Day Lila

Biotech & Longevity · Friday, 2 October 2026

01 Briefing what happened

US regulators approve the first heart valve that can be widened as a child grows, which may spare children repeat open-heart surgery

Biotech & Longevity 34 sources

Edwards Lifesciences' Autus valve goes in as small as 13 millimetres and is later stretched with a balloon to 22. It was tested in 62 children, with results so far covering six months to a year.

13 to 22 mm

how wide the valve can be made, from a toddler's size to about an adult's

it is widened with a balloon passed through a blood vessel, not by opening the chest [1]

62

children in the study the approval rests on

at 12 US hospitals; the FDA reported six-month results for the first 60 [1]

About 4,200

babies born in the US each year with a narrowed or missing pulmonary valve

by the count of the US Centers for Disease Control and Prevention, quoted by the FDA [1]

The lead story — what happened

  • The FDA, the US regulator for medicines and medical devices, approved the Autus Size-Adjustable Valve on 1 October. [1][2]
  • It replaces the pulmonary valve in children born with a faulty one. This valve lets blood leave the right side of the heart for the lungs, and stops it flowing back. [1]
  • About 4,200 babies a year are born in the US with a pulmonary valve that is too narrow or never formed properly, the FDA says. [1]
  • Until now, no replacement valve could be widened after surgery. As the child grows it becomes too small, and a bigger one has meant another open-heart operation. [1][2]
  • The Autus valve can go in as small as about 13 millimetres, the right size for a toddler. [1]
  • Later, doctors widen it with a small balloon threaded in through a blood vessel, up to 22 millimetres, about the size of an adult's valve. [1][2]
  • Its flaps are made of a man-made material instead of animal tissue, which hardens and wears out faster in children. No valve with flaps like these had been approved before. [1]
  • The approval rests on a study of 62 children at 12 US hospitals. Every operation succeeded, with no deaths, strokes or blood clots that needed treatment. [1]
  • Three valve frames cracked and two flaps moved less than they should, but none of these children had symptoms. [1]
  • Two children began to outgrow their valves, and both had them widened without surgery. The FDA says experience with widening is still limited. [1]
  • Edwards Lifesciences, a California maker of heart devices, holds the approval, and a company called Autus Valve Technologies developed the valve. [1][2] Edwards says the children will be followed for 10 years. [2]
  1. 1Smallest size, for a toddler13 mm
  2. 2Largest size, about an adult's22 mm
How wide the Autus valve can be made. It goes in small, and a balloon stretches it as the child grows.

Who is involved

  • The FDA

    the US regulator for medicines and medical devices; it approved the valve through its strictest route for devices

  • Edwards Lifesciences

    a California maker of heart devices; it holds the approval

  • Autus Valve Technologies

    the smaller company that developed the valve

  • Children with a faulty pulmonary valve

    born with a valve that is too narrow, missing or leaking; many need a new valve more than once as they grow

How it unfolded

  1. Until now Children who outgrew a replacement pulmonary valve needed another open-heart operation for a bigger one [1]
  2. Earlier The FDA labelled the valve a breakthrough device, which speeds up its review [1]
  3. The study 62 children at 12 US hospitals got the valve, with no deaths or strokes [1]
  4. 1 Oct 2026 The FDA approves the valve [1][2]
  5. Next 10 years Edwards follows the children to see how the valve holds up [2]

Where this points

The next test is time: whether stretching the valve with a balloon keeps it working as children keep growing, which the FDA says longer studies are still checking. [1]

What is pushing on the whole day

The bar and the word are our reading of how hard each one is pushing today. The arrow is where it is heading. The evidence is in the stories below.

China's faster drug trials High↑

Drugs designed in China now make up about a third of all drugs being developed worldwide, STAT reports. [7] Abbisko, a Shanghai company, finished one trial in 11 months. [8] The US health department launched programmes on Wednesday to speed up its own trials. [5]

Health insurance covering less Building↑

Medicare Advantage plans, private insurance for older Americans, will charge members more in 2027. [16] Nebraska turned down 14% of new Medicaid applicants under its new work rule. [7] A US judge let investors keep suing UnitedHealth over earnings they say it inflated. [17]

Cancers that stop responding Building→

Nearly every pancreatic cancer patient on daraxonrasib, a new pill, eventually stops responding to it, a cancer doctor told the New York Times. [9] AstraZeneca asked US regulators to approve adding a second pill for lung cancers that grew despite its drug Tagrisso. [11]

Research turning to women and children Building↑

The journal Science published a special issue on women's health on Thursday. [20] A five-year UK trial will test a pain programme for endometriosis, which has no cure. [23] The new heart valve is the first built to grow with a child. [1]

The rest of the day

32 more stories on this beat.

