four Otezla generics were authorized simultaneously in Korea
- by Lee, Hye-Kyung Apr 19, 2024 06:24am
- Four generic versions of Amgen's oral psoriasis drug Otezla (Apremilast) have been approved simultaneously in Korea. With the resolution of Otezla’s 'use patent' issue, which had served as an obstacle to the launch of generics, domestic pharmaceutical companies that have previously succeeded in avoiding the drug’s composition patent see
- Policy
- PVA exemptions expanded to drugs below KRW 3 billion
- by Lee, Tak-Sun Apr 18, 2024 05:54am
- Effective this year, the price-volume agreement (PVA) criteria will be expanded to provide an exemption to products with a claim amount below KRW 3 billion. This amount represents an increase from the previous criteria, which was below KRW 2 billion. Also, any product that has undergone more than two price reductions in the last five yea
- Policy
- KRW 10 Bil antiemetic drug Akynzeo seeks reimb for injection
- by Lee, Tak-Sun Apr 18, 2024 05:54am
- HK inno.N is expanding the lineup of 'Akynzeo,' a medicine used to prevent vomiting in cancer patients. In addition to the capsule formulation currently covered by health insurance, the company has applied for reimbursement to the Health Insurance Review and Assessment Service (HIRA) for Akynzeo inj. According to industry sources on the
- Policy
- Will Fasenra be applied RSA for reimbursement in KOR?
- by Lee, Tak-Sun Apr 18, 2024 05:54am
- AstraZeneca has entered into drug price negotiations with the National Health Insurance Service for its ‘Fasenra Prefilled Syringe Inj (benralizumab, AZ),’ a severe eosinophilic asthma treatment that passed the Health Insurance Review and Assessment Service's Drug Reimbursement Evaluation Committee review in March. With other drugs wit
