- Policy
- Is the first generic release of the ADHD tx Concerta?
- by Lee, Tak-Sun Nov 2, 2021 05:53am
- Alvogen Korea has begun to develop a generic development of the ADHD treatment Concerta OROS (Methylphenidate, Janssen Korea). Since there is currently no generic for Concerta in Korea, it is expected to be the first generc if approved. As of the 28th, the MFDS approved AK-D309 54mg's biological equivalence test plan. In this test, Alvoge
- Policy
- Generics for Jardiance have obtained generic for exclusivity
- by Lee, Tak-Sun Nov 2, 2021 05:53am
- Generics of SGLT-2 inhibitory diabetes treatment Jardiance (Empagliflozin, Beringer Ingelheim, Korea) have obtained a number of generic for exclusivity. The number of target items alone amounts to 93. Most of the licensed products have won generic for exclusivity. It will be applied for nine months from October 24, 2025, the date of sale.
- Company
- AstraZeneca co-sells Qtern with Ildong Pharmaceutical
- by Eo, Yun-Ho Nov 1, 2021 05:56am
- According to related industries, AstraZeneca Korea and Ildong Pharmaceutical have decided to jointly promote Qtern, which combines DPP-4 inhibitor Onglyza (Saxagliptin) and SGLT-2 inhibitor Forxiga(Dapagliflozin), which will be released today (1st). Since March 2014, the two companies have already been conducting co-marketing on diabetes
- Policy
- Redundancies in CDRD and PBAC roles in continuous dispute
- by Lee, Hye-Kyung Nov 1, 2021 05:56am
- [News follow-up from a friendly reporter] The functional redundancies in the Cancer Disease Review Committee (CDRC) and Pharmaceutical Benefit Appraisal Committee (PBAC) arose as an issue at the NA Health and Welfare Committee audit recently. At the audit, the National Assembly Health and Welfare Com
- Policy
- HIRA clarifies ‘Opdivo·Keytruda·Tecentriq’ eligibility
- by Lee, Hye-Kyung Nov 1, 2021 05:56am
- The 'Stage ⅢB or higher’ phrase was added to the subjects eligible for reimbursement of ‘Opdivo (nivolumab),’ ‘Keytruda (pembrolizumab),’ and ‘Tecentriq (atezolizumab)’ in NSCLC. The Health Insurance Review and Assessment Service announced that it will implement the ‘Amendment to the Notice on Drugs Prescribed and Administered to
- Company
- Hanmi & Ahn-Gook finally won the Galvus patent dispute
- by Kim, Jin-Gu Nov 1, 2021 05:55am
- The Supreme Court sided with Generic companies in a patent dispute over Galvus (Vildagliptin), a DPP-4 inhibitor-based diabetes treatment. On the morning of the 28th, the Supreme Court dismissed Novartis' appeal against Ahn-Gook Pharmaceutical and Hanmi Pharmaceutical to invalidate the extension of the patent duration. There is a problem
- Policy
- Concerns about the introduction of the Reference Price
- by Kim, Jung-Ju Nov 1, 2021 05:55am
- The government expressed concern over the National Assembly's proposal to review the introduction of the Reference Pricing System. Although they sympathize with the need for rational drug price management, side effects such as an increase in the patient's economic burden are predicted from the reference price system itself. Regarding price
- Policy
- 'Symbenda' withdraws from Korean market 3 years after reimb.
- by Lee, Tak-Sun Oct 29, 2021 05:54am
- A blood cancer drug that took 7 years from approval to reimbursement is being removed from the market only 3 years since starting its sale in earnest. The company that sells the product has pointed to the termination of their agreement as to the cause of its market withdrawal, however, the analysis is that profitability has declined due to d
- Company
- Qtern will be released in Korea after 4 years of approval
- by Eo, Yun-Ho Oct 29, 2021 05:53am
- The DPP-4 inhibitor and SGLT-2 inhibitor diabetes complex Qtern will be released four years after approval in Korea. According to related industries, AstraZeneca Korea will start promotional activities for Qtern, a product that combines Onglyza and Forxiga, on the 1st of next month (November). Qtern was approved in Korea in March 2017, bu
- Policy
- KDCA “will monitor development of oral COVID-19 treatments"
- by Lee, Hye-Kyung Oct 29, 2021 05:53am
- The government expressed its determination to introduce a safe treatment with verified efficacy by continuously monitoring the COVID-19 treatment trends, including the US Merck & Co. (MDS)'s oral COVID-19 treatment, 'molnupiravir .' That was the KDCA's response to when NA member Young-seuk Seo of the Democratic Party of Korea asked in vi
