- Company
- FDA approved Celltrion's anticancer drug Avastin biosimilar
- by Chon, Seung-Hyun Sep 29, 2022 05:50am
- The 3.6 trillion won U.S. market has begun in earnest. Celltrion announced on the 27th that it has obtained a license from the Food and Drug Administration (FDA) to sell the Avastin biosimilar Vegzelma. Vegzelma has been approved for Avastin's indications, including metastatic direct bowel cancer, non-small cell lung cancer, metasta
- 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
- Company
- Daewoong Pharmaceutical SGLT-2 Diabetes New Envlo
- by Kim, Jin-Gu Sep 28, 2022 06:06am
- Daewoong Pharmaceutical has registered a trademark of Enavogliflozin, which is being developed as a new drug for treating diabetes in the line of SGLT-2 inhibitors. Daewoong Pharmaceutical temporarily confirmed the name of the single, second, and third complex series centered on Enavogliflozin as Envlo, and began the last-minute work with the
- Company
- 4th JAKi Cibinqo makes a step towards reimbursement
- by Eo, Yun-Ho Sep 28, 2022 06:06am
- The 4th JAK inhibitor, Cibinqo, is nearing insurance reimbursement in Korea. According to industry sources, Pfizer Korea’s new Janus kinases (JAK) inhibitor ‘Cibinqo (abrocitinib)’ passed the review of the National Health Insurance Review and Assessment Service’s Drug Reimbursement Standard Subcommittee. The company applied for Cib
- Company
- MFDS allows academic marketing of EUA COVID-19 treatments
- by Sep 28, 2022 06:05am
- The Ministry of Food and Drug Safety gave an interpretation that allows academic marketing activities for oral COVID-19 treatments. As drugs approved under the Emergency Use Authorization are as validly approved as officially authorized drugs, such drugs that were left unattended by the Pharmaceutical Affairs Act can also be advertised with
- 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
- Company
- Reduce steroid in long-term use of Dupixent in asthmatic pts
- by Sep 28, 2022 06:05am
- Sanofi's Dupixent was found to improve major symptoms in a three-year long-term follow-up of severe asthma patients while reducing the use of oral corticosteroids. The results of these studies were released at the 2022 ERS Annual Academic Conference held from the 4th to the 6th. Through this conference, Dupixent released a number of data a
- 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
- Company
- MOHW's view of ‘few’ and ‘pediatric’ for PE exemptions
- by Eo, Yun-Ho Sep 27, 2022 05:51am
- Although yet to be finalized, the PE exemption criteria will not be amended' in the direction desired by pharmaceutical companies. In particular, companies are likely to have little room in utilizing the special exemption of the pharmacoeconomic evaluation system due to the restrictions set, such as treatments that are used by ‘few’ pat
- 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
