- Policy
- 18 Champix IMD suspected of selling before patent expiration
- by Lee, Tak-Sun Jun 15, 2020 06:16am
- 18 incrementally modified drugs (IMDs) of Champix (varenicline) are undergoing administrative measure for selling the products before the original’s patent was expired. Some of their item approvals have been revoked by the related administrative measure. Before the Champix’ patent expires next month, the follow-on drug market would flu
- Policy
- The packaging unit of self-injectable medicine is improved
- by Lee, Tak-Sun Jun 15, 2020 06:15am
- The packaging unit of self-administered injections such as Saxenda, which is used for appetite suppression, is expected to be subdivided. In order to prevent misuse, it was decided to put one in one package. In addition, safety information is produced for patients to use it correctly, and educational program development and medication guideli
- Policy
- 13 COVID-19 global clinical trials were approved
- by Kim, Jung-Ju Jun 11, 2020 06:53am
- Global clinical trials for the development of COVID-19 vaccines and treatments have increased 15 fold more than in three months. There are 858 cases worldwide and 13 cases approved in Korea, and clinical trials are actively underway. The KONECT (Chairman Byung-Joon Bae) announced on the 9th that it updated the domestic and foreign clinical t
- Policy
- About 70% of new anticancer drugs are listed
- by Lee, Hye-Kyung Jun 11, 2020 06:22am
- The average listed rate for new drugs approved in Korea was 67.2%. Looking at the rate of chemotherapy drug listed alone, it was 70.2%, which is higher than all new drugs. Korea Institute for Health and Social Affairs This data was shown on the 8th through the 'Health and Welfare ISSUE&FOCUS (Silvia Park, Korea Institute for Pharmaceutica
- Policy
- Kolmar begins patent challenge
- by Lee, Tak-Sun Jun 9, 2020 06:28am
- More and more domestic pharmaceutical companies are greedy with generic drugs from Novartis' DPP-4 diabetes treatment drug 'Galvus'. On the 5th, Kolmar Korea filed a passive trial to confirm the scope of a patent right to avoid patents. It has been 7 months since it was approved for bioequivalence test for development of generics in Novemb
- Policy
- Tightening electronic review on antiinfectives from October
- by Lee, Hye-Kyung Jun 9, 2020 06:28am
- Korea’s Health Insurance Review and Assessment Service (HIRA) is tightening the electronic review system regarding the antiinfectives for systemic use. The list of electronic review subjects include AbbVie Korea’s Mavyret, Gilead Science Korea’s Biktarvy, Ildong Pharmaceutical’s Besivo and many other chronic hepatitis type B and C t
- Policy
- AZ-China joint venture Dizal tests drug in Korea
- by Lee, Tak-Sun Jun 8, 2020 06:15am
- Dizal Pharma, a joint venture company by AstraZeneca and a Chinese firm, is initiating a clinical trial in Korea on non-small cell lung cancer (NSCLC) patients with epidermal growth factor receptor (EGFR) or human epidermal growth receptor 2 (HER2) mutation. The pharmaceutical industry is paying a close attention on the Chinese company
- Policy
- The copayment of Remdesivir is supported by the government
- by Kim, Jung-Ju Jun 8, 2020 06:11am
- While the government announced that it would make special imports of Remdesivir, which is being evaluated as COVID-19 treatment, the quarantine authorities said that the cost of treatment is likely to be paid by the NHIS, and the patient's cost of liability is likely to be paid by the government. Eun-kyung Chung, the head of the Central Di
- Policy
- Court dismisses request to revoke Galvus IMD approval
- by Lee, Tak-Sun Jun 8, 2020 06:11am
- Novartis’ request to revoke Korea’s Ministry of Food and Drug Safety (MFDS) approving Hanmi Pharmaceutical’s Vildagle (vildagliptin hydrochloride) has reportedly been dismissed. In May, Novartis has filed a litigation to cancel a drug approval on Vildagle 50 mg tablet, claiming the Korean-made drug did not fulfill the duty to notify
- Policy
- Abbvie’s Rinvoq was approved
- by Lee, Tak-Sun Jun 5, 2020 06:10am
- Another oral rheumatoid arthritis drug has been approved in Korea. It is Abbvie’s Rinvoq sustained-release tablet 15mg (Upadacitinib). The competing drugs include Pfizer’s Xeljanz (Topacitinib), Lilly' Olumiant (Baricitinib), and Astellas' Smyraf (Peficitinib). On the 4th, the MFDS approved Abbvie’s Rinvoq 15mg as a new drug. It is u
