- 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
- Opinion
- [Reporter's View] Concerns about new drugs for rare diseases
- by Son, Hyung Min Mar 7, 2025 05:56am
- Duchenne muscular dystrophy is a rare muscular disorder caused by the lack of dystrophin, primarily affecting boys. The symptoms typically begin before the age of 3 and rapidly deteriorate, eventually leading to the loss of ability to walk before the age of 10 and above. To date, various genetic targeted therapies for Duchenne muscular d
- Opinion
- [Desk's View] Regulatory changes disrupt the generic mkt
- by Chun, Seung-Hyun Mar 5, 2025 06:00am
- The strategies of Korean pharmaceutical companies for entering generic markets have significantly changed over the past few years. Pharmaceutical companies made entries and withdrawals indiscriminately because of the government's regulatory changes. According to the Ministry of Food and Drug Safety (MFDS) report, prescriptions with approva
- Opinion
- [Reporter's View] Gov't OKs JAK inhibitor drug switching
- by Eo, Yun-Ho Feb 26, 2025 06:30am
- It has been a flexible and swift measure. Drug-switching between JAK inhibitors and biological agents for the treatment of severe atopic dermatitis will be reimbursed starting in March. The Ministry of Health and Welfare (MOHW) issued an administration notice of a partial revision draft of the pharmaceutical long-term care reimbursement requ
- Opinion
- [Reporter's View] Empty marketing of innovative new drugs
- by Son, Hyung Min Feb 18, 2025 05:53am
- As new drugs, such as antibody-drug conjugate (ADC), radiopharmaceutical, gene therapy, obesity drugs, and medications for Alzheimer's disease, have been introduced in various refractory disease areas, follow-on drug research & development (R&D) are gaining popularity. Companies involved in this movement highlight the significance of new d
- Opinion
- [Reporter’s View] Concerns over US drug tariffs
- by Kim, Jin-Gu Feb 13, 2025 05:58am
- The US President Donald Trump has hinted at the possibility of imposing tariffs on drugs imported into the country. Although he says he is still “reviewing” the matter, it would not be surprising if he signs a tariff declaration at any time. The United States has played a major role in the recent development of the Korean pharmaceutical
- Opinion
- [Reporter's View] KRW 400m drug approval fee
- by Lee, Hye-Kyung Feb 12, 2025 06:13am
- Now, the new drug approval fee in South Korea costs KRW 410 million. On September 9th, 2024, the Ministry of Food and Drug Safety (MFDS) issued an administrative notice of 'Revision to the Regulation of Fees for Pharmaceutical Approval.' The revision specifies details of increasing the new drug approval fee to KRW 410 million and reducing th
- Opinion
- [Reporter’s View] Trodelvy makes way to reimb in KOR
- by Eo, Yun-Ho Feb 10, 2025 05:51am
- The wait was worth it. The triple-negative breast cancer (TNBC) treatment Trodelvy (sacituzumab govitecan-hziy) has passed the Drug Reimbursement Evaluation Committee review, nearly 15 months after passing the Health Insurance Review and Assessment Service’s Cancer Disease Review Committee review. The most promising aspect of the news
- Opinion
- [Reporter's View] Slow but steady wins the race
- by Whang, byung-woo Feb 4, 2025 05:55am
- The Korean government has finally launched the National Bio Commission. The launch of this proper control tower has come several years after the government declared the bio-health industry as a national strategic industry. The news of its launch is encouraging, considering how the launch of the committee itself was almost stranded due to
- Opinion
- [Reporter's View] Improving rare disease care environment
- by Eo, Yun-Ho Jan 17, 2025 05:54am
- A few patients can only make a small noise. Despite the need for the improvement of the rare disease treatment environment, which has risen year after year, the voice of its patients that implore difficulties has never ceased to exist. In particular, there are cases where a drug is available, but due to the small number of eligible patien
