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- 2021-08-05 05:02
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Membership login access would be required from February 2020 to access more news and website services.
- Policy
- No prior approval req. filed for Soliris, 47 for Ultomiris
- by Lee, Hye-Kyung Aug 4, 2021 06:01am
- ‘Ultomiris (ravulizumab),’ a follow-on drug of ‘Soliris (eculizumab)’ that was approved for reimbursement from June, has taken away all new prescriptions for the treatment of paroxysmal nocturnal hemoglobinuria (PNH) from Soliris. Reimbursement for Ultomiris, like Soliris, needs to be authorized in advance through a prior authorization ap
- Policy
- Will changes be made to Hemlibra’s reimbursement standards?
- by Lee, Jeong-Hwan Aug 4, 2021 06:01am
- As the Anti-Corruption & Civil Rights Commission (ACRC) in addition to the National Assembly raised the need to ease the reimbursement standards for the hemophilia treatment Hemlibra (emicizumab), the growing sense of urgency on the Ministry of Health and Welfare (MOHW) and the Health Insurance Review and Assessment Service (HIRA)’s behalf
- Policy
- Daewoong has added a line-up of osteoporosis treatments PO
- by Lee, Tak-Sun Aug 3, 2021 08:27pm
- Daewoong's Evimax 45mg was approved on July 29. It is generic for Raloxifene HCl 45mg. The original for Raloxifene HCl is Evista from Alvogen Korea. Evista contains Raloxifene HCl 60 mg. Raloxifene HCl 45mg was first developed by Yuhan. In September 2019, Yuhan was granted 'Raboni 45mg', a product containing Raloxifene HCl 45mg. The comp
- Policy
- The number one treatment for mild COVID is Kaletra
- by Kim, Jung-Ju Aug 3, 2021 08:24pm
- The number one drug used to treat mild COVID in the first half of this year was AbbVie's Kaletra, which amounted to &8361;596 million. The total amount of drugs spent on the entire treatment, including severe cases, amounted to &8361;12.1 billion. Among the data on "COVID-19 Treatment Expenditure in the first half of the year," the "Status
- Policy
- Pfizer aims to commercialize PF-07321332 by the end of 2021
- by Lee, Tak-Sun Aug 3, 2021 08:09pm
- On the 29th, the MFDS approved 3 multi-national clinical plans for "PF-07321332," a candidate for COVID-19 oral treatment applied by Pfizer. The first clinical trial was the oral administration of PF-07321332 to prevent postmortem infections in adults who had contact with people with COVID-19, and the validity and safety of Ritonavir's tw
- Policy
- Peramivir has earned its generic exclusivity
- by Lee, Tak-Sun Aug 2, 2021 08:41pm
- JW Life Science is the first known Peramivir drug to win a generic for exclusivity. It is known to have been applied by JW Life Science's premium technology. Premix preparation is an injection that does not need to be diluted with saline water and is convenient to use. However, GC Pharma and Chong Kun Dang were also allowed to impose prem
- Policy
- Reimbursement criteria for Cosentyx and Taltz inj. expanded
- by Kim, Jung-Ju Aug 2, 2021 06:06am
- Secukinumab injections such as Novartis Korea’s Cosentyx injection and Ixekizumab injections such as Lilly Korea’s Taltz prefilled syringe injection will be covered as first-line biologics for active and progressive psoriatic arthritis refractory to DMARDs. Also, the monitoring cycle of liver and electrolyte levels in patients for orall
- Policy
- Teva's new migraine drug Fremanezumab is released in Korea
- by Lee, Tak-Sun Jul 30, 2021 05:47am
- Teva's new migraine treatment drug Fremanezumab is released in Korea. It was approved by the U.S. Food and Drug Administration (FDA) in May 2018 in the calcitonin gene-released peptide (CGRP) family. The MFDS approved two items of Handok Teva's migraine prevention drug Ajovy on Wednesday. Two formulations of Ajovy Prefilled Syringe and Aj
- Policy
- MSD's Sinemet products have been withdrawn
- by Lee, Tak-Sun Jul 29, 2021 05:52am
- All three items of MSD's Sinemet (Carvidopa-Levodopa) were withdrawn as of Monday. Accordingly, the same active ingredient containing product in Korea is Perkin by Myungin. It is analyzed that Sinemet has lost its competitiveness since the launch of Stalevo (Carvidopa, Entacapone, Levodopa). The MFDS dropped Sinemet CR, Sinemet 25/100 a
- Policy
- Regulations are required on GMP violations
- by Lee, Jeong-Hwan Jul 28, 2021 05:54am
- The National Assembly is discussing legislation with health authorities on health insurance finances for the recovery of drug benefits from pharmaceutical companies, which filed a lawsuit to cancel the disposal of drug price cuts for fraudulent purposes. It is also discussing ways to enhance stability of quality of domestic manufactured me
