Japan could become one of the first countries in the world to end the HIV epidemic, says the president of Gilead Sciences Japan, Kennet Brysting. The idea for now could seem a little too ambitious, but it is not entirely unrealistic, given that the availability of medicines that can prevent transmission of HIV. Drugs are not the cure, but control over the spread of virus to the point where the disease is no longer a major public health threat.

What Is The Role Of Preventative HIV Medicines?

Gilead's have two key drugs, Truvada and lenacapavir. These two are playing a crucial role in prevention. Truvada is taken as a daily pill, while lenacapavir requires two injections per year. It can make the virus undetectable in infected individuals and prevent transmission to those who are not infected yet. In trials, lenacapavir showed 100% efficacy in preventing HIV infections. This is why it is describe as "almost a vaccine".

In 2024, Japan also approved Truvada for HIV prevention, but the country has yet to approve lenacapavir for the same. Until now, people in Japan had been importing generic versions of Truvada or purchasing it from clinics that source it from overseas.

HIV In Japan

Up until now, Japan reported around 25,000 HIV infections, whereas 669 new cases were reported in 2023. For seven consecutive years, the number of new infections remained under 1,000. The downward trend thus shows that the virus has been controlled, however, getting to zero new infections remains the ultimate goal.

Brysting too acknowledged that simply having effective drug is not enough. What is important is to have a proper implementation, access and healthcare support to make sure that these treatments are widely available and effective.

What Are The Challenges In Implementation?

The biggest challenges is testing rates. There is a need to increase testing rates. At this very moment, around 86% people infective with Japan have been tested, but the goal is to increase it up to 95%, with an ideal goal of 100%. Without widespread testing, many infected people may not even know that they are infected and it could transmit the virus.

Another measure issue is the cost of preventative medication. While Japan's health insurance covers treatments for diseases, it does not cover preventative drugs. Those who purchase Truvada for prevention, pay around $470 per month. Some clinics in Tokyo offer generic alternatives too, which is cheaper, but they are not ideal.

Better Healthcare Support

Brysting expressed concern that individuals importing medications might not be consulting doctors regularly, which is essential for monitoring HIV status and overall health. Truvada users need to be tested for HIV initially and every three months, along with screenings for other infections and kidney function checks. Without proper medical supervision, there is a risk of misuse and inadequate protection.

Gilead is in discussions with Japanese authorities to improve access and insurance coverage for Truvada, and progress is being made. Japan has shown efficiency in approving critical medicines, as seen during the COVID-19 pandemic when Gilead’s remdesivir was approved in just three days.

What Is The Way Ahead?

Gilead at this moment is not only focused on HIV and hepatitis C, but also expanding into oncology with innovative treatments like CAR-T cell therapy, which strengthens a patient's immune system to fight cancer.

However, Japan’s strict approval processes can slow down drug availability. Phase 3 clinical trials often need to be conducted within the country, and Japan tends to approve medicines much later than other regions. For instance, Truvada was approved for prevention in Japan 12 years after the U.S. and nearly 20 years after its approval for treatment. inancial factors also play a role. The Japanese government adjusts drug prices annually, often reducing them, which can make long-term investment challenging for pharmaceutical companies.

Creating a new senior position to focus entirely on technology and artificial intelligence, the US Food and Drug Administration (FDA) has just got its first AI chief. The move could change how the agency evaluates medicines, pharmaceutical products and new technologies in the healthcare sector.

On September 8, the US Department of Health and Human Services (HHS) announced that Jared Seehafer, M.S. will be FDA’s first Deputy Commissioner for Technology and Artificial Intelligence. The newly formed role puts AI and technology directly into the agency’s senior leadership structure.

Seehafer has around two decades of experience working at the intersection of software, AI and FDA-regulated medical technology.

As deputy commissioner, he will be the FDA’s senior leader for technology, software and AI and will help establish an agency-wide strategy for their use.

Why Does The US FDA Need An AI Chief?

