- Policy
- Fitusiran for hemophilia receives orphan drug designation
- by Lee, Hye-Kyung May 9, 2025 06:01am
- A long-acting treatment for all types of hemophilia, administered every 2 months, has been designated as an orphan drug in South Korea. According to the “Regulations on the Designation of Orphan Drugs” released by the Ministry of Food and Drug Safety on the 7th, Sanofi's Fitusiran was designated as the 386th orphan drug in Korea. Fitusi
- Company
- U.S. issues orders to produce pharmaceuticals domestically
- by Kim, Jin-Gu May 9, 2025 06:00am
- An executive order issued by U.S. President Donald Trump to promote domestic production of medicines could impose additional burdens on Korean pharmaceutical and biotech companies seeking entry into the U.S. market. Included among the order’s provisions is a requirement to strengthen inspections of manufacturing facilities outside the
- Company
- Pharma closely watches tariffs as U.S. sales surge
- by Chon, Seung-Hyun May 9, 2025 06:00am
- South Korea’s pharmaceutical and biotech companies are focusing on potential tariffs on U.S. exports of their medicines. President Donald Trump’s announcement that tariffs would be imposed on imported pharmaceuticals has left major exporters considering devising countermeasures. Celltrion, whose North American sales have topped KRW 1 trillion,
- Policy
- Ofev reimbursed from May... inflow of generic versions
- by Lee, Hye-Kyung May 9, 2025 05:59am
- The generic drug market is growing for Boehringer Ingelheim's idiopathic pulmonary fibrosis treatment ‘Ofev Soft Capsules (nintedanib),’ which was granted reimbursement and was listed from this month, 8 years after approval. On the 7th, the Ministry of Food and Drug Safety approved 2 items, 100 mg and 150 mg of Whan In Pharm’s ‘Ofenip
- Company
- Lilly retries to make RET-targeted therapy accessible
- by Eo, Yun-Ho May 8, 2025 06:09am
- Patients are hopeful again for RET-targeted cancer therapy, a treatment option once deemed 'pie in the sky.' According to industry sources, Lilly Korea has recently submitted an application for insurance reimbursement listing for its RET (REarranged during Transfection) inhibitor 'Retevmo (selpercatinib),' indicated for the treatment of n
- Company
- BIO KOREA 2025 'Innovation and Collaboration'
- by Whang, byung-woo May 8, 2025 06:09am
- With open innovation emerging as a key topic for fostering a bio ecosystem, scalability based on networking has become a necessity rather than a choice. BIO KOREA 2025, which opened on the 7th, also kicked off its three-day journey with various programs under the theme of “Innovation and Collaboration: Building the Future Together,” marking
- Company
- Industry asks US to exempt Korean drugs from tariffs
- by Kim, Jin-Gu May 8, 2025 06:09am
- In preparation for the US government's potential imposition of tariffs on pharmaceuticals, the Korea Biotechnology Industry Organization (KoreaBIO) has followed the Ministry of Health and Welfare in submitting an official opinion statement. The opinion statement submitted to the US government states that South Korea is a reliable partner i
- Company
- FDA approves Huons' two Lidocaine Inj products
- by Lee, Seok-Jun May 8, 2025 06:08am
- Huons has received U.S. Food and Drug Administration (FDA) approval for two of its lidocaine local anesthetic products, marking its expansion into the North American market. On the 7th, Huons (CEO Soo-young Song) announced that it has obtained FDA approval for its “1% Lidocaine 200 mg/20 mL” and “(2% Lidocaine 400 mg/20 mL multi-dose
- Company
- Global pharmas showcase results at ARVO 2025
- by Cha, Jihyun May 8, 2025 06:08am
- The Association for Research in Vision and Ophthalmology (ARVO 2025) began on May 4 (local time) in Salt Lake City, Utah, USA. ARVO is the world's largest meeting of vision and ophthalmology researchers, attracting over 10,000 participants each year, and ARVO 2025 is being held over five days at the Salt Palace Convention Center. The exhibiti
- Company
- Supreme Court rules in favor of Pharmbio’s Elpag Tab
- by Nho, Byung Chul May 7, 2025 06:02am
- On the 30th, Pharmbio Korea announced that it had won the final appeal in the patent dispute with Novartis, the patent holder of the original drug Revolade (eltrombopag olamine), for its immune thrombocytopenia treatment Elpag (eltrombopag olamine). Pharmbio Korea filed a request for a judgment on the scope of rights for 3 formulation pat
