IRELAND

The outcome of Process - Public Consultation on proposed fees for Human Medicines, Compliance, Medical Devices and Veterinary Medicines for 2025

The public consultations regarding the proposed fees for Human Medicines, Medical Devices, Compliance, and Veterinary Medicines for 2025 concluded on October 30, 2024. The Health Products Regulatory Authority (HPRA) thanks all participants who contributed to this process. Below is a document summarising the matter.

NEW ZEALAND

Updates to Guidelines on the Regulation of Therapeutic Products in New Zealand: Manufacturing of Medicines

Medsafe has revised its guidelines for regulating therapeutic products, focusing on medicine manufacturing. These updates enhance compliance with Good Manufacturing Practice (GMP) standards for prescription medicines, specify the evidence required for GMP compliance, and outline the authorities responsible for issuing GMP certification.

JAPAN

PMDA established PMDA Washington D.C. Office as its first U.S. base

The PMDA Washington D.C. Office was inaugurated on November 1, 2024, marking the agency's first presence in the U.S., following the opening of an Asia office in Thailand in July. As international start-ups, especially in the U.S., accelerate innovative drug development, the PMDA recognises the need for a D.C. office to expedite the introduction of these therapies in Japan.

TURKMENISTAN

Announcement on activities carried out within the scope of regulation on testing, control and calibration of medical devices

As is well known, the authorisation procedures for conformity assessment institutions operating under the Regulation on Testing, Control, and Calibration of Medical Devices, published in the Official Gazette on June 25, 2015 (No. 29397), are conducted by our Institution. Article 11 of this Regulation, titled "Testing, Control, and Calibration Services," outlines the relevant provisions.

BRAZIL

Anvisa and ABDI sign agreement to modernize systems

On November 8, Anvisa and the Brazilian Agency for Industrial Development (ABDI) signed a technical cooperation agreement to modernise Anvisa's information systems. The collaboration aims to enhance operational efficiency through IT investments, promote automation, and reduce reliance on skilled labour for data structuring, ultimately accelerating decision-making within the agency.

SINGAPORE

All private hospitals commit to enhancing health data sharing for more seamless care delivery

All nine private hospitals in Singapore have pledged to contribute their patients' health information to the National Electronic Health Record (NEHR). This initiative will facilitate the sharing of healthcare data across both the public and private sectors, thereby enhancing continuity of care for patients.

BRAZIL

Anvisa discusses challenges in the pharmaceutical and healthcare sectors at Rio Health

Anvisa participated in the Rio Health Forum on November 6-7 in Rio de Janeiro, gathering specialists, academics, and managers to discuss innovation and challenges in Brazil's health and productive sectors. Representing Anvisa were directors, Daniel Pereira and Meiruze Freitas, along with clinical research and health services staff. Key topics included the regulatory sandbox implementation and strategies for advancing cancer treatment technologies, including CAR-T cell therapies.

UNITED STATES

Inquis Medical Announces $40 Million Series B Financing to Accelerate Advancement of Aventus Thrombectomy System Addressing Venus Thromboembolic Diseases

Inquis Medical, a leader in advanced thrombectomy systems, has completed a $40 million Series B financing round, led by Marshall Wace and supported by existing investors like ShangBay Capital, Yu Star, EnPointe Ventures, and Pierre Lamond. This oversubscribed funding will drive substantial growth and support the commercialisation of its innovative technologies.

UNITED STATES

Shockwave Medical Unveils First Clinical Outcomes of New IVL Platform in Late-Breaking Presentation at VIVA 2024

Shockwave Medical, Inc., a subsidiary of Johnson & Johnson MedTech, announced the first clinical outcomes for its Shockwave Javelin Peripheral IVL Catheter, a non-balloon-based lithotripsy platform for treating calcified lesions in peripheral artery disease (PAD). The 30-day results met all performance goals, showing a safety and effectiveness profile similar to balloon-based IVL catheters. These findings, which supported recent FDA clearance, were presented as a late-breaking abstract at the Vascular InterVentional Advances (VIVA) meeting.

UNITED KINGDOM

SolasCure and the U.S. Army Institute of Surgical Research collaborate for combat wound care

SOLASCURE Ltd (“SolasCure”), a biotechnology company focused on developing novel treatments for chronic wound care, has announced a research collaboration with the U.S. Army Institute of Surgical Research (“USAISR”). This partnership aims to evaluate SolasCure’s investigational product, Aurase Wound Gel, for its potential in managing combat wounds. Aurase Wound Gel is a hydrogel that releases tarumase, a recombinant enzyme derived from medical maggots and is currently under development.

Funding

Follow where the money goes, or do you?

Investors often have clear mandates (sector, stage, returns, market) and therefore companies such as medical device startups need to align with these mandates to work together with these funders to accelerate their growth. One particular point of interest, is on the investors’ choice of markets.

Some of these reasons could mean that the investors needed their investment to be resident in certain countries (or not in certain countries), to ensure funds don’t flow out or that the investment benefits the country where the funds come from.

While this appears to be logical, what if the markets of interest lies in other countries?

It’s easy to say “let us launch in all countries” but in practice there would need to be some prioritisation to allocate adequate resources. So do you follow where the investor points, or follow where the sales revenue is at? If you really have to choose, which way to go?

Revenue and exit strategy are always the best materials in a pitch deck for the next round of investment. At the same time, the investors especially venture capital will have the wishes of their LPs to consider. If it is not adhered, it may cause the LP to pull out in extreme cases. There is a lot at stake. Therefore some balancing is needed together with your investors to derive the best way to go. It is the recognition of these factors that is the key.

Still clear as mud?

SWITCH AND TECHINNOVATION 2024

The concurrent events of Singapore Week of Innovation and Technology (SWITCH) and Techninnovation 2024 were held from 28-30 October 2024, spanning across domains such as Health & Biomedical, Environment, Energy & Green Technology, Manufacturing, Trade & Connectivity, Consumer Media, Goods & Services and Transformative Digital Technologies. Although not exclusively healthcare-limited, the events kept us productively engaged from day to night -- It was 3 days of hopping between meetings and talks at Marina Bay Sands Convention Centre, followed by after-events where we reconnected with some existing clients, while also making meaningful connections with new ones. It is always a treat to visit tartup booths to learn about how they are bringing new ideas to healthcare problems, both old and new.

Apart from the plethora of startup booths at SWITCH and Techinnovation, a commonality between them was also the presence of various industry partner booths present to support the healthcare ecosystem. We are fortunate to be in bilateral connection with many of these ecosystem partners -- to meet new founders, and to also help our clients cement their footing in Singapore.

Finally, at SWITCH, we were also able to catch two of the Health & Biomedical Slingshot domain finalists make it to the 1st and 2nd runners up in the overall finals! Our heartiest congratulations to Stemden and Sonire Therapeutics, providing a testament to how technology has advanced the paradigm of healthcare.