From identifying potential drug candidates to analysing clinical-trial data and developing medical devices, the use of AI is increasing rapidly across pharmaceutical and healthcare industries.

But, for regulators, AI presents a different challenge. The FDA must determine whether AI-generated or AI-assisted evidence is reliable enough to support decisions about the safety and effectiveness of a product.

The agency has already begun moving in this direction. In May 2026, the FDA issued draft guidance on the use of artificial intelligence to generate information or data intended to support regulatory decision-making for drugs and biological products.

The FDA has also been exploring AI and cloud-based approaches to make clinical trials more efficient, including a pilot focused on early-phase trials.

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AI May Make Drug Approvals Faster

One of the biggest opportunities is using artificial intelligence to process large volumes of information that regulators already receive during drug development and review.

AI could eventually help regulators identify patterns in clinical-trial data, analyse safety aspects, review large regulatory submissions and support more efficient assessment of complex datasets in health and pharmaceutical sector.

But does faster automatically mean better? AI systems may produce incorrect outputs. So regulators need to understand how an algorithm reached a particular conclusion before relying on it for decisions that affect patients. That makes validation, transparency, data quality and human supervision critical in this area.

Also read: Another Child Dies From Measles In US Amid Vaccine Concerns: Why The Virus Is More Than A Fever And Rash

The Future Of Drug Regulation

The appointment comes alongside several other leadership changes at the FDA. HHS also named Michael Davis as permanent director of the Center for Drug Evaluation and Research, Karim Mikhail as director of the Center for Biologics Evaluation and Research, and Bret Koplow as director of the Center for Tobacco Products.

The broader message from HHS is that the FDA wants to modernise its regulatory infrastructure while accelerating innovation.

“We are building an FDA that moves faster, demands excellence, and delivers results for the American people,” HHS Secretary Robert F. Kennedy Jr. said. “These leaders will drive the reforms needed to confront our nation’s most serious health challenges and strengthen American leadership in medical innovation.”

FDA Acting Commissioner Kyle Diamantas said the appointments were intended to help build the workforce and infrastructure needed to “accelerate innovative” work across the agency.

Small-cell lung cancer (SCLC) is one of the most aggressive forms of lung cancer. It tends to grow rapidly, spread early and often returns even after initially responding well to treatment.

A new drug combination from Amgen and AstraZeneca has shown a significant overall survival benefit in patients with extensive-stage small-cell lung cancer (ES-SCLC), offering a new way to delay the disease's return and progression.

On September 8, the companies said that the Phase III DeLLphi-305 trial found that combining Amgen's tarlatamab, marketed as Imdelltra, with AstraZeneca's durvalumab, marketed as Imfinzi, significantly improved overall survival compared with Imfinzi alone.

Small-Cell Lung Cancer Is Difficult To Treat

The cancer can initially respond well to chemotherapy, but that response often does not last for a long time.

Many tumours become resistant to treatment, allowing the disease to return and become harder to treat. Research has described recurrent SCLC as frequently resistant to further therapy.

This is particularly challenging disease goes in extensive stage, where the cancer has already spread beyond the lung. Even with current treatments, the median overall survival for ES-SCLC remains around one year.

Also read: 25 Years After 9/11: What New Records Reveal About Toxic Air In New York

How Does The New Drug Combination Work?

The two medicines attack the cancer through different mechanisms. Durvalumab is an immune checkpoint inhibitor. It blocks PD-L1, a protein cancers can use to evade the immune system, helping immune cells recognise and attack cancer cells.

Tarlatamab is a bispecific T-cell engager. It is designed to attach to DLL3 on small-cell lung cancer cells and CD3 on T cells, effectively bringing immune cells into contact with the cancer cells so they can destroy them. DLL3 is found on the surface of SCLC cells in about 85%-96% of patients but is minimally expressed on healthy cells.

In the trial, 563 patients whose disease had not progressed after initial treatment with Imfinzi plus platinum chemotherapy and etoposide were randomly assigned to receive either the combination or Imfinzi alone as maintenance treatment.

