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IEI Secures TFDA QMS Approval and ISO 13485 Certification, Reinfo…

[ 메디채널 김갑성 기자 ] Dual certifications streamline global design transfers and regulatory compliance. TAIPEI, Nov. 21, 2025 -- IEI Integration Corp. ("IEI"), a global provider of medical and industrial computing platforms, today announced that its New Taipei City (Xizhi) and Qidu (Keelung) facilities have passed inspection by the Taiwan Food and Drug Administration (TFDA) and been awarded Quality Management System (QMS) approval (Xizhi Certificate No. QMS2376、Keelung Certificate No. QMS2377), while maintaining ISO 13485:2016 certification. As one of Taiwan's manufacturers holdi
- 김갑성 기자
- 2025-11-21 15:35
Telix Opens TMS Yokohama in Japan, Commemorative Lectur…

MELBOURNE, Australia and KYOTO, Japan, Nov. 21, 2025 -- Telix Pharmaceuticals Limited (ASX: TLX, NASDAQ: TLX, "Telix") today announces the official opening of Telix Manufacturing Solutions (TMS) in Yokohama, Japan, the Company's first cyclotron facility in the Asia Pacific region (APAC). TMS Yokohama will enable Telix to provide greater access to radiopharmaceuticals for Japanese patients, initially through clinical supply of TLX250-CDx (a kidney cancer imaging candidate), with plans to supply other Telix investigational and future commercial products, i
- 김갑성 기자
- 2025-11-21 14:22
NovaBridge's Visara Subsidiary Appoints Distinguished Oph…

Cadmus C. Rich, MD, MBA, as Chief Medical Officer, and Carlos Quezada-Ruiz, MD, FASRS, as Chair of the Scientific Advisory Board, bring invaluable clinical development expertise to VIS-101 Program The ability to attract seasoned ophthalmology leaders highlights the compelling opportunity for VIS-101, and underscores our commitment to assembling a world-class team VIS-101, a novel bifunctional biologic targeting VEGF-A/ANG2, has the potential to become the current standard for wet AMD, DME and RVO, and is expected to be Phase-3-ready in 2026 ROCKVILLE, Md., Nov. 21, 2025 -- NovaB
- 김갑성 기자
- 2025-11-21 13:46
National Cancer Institute Broadens Partnership with Medida…

The Medidata Data Experience offering will enable the National Cancer Institute Lead Protocol Organizations to expedite the development of life-saving medicines for patients SINGAPORE, Nov. 21, 2025 -- Medidata, a Dassault Systèmes brand and leading provider of clinical trial solutions to the life sciences industry, today announced that Medidata Health Record Connect and Medidata Rave Companion, both integral components of the Medidata Data Experience, will be available to a select set of National Cancer Institute (NCI) Lead Protocol Organizations (LPO). These solutions
- 김갑성 기자
- 2025-11-21 11:28
Dimora Medical Reaffirms Long-Term Commitment to Pressure…

NEW YORK, Nov. 21, 2025 -- Observed annually on the third Thursday of November each year, Worldwide Pressure Injury Prevention Day serves as a global reminder of the urgent need to prevent pressure injuries, also known as pressure ulcers or bedsores, among vulnerable populations. Established by the National Pressure Injury Advisory Panel (NPIAP) and supported by organizations worldwide, the day aims to raise public awareness, promote evidence-based prevention strategies, and highlight the importance of early intervention for individuals at risk, including those who are bedridden, wheelchair u
- 김갑성 기자
- 2025-11-21 11:14
Colebrook Bosson Saunders Launches Their First Sustain…

HONG KONG, Nov. 21, 2025 -- As the world turns its attention to the environment during COP30, Colebrook Bosson Saunders (CBS), the leader in workplace ergonomics, is underscoring the need for collective action, transparency, and responsibility by the private sector. To support customers and the industry advance positive change, the brand released its first Sustainability Report this year, setting bold 2030 targets that demonstrate its commitment to responsible, forward-focused business. Access the Sustainability Report 2025 here: https://cdn.shopify.com/s/files/1/0788/7
- 김갑성 기자
- 2025-11-21 09:00
페프로민 바이오, BAFFR-CAR T 'PMB-CT01' 데이터, 2025년 ASH 제67차 연례학회 구…

