- Policy
- Stability data requirement eased for metformin approvals
- by Lee, Hye-Kyung Jan 17, 2024 05:29am
- The Ministry of Food and Drug Safety (Minister Yu-Kyoung Oh) will change and ease the stability test submission data requirements for approvals (and changes) of metformin-containing preparation that had been strengthened following the detection of an impurity (N-nitrosodimethylamine (NDMA, NDMA). Metformin is used for the treatment of Typ
- Company
- Orion bids KRW 548.5 bil to enter the pharma industry
- by Kim, Jin-Gu Jan 17, 2024 05:29am
- The Orion Group has become the largest shareholder of LegoChem Biosciences, a prime new drug developer. With the acquisition of LegoChem, Orion is expected to jump into the pharmaceutical bio-industry in earnest, breaking away from its previous passive activities such as signing a memorandum of understandings, making indirect investments
- Company
- KRPIA's new BOD is full of Korean members
- by Eo, Yun-Ho Jan 17, 2024 05:29am
- KRPIA has launched its new board of directors for the 2024 New Year. The Korean Research-based Pharmaceutical Industry Association (KRPIA) has recently announced its new board of directors (BOD). The new BOD stands out as it is primarily made up of Korean members. Among the 13 BOD members, which includes KRPIA chairman Dong-Wook O
- Policy
- High-priced drugs receive reimb in the new year
- by Lee, Tak-Sun Jan 17, 2024 05:29am
- Ultra-high-priced drugs whose costs exceed KRW 100 million are being listed for reimbursement one after another in the new year. Following Koselugo’s reimbursement this month, Luxturna, which will cost KRW 1 billion, is expected to be reimbursed next month. With such ultra-high-priced drugs being listed one after another, voices have be
- Company
- Whan In has exclusive distribution rights for Sanofi's Arava
- by Kim, Jin-Gu Jan 16, 2024 06:09am
- On the 10th, Whan In Pharm announced that the company signed an exclusive promotion and distribution agreement with Sanofi-Aventis for Arava Tablet, a rheumatoid arthritis treatment containing the active ingredient leflunomide, in Korea. Whan In Pharm is recognized for its business specialization in the central nervous system (CNS) fiel
- Policy
- Caution required for use of ADHD drug methylphenidate
- by Lee, Hye-Kyung Jan 16, 2024 06:09am
- The warnings and precaution section of the attention deficit hyperactivity disorder (ADHD) treatment ‘methylphenidate’ is expected to add warnings for increased intraocular pressure and glaucoma. The Ministry of Food and Drug Safety (MFDS) prepared a change to the label of drugs that contain methylphenidate based on a review of the safe
- Company
- Gov't will reduce fines for companies that adopt CPs
- by Kang, Shin-Kook Jan 16, 2024 06:08am
- A revised Fair Trade Act that grants benefits, such as reduced penalty surcharges to companies that have adopted and excellently operated a Fair Trade Compliance Program (CP), will be enforced on June 21st this year. On the 15th, the Fair Trade Commission announced that it would prepare sub-statutes, including the Enforcement Decree and N
- In-Hwa Choi will become KRPIA's new Policy Director
- by Eo, Yun-Ho Jan 16, 2024 06:08am
- KRPIA's head of policy position, which had remained vacant for about a year, is soon set to be filled. According to industry sources, the Korean Research-based Pharmaceutical Industry Association (KRPIA) recently named In-Hwa Choi (60), current Access and Policy Head at Roche, to oversee the association's policy business. Choi will succee
- Company
- Reimbursed drugs hit four-year low amid regulatory changes
- by Chon, Seung-Hyun Jan 16, 2024 06:08am
- The number of drugs on the health insurance reimbursement list has reached its lowest point in four and a half years. Due to pricing revisions for generic drugs and regulations related to joint development, the introduction of new drugs is significantly reduced. The number of approvals has decreased by more than 70% compared to the figures
- Company
- 'Discussing Rinvoq based on Korean RWD'
- by Eo, Yun-Ho Jan 15, 2024 05:47am
- The value of Real World Data (RWD) increases in areas where the development of new treatment options has been slow, primarily due to insufficient medical field experience and limited information beyond randomized controlled trials (RCT). Atopic dermatitis is one of the fields that has seen a shortage of new drugs in the past. However, i
