- Company
- Shaperon files Phase II IND for its AD treatment
- by Lee, Seok-Jun Aug 1, 2023 05:33am
- On the 31st, Sharperon announced that it had submitted an investigational new drug (IND) application to the US Food and Drug Administration to conduct a Phase II trial in the U.S. for its atopic dermatitis treatment, ‘NuGel.’ The company plans to evaluate the pharmacokinetics, safety, tolerance, and efficacy of NuGel through the multin
- Company
- US FDA starts review of GC Biopharma’s Alyglo
- by Kim, Jin-Gu Aug 1, 2023 05:33am
- GC Biopharma announced on July 31st that its drug, 'GC5107B (immunoglobulin 10% for intravenous administration) is being reviewed in earnest by the U.S. Food and Drug Administration. GC5107B is one of GC Biopharma’s blood derivative products that goes by the brand name Alyglo. The company had submitted a Biologics License Application (
- Company
- Pediatric neurofibroma new drug Koselugo will be reimbursed
- by Eo, Yun-Ho Aug 1, 2023 05:33am
- Attention is focusing on whether progress will be made in discussing the insurance coverage of Koselugo, a new drug for pediatric neurofibroma. According to the industry, AstraZeneca's neurofibromatosis new drug Koselugo will be submitted to the HIRA Pharmaceutical Reimbursement Evaluation Committee. As it recently submitted additional suppl
- Company
- Will Hanmi be able to develop its own Saxenda for Koreans?
- by Kim, Jin-Gu Aug 1, 2023 05:33am
- Hanmi Pharm has decided to change the development direction for its GLP-1 class drug ‘efpeglenatide.’ Instead of developing it as a diabetes treatment as before, the company plans to develop the drug as an obesity treatment. The industry’s attention was focused on the Global Phase III trial that Sanofi and Hanmi Pharm had conducted wit
- Company
- Equipped with two new drugs this year alone
- by Jul 31, 2023 05:28am
- Janssen challenges with a new mechanism, BMS widening the gap with maintenance therapy Janssen has added a new drug for multiple myeloma in Korea. This is the second permit this year. It is noteworthy whether Janssen will change the multiple myeloma market where BMS dominates with Celgene. On the 26th, the Ministry of Food and Drug Safety ap
- Company
- Handok will sell original insulin drug Lantus
- by Lee, Tak-Sun Jul 31, 2023 05:28am
- Handok, which had previously stopped selling the insulin biosimilar ‘Glarzia (insulin glargine)', will be marketing and distributing the original insulin 'Lantus' from the 1st of next month. Whether the company will be able to expand its presence in the diabetes treatment market with the original product based on the know-how in insulin
- Company
- Reimb of Bayer’s new heart failure drug Verquvo imminent
- by Eo, Yun-Ho Jul 31, 2023 05:28am
- The new heart failure drug ‘Verquvo’ is expected to be reimbursed in Korea soon. According to industry sources, Bayer Korea’s soluble Guanylate Cyclase (sGC) stimulator ‘Verquvo (Vericiguat)’ has essentially completed drug pricing negotiations with the National Health Insurance Service. Therefore, the drug is expected to be listed fo
- Company
- Erleada can be prescribed at tertiary hospitals in KOR
- by Eo, Yun-Ho Jul 28, 2023 05:30am
- The new prostate cancer drug Erleada has landed in general hospitals in Korea. According to industry sources, Janssen Korea’s metastatic hormone-sensitive prostate cancer (mHSPC) treatment Erleada (apalutamide) has passed the drug committee (DC) review at the Big 5 tertiary hospitals in Korea, - Samsung Medical Center, Seoul National Uni
- Company
- Celltrion applies for approval of its Eylea biosimilar in KR
- by Jung, Sae-Im Jul 27, 2023 05:40am
- On the 26th, Celltrion announced that it had completed applying for the marketing authorization of 'CT-P42,' its biosimilar to the eye disease treatment ‘Eylea (aflibercept).’ Based on its global Phase III trial, Celltrion applied to be approved for all Eylea indications including as a treatment for wet age-related macular degeneration
- Company
- Atozet market, ↑ 225% in 2 years
- by Chon, Seung-Hyun Jul 27, 2023 05:40am
- The hyperlipidemic complex drug Atozet prescription market has grown significantly. It more than tripled in two years due to the entry of generic drugs. About 100 generic products increased their market share to 60%, leading the market expansion. Jeil and HK inno. N stood out among generic products. According to UBIST, a pharmaceutical research
