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2024-11-03 13:33
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Policy
Stelara biosimilar Steqeyma IV approved for use in Korea
by
Lee, Hye-Kyung
Sep 30, 2024 05:46am
Upon receiving approval for ¡®Steqeyma IV,¡¯ a biosimilar version of the autoimmune disease treatment Stelara (ustekinumab), Celltion has now received approval for all its Steqeyma formulations. By adding the interleukin (IL) inhibitor option to the existing family of tumor necrosis factor (TNF)-¥á inhibitors, which includes Remsima, Rems
Policy
COVID-19 drugs to be reimbursable, "KRW 50,000 co-payment"
by
Lee, Jeong-Hwan
Sep 27, 2024 05:53am
The National Health Insurance will cover two COVID-19 treatments, Paxlovid and Veklury, starting on October 1st. The government will list COVID-19 treatments for reimbursement and make a policy revision to support the patient co-payment at the previous price of KRW 50,000. The National Health Insurance coverage for Takeda Pharmaceutica
Policy
2nd Approval-Evaluation-Negotiation pilot project imminent
by
Kim, Jin-Gu
Sep 26, 2024 05:51am
The initiation of the 2nd pilot project for the ¡®approval-evaluation-negotiation linkage system,¡¯ which was introduced to shorten the time from drug approval to reimbursement, is imminent. The Ministry of Health and Welfare has completed receiving drug submissions for the 2nd pilot project from pharmaceutical companies and is in the final revi
Policy
Higher dosage Eylea expected to strike back at biosimilars
by
Lee, Tak-Sun
Sep 26, 2024 05:51am
The competition in the market for the macular degeneration drug Eylea has recently intensified with Samsung Bioepis and Celltrion, which have recently launched biosimilars. The original developer is set to strike back against the competitors. Bayer will release Eylea Inj 8 mg (aflibercept), with an extended treatment interval, into the
Policy
Potential expanded indication for obestiy drug 'Wegovy'
by
Lee, Hye-Kyung
Sep 26, 2024 05:51am
A clinical trial for Novo Nordisk Pharma's obesity drug, 'Wegovy (semaglutide),' will be conducted in South Korea for expanded indication. On September 20th, the Ministry of Food and Drug Safety (MFDS) has approved the 'Phase 2 clinical trial to evaluate the efficacy, safety, and dosage testing of NNC0519-0130, subcutaneously administere
Policy
First generic version of Qudexy XR Cap is approved in KOR
by
Lee, Hye-Kyung
Sep 25, 2024 05:49am
The first generic version of the topiramate-based extended-release epilepsy treatment ¡®Qudexy XR Cap¡¯ has been approved in Korea. The Ministry of Food and Drug Safety granted marketing authorization for Intrio Biopharma¡¯s ¡®Topimed XR Tab. 50mg¡¯ on the 23rd. Unlike ¡®Qudexy XR Cap¡¯ which is an oblong hard capsule formulation, Topi
Policy
Takeda's drug pricing negotiations see different results
by
Lee, Tak-Sun
Sep 25, 2024 05:48am
The drug pricing negotiations for ¡®Ceprotin (Protein C Concentrate (Human))¡¯ a new drug for severe congenital protein C deficiency supplied by Takeda Pharmaceuticals Korea, fell through. On the other hand, the company reached an agreement and completed negotiations to expand the reimbursement for the ovarian cancer treatment Zejula Cap.
Policy
Pharmbio releases first generic Revolade with reimb in OCT
by
Lee, Tak-Sun
Sep 24, 2024 05:46am
The first generic version of the immune thrombocytopenia treatment ¡®Revolade&160;(eltrombopag&160;olamine)¡¯ will be released into the market in October. Pharmbio Korea¡¯s Revolade generic has succeeded in receiving reimbursement listing 1 year after its approval in Korea. The company had been delaying its launch due to the burden of p
Policy
AZ's bispecific ab 'Rilvegostomig' vs Keytruda trial
by
Lee, Hye-Kyung
Sep 20, 2024 05:51am
A Phase 3 trial comparing a combination therapy containing 'Rilvegostomig (Trial name: AZD2936),' AstraZeneca's bispecific antibody gathering attention as the next-generation medicine, to 'Keytruda (pembrolizumab),' a type of immunotherapy drug used to treat cancer, will be conducted in South Korea. The Ministry of Food and Drug Safety (M
Policy
Cushing¡¯s syndrome drug Isturisa is approved in Korea
by
Lee, Hye-Kyung
Sep 20, 2024 05:51am
Various doses of ¡®Isturisa¡¯ (osilodrostat), a treatment for Cushing's syndrome, are expected to be approved in Korea soon. According to industry sources on the 19th, the Ministry of Food and Drug Safety concluded the safety and efficacy review of Recordati Korea's Isturisa Film Coated Tab 1mg earlier this month and recently completed th
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