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2025-10-23 22:12
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Policy
Tadalafil, only concern for abuse in erectile dysfunction
by
Lee, Hye-Kyung
Mar 11, 2025 05:54am
¡¯Tadalafil,¡¯ whose indications have been expanded to treat not only erectile dysfunction but also benign prostatic hyperplasia, is expected to partially get rid of the shackles of being a drug with concerns for misuse and abuse. According to the Ministry of Food and Drug Safety's ¡°Partial Amendment to the Regulations on Designation of D
Company
Besremi demonstrates effects in polycythemia vera
by
Whang, byung-woo
Mar 11, 2025 05:54am
"In polycythemia vera, 10&8211;20% of patients develop resistance or intolerance to hydroxyurea treatment. Since no other treatment option is available, reimbursement for the new treatment option must be considered." Although the average survival for polycythemia vera is around 14.1 years, typically considered a comparatively lower mortality
Company
Celltrion¡¯s Xolair biosimilar Omlyclo is approved in the US
by
Chon, Seung-Hyun
Mar 11, 2025 05:54am
Celltrion announced on the 10th that ¡®Omlyclo,¡¯ its biosimilar version of ¡®Xolair¡¯ has was approved by the US Food and Drug Administration (FDA). Xolair is an antibody biologic used for allergic asthma, chronic rhinosinusitis with nasal polyps (CRSwNP), and chronic spontaneous urticaria (CSU). Xolair posted global sales of approximate
Policy
Keytruda will be considered for DREC next time
by
Lee, Tak-Sun
Mar 11, 2025 05:54am
The expanded use of scope application of the immune cancer drug Keytruda, which passed the Cancer Disease Review Committee, is expected to be considered for the Drug Reimbursement Evaluation Committee (DREC) review as soon as April. Previously, the 2nd DREC review for 2025, held on March 6, did not include Keytruda. As Keytruda's DREC rev
Company
AbbVie¡¯s Rinvoq to benefit most from changes in KOR
by
Whang, byung-woo
Mar 10, 2025 06:05am
Expansion has been growing on the expansion of related prescription markets with the government approving reimbursement for switching between atopic dermatitis treatments, which has been in high demand in the field. The industry expects an increased number of treatment options and an expanded scope of reimbursement to enable more effective tr
Company
Greenlight for reimbursement of ' Tepmetko'
by
Eo, Yun-Ho
Mar 10, 2025 05:51am
The MET-targeted anticancer drug 'Tepmetko' has gained the greenlight to the insurance reimbursement coverage. According to industry sources, Merck Korea has agreed to the drug pricing negotiations with the National Health Insurance Service (NHIS) for its Tepmetko (tepotinib), a treatment for patients with topically advanced or metastati
Opinion
[Reporter's View] K-Bio's global entry and transparency
by
Whang, byung-woo
Mar 10, 2025 05:51am
The active overseas expansion of domestic bio companies is considered to be one of the essential strategies for continuous growth. News is coming in on domestic companies participating in overseas academic societies and conferences. This has become an important strategy for strengthening competitiveness and building trust in the global ma
Company
The cardiomyopathy drug 'Vyndamax' is reimbursed
by
Whang, byung-woo
Mar 10, 2025 05:50am
'Vyndamax,' a new drug for the treatment of transthyretin amyloid cardiomyopathy, has recently been added to the insurance reimbursement list after five attempts. Three years have passed since the company initially applied for the listing. Consequently, the prescription of Pfizer Korea's Vyndamax (tafamidis 61 mg) is now covered with reimb
Policy
734 SGLT2is add precautions for ketoacidosis
by
Lee, Hye-Kyung
Mar 10, 2025 05:50am
Precautions for antidiabetic SGLT2 inhibitors will be strengthened in the near future. 734 ertugliflozin, empagliflozin, and dapagliflozin drugs that have been approved in Korea are expected to be subject to the changed regulations. The Ministry of Food and Drug Safety will prepare an ¡®Order for labeling changes (draft)¡¯ based on the
Company
Reimb approval JAKi switching can change RA treatment in KOR
by
Son, Hyung Min
Mar 7, 2025 05:56am
¡°The realistic goal for treating rheumatoid arthritis is remission, not cure. With various treatment options introduced for the disease, patients can expect good results if they start treatment by administering the right treatment for them. In particular, since switching is now allowed for oral treatment options like JAK inhibitors, this ma
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