- Policy
- All prescription drugs to hand in bioequivalence test result
- by Lee, Tak-Sun Nov 20, 2019 06:33am
- Subject for bioequivalence test is to expand out to all prescription drugs. Also, drug specification with test criteria and procedure would be required, as well as Good Manufacturing Practice (GMP) evaluation result from external contract manufacturing companies. Korean Ministry of Food and Drug Safety (MFDS) announced on Nov. 18 its pla
- Company
- Boycott against Japan makes no impact on drug sector
- by Kim, Jin-Gu Nov 20, 2019 06:33am
- Although this year’s deficit generated from trade with Japan is expected to hit the lowest point, the pharmaceutical sector has not been affected on a notable level. For last six years, Japanese drug import volume skyrocketed by around 57 percent. The import volume easily overwhelmed the Korean export volume, resulting in inevitable heavy d
- Policy
- Consigned items duty to produce on the rise, Overregulation
- by Lee, Tak-Sun Nov 20, 2019 06:33am
- As the MFDA foretells the resurgence of mandatory production of three batches of consignment items as a solution to the problem of generic stagnation, the pharmaceutical industry is pushing for excessive regulation. It is dissatisfied that consignment production is bound to be stopped if mandatory production of consignment items is obliga
- Policy
- Annual sales↑to ₩6.5 billion by generic exclusivity
- by Lee, Tak-Sun Nov 20, 2019 06:32am
- According to a survey result, the drug costs in 2018 were reduced by up to &8361;4.8 billion due to generic drug exclusivity. Sales of generic pharmaceutical companies increased by up to &8361;6.5 billion while the original company's drug costs were reduced by &8361;11.3 billion. Myung-jin Chung, general manager of KHIDI, announced t
- Company
- Korean companies into new drug R&D-specializing subsidiaries
- by Lee, Seok-Jun Nov 20, 2019 06:31am
- Growing number of Korean companies are launching subsidiaries solely dedicated for new drug R&D. The companies are taking a concentration strategy on their drug pipelines. Some say the subsidiaries could be used in the future as strategic options, such as means of fund raising or corporate listing. Crystal establishes M&A-specia
- Company
- Ferinject for bloodless surgery, reimbursement started up
- by Nho, Byung Chul Nov 20, 2019 06:19am
- It is noted whether high dose iron injection, Ferinject may be included as insurance reimbursement for bloodless surgery (Minimal Transfusion). According to the industry, JW Pharmaceutical applied for a non-reimbursement item, Ferinject, to HIRA on the 18th. High-dose iron is effective as a transfusion replacement therapy for surgical
- FDA and EMA warn patients taking high dose of Xeljanz
- by Nho, Byung Chul Nov 19, 2019 06:34am
- The European Medicines Agency (EMA) has decided to limit high dose prescription of a Janus kinase (JAK) inhibitor medicine, Xeljanz (tofacitinib citrate), following a similar move by the U.S. Food and Drug Administration (FDA), and now Korean Ministry of Food and Drug Safety (MFDS) is also expected to make a similar decision in response.
- Company
- Power of Innovative Drugs, Keytruda & Spinraza Shake Market
- by Chon, Seung-Hyun Nov 19, 2019 06:34am
- New products, which are regarded as innovative new drugs in the domestic pharmaceutical market, are shaking the upper hand. Keytruda, an immunocancer drug, spearheaded Lipitor to the chin with a steep rise. Rare disorder treatment “Spinraza” presented a remarkable quarterly sales of &8361;20 billion immediately after applying for health i
- Product
- The Minister Lee, Enhanced post-de-factor management
- by Jung, Heung-Jun Nov 18, 2019 10:21pm
- Lee Eui-kyung, the Minister of MFDS has released a long-term follow-up plan to strengthen the post-de-factor safety management system. On the 15th, the Minister Lee attended Korean Academy of Social & Managed Care Pharmacy and presented the four directions of drug safety management in four categories: patient safety, accessibility, safety
- Policy
- Champix patent expires soon, follow-ons eager to launch
- by Lee, Tak-Sun Nov 18, 2019 10:21pm
- Despite a joint sales deal with Pfizer Korea on a quit-smoking medication Champix (varenicline tartrate), Yuhan Corporation is currently developing a follow-on medicine of the original. Seemingly, Yuhan is preparing for the Pfizer’s Champix’s patent to expire in next July. On Nov. 11, Ministry of Food and Drug Safety (MFDS) approve
