- Policy
- Janssen, granted permission to import advanced bio medicines
- by Lee, Tak-Sun Oct 21, 2021 05:14am
- Janssen Korea has obtained the second approval for the import business of advanced bio medicines after Novartis Korea. Janssen is also expected to introduce related products in the near future because advanced bio-medicine items designated by the MFDS can only be approved if it is approved for the advanced bio-medicines import business. On
- Policy
- Vegzelma is the name of Celltrion's Avastin biosimilar
- by Lee, Tak-Sun Oct 21, 2021 05:14am
- Celltrion reported on the 1st that it had submitted an application for approval of the biosimilar "CT-P16" of Avastin (Bevacizumab), Roche's colorectal cancer treatment, to the MFDS and the U.S. FDA. According to the MFDS on the 19th, Celltrion's Avastin biosimilar, which was recently applied for permission, is Vegzelma. This is the fir
- 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
- 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
- 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
- Policy
- Korea United Pharm's Galvusmet generic is the first approved
- by Lee, Tak-Sun Oct 19, 2021 06:00am
- Korea United Pharm received approval for the first generic of Novartis’s DPP-4 inhibitor, ‘Galvusmet (vildagliptin/metformin hydrochloride),’ an antidiabetic treatment. With the approval, the company will likely be competing with Hanmi Pharmaceutical next year, which marked the start of Galvusmet latecomers with a salt-modified drug i
- Policy
- Keytruda·Tagrisso is in the process of expanding benefits
- by Lee, Hye-Kyung Oct 18, 2021 05:54am
- There was an opinion calling for expediting the expansion of the benefit standard for tumor-agnostic therapy. Independent lawmaker Lee Yong-ho said in a parliamentary audit of the National Assembly's Health and Welfare Committee on the 15th, "Benefits of Keytruda & Tagrisso have not expanded and are causing pain to patients," adding, "Ke
