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- 2020-07-12 13:13
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Membership login access would be required from February 2020 to access more news and website services.
- Policy
- Mixed responses on exempting PE for antibiotics
- by Eo, Yun-Ho Jul 10, 2020 06:14am
- The people are voicing both positive and negative reactions on the pharmacoeconomic evaluation (PE) exemption track opened to antibiotics. Considering the unique characteristic of the drug, expanding the coverage on antibiotics with the difficulty of conducting PE is an improvement. But there is a dispute brewing on the definition of ant
- Policy
- Dongkuk's DKF-313 entered clinical trial phase III
- by Lee, Tak-Sun Jul 10, 2020 06:13am
- The prostate hyperplasia complex developed by DongKook Pharmaceutical enters Phase III clinical trials. YuYu Pharma is also developing the same prostate hyperplasia complex, which attracts interest in the competition between the two companies. On the 9th, the MFDS approved the clinical trial phase III trial (IND) for 'DKF-313', which Do
- Policy
- Safety verification data should be submitted for Metformin
- by Lee, Tak-Sun Jul 10, 2020 06:13am
- When applying for the approval of Metformin, a diabetes treatment drug for which carcinogenic substance NDMA has been detected, additional safety verification data should be submitted in the future. In particular, data that can prove that NDMA is not generated during the process should also be attached. According to the industry on the
- Policy
- Government asks Gilead to import Remdesivir for 5,360 people
- by Lee, Jeong-Hwan Jul 10, 2020 06:13am
- While COVID-19 Pandemic was prolonged, it was found that the government limited the amount of Remdesivir, which was known to be effective in COVID-19 treatment, to 5,360 servings. The Central Disease Control Headquarters requested an emergency import of Remdesivir for 360 people and the pandemic preparation for 5,000 people. Kang Giyun, a
- Policy
- Hanmi loses out on patent trial, drops Vildagle approval
- by Lee, Tak-Sun Jul 9, 2020 06:26am
- Hanmi Pharmaceutical dropped the sales approval on antidiabetic dipeptidyl peptidase-4 (DDP-4) inhibitor Vildagle 50 mg tablet (vildagliptin hydrochloride) that the company won by excluding the indication relevant to Galvus’ extended patent. Sources interpret the Korean company’s action was following up with the failed attempt to evade
- Policy
- The Korean New Deal was confirmed by supplementary budget
- by Kim, Jung-Ju Jul 9, 2020 06:26am
- During the COVID-19 situation, supplementary budget of &8361;1.088 trillion was established to strengthen the MOHW for the so-called 'Korean New Deal' project. At the plenary session of the National Assembly on the night of the 3rd, the MOHW focused on ▲strengthening K-disinfection capabilities and R&D investment, ▲ establishing a non-f
- Policy
- 13 drugs were sold before patent termination
- by Lee, Tak-Sun Jul 8, 2020 05:37am
- Domestic pharmaceutical companies were caught largely on charges of sales before patent termination. These pharmaceutical companies reported to the MFDS that they would sell after the end of the patent at the time of the application, but the sale was made even before the end of the patent through reporting on supply. The industry believ
- Policy
- Ticagrelor Napadisylate by Chong Kun Dang was applied
- by Lee, Tak-Sun Jul 7, 2020 06:13am
- It has been shown that Chong Kun Dang developed a salted product of Ticagreler (Brilinta, AstraZeneca) and applied for permission to the MFDS. It is the first product to be approved as a Ticagrelor salt product. Anti-thrombotic agent, Ticagrelor, is a poorly soluble drug and is known to have poor solubility, so it has been noted whether sa
- Policy
- Daewoong's Camostat was approved for clinical trial phase II
- by Lee, Tak-Sun Jul 7, 2020 06:12am
- Daewoong has been approved for clinical trials in patients with mild and moderate COVID-19 as a drug with Camostat Mesilate used as a treatment for pancreatitis. The MFDS approved a plan for phase II clinical trial for 'DWJ1248', which Daewoong applied for on the 6th. DWJ1248 is known as Camostat Mesilate. Daewoong holds Foistar (Camost
- Policy
- Stepped drug pricing applied on maximum price as of Aug 1
- by Kim, Jung-Ju Jul 7, 2020 06:12am
- The Korean government unveiled the specified schedule and plan to apply stepped drug pricing system, also known as the upper limit price reevaluation on listed drug. Although the Regulatory Reform Committee ordered Ministry of Food and Drug Safety (MFDS) to drop the ‘1+3 joint bioequivalence test system’ from the revised ‘Regulation o