Each with its own sources. None of these is a link to the story above.

  1. 02

    Sanofi pays $1 billion for Dupixent's successors

    Sanofi and Regeneron, the two drugmakers behind Dupixent, said on Thursday that they will expand their partnership. [3][4] Sanofi will pay Regeneron $1 billion up front, and up to $7 billion more if the new drugs pass set tests. [4] Dupixent, a medicine for eczema and asthma, sold $10.9 billion in the first half of this year. [3] Key patents protecting it run out over the next five years. [3] The deal covers four longer-lasting antibodies aimed at the same targets, and only one has reached human testing. [3]

    Why it matters — When the patents end, other companies can make close copies of Dupixent. [3] An analyst at RBC Capital Markets, an investment bank, said the new drugs are still very early, with no substantial data yet. [3]

  2. 03

    US plans faster drug trials

    The US health department launched new programmes on Wednesday to speed up the testing of new medicines. [5] The main one, SURPASS, is a five-year programme run by ARPA-H, the department's research funding agency. [6] It asks teams to design testing that runs as one continuous process, instead of separate phases with paperwork between them. [5][6] A new drug now takes about 10 years and $1 billion to $2 billion to develop, and more than 90% fail, the department says. [5]

    Why it matters — China passed the US in its share of early-stage trials in 2021. [5] In Australia, trials can start six to 12 months sooner and cost about half as much, a think-tank report says. [5] The announcement did not say how much money the programme has. [6]

  3. 04

    China pitches its drugmakers in Shanghai

    STAT, a US health news site, sent a reporter to a two-day biotech summit in Shanghai's Science City district. [7][8] Drugs designed in China now make up about a third of all drugs being developed worldwide, and draw more than half of all licensing and partnership deals. [7] Zhui Chen, a co-founder of Abbisko, a Shanghai company now worth $6 billion, said it ran a trial for Germany's Merck KGaA in 11 months. [8] Merck's managers then asked whether Abbisko could train their staff. [8]

    Why it matters — China's ruling Communist Party expects its drugmakers to have at least five blockbusters by 2030, STAT reports. [7] A blockbuster is a drug that sells more than $1 billion a year. That is the competition the new US trial programmes are meant to answer. [5]

  4. 05

    Why the new pancreatic cancer pill stops working

    Daraxonrasib, a pill approved in the US in August, roughly doubled how long people with advanced pancreatic cancer typically lived. [9] But it is not a cure, and it can suddenly stop working after about seven months. [9] Ben Sasse, a former US senator from Nebraska, said in late September that his stage 4 cancer had stopped responding to it. [9] On 25 September, at a cancer meeting in San Diego, researchers presented early clues from tumour samples taken from 66 patients. [9]

    Why it matters — Nearly every pancreatic cancer patient on the drug eventually becomes resistant to it, said Andrew Aguirre, a cancer doctor at the Dana-Farber Cancer Institute in Boston. [9] The researchers hope that learning how the cancer escapes will help them keep patients alive longer. [9]

  5. 06

    A second pill for lung cancer that comes back

    AstraZeneca has asked the FDA to approve two pills taken together, Orpathys and Tagrisso, for a kind of lung cancer, its Chinese partner HUTCHMED said on 29 September. [11] Tagrisso blocks EGFR, a faulty growth signal that drives some lung cancers. [11] One of the commonest ways those cancers start growing again is by turning up a second signal, MET, which Orpathys blocks. [11] In a final-stage trial called SAFFRON, the pair held the cancer back and kept patients alive longer than chemotherapy. [11]

    Why it matters — The combination is already approved in China, on the strength of an earlier Chinese trial. [11] If the FDA agrees, patients whose cancer grew despite Tagrisso could take two pills instead of chemotherapy. [11]

  6. 07

    A cold virus helps chemo in pancreatic cancer

    A modified cold virus called VCN-01 helped chemotherapy against pancreatic cancer that had spread, in a trial published in Nature Medicine on 30 September. [10] The virus infects cancer cells and makes an enzyme that breaks down part of the dense tissue around pancreatic tumours. [10] In 101 patients, those given the virus with chemotherapy typically lived 10.6 months, against 8.6 months on chemotherapy alone. [10] At 18 months, 31.1% of the virus group were alive, against 8.5% of the others. [10]

    Share of patients alive 18 months after starting treatment, in a trial of 101 people with pancreatic cancer that had spread.

