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In dit nummer

Navigating Manufacturing, Infrastructure & Regulatory Hurdles in CAR T-CELL THERAPY GROWTH CAR T-cell therapy is a highly personalised treatment that depends on a unique and complex manufacturing and delivery process to reach patients quickly and reliably. From leukapheresis to final product delivery, the process is continuous and time sensitive, posing significant operational challenges. How is the industry addressing them, and what steps are needed to build a sustainable manufacturing ecosystem?

US PLUGS CHINESE PHARMA COLLABS

While several countries, including India and Japan, have faced prolonged trade frictions with the US over tariffs, the contest with China extends beyond tariffs into a second, more strategic front in the pharmaceutical sector. Here, the tussle is not only about trade tariffs but also about the deepening collaborations between US pharma giants and Chinese drugmakers. In recent years, several multinational companies have turned to China in search of the next wave of blockbuster drugs, drawn by the country’s rapid advances in R&D and its mature supply chain.

2 mins

Australia to implement new pneumococcal vaccine on National Immunisation Programme

Australian children will now have stronger protection against pneumococcal with the Australian Government implementing a new and improved vaccine on the National Immunisation Programme (NIP).

1 mins

Malaysia and Singapore sign MoU to fast-track medical device market access

The Medical Device Authority (MDA) of Malaysia and the Health Sciences Authority (HSA) of Singapore have signed a Memorandum of Understanding (MOU) to deepen regulatory cooperation and officially launched a 6-month pilot of the Medical Device Regulatory Reliance Programme as part of the MoU.

1 mins

Abbott receives regulatory approval for first denosumab biosimilar in Thailand

Abbott has received regulatory approval for the first denosumab biosimilar in Thailand, expanding access to advanced therapies for osteoporosis and cancer-related bone loss.

1 mins

India joins Health AI Global Regulatory Network to strengthen oversight of AI in healthcare

HealthAI - The Global Agency for Responsible AI in Health, has welcomed India as a pioneer country joining the HealthAI Global Regulatory Network (GRN), a global network of health regulators dedicated to the safe and effective use of artificial intelligence (AI) in healthcare.

1 mins

Mabwell and Aditum Bio ink $1 B deal for siRNA cardiovascular therapies

Mabwell (Shanghai) Bioscience and US-based Aditum Bio have announced the launch of Kalexo Bio, a new company formed in conjunction with an exclusive global license agreement to develop 2MW7141, a novel dual-target siRNA candidate for lipid management in patients with dyslipidemia and for the prevention of high-risk atherosclerotic cardiovascular disease (ASCVD) events.

1 mins

CSL partners with VarmX on first-in-class coagulation treatment in $2.2 B deal

Australia's CSL Limited has entered into an agreement with privately held Dutch biotech company, VarmX BV, to develop a new treatment to restore blood coagulation in patients taking a FXa inhibitor.

1 mins

TVM Capital Healthcare announces first closing of $150 M Southeast Asia Fund

Singapore-based TVM Capital Healthcare, a global private equity investor and operator specialised in healthcare growth capital across emerging markets, has announced the first closing of its $150 million TVM Healthcare Southeast Asia Fund (SEA Fund).

1 mins

ADB approves $106.9 M to strengthen secondary healthcare services in Sri Lanka

The Asian Development Bank (ADB) has approved a $106.9 million financing package to strengthen Sri Lanka's secondary curative care services, improve communicable disease prevention and control, and enhance the healthcare sector's governance and management capacity.

1 mins

University of Sydney partners with Siemens Healthineers for MRI research capability

Australia's University of Sydney has unveiled a $9 million partnership with Siemens Healthineers centred on the opening of the state's most advanced magnetic resonance imaging (MRI) scanner.

1 mins

PHC Holdings inks MoU to transfer Eversense CGM distribution to Senseonics

Japan-based PHC Holdings Corporation and its subsidiary Ascensia Diabetes Care, a global diabetes care company, have announced that Ascensia has signed a Memorandum of Understanding (MoU) to transfer the commercial operations for Eversense Continuous Glucose Monitoring (CGM) systems to Eversense maker Senseonics Holdings, Inc.

