- Policy
- Sama Pharm’s ‘Daxas’ generic approved
- by Lee, Tak-Sun Sep 14, 2021 05:55am
- Sama Pharm received approval for the first generic of the COPD treatment ‘Daxas (roflumilast, AstraZeneca Korea)'. As Sama was the only company that succeeded in avoiding the composition patent of Daxas, if the generic is released immediately, the company will be able to preoccupy and monopolize the market for the time being. The Mini
- Policy
- Moon "Invest ₩2.2 trillion in 5 years for vaccines"
- by Lee, Tak-Sun Sep 14, 2021 05:55am
- President Moon Jae-in announced that South Korea will “invest &8361;2.2 trillion to increase its vaccine competency over the next 5 years.” On September 13th, President Moon expressed such plans in a recorded welcome address for the 'Global Bio Conference' that is being held at the Grand Intercontinental Parnas Hotel in Seoul. Moon sa
- Policy
- Hanmi pushes for Champix follow-on despite hardships
- by Lee, Tak-Sun Sep 13, 2021 05:55am
- One pharmaceutical company is determined to develop a follow-on of the smoking cessation drug, ‘Champix’ (Pfizer, varenicline tartrate), and it is Hanmi Pharmaceuticals. Hanmi Pharmaceuticals had succeeded in the early release of its drug as a salt-modified drug, but had lost the patent challenge failed to enter the market. After the
- Policy
- Voluntary recovery of 73 drugs with excess impurities
- by Lee, Tak-Sun Sep 13, 2021 05:55am
- 73 items from about 36 companies with blood pressure exceeding impurities will be recovered. Patients can also be exchanged for normal products at pharmacies. However, the MFDS explained that concerns about human harm are very low, and that it is not a situation to stop taking them arbitrarily. It announced on the 9th that some of the drugs c
- Policy
- Financial savings should be given for new domestic drugs
- by Lee, Jeong-Hwan Sep 10, 2021 05:58am
- The domestic pharmaceutical industry argued that new domestic development drugs, which contributed to improving the financial soundness of health insurance through steady R&D investment, should be excluded from the list of "The Price-Volume Agreement (PVA)" or introduced a system that limits the number of applications. Even after the registra
- Policy
- The evaluation criteria's determination for reimbursed drugs
- by Lee, Hye-Kyung Sep 10, 2021 05:58am
- If the administration cost is lower than that of alternative drugs, it is possible to apply for adjustment to raise the upper limit of the drug. However, it should be the case where the number of companies in the formulation with the same administration route or component is one. The HIRA recently guided the pharmaceutical industry to answer que
- Policy
- Will it be possible to expand the benefit of Prolia?
- by Lee, Jeong-Hwan Sep 10, 2021 05:58am
- Attention is focusing on whether the criticism that biopharmaceuticals that treat osteoporosis by preventing bone absorption or activating bone formation are not fully enjoyed due to restrictions on Korea's benefit standards can be resolved. This is directly related to Amgen's Prolia (Denosumab) and Evenity (Romosumab) access to patients, as
- Policy
- A bill to revise some of the Jeju Special Law
- by Lee, Jeong-Hwan Sep 9, 2021 05:55am
- The bill banning the opening of for-profit hospitals and pharmacies in Jeju is aimed at preventing controversy over the Greenland International Medical Center by deleting special provisions on the opening of foreign medical institutions and foreign-only pharmacies. The plan aims to eliminate controversy that could cause confusion in the do
- Policy
- Proposal of a bill to abolish special cases for Jeju
- by Lee, Jeong-Hwan Sep 8, 2021 06:05am
- A bill has been proposed by the National Assembly to abolish special cases for the opening of Jeju for-profit hospitals. The move is aimed at resolving the controversy over the establishment of for-profit hospitals by deleting special cases for opening foreign medical institutions. On the 7th, Representative Wi Sung-gon of Democratic Party
- Policy
- 3 companies voluntarily recall varenicline products
- by Lee, Jeong-Hwan Sep 8, 2021 06:05am
- Results of the safety investigation conducted by the Ministry of Food and Drug Safety on the N-nitroso-varenicline (NNV) impurity that was found in the smoking-cessation aid varenicline showed that the impurity’s risk of harming the human body was very low. However, all drugs that contain over ‘733ng (nanograms)/day’ of NNV will be