    Why it matters — The survival gain passed the trial's main statistical test in one count of 96 patients, but not when all 101 were counted. [10] Serious side effects hit 22.6% of those given the virus, and the authors say a larger, blinded trial is needed. [10]

  7. 08

    US insurers for older people cut back

    Medicare Advantage plans are private plans that older Americans can choose instead of the US government's own Medicare. The insurers that run them are raising what members pay out of their own pockets in 2027. [16] They are also cutting money for dental work and other extras, and dropping plans with wide choices of doctors and hospitals, STAT found in new federal data. [16] Big insurers such as UnitedHealth Group and Humana are doing this to raise profits, after investors complained that profits had come in lower than promised. [16]

    Why it matters — Members who do not compare plans during the yearly sign-up period, which opens on 15 October, may find their doctor is no longer covered. [16] The cuts come even though the insurers won a payment increase from the Trump administration in April. [16]

  8. 09

    32 children die in India's forest villages

    At least 32 children have died since May in remote forest villages in Balaghat, a district of India's Madhya Pradesh state, officials say. [22] Most were Baiga, one of India's 75 tribal groups officially counted as particularly vulnerable. [22] Officials link about eight to 10 deaths to measles and about 10 to malaria, which may have been made worse by hunger and slow treatment. [22] The nearest state hospital is about 70km away, along dirt tracks that turn to mud in the monsoon. [22]

    Why it matters — Records showed 90% to 95% of children vaccinated in some areas, but health workers found children with no records at all. [22] Officials then offered the measles vaccine to every child under 15, and say the outbreak has now slowed. [22]

  9. 10

    Hidden artery plaque, even in the young

    About 1 in 13 adults aged 18 to 29 already had plaque, a fatty build-up, in at least one artery, in a scan study of 16,808 people in Denmark and Spain. [24] None had known heart or artery disease. [24] This build-up drives most heart disease, and it can grow for decades without any symptoms. [24] By ages 60 to 70, about 9 in 10 had some. [24] The study, called REACT, was published in the New England Journal of Medicine and paid for by the Novo Nordisk Foundation. [24]

    1 of 13

    Adults aged 18 to 29 with hidden plaque

    About 1 in 13 of the youngest adults scanned already had plaque in at least one artery.

    Why it matters — The usual risk scores, built from age, blood pressure and cholesterol, found only a small share of the people who already had plaque. [24] Having plaque does not mean a heart attack will follow, and the researchers want quick ultrasound scans to find it early. [24]

  10. 11

    Melanoma drugs before surgery, five years on

    Giving immunotherapy before surgery for advanced melanoma, a skin cancer, left most patients alive five years later, a pooled study of 1,038 patients from 26 hospitals found. [25] Immunotherapy drugs help the immune system attack a cancer. Five years on, 83.3% of those given one immunotherapy drug and 87.5% of those given two were alive. [25] Among patients whose tumours had mostly died by the time of surgery, about 98% were alive. [25] Patients given BRAF and MEK pills instead did worse, at 69.8%. [25]

    Share of melanoma patients alive five years after treatment given before surgery, by the kind of treatment they got.

    Why it matters — Immunotherapy before surgery is already standard care for this stage of melanoma, and this is a five-year count of how it has done. [25] Patients whose tumours responded early gained nothing from more of the drug after surgery. [25]

  11. 12

    US health survey to drop disability questions

    The US Centers for Disease Control and Prevention plans to cut its yearly National Health Interview Survey for adults from 482 questions to 150, STAT reported on 1 October. [15] The survey has collected Americans' health data since 1957. [15] The redesign, proposed in August, drops questions about hearing aids, tiredness, thinking, and wheelchairs and scooters. [15] The US health department said the changes were driven by the cost of collecting data, but would not say why the disability questions went. [15]

    The adult survey would shrink by about two thirds, and the questions cut include ones about hearing, thinking and wheelchairs.

