Business
BioSpectrum Asia
US FDA approves first and only at-home selfcollection device for cervical cancer screening
Teal Health, a women's health company on a mission to eliminate cervical cancer, has announced the US Food and Drug Administration's (FDA) approval of the Teal Wand, the first and only at-home vaginal sample self-collection device for cervical cancer screening in the United States (US).
1 min |
BioSpectrum Asia June 2025
BioSpectrum Asia
"APAC now leads global clinical development of multi-specific antibodies, accounting for over 40% of trials"
According to market projections, the biologics sector is expected to grow from $451 billion in 2024 to $938 billion by 2034, reflecting a CAGR of 7.6 per cent. While biologics, including vaccines, gene therapies, and monoclonal antibodies, offer targeted, effective treatments for cancer, autoimmune disorders, and rare conditions, these can be complex and costly to produce.
4 min |
BioSpectrum Asia June 2025
BioSpectrum Asia
Olympus appoints Bob White as new CEO
Japan-based medtech company Olympus Corporation has announced the appointment of a Chief Executive Officer (CEO) aimed at accelerating its ongoing transformation efforts in the medtech space.
1 min |
BioSpectrum Asia June 2025
BioSpectrum Asia
Nuclera establishes distribution network across APAC and Middle East
Nuclera, a UK-based biotechnology company accelerating protein expression and optimisation through its benchtop eProtein Discovery System, has established a distribution network across Asia Pacific (APAC) and the Middle East.
1 min |
BioSpectrum Asia June 2025
BioSpectrum Asia
New imaging technique in Japan to personalise heart disease treatment
Researchers from the University of Tokyo, Japan have found a way to observe clotting activity in blood as it happens, without needing invasive procedures.
1 min |
BioSpectrum Asia June 2025
BioSpectrum Asia
Nandakumar Kalathil steps in as Country General Manager for Agilent India
Agilent has announced the appointment of Nandakumar (Nanda) Kalathil as the Country General Manager (CGM) for Agilent India.
1 min |
BioSpectrum Asia June 2025
BioSpectrum Asia
Johnson & Johnson Medtech partners with Qure.ai to boost early detection of lung cancer in India
Johnson & Johnson MedTech, a global leader in surgical technologies and solutions, has onboarded Indian startup Qure. ai, a global leader in artificial intelligence (AI) for healthcare, as a strategic partner to enhance early detection of lung cancer in India.
1 min |
BioSpectrum Asia June 2025
BioSpectrum Asia
Ensuring Compliance with Surprise Inspections
On May 6, the US Food and Drug Administration (US FDA) announced its intent to expand the use of unannounced inspections at foreign manufacturing facilities that produce foods, essential medicines, and other medical products intended for American consumers and patients.
2 min |
BioSpectrum Asia June 2025
BioSpectrum Asia
Apollomics, LaunXP ink $50 M deal for NSCLC treatment in Asia
US-based Apollomics Inc., and Taiwan-based LaunXP International Co., an affiliate of LaunXP Biomedical Co., have entered into an agreement for the development and commercialisation in Asia (excluding mainland China, Hong Kong and Macau) of vebreltinib, Apollomics' proprietary c-Met inhibitor, in combination with an EGFR inhibitor (EGFRI) for the treatment of non-small cell lung cancer (NSCLC).
1 min |
BioSpectrum Asia May 2025
BioSpectrum Asia
GSK joins hands with Korea's ABL Bio for treatment of neurodegenerative diseases
South Korea-based startup ABL Bio Inc. has announced a worldwide licensing agreement enabling GlaxoSmith-Kline Pharmaceuticals (GSK) to develop novel medicines for neurodegenerative diseases by utilising ABL Bio's blood-brain barrier (BBB) shuttle platform, Grabody-B.
1 min |
BioSpectrum Asia May 2025
BioSpectrum Asia
"The biosimilar developers are eagerly awaiting revised CDSCO regulations that might lead to simplification of the development pathway for biosimilars"
In an interaction with BioSpectrum, I Dr Dr Jitendra Kumar, Managing Director, Biotechnology Industry Research Assistance Council (BIRAC), India reflects on the evolution of India's biosimilars sector and shares his insights on the country's growing role in the global biosimilars landscape over the next decade.
