- Policy
- CSL, Australian company, licensed for business in Korea
- by Lee, Tak-Sun Apr 28, 2020 06:24am
- CSL, an Australian global pharmaceutical company, conducts full-scale marketing in Korea. It was the first time in the domestic pharmaceutical industry to acquire a business license and an item license. CSL Behring Korea, a subsidiary of CSL, received a drug import license from the MFDS on the 16th. General manager, Ji-Young Sohn, who ha
- Policy
- 19 new drugs & 1 new medical device were approved
- by Lee, Tak-Sun Apr 27, 2020 06:10am
- In the first quarter, 19 new drugs and 1 newly developed medical device were approved. The MFDS (Minister Eui-kyung Lee) made the announcement on the 23rd, when it released a list of new medical products that were first approved in Korea, such as new drugs and newly developed medical devices, in the first quarter of 2020. Previously, the s
- Policy
- It has been successful in expanding the coverage of new drug
- by Lee, Jeong-Hwan Apr 27, 2020 06:09am
- It was evaluated that the government has achieved success in strengthening generic management, such as strengthening guarantees like new drugs for anticancer and rare diseases last year, and announcing plans to revise the generic drug pricing system. In the case of Ranitidine, a gastrointestinal drug containing carcinogenic substance NDMA,
- Policy
- Chong Kun Dang’s Esoduo, registered additional patents
- by Lee, Tak-Sun Apr 24, 2020 06:26am
- Chong Kun Dang’s anti-ulcer agent Esoduo (Esomeprazole magnesium trihydrate), has added an additional patent. Basically, if the original drug patent is listed on the MFDS’ patent list, late candidates must succeed in the patent challenge to ensure early release. Items that are commercially available without patent challenge may be subje
- Policy
- Betmiga's first generic, Hemlibra registered next month
- by Kim, Jung-Ju Apr 24, 2020 06:26am
- 2 items including Mirabeg 50mg, which are the first generic drugs for overactive bladder, and Hemlibra 30mg for hemophilia treatment (Emicizumab) by JW Pharmaceutical are confirmed to be registered next month, and are added to the drug benefit standard. In addition, oral administration of Clopidogrel is acceptable for children with Kawasak
- Policy
- Chong Kun Dang's own brand botulinum sales countdown
- by Lee, Tak-Sun Apr 23, 2020 06:27am
- Chong Kun Dang's anti-wrinkle agent botulinum toxin will be released to the market soon after receiving national lot release. In the meantime, Chong Kun Dang has been selling Hugel's brand 'Botulax', but it ended the contract last year and prepared to sell its own brand. According to the industry on the 22nd, Chong Kun Dang secured the
- Policy
- Atnahs is insisting on infringement against generics
- by Lee, Tak-Sun Apr 23, 2020 06:26am
- Generic for Bonviva , an osteoporosis treatment drug launched in 2012, was lately caught up in a patent dispute. This is because the changed patent holder is insisting on infringement of indications and dosage patents against generics. According to the industry on the 21st, Atnahs, UK, which took over the patent right of Bonviva from Ro
- Policy
- Samsung developed mobile blood pressure measurement app
- by Lee, Tak-Sun Apr 23, 2020 06:26am
- The MFDS (Chief Lee Eui-kyung) announced on the 20th that it approved the world's first software as a medical device (SaMD) that measures blood pressure using a 'mobile app'. This medical device is a 'blood pressure app' developed by 'Samsung Electronics Co., Ltd.'. It measures blood pressure easily by using a smart watch (mobile platform) on
- Policy
- MSD, commercialize adult male oral HPV prevention vaccine
- by Lee, Tak-Sun Apr 22, 2020 06:04am
- MSD conducts vaccine clinical trials to prevent oral HPV (human papillomavirus) infection in adult men. MSD has already introduced vaccines to prevent human papillomavirus through 'Gardasil · Gardasil9', but there are no indications for oral HPV prevention in adult men. The MFDS approved IND for phase III of an HPV vaccine (V503) submitte
- Policy
- Controversy over Rutatera's exclusion from disaster expenses
- by Lee, Jeong-Hwan Apr 22, 2020 06:02am
- It has been pointed out that the NHIS is causing economic damage to patients by not applying disaster medical expenses to anticancer drugs for the treatment of rare tumors, which has greatly increased the cost of medication due to the COVID-19 pandemic. The NHIS announced that it was unable to apply disaster medical expenses for the reason