The combination improved overall survival, progression-free survival and response rate. No new safety concerns were identified.

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Hope For Patients With SCLC

The significance of the findings lies in effectively controlling the cancer after initial treatment, when the disease is at the highest risk of returning.

Jacob Sands, MD, Associate Chief of the Lowe Center for Thoracic Oncology at Dana-Farber Cancer Institute, said: “Given the aggressive nature of small cell lung cancer, many patients quickly relapse on current therapy and never reach second-line treatment.” He added that the results suggest the potential to reshape the natural history of the disease.

Susan Galbraith, AstraZeneca's Executive Vice President of Oncology Haematology R&D, said the results showed an “unprecedented improvement in overall survival” for patients with this highly aggressive cancer.

The full trial data are yet to be presented at a medical meeting and will be submitted to regulatory authorities.

Toxic air persisted for months after the fatal 9/11 attacks on the World Trade Center, which killed more than 2,000 people, even as officials played down the health risks at Ground Zero in New York’s Manhattan, according to a trove of newly released files.

New York City Mayor Zohran Mamdani today released more than 170,000 documents from government agencies related to post-9/11 air quality and health risks. He accused officials of lying to the public about the dangers of toxic air at Ground Zero, where the World Trade Center towers collapsed in 2001.

“People got sick because the leaders they trusted lied and told them they were safe to breathe in toxic air,” Mamdani said at a news conference with survivors.

“As the years pass and the human toll grows, we reckon with the cost of September 11th whenever another New Yorker is stolen from us too soon. Now, close to 25 years later, more people have died from 9/11-related illnesses than were killed on the day itself.

“The very least our city owes the families, survivors and first responders whose lives were forever changed by the September 11th attacks is transparency and accountability. That is why I am proud that our administration has launched the City’s first public records portal dedicated to the environmental and health impacts of 9/11 and reached a settlement in these lawsuits,” said Mayor Mamdani.

What Do the Documents Reveal?

The files, released Tuesday and made available through an online portal, include 68 boxes of documents that were discovered last year, the Harding Memo and records concerning World Trade Center 7.

The 68 boxes had not been located until 2025, despite multiple Freedom of Information Law (FOIL) requests.

One key document is the October 2001 “Harding Memo”, in which an aide warned former Deputy Mayor Robert Harding, who served under then-Mayor Rudy Giuliani, that the city could face as many as 35,000 legal claims over its response to the attacks.

The memo states that the city could face lawsuits because health advisories had caused individuals “to return to the area too soon (causing toxic exposure or emotional harm).”

“There was poison in the air and on the ground and in the window sills and in your air conditioners and covering your pets and your clothes, and it stayed there for months. Everyone knew. And now it's very clear that the city knew as well,” said advocate Jon Stewart, CBS News reported.

Days after the attacks, city and federal officials, including the US Environmental Protection Agency (EPA), declared that the air near the Twin Towers was safe. Subsequent research, however, found that people had been exposed to toxic chemicals.

Christine Todd Whitman, who headed the EPA at the time, later apologized for the declaration, saying the agency “did the very best we could at the time with the knowledge we had,” BBC reported.

What Happened On 9/11?

In Lower Manhattan, the plane crashes and subsequent collapse of the Twin Towers created massive dust clouds that filled the air. Hundreds of highly populated city blocks were covered with ash, debris and harmful particles, including asbestos, silica, metals, concrete and glass.

According to the US CDC, fires within the debris pile and the collapse of 7 World Trade Center continued to burn through the end of December 2001, with flare-ups continuing into 2002. The fires released carcinogenic combustion by-products, while contaminants remained in Lower Manhattan and parts of Brooklyn for an undetermined period after 9/11.

Responders, local workers, residents, students and others faced potential exposure in the early days and in the months that followed. They could have been exposed to residual materials indoors and outdoors, as well as toxic gases, smoke, vapozrs and combustion by-products from continuing fires.