| Date |
Subject |
Media |
| 2025-09-08 |
Medeon Biodesign’s Aortic Arch Repair Device Duett Receives FDA Approval for Phase II Clinical Trial
|
Medeon Biodesign announced yesterday that its subsidiary, Aquedeon Medical, Inc., has received approval from the U.S. Food and Drug Administration (FDA) to initiate a pivotal Phase II clinical trial for Duett, its aortic arch repair device. Building on the 35 cases previously approved, the expanded study will now enroll between 72 and 90 patients. The trial aims to validate Duett’s clinical value at scale, marking another critical step toward securing FDA market clearance. |
| 2025-09-03 |
Taiwan Bio Therapeutics Acquires TRACT Therapeutics to Expand Transplant Rejection and Autoimmune Disease Markets
|
Taiwan Bio Therapeutics announced on the 13th that it has signed a merger agreement with its partner, TRACT Therapeutics, Inc. Through its wholly owned U.S. subsidiary, Taiwan Bio Holding LLC, the company will acquire 100% equity in TRACT for US$3.5 million in cash. The transaction will be completed following approval by relevant authorities, officially bringing TRACT under the Taiwan Bio Therapeutics Group. |
| 2025-09-03 |
Bora Pharmaceuticals Responds to Section 232 Tariffs with Two Strategies
|
Bora Pharmaceuticals announced at its investor conference on the 12th that it will adopt two strategies to counter potential Section 232 tariffs: a “manufactured-to-market” model and the establishment of an offshore capital pool (BlockGoogle). Chairman Bobby Sheng expressed optimism that operations in the second half of the year will outperform the first half. The company’s acquisition targets remain unchanged, with several promising prospects under evaluation, though developments under Trump’s administration are still being closely monitored. |
| 2025-09-03 |
General Biologicals Advances on Three Fronts with Multiple CLIA Reagents Securing TFDA Approval
|
General Biologicals announced that its chemiluminescence immunoassay (CLIA) technology platform is achieving successive milestones. Following the approval of its fully automated chemiluminescence immunoassay analyzer by Taiwan’s Food and Drug Administration (TFDA) for special medical device manufacturing and licensing, the company has now obtained five TFDA medical device licenses for CLIA reagents. An additional 20 reagent applications are currently under review. Several hospitals have already begun testing, and collaborations have been launched with three clinical laboratories in Taiwan, while discussions are ongoing with other hospitals and labs, helping to expand momentum in the precision medicine sector. |
| 2025-09-03 |
SunWay Biotech’s Probiotic Strain Receives U.S. FDA GRAS Certification, Opening Export Opportunities
|
SunWay Biotech announced that its best-selling probiotic strain, Lactobacillus paracasei NTU 101, has received the U.S. Food and Drug Administration (FDA) “Generally Recognized As Safe” (GRAS, GRN001232) certification. This milestone not only paves the way for SunWay to expand its export opportunities but also marks the first Lactobacillus paracasei strain in Taiwan to obtain this recognition, underscoring the company’s strong research capabilities and strategic business vision. |
| 2025-09-03 |
Pan-Chyr Yang, Chairman of DIAMOND BIOFUND: Unleashing Three Forces to Propel Taiwan’s Biotech Industry Globally
|
Pan-Chyr Yang, Chairman of DIAMOND BIOFUND, stated yesterday (11) that the global biotech sector is at a pivotal intersection of multiple innovations, including AI applications, precision medicine, and cell therapy. Taiwan, with its comprehensive clinical and translational capabilities, must accelerate the integration of R&D, capital, and international market access. He emphasized that through the combined forces of long-term funding, institutional design, and global alignment, Taiwan’s biotech industry can be guided toward global leadership. |
| 2025-09-03 |
Asia-Pacific Biotechnology Investment Forum Kicks Off Executive Yuan Secretary-General Ming-Hsin Kung: Three Key Strategies to Strengthen Global Links in Biotech Industry
|
The 2025 Asia-Pacific Biotechnology Investment Forum opened yesterday (11). Executive Yuan Secretary-General Ming-Hsin Kung emphasized that with the integration of AI, ICT industries, and clinical applications, Taiwan’s biotech sector is not merely focused on manufacturing medical products but is redefining the future of healthcare. The government will implement three key strategies: supporting the transformation and upgrading of traditional industries, encouraging innovative R&D, and accelerating market adoption while strengthening local supply chains to connect with global markets. |
| 2025-09-02 |
Healthy Ageing Tech Show: NTU and Taipei Veterans General Hospital Showcase Smart Healthcare Achievements
|
The second “Healthy Ageing Tech Show” opened on the 8th at Taipei World Trade Center Exhibition Hall 1 under the theme “Rejuvenation.” The three-day event attracted more than 350 exhibitors and 1,200 booths, highlighting health promotion, smart technology, and age-friendly environments in response to an ageing society. The National Taiwan University (NTU) Healthcare System and the Taipei Veterans General Hospital (Taipei VGH) System both joined the showcase, presenting their results and innovations in elderly care and smart healthcare. |
| 2025-09-02 |
Healthy Ageing Tech Show Opens, Kaohsiung Pavilion Showcases AI Smart City for Aging-in-Place
|
The 2025 Healthy Ageing Tech Show opened on August 8 at the Taipei World Trade Center Hall 1 and runs through August 10. The Kaohsiung City Government, together with its Health, Social Affairs, Education, Sports Development, Transportation, Public Works, Labor, and Tourism bureaus, collaborated with industry partners to set up the Kaohsiung Pavilion under the theme “Ageless Enjoyment, Happy Kaohsiung.” The pavilion features smart healthcare, social care, sports and wellness, and lifelong learning for seniors, demonstrating how technology can accompany older adults toward healthy aging. |
| 2025-09-02 |
Industry and Government Join Forces to Shape the Capital’s Vision! Taipei Pavilion Debuts at the Healthy Ageing Tech Show to Build an Age-Friendly City
|
The second Healthy Ageing Tech Show was held from August 8 to 10 at the Taipei World Trade Center Exhibition Hall 1. With the theme “Ageing Well Together, Walking with Taipei,” the Taipei City Government set up the “Taipei Pavilion” at Booth A432c. The pavilion integrated three core elements—interactive experiences, age-friendly design, and senior services—highlighting the city’s diverse achievements in ageing policies. By collaborating with local innovative enterprises, the city presented its vision of creating an intelligent, resilient, and inclusive age-friendly capital, inviting citizens to join in the event. |
