- Policy
- The MFDS announces it will shorten the lot release period
- by Lee, Tak-Sun Dec 29, 2020 06:08am
- The MFDS announced on the 27th that a preliminary review is currently underway for three items of COVID-19 vaccines developed by overseas pharmaceutical companies, and that a domestic antibody treatment development company is planning to apply for use approval within this month. The MFDS said that it would approve the COVID-19 vaccine with a tar
- Company
- High import drug dependency, Korean drug ratio keeps falling
- by Chon, Seung-Hyun Dec 29, 2020 06:08am
- The dependency on imported pharmaceutical products in the South Korean market seems to be getting higher. The volume of the country’s locally manufactured complete product and active pharmaceutical ingredient (API) has fallen for two consecutive years. The self-sufficiency in API has even halved in just two years. According to the ‘Food an
- Policy
- Stop the politicization of COVID-19!
- by Lee, Jeong-Hwan Dec 28, 2020 07:25pm
- Cheongwadae directly refuted criticism from some media and opposition parties that President Moon Jae-in and the government coping with the lack of efforts to secure COVID-19 vaccine supplies. Since last April, President Moon's instructions regarding securing the corona vaccine have been disclosed, and a strong appeal to stop the politica
- Company
- Technology exports are active despite COVID-19 outbreak
- by An, Kyung-Jin Dec 28, 2020 06:14am
- The world is struggling with the surprise attack of COVID-19, but domestic pharmaceutical and bio companies' new drug technology export performance is very active. SK Biopharm received the most down payment for the second consecutive year as it transferred the copyright to the Japanese region for a new epilepsy drug developed with its own tec
- Company
- Hanmi and SK win the final round of Xarelto patent dispute
- by Kim, Jin-Gu Dec 28, 2020 06:13am
- South Korean pharmaceutical companies won the patent dispute on Bayer’s non-Vitamin K antagonist oral anticoagulants (NOAC) Xarelto (rivaroxaban). As a result, Hanmi Pharmaceutical and SK Chemicals have overcome the last obstacle to prepare an early launch of rivaroxaban generic in next October. On Dec. 24, the Supreme Court ruled in
- Policy
- RSA-renewed Blincyto and PVA Xalkori pricing reduced
- by Kim, Jung-Ju Dec 28, 2020 06:13am
- Amgen Korea’s Blincyto 35 μg (blinatumomab) renewed the risk sharing agreement (RSA) with the National Health Insurance Service (NHIS) prior to its termination. As a result, the pricing was lowered by 11.4 percent, effective from next month. With surging sales, Pfizer Pharmaceutical Korea’s Xalkori (crizotinib) is now categorized as a sub
- Policy
- The MFDS begins preliminary review of Janssen's vaccine
- by Lee, Tak-Sun Dec 28, 2020 06:12am
- Following AstraZeneca and Pfizer, Janssen also applied for a preliminary review to the MFDS for approval. The MFDS announced on the 22nd that Janssen (Johnson & Johnson) has applied for a preliminary review before applying for approval of COVID-19 Vaccine. This vaccine is one of the vaccines that the government has announced plans to i
- Company
- Multinational companies enjoy winter holidays up to 17 days
- by Eo, Yun-Ho Dec 24, 2020 06:10am
- This year, a number of multinational pharmaceutical companies' executives and staff members are entering long-term winter holidays. As a result of Dailypharm's survey of the year-end holidays of 20 major multinational companies on the 23rd, it was confirmed that more than 10 companies designated winter holidays for more than 10 days. In pa
- Policy
- Government TF to counteract pricing reduction litigations
- by Lee, Hye-Kyung Dec 24, 2020 06:10am
- The South Korean health authority is seeking for measure to keep their drug pricing reduction decision effective. Until recently, the Ministry of Health and Welfare (MOHW), the National Health Insurance Service (NHIS) and the Health Insurance Review and Assessment Service (HIRA) have been operating a taskforce for pricing reduction litigatio
- Policy
- TOC prevents the first approval of COVID-19 vaccine in Korea
- by Lee, Tak-Sun Dec 24, 2020 06:10am
- This is a response from the health authorities to concerns that the COVID-19 vaccine developed by AstraZeneca will be introduced in Korea in February-March next year, although approval by the US FDA is delayed. The MFDS is independently screened regardless of overseas institutions. However, Korea's licensing regulations require approval fr