1 mins

Nanyang Biologics partners with NVIDIA, HPE & Equinix to build AI-powered drug discovery platform

Nanyang Biologics (NYB) enters a strategic collaboration with NVIDIA, Hewlett Packard Enterprise (HPE), and Equinix to build 'VECURA'-an artificial intelligence (AI)-powered drug discovery platform that combines advanced predictive models with a proprietary library of millions of natural compounds.

1 mins

Stryker expands R&D footprint in India with new facility in Bengaluru

US-based Stryker, a global leader in medical technologies, has announced the expansion of its R&D presence in India with the opening of a new facility in Bengaluru, India.

1 mins

Epigenic Therapeutics raises $60 M to accelerate clinical development of medicines

China-based startup Epigenic Therapeutics, a clinical-stage innovative drug development company, has announced the completion of a $60 million Series B round of financing led by Lapam Capital, with continued participation from existing investors Qiming Venture Partners and OrbiMed, and addition of new investors including IFSC and a renowned investment firm in the industry.

1 mins

CUREator backs Monash biotech to advance new therapeutics for polycystic kidney disease

xCystence Bio, a Monash University biotech startup, has secured a top-up funding boost from Brandon BioCatalyst's CUREator incubator to drive the development of urgently needed therapeutics for Polycystic Kidney Disease (PKD).

1 mins

India signs MoU with Pfizer to strengthen healthcare innovation ecosystem

In a significant step towards strengthening India's healthcare innovation ecosystem, the Department for Promotion of Industry and Internal Trade (DPIIT), Ministry of Commerce and Industry, Government of India, has signed a Memorandum of Understanding (MoU) with US-based Pfizer Limited.

1 mins

Avasa secures funding to proceed with US FDA clearance

Auckland-based medtech startup Avasa has secured the first close of its Pre-Series-A capital raise.

1 mins

PAHO intensifies call to strengthen vaccination in light of rising measles cases

The Pan American Health Organization (PAHO) is urging countries in the Americas to strengthen vaccination efforts, improve surveillance, and accelerate outbreak response following a rise in measles cases in the region.

1 mins

New Mpox vaccine study to launch in outbreak-affected DRC

New research due to launch in the Democratic Republic of the Congo (DRC) will provide important real-world data on the performance of the LC16m8 mpox vaccine in African populations, amid a major outbreak of the deadly virus which remains a continental public health emergency.

1 mins

US FDA grants accelerated approval to first treatment for Barth Syndrome

The US Food and Drug Administration (FDA) has granted accelerated approval to Forzinity (elamipretide) injection as the first treatment for Barth syndrome, in patients weighing at least 30 kg.

1 mins

UK offers free chickenpox vaccination for first time to children

Thousands of children will be protected against chickenpox for the first time in England through a new vaccination programme that will keep kids in school and parents in work while also saving the National Health Service (NHS) vital funds.

1 mins

WHO urges cost effective solutions on NCDs and mental health

The World Health Organization (WHO) has released a new report titled \"Saving lives, spending less\", revealing that an additional investment of just $3 per person annually in tackling noncommunicable diseases (NCDs) could yield economic benefits of up to $1 trillion by 2030.

1 mins

WHO publishes report to help countries ensure equitable access to controlled medicines

The World Health Organization (WHO) has published the full edition of its guideline on balanced national controlled medicines policies, marking the first comprehensive global framework designed to ensure access to controlled drugs for medical and scientific uses, while minimising risks to public health that may arise due to misuse and diversion.

1 mins

Navigating Manufacturing, Infrastructure & Regulatory Hurdles in CAR T-CELL THERAPY GROWTH

CAR T-cell therapy is a highly personalised treatment that depends on a unique and complex manufacturing and delivery process to reach patients quickly and reliably. From leukapheresis to final product delivery, the process is continuous and timesensitive, posing significant operational challenges. How is the industry addressing them, and what steps are needed to build a sustainable manufacturing ecosystem? Let's dig deeper.

