- Company
- Evrysdi is expected to enter Korea
- by Eo, Yun-Ho Oct 28, 2020 06:03am
- The third SMA treatment is expected to enter Korea following Biogen's Spinraza approved in 2017 and Novartis' Zolgensma, which is currently undergoing approval review. According to related industries, Roche also submitted an application for Evrysdi (Risdiplam) to the MFDS after approval from the US FDA in August. All of these drugs are t
- Company
- Sanofi launches Dupixent '200mg' in Korea
- by Oct 28, 2020 06:02am
- Sanofi-Aventis Korea (CEO Kyung-eun Bae) announced that it will release Dupixent PFS 200mg (Dupilumab), a biologic drug for atopic dermatitis and asthma on the 26th. Accordingly, Dupixent is available in two doses, 200mg in addition to the 300mg previously released. According to the MFDS, Dupixent 200mg can be used for moderate-severe
- Company
- Ilyang's leukemia treatment Supect, approved by Russian GMP
- by Oct 28, 2020 06:02am
- The factory that manufactures Ilyang's Supect has passed the GMP (Manufacturing, Processing, Packing or Holding of Drugs) due diligence conducted by the Russian government. According to the pharmaceutical industry on the 26th, the Ministry of Industry and Trade of Russia determined that Ilyang’s plant located in Jecheon-si, Chungcheongbuk
- Company
- Tecentriq as 1st reimbursed immunotherapy for TNBC and HC
- by Eo, Yun-Ho Oct 27, 2020 06:12am
- An immunotherapy Tecentriq (atezolizumab) is seeking for the National Health Insurance (NHI) reimbursement in treating patients with either triple-negative breast cancer (TNBC) or hepatocellular carcinoma. A pharmaceutical industry source reported Roche Korea has recently submitted an application to expand reimbursement for indication to
- Policy
- Godex continues to monopolize the market
- by Lee, Tak-Sun Oct 27, 2020 06:11am
- Celltrion's liver disease treatment 'Godex capsule', which has grown to about &8361;60 billion per year, was developed as tablet formulations rather than conventional capsule formulations and is pursuing product approval. Godex capsule has no competing generics, but as the patent expired in November last year. Accordingly, Celltrion has
- Policy
- Kyongbo joins Galvus latecomer competition with IMD
- by Lee, Tak-Sun Oct 27, 2020 06:11am
- Kyongbo Pharmaceutical joined the competition among the dipeptidyl peptidase-4 (DPP-4) inhibitor Galvus (vildagliptin) latecomers. The South Korean company has reportedly applied for the authority’s approval on its new incrementally modified drug (IMD). According to the Ministry of Food and Drug Safety (MFDS) and the pharmaceutical indu
- Company
- Domestic supply of Nimbex has been discontinued
- by Oct 27, 2020 06:11am
- According to the distribution industry on the 23rd, 'Mitsubishi Tanabe, which is in charge of distribution and sales of Nimbex in Korea, sent an official letter to the wholesale industry and announced that Nimbex will cease distribution in Korea on November 3rd. Mitsubishi Tanabe said, "Due to internal circumstances such as the productivit
- Policy
- Continued administration of Remdesivir was recommended
- by Lee, Tak-Sun Oct 27, 2020 06:11am
- Domestic health authorities recommended that patients continue to administer 'Remdesivir', a treatment for COVID-19. Although the WHO announced that it was not effective, it was not the final clinical trial result, and the US clinical trial reliability, which was the basis for the approval, was highly regarded. The MFDS and the Korea Dise
- Company
- Pfizer’s EGFR TKI Vizimpro to get listed by the year-end
- by Eo, Yun-Ho Oct 26, 2020 06:15am
- Pfizer’s epidermal growth factor receptor (EGRF) tyrosine kinase inhibitors (TKI) Vizimpro (dacomitini) is predicted to get listed for National Health Insurance (NHI) reimbursement within this year. The pharmaceutical industry sources reported the fifth ERGR TKI Vizimpro is to begin the pricing negotiation with National Health Insurance
- Policy
- Stribild was withdrawn in Korea
- by Lee, Tak-Sun Oct 26, 2020 06:15am
- Stribild, which once ran the No. 1 HIV treatment market with an annual sales of &8361;20 billion, withdrew from the domestic market. It has been 7 years and 8 months since the approval in February 2013. Stribild has been on a roll as a drug that enhances the convenience of AIDS patients by containing four ingredients in one pill, but it
