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2023-12-07 13:34
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Company
Novartis loses 2nd trial for its Entresto patent
by
Kim, Jin-Gu
Nov 13, 2023 05:23am
The second trial over Novartis¡¯s heart failure treatment ¡®Entresto (valsartan+ sacubitril) again ended with the victory of the Korean generic companies. If the companies succeed in winning the remaining 2 suits, the companies will be one step closer to the early release of their generics. Generic companies win first and second tr
Company
Amvuttra receives orphan drug designation
by
Eo, Yun-Ho
Nov 13, 2023 05:23am
¡®Amvuttra,¡¯ the first new drug for amyloidosis with polyneuropathy to be introduced since ¡®Vyndaqel,¡¯ has been designated an orphan drug in Korea. The Ministry of Food and Drug Safety announced so through a recent notice of orphan drug designation. siRNA therapy Amvuttra (Vutrisiran) is administered subcutaneously at once every thr
Policy
Looking at the review date for GIFT No. 1 Lunsumio
by
Lee, Hye-Kyung
Nov 13, 2023 05:23am
"The goal of the GIFT program is to shorten the general review period by 25%. The statutory review period is 120 days for chemical drugs and 115 days for biopharmaceuticals, but GIFT items In the case of, the goal is to complete the review within 90 days.¡± Park Jae-Hyeon, head of the rapid review division of the Ministry of Food and Drug
Company
NMOSD drug Enspryng likely to be reimbursed in December
by
Eo, Yun-Ho
Nov 13, 2023 05:23am
¡®Enspryng¡¯ a new drug for neuromyelitis optica spectrum disorder (NMOSD), is expected to be listed for reimbursement in Korea within the year. According to industry sources, Roche Korea completed drug pricing negotiations with the National Health Insurance Service for the reimbursement of its NMOSD treatment Ensprying (satralizumab). Th
Opinion
[Reporter¡¯s view] Successive large-scale technology exports
by
Kim, Jin-Gu
Nov 10, 2023 05:19am
There is some good news coming from the pharmaceutical and bio industry. Chong Kun Dang and Orum Therapeutics have signed large-scale technology export contracts with global pharmaceutical companies. On the 6th, Chong Kun Dang signed a technology export contract with Novartis worth a total of $1.305 billion (about 1.7 trillion won). This is
Product
¡®Cutting budget for essential drugs neglects public health'
by
Kang, Hye-Kyung
Nov 10, 2023 05:19am
The Korean Pharmacists for Democratic Society (CEO Hyeong-geun Shin) criticized the full budget for the stable supply of essential national medicines and urged for additional budget allocation. On the 9th, before the National Assembly¡¯s Health and Welfare Committee presented and deliberated on the next year's budget and proceeded with de
Company
Korea Pharma applies for approval of its 24hr ADHD drug
by
Lee, Seok-Jun
Nov 10, 2023 05:19am
Korea Pharma announced on the 9th that it had applied for marketing authorization for its 24-hour long-acting ADHD treatment ¡®Methydur SR Cap.¡¯ Methydur is a treatment for attention deficit hyperactivity disorder (ADHD) in children and adolescents developed by Orient Pharmaceuticals in Taiwan. The main substance contained in Methydur i
Company
Development active for microbiome-based therapies in Korea
by
Nho, Byung Chul
Nov 10, 2023 05:19am
Microbiome-based therapies have been expanding their therapeutic areas from simple digestives to immunology and oncology, receiving industry attention. Based on research results that showed that imbalances in the human microbiome are highly correlated with various incurable diseases, such as cancer and obesity, and can cause immune and me
Company
Will Lixiana hit the 100 billion won mark for the NOAC RX?
by
Kim, Jin-Gu
Nov 10, 2023 05:19am
Attention is focused on whether Daiichi Sanko Lixiana will become the first NOAC drug to exceed 100 billion won in annual prescription sales. As of the third quarter, the cumulative prescription amount was 78.2 billion won, and if this trend continues, it is expected that prescriptions will easily exceed 100 billion won by the end of the year
Company
Will Trodelbi become a second-line standard tx
by
Nov 9, 2023 05:43am
Antibody Drug Conjugate (ADC) anticancer drugs first appeared in the domestic triple-negative breast cancer treatment market. To date, there have been no treatment options targeting triple-negative breast cancer treatment other than immunotherapy drugs and PARP inhibitors. Gilead is aiming to make Trodelbi the standard treatment option in t
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