HLB said Thursday that its U.S. subsidiary Verismo Therapeutics has won the fast-track designation from the Food and Drug Administration for its CAR-T drug, SynKIR-110, as a mesothelioma treatment.The fast-track designation is a process of the FDA to support the development of new drugs or those wit
Controversy breeds after three doctors were sued for stopping a patient’s life-sustaining treatment. The person who sued the doctor is a “third party" not directly related to the decision on life-sustaining treatment -- the perpetrator who beat the patient to brain death.According to police in Masan
Kyowa Kirin has completed the reimbursement negotiation with the Korean government for Crysvita, a hypophosphatemic rickets treatment, in just 30 days.As a result, the drug will likely become the first treatment to benefit from Korea’s new accelerated reimbursement process, which expedites the revie
Wells Bio said on Thursday that it obtained medical device approval from the Japanese Pharmaceuticals and Medical Devices Agency (PMDA) for its careSTART G6PD Biosensor Analyzer.Accordingly, the company will begin exporting the device to Japan this month.The biosensor analyzer is a medical device th
Hanmi Pharmaceutical said it would disclose new drug research projects at the upcoming annual meeting of the American Association for Cancer Research (AACR 2023) in the U.S. The company’s move will attract much attention from the pharmaceutical industry because Hanmi has stopped working on its exist
The Ministry of Food and Drug Safety (MFDS) said on Thursday that it has designated the Z-med Ⅱ Percutaneous Transluminal Valvuloplasty Catheter, a balloon-expandable valve catheter, as a rare medical device to aid patients who require an aortic valve replacement.Similar to orphan drugs, rare medica
GE HealthCare has recently become an independent entity, having spun off from the larger GE organization. With a focus on precision care, the company aims to improve patient outcomes by integrating segmented care and addressing gaps in healthcare workflows. To achieve this, GE Healthcare utilizes a
A factor as important as efficacy and safety for a new drug is its access. No matter how a new drug improves survival and side effects, it is a pie in the sky if patients cannot use the medicine. The easiest and hardest way to increase a new drug’s access in Korea is its national health insurance re
Sanofi's interleukin inhibitor Dupixent and AbbVie's JAK inhibitor Rinvoq are going head-to-head to acquire a larger share in the pediatric severe atopic dermatitis treatment market.The Ministry of Health and Welfare (MOHW) announced last Saturday that it has expanded the reimbursement criteria for
T&R Biofab said on Wednesday that its researchers published a paper describing a 3D bioprinting technology capable of printing capillaries within organoids with characteristics similar to those of human organs.Organoids are self-organized 3D tissue cultures derived from stem cells which can replicat
TiumBio said it will begin phase 1a clinical trials for TU7710, a new bypassing agent for hemophilia A and B, after the Ministry of Food and Drug Safety approved its investigational new drug application on Monday.TiumBio expects that the drug will improve patient convenience by reducing the number o
Severance Hospital said it became the first tertiary-level hospital in Korea to introduce an artificial intelligence (AI) voice bot, AI Serabot, to help manage patients' medical schedules, including check-ups and changing appointment dates.This system aims to assist patients who may forget their med
Competition is intensifying between the two Interleukin (IL)-23 inhibitors in the treatment market for psoriasis and psoriatic arthritis, as latecomer Skyrizi (risankizumab) of AbbVie closely chases frontrunner Tremfya (guselkumab) of Janssen.According to data at market surveyor IQVIA, Tremfya’s sal
"We understand that there are concerns about the regulatory innovation promoted by the Ministry of Food and Drug Safety (MFDS), but the purpose of the regulatory innovation is to make the fence surrounding safety stronger, not to break it. We will not stop with last year's regulatory innovation 1.0,
Despite being a latecomer to the microbiome industry, Korea still shows high potential, experts said.Several domestic and foreign industry experts gathered for the microbiome treatment seminar organized by the Korea Biotechnology Industry Organization (KoreaBIO) at the Shinhan Investment Hall in Yoe
Novartis said that the Ministry of Food and Drug Safety has expanded the indication for Kymriah (ingredient: tisagenlecleucel), the world's first CAR-T therapy, to include the treatment of adult patients with relapsed or refractory follicular lymphoma after two or more prior therapies.This marks Kym
Lotte Healthcare said it has granted stock options to nine executives including CEO Lee Hoon-ki and Executive General Manager Woo Woong-jo.The decision aimed to reinforce the company's position as one of Lotte Group's new growth engines and to further enhance corporate value in the mid-to-long-term
The government announced on Tuesday that it aims to establish Korea as one of the top five medical device export powers by investing 10 trillion won ($7.6 billion) in research and development (R&D) of medical devices between 2023 and 2027, in collaboration with the private sector.In addition, the go
CG Bio said it participated in the Aesthetic and anti-aging Medicine World Congress (AMWC) 2023, an anti-aging conference held in Monte Carlo, Monaco, from March 30 to April 1, and signed supply contracts worth 16.5 billion won ($12.6 million) with Argentina and France. The company said that it sign
Some 8 percent of people in their 30s do not use medical services on time, and only 37 percent of Koreans felt satisfied with their health, a report showed.Also, younger generations with limited access to medical services showed lower satisfaction with the healthcare system than their older counterp