10+ mins

Middle East Leverages AI for Real Gains

The Middle East is not only investing in digital healthcare, but building around it. From national health strategies to growing startup hubs, the region is turning infrastructure gaps into launch pads. With a projected compound annual growth rate (CAGR) of 9.2 per cent, the Middle East's digital healthcare market is poised to reach $7.9 billion by 2028. Moreover, the United Arab Emirates (UAE) has now launched a strategic initiative aimed at strengthening its position as a leading global hub for entrepreneurship and innovation, especially with the advent of artificial intelligence (AI) and other technologies. But there are certain barriers affecting technology adoption and startup scale-up in the region. Let's look into this in detail.

7 mins

How Asia is Pioneering LONGEVITY BIOTECH

Ageing is fast emerging as a focus area in Asia, with 2025 witnessing a flurry of activity across startups, research initiatives, and investment. As the region positions itself in the longevity biotech space, the key question is what drivers and initiatives are shaping its growth and what it will take to build a globally competitive ecosystem. Let's find out.

7 mins

India Introduces Stricter Cosmeceutical Rules to Tackle Counterfeit Products

A huge craze among consumers for cosmeceuticals, by going into marketing and brand appeal, is setting a dangerous precedent. Above all, fake cosmetic products have flooded the Indian market, which are easily available online and across street markets. Keeping this in mind and to stop unscrupulous ads, the Ministry of Health and Family Welfare, Government of India has officially published the Cosmetics (Amendment) Rules, 2025, on July 29, which introduce a series of changes to the existing Cosmetics Rules, 2020. Experts weigh in on how this Act can be a gamechanger in the cosmeceutical sector, provided strict norms are followed.

6 mins

'AI holds enormous promise to aid clinicians in making informed decisions among many different treatment pathways'

In July 2025, the FDA approved the Oncomine Dx Express Test, a next-generation sequencing (NGS) platform developed by Thermo Fisher Scientific. The firm is now seeking approval in Japan, where cancer is the leading cause of death, with over one million new cases diagnosed annually. Thermo Fisher Scientific has submitted a medical device manufacturing and marketing approval application to Japan's Ministry of Health, Labour and Welfare for the Oncomine Dx Express Test Multi-CDx System, which automates the entire diagnostic workflow and delivers results in as little as 24 hours. Designed for rapid, high-precision diagnostics in breast cancer and solid tumours, the system aims to personalise care and accelerate treatment decisions. Jane Li, Senior Director of Pharma CDx and CRO Partnerships, Clinical Sequencing, discusses how the new system advances on the earlier test, trends in pharma-diagnostic collaborations globally and in Asia, key challenges in scaling NGS adoption, and the role of automation and AI in shaping the future of personalised medicine. Edited excerpts:

4 mins

"Sebia India will introduce pipeline of new products across Autoimmunity, Infectious Diseases"

France headquartered Sebia, a global leader in specialty diagnostics, is continuing its geographic footprint to better serve its customers. Over the decades, the company has earned worldwide recognition for its pioneering expertise in Multiple Myeloma screening, diagnosis, and monitoring, as well as its leadership in hemoglobinopathies diagnosis. In recent years, Sebia has significantly expanded its portfolio in autoimmunity and infectious disease diagnostics through strategic acquisitions – ORGENTEC in 2021 and ZEUS Scientific in 2022. The company is now all set to strengthen its presence in India, thereby expanding its reach, building talent, and raising awareness. Sebia established its presence in India in 2019, and has achieved consistent double-digit growth year after year. To find out more about the company's growth plans in India, BioSpectrum spoke to Heejin Roh, Vice President – Commercial Operations, Asia Pacific, Sebia. Edited excerpts:

4 mins

How AI Is Accelerating Drug Repurposing & Therapeutic Innovation in India

With India facing increasing disease burdens and deficiencies in healthcare infrastructure, AI is becoming a driving force for quicker, more intelligent therapeutic advancements. Indian startups and institutions are making significant contributions through drug repurposing, enhancing diagnostics, genomics, and clinical research.

