- Policy
- Item management of accelerated approval is strengthened
- by Lee, Tak-Sun Dec 31, 2020 06:20am
- The MFDS has established a policy that it will not approve the extension of the deadline if the clinical trial is unsatisfactory for phase III accelerated approval item. Periodic reports should be submitted in the middle of Phase III, and surveys will be conducted if necessary for items with no results. It was to supplement this by crea
- Company
- Celltrion has applied for approval of COVID-19 treatment
- by Chon, Seung-Hyun Dec 31, 2020 06:20am
- Celltrion applied for accelerated approval of an antibody treatment COVID-19, the MFDS initiated a review. Celltrion announced on the 29th that it has applied to the MFDS for accelerated approval of CT-P59 (Regdanvimab), COVID-19 antibody treatment. An application for authorization was filed based on the recently ended global phase II clinic
- Company
- Who would manufacture Moderna vaccine in South Korea?
- by Kim, Jin-Gu Dec 31, 2020 06:20am
- President Moon Jae-in and Moderna CEO Stephane Bancel reportedly had a conference call over supplying COVID-19 vaccines for 20 million people in South Korea. Now the question is who would sign the consignment production contract for the vaccine in South Korea. The pharmaceutical industry is mentioning four names of potential candidates, incl
- Policy
- Benlysta is about to be listed as RSA (Refund·Expenditure)
- by Kim, Jung-Ju Dec 31, 2020 06:19am
- Benlysta (Belimumab), a new treatment for systemic lupus erythematosus by GSK, can be listed on the ‘Pharmaceutical Benefit List and Upper Limit Price List’ in February next year as soon as the administrative procedures are carried out sequentially. According to the pharmaceutical industry on the 28th, the government will promote insurance
- Company
- Pradaxa and Xarelto to face generic market opening up soon
- by Kim, Jin-Gu Dec 30, 2020 06:03am
- Six South Korean pharmaceutical companies that successfully evaded Pradaxa (dabigatran) and Xarelto’s (rivaroxaban) patents would release generics in advance in July next year. The industry predicts the non-Vitamin K antagonist oral anticoagulants (NOAC) market currently led by the originals would take a sharp turn soon. Moreover, a generic
- Policy
- Generic for Teribone was approved & the competition began
- by Lee, Tak-Sun Dec 30, 2020 06:02am
- As a treatment for osteoporosis, generics have begun to be released in the latest bone formation promoting agents. Following Lilly's Forsteo, Dong-A ST's Teribone was also a generic version. The MFDS approved Terrosa 56.5μg (Teriparatide acetate) from BMIKOREA on the 28th. Terrosa is a generic of Teribone subcutaneous injection 56.5 μg
- Company
- Samsung Bio & Hanmi will participate at JPM 2021
- by Kim, Jin-Gu Dec 30, 2020 06:02am
- 20 domestic pharmaceutical bio companies announced their participation in the JPMorgan Healthcare Conference, which will be held early next year. Among them, Samsung Biologics was the only one to be assigned a main session presentation. Celltrion, who attended every time, declared absence after 10 years. The JPMorgan Healthcare Conferen
- Company
- Successful year for Korean new drug, biosimilar and test kit
- by An, Kyung-Jin Dec 29, 2020 06:09am
- The year 2020 was a fruitful year for the South Korean companies and their R&D outcomes showcased in the global market. Yuhan Corporation licensed out its novel lung cancer treatment ‘lazertinib’ to Janssen for 100 billion won. SK Biopharmaceutical put the gears in motion for its anti-epileptic drug Xcopri sales in the U.S. market. The
- Policy
- Vaccination will be given for medical staff and the elderly
- by Lee, Jeong-Hwan Dec 29, 2020 06:09am
- The Democratic Party of Korea, the government, and Cheongwadae have decided to start vaccinating COVID-19 from February of next year. On the 27th, the Party, the government, and Cheongwadae held a party government council at the National Assembly to discuss support measures for COVID-19 damage, measures to secure treatment and isolation fa
- Policy
- What are the major systems of the MOHW, the MFDS, & the KCDA
- by Kim, Jung-Ju Dec 29, 2020 06:08am
- From next year, medical expenses for rare diseases and diseases subject to the exempted calculation will be expanded. In addition, the national infrastructure necessary for rapid introduction and verification of the safety and effectiveness of COVID-19 vaccines and treatments using high-tech new technologies will be expanded. The Ministry
