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2025-05-04 09:37
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Policy
[Reporter's view] Focus on non-face-to-face contraceptives
by
Lee, Jeong-Hwan
Sep 14, 2023 06:37am
The Ministry of Health and Welfare will hold a public hearing to prepare a reform plan for the non-face-to-face medical treatment pilot project from 2 p.m. today (14th). After disclosing the status of the pilot project, the plan is to hold a panel discussion to hear opinions from the medical community, pharmaceutical industry, platform app i
Policy
Monterizine generics prepare for release in Oct
by
Lee, Tak-Sun
Sep 13, 2023 05:28am
Companies are preparing to release their generic versions of Hanmi Pharm¡¯s Monterizine (Montelukast+Levocetirizin) in October at the earliest. The generic drugs that were approved in August obtained first generic exclusivity and were able to move up their reimbursement listing date. According to the industry sources on the 8th, the p
Policy
BT public-private council will soon resume operations
by
Lee, Jeong-Hwan
Sep 13, 2023 05:28am
The Ministry of Health and Welfare is expected to soon resume the operation of the 'BT (breakthrough therapy) Public-Private Council', a pharmaceutical industry discussion body necessary for establishing and implementing BT price preference policies. The Ministry of Health and Welfare is expected to establish standards for preferential dr
Policy
Will Enhertu pass PE evaluations for reimb in KOR?
by
Lee, Tak-Sun
Sep 13, 2023 05:28am
Due to delays in the review of the economic feasibility of the anticancer drug Enhertu (trastuzumab deruxtecan), the industry is seeing delays in its reimbursement agenda being submitted for deliberation to the Drug Reimbursement Evaluation Committee. The agenda had previously passed the Cancer Disease Deliberation Committee review after re
Policy
Forxiga's generics, advertised for off-label indications
by
Lee, Hye-Kyung
Sep 12, 2023 05:37am
Forxiga's generic development companies that promoted 'chronic heart failure, chronic kidney disease' in their drug advertisements were subject to administrative sanctions. On August 18th and 22nd, the Ministry of Food and Drug Safety suspended Boryung and Aju Pharmaceuticals from advertising for products containing Dapagliflozin for thre
Policy
Pfizer¡¯s ALL drug Besponsa renews RSA in KOR
by
Lee, Tak-Sun
Sep 12, 2023 05:37am
&160; Pfizer Korea¡¯s&160;acute&160;lymphoblastic leukemia (ALL) treatment ¡®Besponsa (inotuzumab ozogamicin)¡¯ has recently renewed its risk-sharing agreement (RSA) with the government.&160; &8232; The company had signed an Expenditure Cap Type RSA for the drug in 2019. &8232; According to the National Health Insurance Service and
Policy
Vytorin generics suffer blow from reevaluations
by
Lee, Tak-Sun
Sep 11, 2023 05:30am
The hyperlipidemia combination ¡®Vytorin (ezetimibe+ simvastatin) suffered a direct blow from the insurance price ceiling reevaluations conducted in Korea. As a result, only two companies were able to maintain the highest insurance ceiling price for their generics. In particular, Genuone Sciences was the only company to maintain the highes
Policy
Next year's new drug R&D budget: 58 billion won
by
Lee, Jeong-Hwan
Sep 8, 2023 05:34am
The Ministry of Health and Welfare has set the national new drug development (R&D) budget for next year (2024) to 57.99 billion won, an increase of about 16.1 billion won from this year's budget of 41.19 billion won. 10.4 billion won was allocated to research to expand the new drug base, 16.5 billion won to research to build a new drug R&D e
Policy
Advanced biologics to receive expedited review
by
Lee, Hye-Kyung
Sep 8, 2023 05:33am
Advanced biological drugs that have demonstrated a significant improvement in safety or effect compared to existing treatments will be regarded as ¡®drugs with no alternatives¡¯ and allowed to receive expedited review in Korea. Until now, only advanced biopharmaceuticals with limited scope of application (such as patients who have posit
Policy
Yooyoung will newly release repackaged flagship Pravafenix
by
Lee, Tak-Sun
Sep 7, 2023 03:50pm
Yooyoung Pharmaceutical has voluntarily withdrawn the marketing authorization for its product, ¡®Pravafenix Cap¡¯, as the product is due for a packaging renewal. As a flagship product, Pravefenix Cap has been recording annual sales of approximately 20 billion KRW. The newly self-packaged product is expected to be listed for reimbursement
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