4 mins

National Yang Ming Chiao Tung University, TSH Biopharm collaborate to foster pharma talent in Taiwan

Taiwan's National Yang Ming Chiao Tung University (NYCU) and TSH Biopharm have signed a five-year industry-academia collaboration Memorandum of Understanding (MOU).

1 mins

AIU and Acumen join hands to transform India-Japan higher education collaboration

The Association of Indian Universities (AIU) and Acumen, part of the Sannam S4 Group, have announced the formalisation of a pivotal strategic partnership through a Memorandum of Understanding (MOU) designed to significantly accelerate the internationalisation of Indian higher education sector, to provide new international study options for Indian students and to create meaningful graduate career outcomes in Japan.

1 mins

Scientists in Australia grow living skin in world-first

Australia's University of Queensland (UQ) researchers have been the first in the world to successfully grow fully functioning human skin in a laboratory.

1 mins

HKMU licenses tech for non-invasive prostate cancer screening

Hong Kong Metropolitan University (HKMU) recently achieved its first-ever technology licensing agreement, a milestone in the University's efforts to translate research into impactful, real-world applications.

1 mins

Korea makes smart patch that can run tests using sweat instead of blood

A research team at Korea Advanced Institute of Science and Technology has developed a smart patch that can precisely observe internal changes through sweat when simply attached to the body.

1 mins

New Zealand to lead new gene therapy trial for muscular dystrophy

The first clinical trial of a new treatment for a rare form of muscular dystrophy is being led by New Zealand-based University of Auckland's Centre for Brain Research.

1 mins

Shimadzu launches Gas Chromatograph FluxEdge GC System

Japan-based Shimadzu has released the FluxEdge GC System, equipped with FluxEdge, its proprietary trace gas sampling/switching technology.

1 mins

Fujifilm Biosciences introduces BalanCD HEK293 Perfusion A Medium

Fujifilm Biosciences, a global leader in the innovation and manufacture of cell culture solutions for the life science market, has announced the commercial launch of BalanCD HEK293 Perfusion A.

1 mins

Trump's Counter Productive Tariff Moves

On September 25, 2025, US President Donald Trump announced that the United States would impose a 100 per cent tariff on all branded and patented pharmaceutical imports starting October 1, unless the companies importing them are actively building manufacturing facilities in the US, defined as “breaking ground” or “under construction.” As of September 26, no official guidance or regulations had been released regarding how this policy would be implemented. The announcement has raised significant concerns from healthcare stakeholders, particularly the American Hospital Association (AHA), which represents nearly 5,000 hospitals, health systems, networks, and 43,000 individual members.

2 mins

Lees alle verhalen van BioSpectrum Asia

BioSpectrum Asia Description:

Uitgever: MM-Activ-Sci-Tech-Communication

Categorie: Business

Taal: English

Frequentie: Monthly

BioSpectrum Asia Magazine is a monthly magazine published by MM Activ Sci-Tech Communication in India. It is a leading biotechnology magazine in Asia, covering a wide range of topics related to the biotechnology industry, including:

* Biotechnology news and trends: BioSpectrum Asia covers the latest biotechnology news and trends from India and around the world.

* Biotechnology company profiles and interviews: The magazine profiles leading biotechnology companies in Asia and interviews their CEOs and other top executives.

* Biotechnology research and development: BioSpectrum Asia covers the latest biotechnology research and development from academic institutions and pharmaceutical companies.

* Biotechnology product reviews: The magazine reviews the latest biotechnology products and services.

* Biotechnology industry events: BioSpectrum Asia covers biotechnology industry events from around the world.

BioSpectrum Asia Magazine is a must-read for anyone who wants to stay informed about the latest advances in biotechnology and their potential to impact the world around us.