4 min |
BioSpectrum Asia May 2025
BioSpectrum Asia
Rise of Chinese companies in global medtech sector
The global medical technology (medtech) sector is undergoing a profound transformation, driven significantly by the rapid and strategic ascent of Chinese companies. The long-held narrative of China solely as a manufacturer of low-cost goods is dangerously outdated. Today, Chinese medtech firms are not merely competing on the global stage; they are increasingly setting the pace in innovation, enhancing product quality, and expanding their international reach. This shift necessitates a strategic reassessment by established players and presents both significant opportunities and complex challenges for the entire healthcare ecosystem. This article dissects the key drivers behind China's medtech surge, analyses their global expansion strategies, evaluates their competitive positioning, and provides an outlook on the future landscape.
4 min |
BioSpectrum Asia May 2025
BioSpectrum Asia
Medical Device Classification and FDA Approval: What Startups Need to Know
For many innovators, the United States represents a key market, being the world's largest for medical devices. However, entering the US market requires navigating the US Food and Drug Administration's (FDA) stringent regulatory landscape, where accurate device classification is crucial. To assist innovators, the Regulatory Information and Facilitation Center (RIFC) at Venture Center, Pune has released a whitepaper early this year that offers practical insights, featuring examples of devices developed by Venture Center-supported startups to illustrate how medical devices are categorised based on risk.
3 min |
BioSpectrum Asia May 2025
BioSpectrum Asia
AstraZeneca invests $2.5 B to establish sixth global strategic R&D centre in China
British pharmaceutical company AstraZeneca has announced an investment of $2.5 billion in Beijing to establish its sixth global strategic R&D centre together with major research and manufacturing agreements that will further advance life sciences in China.
1 min |
BioSpectrum Asia May 2025
BioSpectrum Asia
APAC Vaccine Powerhouses Flex Capacity & Quality Muscle
Asia is the epicentre of global vaccine manufacturing, with India and China together supplying over a billion doses annually. Now, emerging players like South Korea, Singapore, and Australia are stepping up, investing in next-gen platforms and expanding capacity to meet global demand. Let's map the manufacturing footprint of Asia's leading vaccine manufacturers, tracking their current capacity, expansion plans, and the strategic shifts that are transforming the region into a global vaccine production hub.
10+ min |
BioSpectrum Asia May 2025
BioSpectrum Asia
"Asia-Pacific region has firmly established itself as a global vaccine export powerhouse"
Suchitra Ella, Managing Director of Bharat Biotech, India delves into the evolution of vaccine manufacturing capacity in the Asia-Pacific region over the past decade and explores key lessons learned from the COVID-19 pandemic that will shape the future of vaccine production and distribution. Edited excerpts:
4 min |
BioSpectrum Asia May 2025
BioSpectrum Asia
Biomarkers in Kidney Health: Enhancing Early Detection and Treatments
Emerging biomarkers such as neutrophil gelatinase-associated lipocalin (NGAL) and kidney injury molecule-1 (KIM-1) have shown great potential in the early diagnosis of kidney injury. These biomarkers are extremely sensitive indicators of tubular injury, and they can detect renal damage at stages when conventional markers are still within normal ranges. While these novel biomarkers have high sensitivity and specificity, incorporating them into ordinary clinical practice raises several problems. Despite its potential, more study is needed to validate these biomarkers in large-scale, long-term clinical studies.
4 min |
BioSpectrum Asia May 2025
BioSpectrum Asia
Korea and Romania to strengthen cooperation in healthcare
The Ministry of Health and Welfare, South Korea recently held a bilateral meeting with Alexandru Rafila, Minister of Health of Romania.
1 min |
BioSpectrum Asia May 2025
BioSpectrum Asia
Australia lays focus on nanotechnology to improve odds in treating aggressive breast cancers
Australia's University of Queensland researchers are designing nanotechnology they believe could improve how we treat the most aggressive form of breast cancer.
1 min |
BioSpectrum Asia May 2025
BioSpectrum Asia
Thermo Fisher Scientific introduces Krios 5 Cryo-Transmission Electron Microscope
Thermo Fisher Scientific has introduced the Thermo Scientific Krios 5 Cryo-Transmission Electron Microscope (TEM). This next-generation, atomic-resolution platform leverages enhanced optics and AI-enabled automation to study molecular structures and interactions at a throughput and fidelity that was previously unattainable.
