- Policy
- Drug substances with impurities are collected voluntarily
- by Lee, Tak-Sun Sep 16, 2021 05:59am
- The recovery of antihypertensive drugs exceeding impurities is expanding. Following the Drug product, Drug substance began to recover. The MFDS announced on the 14th that it will voluntarily retrieve some of Kukjeon and Pharmacostech's Irbesartan's Drug Substance. Kukjeon and Pharmacostech start collecting four manufacturing number products e
- Policy
- 299 items were voluntarily withdrawn
- by Lee, Hye-Kyung Sep 15, 2021 06:12am
- The NHIS's self-evaluation came out that the "National Health Insurance Medical Care Benefit Standards" revised on October 8 last year prevented the registration at will. At the Korea Special Press Association briefing held on the 14th, Lee Sang-soo, executive director of insurance benefit, said, "As soon as the drug benefit list was regis
- Policy
- Controversy over the price of COVID PO of ₩900,000
- by Lee, Jeong-Hwan Sep 15, 2021 06:11am
- While the government, which judged that oral treatments are needed to shift the COVID-19 phase, is negotiating pre-purchase with global pharmaceutical companies, it is pointed out that drug prices will reach &8361;900,000. The government also acknowledges that the price of oral COVID-19 treatment is expensive, but if they have a therapeut
- 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
