- Policy
- The introduction of vaccine will be discussed after results
- by Lee, Tak-Sun Nov 12, 2020 06:28am
- The MFDS said it would discuss the final clinical results of Pfizer's COVID-19 vaccine, which showed the potential for clinical success, for introduction. Seo Kyung-won, the head of the drug review department at the MFDS, made such a statement at a briefing on the approval status of vaccines for the treatment of COVID-19 held on the 10th
- Policy
- Boryung introduced Symbenda's first generic in Korea
- by Lee, Tak-Sun Nov 12, 2020 06:19am
- Boryung introduces a generic drug which was reimbursed in 2 years ago. Boryung's Bendamustine HCl is the first generic for Symbenda. The MFDS approved Boryung's Bendamustine HCl on the 11th. It is a generic for Symbenda which was approved by Ezai Korea in 2011, and is the first generic in Korea. Symbenda was approved in 2011, but it took sev
- Policy
- Budget Subcommittee passes KRW 965 bln for COVID-19 vaccine
- by Lee, Jeong-Hwan Nov 12, 2020 06:19am
- The Budget and Accounting Evaluation Subcommittee of the National Assembly Health and Welfare Committee has deliberated and decided on the 2021 budget plans for the Ministry of Health and Welfare (MOHW), the Ministry of Food and Drug Safety (MFDS) and the Korea Disease Control and Prevention Agency (KDCA). The subcommittee explained the
- Policy
- Pfizer’s COVID-19 vaccine needs to be reviewed
- by Kim, Jung-Ju Nov 12, 2020 06:19am
- With the interim results announced that the effectiveness of the COVID-19 vaccine being developed together by Pfizer in the United States and BioNTech in Germany is more than 90% effective, the Korean government has decided to take a cautious approach in the future. It is because the clinical results of other products are expected to be re
- Policy
- The re-evaluation of α-GPC will be implemented next month
- by Lee, Tak-Sun Nov 11, 2020 08:48am
- The MFDS stated that the clinical re-evaluation schedule of the brain function improving drug, Choline alfoscerate has not changed. The clinical plan must be submitted by the 23rd of next month. If the deadline is not met, the sale will be suspended immediately. Shin Seung-seung, an official of the Drug Safety Assessment Division of the
- Policy
- Yuhan’s no-food-required fenofibrate tablet approved
- by Lee, Tak-Sun Nov 11, 2020 06:07am
- Yuhan Corporation has received the health authority’s approval on a fenofibrate tablet, orally taken regardless of meal consumption, to treat hyperlipidemia. The form and administration method are unique to the drug only in South Korea. GC Pharma with the original fenofibrate Lipidil supra is also in process of developing a tablet with the
- Policy
- A tough market for new Rosuzet generic
- by Lee, Tak-Sun Nov 10, 2020 06:06am
- Although the door for generics is to open next year when the post marketing surveillance (PMS) period is terminated for the rosuvastatin and ezetimibe combination drug treating dyslipidemia, the market annually generating 150 billion won is actually not expecting any new generic. Many of pharmaceutical companies have already received the
- Policy
- NA “Age over 65 pneumococcal vaccine should use Prevenar13"
- by Lee, Jeong-Hwan Nov 10, 2020 06:05am
- The National Assembly pointed out the National Immunization Program (NIP) for the pneumococcal vaccine for elderly population aged over 65 should be switched from the existing 23-valent pneumococcal protein polysaccharide vaccine (PPSV23) to 13-valent pneumococcal conjugate vaccine (PCV13). The lawmakers claim the state should provide expens
- Policy
- Kang-rip Kim emphasized COVID-19 tx & vaccine development
- by Lee, Tak-Sun Nov 10, 2020 06:05am
- Kang-rip Kim (54 yrs old), the new head of the MFDS, emphasized, "We must concentrate our regulatory competencies as much as possible for the development of COVID-19 treatment and vaccine." At the inauguration ceremony held at the headquarters of the MFDS in Osong, Chungbuk on the evening of the 2nd, he said that he is at the forefront o
- Policy
- MOHW “COVID-19 vaccine-treatment approval early next year”
- by Lee, Jeong-Hwan Nov 9, 2020 06:18am
- Minister Park Neung-hoo of Health and Welfare stated the South Korean government is anticipating a temporary use approval of COVID-19 vaccine in March next year and treatment early year. However, the minister said the vaccine would most likely to be an imported product by a multinational pharmaceutical company, and Korean-made treatment
