- Policy
- Withdrawal of Hanmi's Olita permit, cancellation of benefit
- by Lee, Tak-Sun Sep 29, 2022 05:50am
- The benefit of Olita, a new domestic drug, will be canceled following the withdrawal. It has been six years since it was approved as the new domestic drug No. 27 in May 2016. Since Hanmi Pharmaceutical already announced the suspension of development in April 2018, the withdrawal of the license and cancellation of the benefit were scheduled, b
- Policy
- Boryung Zepzelca, conditional approval with phase 2 data
- by Lee, Hye-Kyung Sep 29, 2022 05:49am
- It has been confirmed that Boryung's new small cell lung cancer drug Zepzelca has received conditional approval only with phase 2 clinical data. Based on the Ministry of Food and Drug Safety's notice, anti-cancer drugs have been subject to conditional approval for phase 3 since January this year, and the revision of the Pharmaceutical Affa
- Policy
- Janssen's Talquetamab, approved for Phase 3 in Korea
- by Lee, Hye-Kyung Sep 28, 2022 06:05am
- While Janssen's Talquetamab is undergoing phase 3 clinical trials around the world, phase 3 approval has been granted to 44 patients in Korea. On the 26th, the Ministry of Food and Drug Safety approved the Talquetamab subcutaneous injection and Daratumumab subcutaneous injection (Tal-DP) or Daratumumab subcutaneous injection and Daratumuma
- Policy
- Generic for Acelex will be released
- by Lee, Tak-Sun Sep 27, 2022 05:51am
- Generic drugs of the domestic anti-inflammatory drug Acelex developed by Crystal Life Science will be on the market from next month. It has been seven years since Acelex was licensed in Korea, and attention is being paid to whether generic, like the original, will be able to expand its market. This is because Celecoxib has high market dominan
- Policy
- Hutecs targets pitavastatin market with its lowest-price
- by Lee, Tak-Sun Sep 27, 2022 05:51am
- Hutecs Korea Pharmaceutical throws a winning bid in the hyperlipidemia treatment pitavastatin market represented by the original drug Livalo. As the 21st latecomer introduced to the market, Hutecs’ generic is putting pressure on other competitor companies, being listed at a price lower than 85% of the current lowest price. According t
- Policy
- MFDS in discord regarding promotion of oral COVID-19 Txs
- by Sep 26, 2022 06:08am
- The government is encouraging the use of oral COVID-19 treatments in high-risk groups, however, accessibility to such has been limited for healthcare professionals due to limitations in emergency use approvals. The Ministry of Food and Drug Safety is being criticized for being passive in making legal interpretations for emergency use autho
- Policy
- Lipiodol’s price reduced from 25th... 2-year suit dismissed
- by Kim, Jung-Ju Sep 26, 2022 06:07am
- The price of Guerbet Korea’s liver cancer contrast medium, Lipiodol Ultra-Fluid (iodized oil, 12.8g/10mL), which had been under legal dispute for the past 2 years after the government decided to remove the drug from the reimbursement list, will be reduced from the 25th this month. This is because the pricing discount that had been ori
- Policy
- HCV treatment Epclusa·Vosevi start pricing negotiations
- by Lee, Tak-Sun Sep 23, 2022 05:52am
- The National Health Insurance Service is known to be conducting pricing negotiations with Gilead Science Korea for the company’s new Hepatitis C treatments, ‘Vosevi (sofosbuvir/velpatasvir/voxilaprevir)’ and ‘Epclusa (sofosbuvir/velpatasvir).’ The two drugs received conditional approval from the Drug Reimbursement Evaluation Committee
- Policy
- On-site inspections of overseas plants will resume next year
- by Lee, Hye-Kyung Sep 23, 2022 05:52am
- On-site inspections of overseas biopharmaceutical manufacturing plants, which have been suspended due to COVID-19, will resume. The Ministry of Food and Drug Safety's Biopharmaceutical Quality Management Division recently sent an official letter to representatives of biopharmaceutical importers, the KOBIA, the KPBMA, Korea Pharmaceutical Trad
- Policy
- Leclaza to receive first monitoring for PVA negotiations
- by Lee, Tak-Sun Sep 23, 2022 05:52am
- The National Health Insurance Service disclosed drugs subject to monitoring for Type A and Type B of the Price-Volume Agreement negotiations in the fourth quarter of 2022. The list is attracting attention as Yuhan Corp’s novel non-small-cell lung cancer drug Leclaza was also selected for monitoring, as well as domestic homegrown drugs s
