- Policy
- Forxiga's pro-drug by Dong-A ST, conducted clinical trials
- by Lee, Tak-Sun Jul 14, 2020 06:11am
- Dong-A ST recently succeeded in overcoming a material patent, and SGLT-2 suppression-based diabetes treatment Forxiga by AstraZeneca is speeding up commercialization. IND has already been approved by the MFDS in April. According to the MFDS on the 10th, IND of Dong-A ST's 'DA-2811' was approved on April 16 to confirm its equivalence with
- Policy
- NHIS expects avg 322 generic pricing negotiations per month
- by Lee, Hye-Kyung Jul 13, 2020 06:12am
- Korea’s National Health Insurance Service (NHIS) is to start negotiating with generics over healthcare reimbursement contracts from the second half of the year. At a press conference convened on July 7, NHIS Reimbursement Executive Director Kang Chung-hee stated, “For the pricing negotiation on generics to be conducted from August to S
- Policy
- Clarifying the conditional approval target
- by Lee, Tak-Sun Jul 13, 2020 06:12am
- The MFDS strictly enforces the Advanced Bio Act (the Act on the “Safety and Support of Advanced Regenerative Medical and Advanced Biopharmaceuticals”), and said that concerns about safety are only a concern. However, the conditional approvals subject to the enacted legislation will maintain the previous conditions. Ho-sang Jeong, chie
- 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