    Why it matters — More than a quarter of Americans have a disability, and advocates say the cuts will mean they are counted even less. [15] A paper co-written by CDC statisticians found the survey may already miss 75% of people with intellectual and developmental disabilities. [15]

  12. 13

    Nebraska's work rule removes Medicaid cover

    Medicaid is the US health plan for people on low incomes. Nebraska's new work rule for Medicaid is already costing people their cover, an analysis by KFF found. [7] Fourteen percent of new applicants were turned down for not meeting the work rule. [7] Seven percent of people trying to renew lost their cover for the same reason. [7] From January, Nebraskans will have to send extra documents to prove they qualify. [7]

    Why it matters — The state is also expected to narrow who counts as too frail to work, which could push the numbers higher. [7] STAT has reported that the rules are hard for residents to understand. [7]

  13. 14

    UnitedHealth must face investors' earnings claim

    A US federal judge ruled on 30 September that part of an investor lawsuit against UnitedHealth Group, a Minnesota-based health insurance company, can go ahead. [17] CalPERS, the pension fund for California's public employees, says UnitedHealth inflated its 2024 earnings by $3.3 billion to hide that its Medicare Advantage plans were doing worse. [17] Judge Jeffrey Bryan threw out most of the fund's other claims as too vague, or as ordinary sales talk. [17]

    Why it matters — One of the lawsuit's central claims is that UnitedHealth made its Medicare Advantage patients look sicker on paper to get more money from the US government. [17] That is the same insurance business now cutting extras for 2027. [16]

  14. 15

    Two more weight-loss shots report in Milan

    Two more weight-loss injections reported results this week at the European diabetes meeting in Milan. [12] Boehringer Ingelheim, a German drugmaker, said people with obesity and type 2 diabetes who stayed on its shot survodutide lost 13% of their weight, against 3% on a dummy shot. [12] AbbVie's ABBV-295, which works on amylin, a digestive hormone,, took off up to 10% in 12 weeks in a small early trial. [12] Given once a month it took off 8%, and a third of people felt sick, against a fifth on the dummy. [12]

    Why it matters — Both companies licensed these drugs from smaller firms: Boehringer from Zealand Pharma, and AbbVie from Gubra for $350 million. [12] These latecomers hope to compete with Wegovy and Zepbound partly by needing fewer injections, such as one a month. [12]

  15. 16

    An antibody shot tested against a Covid vaccine

    Invivyd, a small biotech company, reported on 29 September that its antibody shot VYD2311 caused fewer side effects than Pfizer's Covid vaccine Comirnaty, in a final-stage trial called LIBERTY. [13] The shot is a lab-made antibody, meant to protect against Covid infection the way a vaccine does. [13] Six days after the shot, 57% of people given VYD2311 reported headaches, chills, tiredness or a sore arm, against 91% given Comirnaty. [13] It could also be given safely alongside Comirnaty. [13]

    Share of people reporting headache, chills, tiredness or a sore arm six days after the shot, in the LIBERTY trial.

    Why it matters — Invivyd wants to offer an alternative to vaccines, and LIBERTY compared the two head to head. [13] The side-effect result does not show how well the antibody prevents infection.

  16. 17

    Ebvallo's third try in the US

    Pierre Fabre Laboratories, a drugmaker, has asked the FDA a third time to approve Ebvallo, a cell treatment the US regulator has turned down twice. [14] Ebvallo treats a deadly complication of infection with the Epstein-Barr virus. [14] It has been available in Europe since late 2022. [14] The FDA rejected it in 2025 over manufacturing problems, and again in January. [14] The new application uses updated results from a trial with no comparison group, plus records from patients treated in Europe. [14]

    Why it matters — Atara Biotherapeutics, which first developed Ebvallo, said after the January refusal that the FDA had gone back on an earlier agreement. [14] So patients in the US are still waiting for a treatment that patients in Europe have had for nearly four years. [14]

  17. 18

    A new medicine for FOP, a rare bone disease

    The FDA has approved Atebrioz, a drug from Mirum Pharmaceuticals, for FOP, an ultra-rare bone disease, Mirum said in late September. [14] In FOP, bone slowly forms in muscle and other soft tissue. Incyte, another drugmaker, had already finished the final tests when it licensed the drug to Mirum in May for $16 million up front. [14] It is approved for adults and children aged 12 and over. [14]

