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2025-09-11 19:52
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Policy
Domestic new drug No. 36 Envlo has been approved
by
Lee, Hye-Kyung
Dec 5, 2022 05:53am
Envlo 0.3mg, the 36th domestic development new drug, has been approved in Korea. The Ministry of Food and Drug Safety (Director Oh Yoo-kyung) announced on the 30th that it has approved Daewoong Pharmaceutical's Envlo to improve blood sugar control in patients with type 2 diabetes. Envlo is an adjunct to diet and exercise therapy administer
Policy
Roche¡¯s Lunsumio receives 1st GIFT designation in Korea
by
Lee, Hye-Kyung
Dec 1, 2022 05:46am
The Ministry of Food and Drug Safety (Minister: Yu-Kyung Oh) announced that it had designated Roche Korea¡¯s ¡®Lunsumio Inj (mosunetuzumab)¡¯ as the first product subject to the Global Innovative product on Fast Track (GIFT) program it has been operating since September to support the development of innovative medical products in Korea.
Policy
The price of Donepezil 5mg fell below 500 won
by
Lee, Tak-Sun
Dec 1, 2022 05:46am
Donepezil, which is most commonly used to treat dementia, fell to less than 500 won for 5mg due to the step-type drug price implemented in July 2020. The drug prices refer to 85% of the lowest price of the upper limit of the same product registered if more than 20 products are registered. According to industries on the 29th, Donepezil HCl app
Policy
Pediatric drugs eligible for PE exemptions from January
by
Kim, Jung-Ju
Dec 1, 2022 05:46am
The government expects the ¡®Measures to Improve Patient Access and Reinforce Reimbursement Management for High-Priced Severe Disease Treatments¡¯ that gained industry attention for increasing the scope of use of the pharmacoeconomic evaluation exemption system (PE exemption system) will be applied to drugs that apply for reimbursement in J
Policy
First Forxiga follow-on Dapapro listed at KRW 684
by
Lee, Tak-Sun
Nov 29, 2022 05:54am
The first follow-on of the antidiabetic SGLT-2 inhibitor ¡®Forxiga Tab (dapagliflozin, AstraZeneca)¡¯ will be listed at ¡®Dapapro Tab¡¯ with reimbursement at KRW 684 on December 1. The price has been set at 90% of the original due to premium pricing as a data submission drug due to salt modification, etc. Dapapro Tab succeeded in avoid
Policy
Avastin biosimilar will be reimbursed starting next month
by
Lee, Tak-Sun
Nov 29, 2022 05:53am
Celltrion's Avastin biosimilar Vegzelma will be listed on the 1st of next month. As a result, Roche, which owns the original Avastin, has joined Alvogen Korea, a biosimilar company, Samsung Bioepis, and Celltrion, making the market competition a four-way race. According to industries on the 25th, Celltrion Vegzelma's 0.1g and 0.4g will be
Policy
Actilyse's price to rise 15% from next month
by
Kim, Jung-Ju
Nov 28, 2022 05:50am
The price of Boehringer Ingelheim¡¯s acute myocardial infarction treatment Actilyse Inj. (alteplase) will rise 15% from next month after applying for drug pricing adjustments. Aju Pharm¡¯s acute back pain reliever (aceclofenac, eperisone hydrochloride) will newly receive a 10% premium for 1 year. Also, the 30.4% premium pricing for Hanmi Phar
Policy
Crysvita, referred to the welfare committee
by
Lee, Jeong-Hwan
Nov 28, 2022 05:50am
A petition for national consent calling for quick approval of the rapid use of "Crysvita," a treatment for hypophosphatemia, a rare disease, was recently referred to the National Assembly's Health and Welfare Committee with 50,000 consent. Crysvita is a treatment for XLH hypophosphatemia rickets and osteomalacia supplied by Kyowa Kirin Korea
Policy
IVI-Biovac has signed an agreement to develop an OCV
by
Lee, Hye-Kyung
Nov 28, 2022 05:49am
The International Vaccine Research Institute (IVI) announced on the 24th that it has signed a license and technology transfer agreement with Biovac, located in South Africa, for the local manufacture of IVI's OCV. This agreement is meaningful in securing the manufacturing capacity of raw materials, that is, the ability to produce antigens/raw
Policy
SGLT2+DPP4 standards expanded, will it be over again?
by
Lee, Tak-Sun
Nov 24, 2022 05:51am
The expanded application of salary standards for the combination of diabetes treatment SGLT-2 inhibitor-based drugs and DPP-4 inhibitor-based drugs is expected to pass another year. Since the Korean Diabetes Association requested expansion in 2016, there have been expectations for application within this year as full-scale discussions hav
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