어바인, 캘리포니아, 2025년 11월 21일 -- 재발•불응(r/r) B세포 악성 종양 치료를 위한 혁신 치료제를 개발하는 임상단계 바이오테크 기업 페프로민 바이오(PeproMene Bio, Inc.)가 자사 PMB-CT01(BAFFR-CAR T) 임상 1상 연구 초록 두 건이 2025년 미국혈액학회(American Society of Hematology, ASH) 연례학회에서 구두 발표로 채택됐다고 밝혔다. 해당 초록들은 고강도 사전 치료 이력이 있는 r/r B세포 급성 림프구성 백혈병(B-ALL) 및 r/r B세포 비호지킨 림프종(B-NHL) 환자를 대상으로 한 PMB-CT01의 초기 안전성 및 유효성 프로파일을 제시한다. 여기에는 기존 CD19 표적 치료에 실패했거나 CD19 음성 질환을 가진 환자도 포함된다. 임상 1상 단계적 용량증량 연구(NCT04690595, NCT05370430)의 중간 결과는 BAFF-R이 CD19 항원 소실을 극복하면서 내구성을 유지하고 독성이 낮은 차별화된 표적임을 시사한다. r/r B-NHL 안전성:PMB-CT01은 매우 우수한 내약성을 보였다. 1등급 초과의 사이토
- 김갑성 기자
- 2025-11-21 08:08
NABR: CITES 상임위원회, 긴꼬리원숭이 사육 실태 조사 결과 공개

워싱턴, 2025년 11월 21일 -- 동물종 거래 실태를 감시하는 국제기구인 CITES 상임위원회(CITES Standing Committee)가 과학적인 절차에 따라 방대한 자료를 제출한 캄보디아 정부에 사의를 표하면서 캄보디아의 동물 사육 방식에 대한 심사 결과를 발표했다. 차기 상임위원회 회의에 앞서 2025년 11월 12일에 발표된 이 보고서는 https://cites.org/eng/sc/79/agenda-documents에서 열람할 수 있다. 보고서는 몇 가지 긍정적인 조사 결과와 함께, 특히 캄보디아의 세관 및 검사 절차가 "국가 단일 창구 시스템을 통해 효과적으로 일원화 및 조정되었을 뿐 아니라, 검사와 문서화를 통해 투명성도 뒷받침한다"라고 기술하고 있다. 또한 보고서에서는 심사 과정 내내 보여준 "캄보디아의 개방성과 협조"에 찬사를 보내는 한편, "캄보디아가 입법 체계를 개선하고, 추적성을 강화하며, CITES 절차를 준수하려는 노력을 기울이고 있다"고 평가했다. 긴꼬리원숭이는 인간과 생물학적으로 매우 비슷해서, 전 세계 생물의학 연구에 꼭 필요한
- 김갑성 기자
- 2025-11-21 01:59
PeproMene Bio's PMB-CT01 BAFFR-CAR T Data Selected for Two O…

IRVINE, Calif., Nov. 20, 2025 -- PeproMene Bio, Inc., a clinical-stage biotechnology company developing novel therapies for relapsed and refractory (r/r) B-cell malignancies, announced that two abstracts from its ongoing Phase 1 studies of PMB-CT01 (BAFFR-CAR T) have been accepted for oral presentations at the 2025 American Society of Hematology (ASH) Annual Meeting. The abstracts showcase the emerging safety and efficacy profile of PMB-CT01 in heavily pretreated r/r B-cell Acute Lymphoblastic Leukemia (B-ALL) and r/r B-cell Non-Hodgkin Lymphoma (B-NHL), including patients who
- 김갑성 기자
- 2025-11-20 23:12
HitGen Receives New Funding to Discover Novel Therapeutic…

Company enters into new agreement with the Gates Foundation to identify novel drug leads targeting tuberculosis and malaria and new agents for non-hormonal contraception. CHENGDU, China, Nov. 20, 2025 -- Shanghai Stock Exchange listed company HitGen Inc. ("HitGen", SSE: 688222.SH), today announced that it has entered into a new contract agreement with the Gates Foundation. HitGen will leverage its industry-leading DNA-encoded library (DEL) platform to identify novel drug leads for the treatment of underserved diseases including tuberculosis and malaria, as well a
- 김갑성 기자
- 2025-11-20 22:30

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발행인 : 최희정 | 편집인 : 김갑성 |
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