    Why it matters — Atebrioz will compete with FOP medicines from Regeneron and Ipsen. [14] Mirum paid a small sum for a drug whose final tests were done, and had an approval within months. [14]

  18. 19

    Big FDA decisions due before the year ends

    Several big FDA decisions are due before the end of 2026, BioPharma Dive reports. [34] Roche's breast cancer pill giredestrant faces two, by 30 November and 18 December. [34] After surgery, giredestrant with hormone therapy cut the risk of the cancer returning, or of death, by 30%. [34] Gilead's cell treatment anito-cel, for the cancer multiple myeloma, is due by 23 December. [34] In testing, 96% of patients whose cancer had come back after at least three earlier treatments responded. [34]

    Why it matters — Until a new commissioner is confirmed, the FDA is run by its acting head, Kyle Diamantas. [34] Heidi Overton, the nominee, may not get a US Senate vote before the US Senate breaks on 5 October, an analyst at RBC Capital Markets wrote. [34]

  19. 20

    How a diabetes drug protects kidneys

    A year-long trial looked for how semaglutide, a weekly diabetes injection, protects the kidneys of people with type 2 diabetes and kidney disease. [26] Its 106 patients got a weekly shot of the drug or a dummy, and some had kidney scans and biopsies before and after. [26] The trial's main measures, of oxygen, blood flow and swelling in the kidney, did not change. [26] Other measures suggested the drug eased resistance to blood flow into the kidney and slowed scarring. [26]

    Why it matters — Semaglutide was already known to protect the kidneys in diabetes, and this trial, published in Nature Medicine on 1 October, looked for the reason. [26] Because the main tests came back flat, the explanation rests on secondary results from smaller groups. [26]

  20. 21

    A new switch for sickle cell treatment

    Researchers at Boston Children's Hospital and the Broad Institute found a new genetic switch that holds back fetal haemoglobin. [27] Haemoglobin is the molecule in red blood cells that carries oxygen. Within the first year of life, the body mostly switches from the fetal kind to the adult kind. [27] Studying the DNA of more than 28,000 people, they found that a gene called BACH2 keeps it switched off. [27] Blocking BACH2 in lab cells raised fetal haemoglobin, the team reported in Nature. [27]

    Why it matters — Casgevy, an approved gene-editing treatment for sickle cell disease, turns fetal haemoglobin back on through a different switch. [27] A second, separate switch could lead to a simpler treatment, though for now it is a laboratory finding. [27]

  21. 22

    Contraception for men may be five to 10 years away

    The World Health Organization said last week that it expects reversible contraception for men within five to 10 years, the Guardian reported on 1 October. [21] Most of these methods use hormones to switch off sperm production, which must be kept up every day. [21] A US-funded worldwide trial is testing a hormone gel rubbed into the shoulders daily, and early results are surprisingly effective, said Richard Anderson of Edinburgh University. [21] His group of 40 couples had no pregnancies. [21]

    Why it matters — About 30% of couples already rely on a method used by the man, yet men's options have barely changed since the condom. [21] The basic science has been known for decades, the Guardian says; turning it into a product is what has been slow. [21]

  22. 23

    Science puts out a women's health issue

    The journal Science published a special issue on women's health on 1 October. [20] Its editors, all women, named political attacks on women's health care and cuts to research funding as reasons for it. [20] One review says women have lasting pain without a clear physical cause about twice as often as men, and that female pain is poorly understood. [20] Another argues that the XX and XY chromosomes should be considered in every precision-medicine plan. [20]

    Why it matters — Women remain poorly represented in clinical trials, STAT notes. [20] Much of the attention on women's health still centres on having babies. [20]

  23. 24

    UK trial of a pain plan for endometriosis

    A five-year, 2.3 million pound UK trial will test whether a 12-week pain programme helps women with endometriosis whose pain surgery and medicine have not controlled. [23] Endometriosis is a disease in which cells like the womb lining grow in other parts of the body and cause long-term pain. [23] The programme, led by the University of Aberdeen and NHS Grampian, combines talking therapy, specialist physiotherapy and medicine. [23] Women will get it with their usual care, or usual care alone, and the results will be compared. [23]

    Why it matters — There is no cure for endometriosis, and diagnosis can take years. [23] The trial will also measure whether the programme is worth what it costs. [23]

