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01 / 05
Stem Cell Therapies “Come of Age” with Approvals in Japan

Science | Health & Medical Care

Stem Cell Therapies “Come of Age” with Approvals in Japan

“Twenty years after they were first created in Japan, extraordinarily versatile stem cells made from the body’s own cells may finally realize their promise for regenerating diseased tissue. Last month, an advisory panel to Japan’s health ministry recommended limited marketing approval for therapies using induced pluripotent stem (iPS) cells for heart failure and Parkinson’s disease. In a controversial arrangement, their makers will be able to sell the products for 7 years while continuing studies to determine just how well the therapies work. IPS cells are moving closer to medical use in other countries as well, with dozens of potential therapies in clinical trials…

One of the new therapies, intended for heart disease patients, was developed by Kyoto University’s Center for iPS Cell Research and Application (CiRA) in collaboration with a University of Osaka group led by cardiovascular surgeon Yoshiki Sawa. Heart muscle cells derived from iPS cells are formed into small patches. Applied to a diseased heart’s surface, the muscle patches boost contraction while also releasing cytokines that promote blood vessel formation.

Eight heart disease patients have received RiHEART patches made by Cuorips, a startup spun off from the university. The company has reported in press briefings and two peer-reviewed papers—in Frontiers in Cardiovascular Medicine in 2022 and 2023—that there were no serious safety issues and patients’ heart function improved.

The Parkinson’s therapy, developed by a group led by neurosurgeon Jun Takahashi, CiRA’s current director, coaxes iPS cells to form replacements for the dopamine-producing neurons that die off in Parkinson’s. In a small pilot trial, surgeons drilled holes into the skulls of six Parkinson’s patients and injected the replacement cells. There were no safety issues, and four of the patients showed improvement 24 months after transplantation, Takahashi and colleagues reported in Nature last year. Sumitomo Pharma and RACTHERA are commercializing the treatment, dubbed Amchepry.”

From Science.

The Guardian | Health Systems

First Malaria Drug for Babies Is Approved in Major Milestone

“The first malaria treatment for babies has been approved by the World Health Organization, opening the door to widespread use around the globe.

In parts of Africa, up to 18% of children under six months will be infected with malaria, but there has historically been no safe treatment for the smallest of them. There were 610,000 deaths from malaria in 2024, about three quarters of which were under-fives in Africa…

Medical leaders hope that Coartem Baby, which can be used to treat infants as small as 2kg (4.4lb), will fill the treatment gap. The drug comes as sweet cherry-flavoured tablets that can be dissolved into liquids, including breast milk…

Coartem Baby now has WHO prequalification, which indicates it meets international standards of quality, safety and efficacy, and will enable public-sector procurement for many countries with high rates of malaria, particularly in sub-Saharan Africa.”

From The Guardian.

POWER magazine | Energy Production

NRC Unveils New Path for High-Volume Microreactor Licensing

“The U.S. Nuclear Regulatory Commission (NRC) has proposed a sweeping new licensing framework designed to push microreactors out of the lab and onto the grid at unprecedented speed. The proposed rule, called Part 57, is paired with a broader agency overhaul that earlier this year created the Office of Advanced Reactors (OAR), headed by longtime NRC official Jeremy S. Bowen. Together, the two moves represent the most significant shift in U.S. nuclear regulation in a generation—a direct response to White House Executive Order 14300 (Ordering the Reform of the Nuclear Regulatory Commission) and the bipartisan Accelerating Deployment of Versatile, Advanced Nuclear for Clean Energy (ADVANCE) Act.

Announced April 24, the proposed Part 57 rule creates a streamlined, risk-informed pathway for licensing microreactors and other reactors with comparable risk profiles. The NRC and industry estimate it will save between $3.76 billion and $11.84 billion, depending on discount rate, largely by ‘reducing exemption requests and streamlining reviews.’ Construction permit and operating license timelines could shrink to six months to a year.”

From POWER magazine.

Associated Press | Trade

India and New Zealand Sign a Free Trade Agreement

“India and New Zealand on Monday signed a free trade agreement to deepen economic ties and expand market access, as both countries navigate mounting global trade disruptions.

The deal comes as New Delhi moves to diversify export markets to offset the impact of steep tariffs imposed by the United States and instability in shipping and energy routes due to the Iran war. For New Zealand, the agreement is part of a broader push to reduce reliance on China, its largest trading partner.

The agreement was signed in New Delhi by India’s Commerce and Industry Minister Piyush Goyal and visiting New Zealand Trade and Investment Minister Todd McClay.

Negotiated over nine months and agreed in December, the deal will cut or eliminate tariffs on 95% of New Zealand’s exports to India, while making all Indian exports to New Zealand duty-free. Wellington has also committed to invest $20 billion in India over the next 15 years.”

From Associated Press.

Reuters | Motor Vehicles

California Allows Manufacturers to Deploy Heavy Autonomous Vehicles

“The California Department of Motor Vehicles (DMV) on Tuesday adopted new regulations for autonomous vehicles, ​allowing manufacturers to test and deploy heavy-duty ‌driverless vehicle technology on the state’s roads…

Here are a few ⁠details:

  • The move lifts the ban on operating ​autonomous vehicles weighing over 10,001 pounds (4,536.4 kg), opening ​California to autonomous freight operations.
  • However, vehicles will still be required to stop at patrol stations and comply with state ​and federal commercial motor vehicle rules.
  • Medium-duty autonomous ​vehicles up to 14,001 pounds will be allowed to ‌be ⁠operated by public agencies and universities.
  • In 2023, California Governor Gavin Newsom vetoed a bill to prevent heavy-duty driverless trucks from operating in the state.
  • The DMV ​had since ​been working ⁠toward developing a regulatory framework to lift that restriction.
  • The new rules ​require manufacturers to begin with testing using ​a ⁠safety driver and progress to driverless testing before applying for commercial deployment.
  • Manufacturers must complete 50,000 miles (80,467.2 ⁠km) ​for light-duty vehicles and 500,000 ​miles for heavy-duty vehicles for testing at each phase.”

From Reuters.