1 min |
BioSpectrum Asia May 2025
BioSpectrum Asia
China gives nod to first haemophilia B gene therapy
Belief BioMed (BBM) and Takeda China have jointly announced that BBM-H901 (Dalnacogene Ponparvovec Injection), has been officially approved by the National Medical Products Administration (NMPA) for the treatment of adult patients with moderate to severe haemophilia B (congenital coagulation factor IX deficiency).
1 min |
BioSpectrum Asia May 2025
BioSpectrum Asia
TARIFF WAR PUTS PHARMA IN CROSSHAIRS
While several other countries in the world have probably heaved a sigh of relief, though, for three months, China has launched an onslaught on the US in the bitter trade tariff war.
2 min |
BioSpectrum Asia May 2025
BioSpectrum Asia
Medtech education in APAC keeping pace with innovation
As medical devices grow smarter and more interconnected using AI, robotics and virtual reality, the need to train professionals is growing urgently. To position itself as a global powerhouse for medical technology, Asia Pacific (APAC) countries such as China, Japan, Korea, India, Singapore, Vietnam, Thailand, Taiwan are ramping up medtech education initiatives, recognising the critical role that talent pipelines, partnerships, and digital innovation play in advancing their healthcare economies. Let's take a closer look at the new initiatives being taken up by the APAC region for strengthening the medtech education sector amidst many challenges and opportunities.
7 min |
BioSpectrum Asia May 2025
BioSpectrum Asia
"South Korea is rapidly emerging as a global biotech powerhouse"
Orum Therapeutics debuted on the Korea Exchange (KOSDAQ) on February 14, 2025, raising ₩50 billion in South Korea's first biopharma IPO of the year. With a focus on targeted protein degraders for cancer treatment, CEO S J Lee outlines how Orum is advancing and positioning itself at the forefront of oncology innovation. Edited excerpts;
2 min |
BioSpectrum Asia May 2025
BioSpectrum Asia
University of Hyderabad and Flinders University cement partnership in healthcare
The University of Hyderabad (UoH), India and Australia's Flinders University have entered into a landmark strategic partnership, formalised through the signing of a Memorandum of Understanding (MoU).
1 min |
BioSpectrum Asia May 2025
BioSpectrum Asia
Saisei Ventures introduces Executive Fellows Programme for Japan's biotech leadership pipeline
Saisei Ventures, a leading venture investment firm focused on advancing Japanese biotechnology and therapeutic innovations, has announced the launch of its Executive Fellows Programme, a structured mentorship initiative designed to strengthen the next generation of biotech entrepreneurs and executives in Japan.
1 min |
BioSpectrum Asia May 2025
BioSpectrum Asia
Africa CDC unveils strategic plan to transform health financing
With external health aid to Africa expected to plunge by 70 per cent between 2021 and 2025, the Africa Centres for Disease Control and Prevention (Africa CDC) has launched a continent-wide strategy to radically transform how health systems are financed, putting African resources at the centre of African health.
1 min |
BioSpectrum Asia May 2025
BioSpectrum Asia
Singapore expands startup hub in Tokyo to propel deep tech innovation
NUS Enterprise, the entrepreneurial arm of the National University of Singapore (NUS), is expanding its presence in Japan with the launch of its second BLOCK71 office in Tokyo.
1 min |
BioSpectrum Asia May 2025
BioSpectrum Asia
Swiss awards 5-Year grant to FIND for innovative malaria testing
The FIND Board has received notice of an award from the Swiss government of a grant to develop an innovative point-of-care rapid diagnostic test (RDT) for P. vivax malaria.
1 min |
BioSpectrum Asia May 2025
BioSpectrum Asia
The Rise of K-Biotech
After K-pop, K-dramas, and K-beauty, South Korea is now turning its focus to biotechnology. Through a series of government initiatives and industry investments, the country is working to position itself as a major player in the global biotech sector. From manufacturing capacity to research and development, Korea is laying the groundwork to become a significant force in the biotech industry.
7 min |