- 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
- Company
- General hospitals to prescribe Jeil Pharmaceutical Lonsurf
- by Eo, Yun-Ho Jul 10, 2020 06:13am
- Major general hospitals in Korea are readying prescription of Jeil Pharmaceutical’s Lonsurf indicated to treat patients with colorectal cancer. According to pharmaceutical industry sources, Lonsurf (tipiracil/ trifluridine) has been passed by drug committees (DCs) at the Big Five&8212;Seoul National University Hospital, Samsung Medical
- Company
- 66 companies complain choline alfoscerate coverage reduction
- by Jul 10, 2020 06:13am
- A group of pharmaceutical companies filed a complaint against the government’s decision to reduce coverage on choline alfoscerate drugs. On July 8, 66 pharmaceutical companies with choline alfoscerate issued a joint statement about their complaint filed for Korea’s Health Insurance Review and Assessment Service (HIRA) to reassess the
- 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
- Company
- No obligation to notify the originals of the split strategy
- by Kim, Jin-Gu Jul 9, 2020 06:27am
- In the patent dispute of Galvus (Vildagliptin),” a diabetes treatment for DPP-4 inhibitors that was recently completed, a blind spot in the licensed patent linkage system occurred. Generic company did not “notify” the original company of the fact that they applied for an item license in the process of challenging patents with a so-called
- Company
- Amgen won the second trial of 'Enbrel' patent
- by Kim, Jin-Gu Jul 9, 2020 06:26am
- Samsung Bioepis' Enbrel biosimilar 'Eticovo' (Etanercept) is expected to postpone the US debut. A patent lawsuit was conducted that could affect the Eticovo's early launch strategy, but the US court sided with the original company. According to the pharmaceutical industry on the 6th, the U.S. Federal Court of Appeals earlier this month
- 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
