- Policy
- The status of clinical trials is reported annually
- by Lee, Tak-Sun Oct 21, 2021 05:14am
- The subject of conditional approval and Priority review will be more clarified, and follow-up management will be strengthened. Previously, conditional approval regulations were in the notice, but it is expected that management and operation will be strengthened, including related contents in the Pharmaceutical Affairs Act, and procedural jus
- Company
- Q3 exports of Biopharmas 'Good’ Diagnostic kits ‘Slow'
- by Kim, Jin-Gu Oct 21, 2021 05:13am
- While pharmaceutical exports in Q3 increased slightly compared to the same period of the previous year, the performance of biopharmaceuticals and chemical drugs have shown mixed results. Export of biopharmaceuticals increased 13% YOY and continued on its strong flow from last year, however, export of chemical drugs fell 13%. Also, diagnost
- Company
- Pfizer applies for reimbursement of 3rd-gen ALKi Lorviqua
- by Eo, Yun-Ho Oct 20, 2021 05:56am
- Pfizer is aiming to introduce a second ALK inhibitor after ‘Xalkori’ into Korea’s prescription market. According to industry sources, Pfizer Korea has recently submitted a reimbursement listing application for its anaplastic lymphoma kinase (ALK) tyrosine kinase inhibitor (TKI), ‘Lorviqua (lorlatinib),’ which is in progress. Pfiz
- Policy
- The gov. begins research on preferential tx
- by Lee, Jeong-Hwan Oct 20, 2021 05:56am
- The MOHW has launched a research service to prepare preferential measures for new drugs developed by innovative pharmaceutical companies in Korea. The policy is to innovate pharmaceutical companies and achieve health insurance fiscal consistency, such as giving incentives when adjusting drug prices and supporting drug prices linked to R&D inv
- Company
- Moderna Korea speeds up group organization
- by Oct 20, 2021 05:56am
- Moderna Korea, which had shown little activity for almost 6 months after establishing its Korean subsidiary, is busy recruiting members in secrecy. With the active hiring and imminent production of Moderna vaccines, officials predict that the company will be starting its official activity soon. According to industry sources on the 19th,
- Policy
- It will improve side effects caused by non-face-to-face tx
- by Lee, Jeong-Hwan Oct 20, 2021 05:56am
- The National Assembly is trying to solve problems arising from the implementation of non-face-to-face treatment temporarily allowed due to COVID-19 for more than a year and reduce social concerns. Instead of allowing non-face-to-face treatment temporarily and extensively, the ruling party-centered National Assembly officially introduces it a
- Policy
- One-shot treatment Kymriah passed the cancer committee
- by Lee, Hye-Kyung Oct 20, 2021 05:55am
- Kymriah (Tisagenlecleucel) of Novartis Korea, a "one-shot treatment" with an ultra-high cost of 500 million won per dose, passed the Cancer Drugs Benefit Appraisal Committee. At the Cancer Drugs Benefit Appraisal Committee held last month, the gap between health authorities and pharmaceutical companies was barely narrowed at the second Can
- Policy
- What's Kymriah's procedure after passing the Committee?
- by Lee, Hye-Kyung Oct 19, 2021 08:54pm
- It seems that it will take time for the ultra-high-priced one-shot treatment Kymriah (Tisagencleucel) to be registered. In particular, it is because the setting of additional financial sharing conditions for pharmaceutical companies, which was not easy in the Cancer Drugs Benefit Appraisal Committee, may pass the Drug Reimbursement Evaluatio
- Policy
- The benefit of 7 α-GPC products will be suspended
- by Lee, Hye-Kyung Oct 19, 2021 08:53pm
- Benefits for seven items that have been canceled for not participating in the clinical re-evaluation of the brain function improvement drug Choline alfoscerate will be suspended from the 21st. The MOHW announced on the 18th that it has decided to suspend health insurance benefits for drugs that have been canceled for product licenses due to c
- Company
- Hugel’s Geodu BTX plant completes EMA inspection
- by Lee, Seok-Jun Oct 19, 2021 06:00am
- [Hugel announced that the European Medicines Agency completed the on-site inspection of its ‘Geodu plant’ in Chuncheon on the 18th. The Geodu plant has a fully automated state-of-the-art system that can manufacture over five million botulinum toxin vials a year. EMA conducted an on-site inspection on the Geodu plant’s manufacturing
