- Policy
- Galvus SR developed by Alvogen, 100mg once daily
- by Lee, Tak-Sun Dec 13, 2019 06:34am
- Alvogen Korea is trying to differentiate itself from domestic competitors by developing Galvus SR tablets. The drug Alvogen develops is a sustained-release multi-layered tablet containing Vilagliptin, which is known to be taken once a day, unlike the original. The MFDS approved Alvogen Vildagliptin SR tablet’s clinical protocols on the 2
- Company
- Lilly releases first non-reimbursed 'Emgality'
- by Eo, Yun-Ho Dec 13, 2019 06:34am
- Eli Lilly's migraine new drug 'Emgality' was released in Korea. Lilly Korea announced on the 12th that it will release non-reimbursed CGRP-targeted migraines prevention drug, Emgality (Galcanezumab). This drug is a humanized monoclonal antibody that binds to the Calcitonin gene-related peptide (CGRP) molecule which plays a key role in ca
- Product
- Stock-out Cytotec and Livalo V supply to resume from January
- by Kim, Min-Gun Dec 12, 2019 10:52pm
- Some doses of Pfizer Korea’s stomach ulcer preventing drug Cytotec (misoprostol) has run out of stock and the company say the supply would resume around early next year. Sources from the pharmaceutical industry reported on Dec. 11 that there is a temporary shortage on 200 mcg 120 BTL dose of Cytotec. Pin pointing at the delay in manu
- Policy
- 'WHO PQ' for 3 domestic vaccines, including Skycellflu
- by Lee, Jeong-Hwan Dec 12, 2019 10:52pm
- Three domestic vaccines have secured international procurement bidding rights, obtaining WHO Prequalification (PQ). SK Bioscience's Sky Cellflu Multi inj, Sky Cellflu inj, and Sky Varicella inj are the main characters. On the 11th, the Ministry of Food and Drug Safety (The Minister, Eui-Kyung Lee) said, "The domestic vaccines passed the W
- Policy
- RSA opening more doors to new drugs, even to follow-ons
- by Kim, Jung-Ju Dec 12, 2019 06:31am
- More doors are to be opened for high-cost drugs to take the risk sharing agreement (RSA) track and to enhance patients’ access to treatments. The key change is to be made on the RSA eligibility, which was initially limited to first-in-class drug, to include follow-on drug. Accordingly, the RSA is expected to be available for highly unce
- Policy
- Court controversy, the price of Synovian reduction postponed
- by Kim, Jung-Ju Dec 12, 2019 06:31am
- LG Chemicals dissatisfied with the drop in insurance prices, and the price of 3 ml of Synovian (BDDE cross-linked sodium hyaluronate gel), which is fighting a legal battle with the government, is being provisionally maintained. The trial is in progress, and the court has limited the time limit from the date of the sentence to 30 days. T
- Company
- Metformin? Pharmaceuticals, maximizes fear of impurities
- by Chon, Seung-Hyun Dec 12, 2019 06:31am
- In the pharmaceutical industry, fear of impurities rarely disappears. As the aftershocks of Valsartan, Ranitidine, and Nizatidine persist, the possibility of detecting impurities in the diabetic Metformin has emerged. Metformin is the most widely used drug for primary diabetes treatment. Therefore, if the drug is suspended due to the detection
- Policy
- 5 years after the drug patent linkage system
- by Lee, Tak-Sun Dec 12, 2019 06:30am
- "There are many cases where overseas pharmaceutical companies have succeeded in using the US-licensed patent linkage system. But Korean pharmaceutical companies haven't even tried it. It's time to think about why they are not using the system". More than five years have passed since the introduction of Korean licensed patent linkage system
- Policy
- 10 new rare diseases applied with special case from 2020
- by Kim, Jung-Ju Dec 11, 2019 10:20pm
- Special case insurance benefit would be applied on ten new rare diseases including adult-onset Stills disease and Kienbock’s disease from next year. Korean Ministry of Health and Welfare (MOHW) issued a revised notice on Tuesday of ‘Standard on Special Case Insurance Benefit for Individual Copayment’ reflecting the changes. The specia
- Company
- China okays Samsung’s Herceptin biosimilar Phase 3 trial
- by Lee, Seok-Jun Dec 11, 2019 10:20pm
- The Chinese health authority has green lit Samsung Bioepis’ first clinical trial in China. On Dec. 10, Samsung Bioepis announced China’s National Medical Products Administration (NMPA) has approved the company’s Phase 3 investigational new drug protocol on SB3, a biosimilar version of Hercpetin with trastuzumab. The first patient of
