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- '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
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- Tarlatamab designated as an orphan drug for SCLC
- by Eo, Yun-Ho Jan 15, 2024 05:36am
- Amgen’s drug candidate ‘Tarlatamab,’ intended for treating small cell lung cancer (SCLC), has received orphan drug designation in Korea. The Ministry of Food and Drug Safety (MFDS) announced this decision through its first orphan drug designation posting of the New Year. The approved indication is for treating adult patients with pro
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- Boryung partners with Baxter for 2 anesthesia drugs in Korea
- by Kim, Jin-Gu Jan 12, 2024 07:06am
- Boryung announced on the 10th that it signed a sales agreement with Baxter Korea to sell inhalation anesthesia ‘Suprane Solution (desflurane)’ and blood substitute ‘Plasma Lyte 148 Inj’ in the domestic market. Suprane, developed by Baxter, is a premier inhalation anesthesia for inducing or maintaining anesthesia during surgery. It offers
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- Generic companies partially win Trajenta patent challenges
- by Kim, Jin-Gu Jan 12, 2024 07:06am
- Generic companies have won the dispute over unregistered use patents of Trajenta (linagliptin). Although the unregistered formulation patent remains, this patent is reportedly relatively easy to avoid or invalidate. As such, the industry expects there is a higher possibility that generic versions of Trajenta will be released earlier after
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- New colorectal cancer drug Braftovi will receive reimb
- by Jan 12, 2024 07:05am
- All eyes are on Braftovi, a new targeted drug for metastatic colorectal cancer emerging after a 15-year gap, for its potential to address unmet demands for treatment options. Experts have assessed that, based on proven efficacy, Braftovi is likely to be highly utilized. On the 11th, Ono Pharmaceutical Korea held a press conference celeb
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- Nexviazyme prescriptions are available at general hospitals
- by Eo, Yun-Ho Jan 12, 2024 07:05am
- Prescriptions for Pompe disease treatment ‘Nexviazyme’ will be available at general hospitals. According to the industry, Sanofi-Aventis Korea’s Nexviazyme (Avalglucosidase Alfa) has recently passed the Drug Committee (DC) of tertiary general hospitals, including Samsung Seoul Hospital, Seoul National University Hospital, Seoul Asan
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- FDA approves BLA for Dong-A ST’s Stelara biosimilar
- by Chon, Seung-Hyun Jan 11, 2024 05:45am
- Dong-A ST announced on the 5th that Accord Biopharma, a subsidiary of Intas Pharmaceuticals, has completed Biologics License Application (BLA) for Stelara biosimilar ‘DMB-3115’ to the U.S. Food and Drug Administration (FDA). The BLA, originally submitted in October 2023, has now been approved by the FDA. The BLA submission was based on
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- Dong-A ST signs MOU with Israel’s Eleven Therapeutics
- by Son, Hyung-Min Jan 11, 2024 05:45am
- On the 9th, Dong-A ST announced that it had signed a memorandum of understanding (MOU) with Israel-based Eleven Therapeutics to develop an RNA-based gene therapy at the JP Morgan Healthcare Conference in San Francisco, USA. The two companies will conduct joint research to discover targeted RNA therapies for fibrotic diseases using Eleven
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- 5th JAK inhibitor Jyseleca lands in general hospitals in KOR
- by Eo, Yun-Ho Jan 11, 2024 05:45am
- Another JAK inhibitor can now be prescribed at general hospitals in Korea. According to industry sources, Gilead's Jyseleca (filgotinib) has passed the drug committee (DC) review of major national hospitals and medical institutions like Seoul Asan Medical Center and Hanyang University Hospital. After the drug was approved for reimburse
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- K-pharma advances in new Alzheimer’s drug discovery
- by Jan 9, 2024 05:50am
- New drugs for treating Alzheimer’s disease developed by Korean pharmaceutical companies have entered the late phase of clinical trials, and industry watchers are closely monitoring their potential for commercialization. Aribio has recently submitted an Investigational New Drug (IND) application for its oral treatment candidate AR1001 for Alz