  24. 25

    Surgeon general pick passes a Senate committee

    Nicole Saphier, President Trump's third choice for US surgeon general, passed the US Senate health committee on 30 September in a party-line vote. [18] The surgeon general is the US government's top public health educator. [18] Saphier is a radiologist who has appeared on Fox News. [18] Trump's first two picks, Casey Means and Janette Nesheiwat, could not win enough support. [18]

    Why it matters — At her hearing Saphier said she had seen no reputable evidence that vaccines cause autism, and called the measles vaccine the greatest tool against measles. [18] The full US Senate has not set a date for its vote. [18]

  25. 26

    FDA looks for new outside advisers

    The FDA is recruiting new members for its advisory committees, the panels of outside experts who weigh evidence on medicines and devices. [19] It published two notices on 30 September, one for scientists and one for members of the public. [19] Nominations close on 15 November for public members and on 30 November for scientists. [19] People may nominate themselves, and members serve up to four years. [19]

    Why it matters — Advisory meetings largely stopped under the former FDA head Marty Makary, and picked up again this year, BioPharma Dive reports. [34] The FDA called the panels a cornerstone of its process. [19]

  26. 27

    US appeals to cap stays of foreign researchers

    The US Department of Homeland Security appealed on 30 September against a court order blocking its plan to cap how long international students and postdoctoral researchers can stay in the US. [7] Postdoctoral researchers are scientists still training after a doctorate. The plan would limit them to four years, where until now they could stay for the length of their training. [7] The department says the old policy encouraged fraud. [7]

    Why it matters — Academic groups sued, saying the cap breaks the law on how new rules are made and would hurt US science. [7] A federal judge blocked the cap while the lawsuit continues, and the department wants the US Court of Appeals for the First Circuit to lift that block. [7]

  27. 28

    A germ that hides deep in the kidney

    MRSA, a staph germ that common antibiotics cannot kill, hides deep inside the kidney during blood infections, a study in mice found. [28] The innermost part of the kidney, where urine is concentrated, is so salty that immune cells are slow to reach it. [28] There the germs grew using the tissue's own chemicals, called polyamines, and spread outward. [28] Furosemide, an approved water pill, let immune cells in faster and limited the spread in mice. [28]

    Why it matters — Deaths from staph infections worldwide have doubled since 1990. [28] The work is in mice, and the authors call water pills only a candidate add-on treatment. [28]

  28. 29

    Gut bacteria differ in younger cancer patients

    Adults aged 50 or younger with bowel or breast cancer had different gut bacteria from people diagnosed later, a Mayo Clinic study of 1,364 cancer patients found. [29] Younger bowel cancer patients had more of a bacterium, Veillonella parvula, that feeds on lactate, a chemical tumours make in large amounts. [29] The study, published in Cell, used stool samples taken before treatment began. [29] Bowel cancer is rising about 3% a year among US adults aged 20 to 49. [29]

    Why it matters — The authors say the links do not show that the bacteria cause early cancers. [29] They narrow the search to the changes most worth testing next. [29]

  29. 30

    AI finds vaccines that need no freezer

    Researchers used AI to find recipes that keep mRNA vaccines working without ultra-cold storage, in a paper in Nature Biotechnology on 28 September. [30] Dried versions of vaccines built like Moderna's and Pfizer-BioNTech's kept all their strength after more than two months at 37C. [30] In rodents and monkeys they worked as well as fresh vaccines. [30] The AI needed six rounds of lab tests, done within one month. [30]

    Why it matters — The need for ultra-cold storage limits how widely mRNA vaccines can be sent. [30] These tests were in animals, not people. [30]

  30. 31

    AI rebuilds pictures from brain scans

    Researchers at Israel's Weizmann Institute built an AI that recreates the picture a person is looking at from a brain scan, MIT Technology Review reported on 1 October. [31] It was trained on scans of eight people who each viewed about 9,000 images. [31] It needs one hour of scans of a new person, where earlier tools needed about 40. [31] It still makes mistakes, such as turning a cake into a pile of sandwiches. [31]

    Why it matters — Its makers hope it could help people who cannot move or speak to communicate. [31] Other scientists warn that tools like it could one day read thoughts without a person's consent. [31]

  31. 32

    A switch that sets when fat burns

    Scientists at the University of Copenhagen found that a protein called SLC25A34 helps decide when brown fat burns fuel to make heat, they reported in Science. [32] In mice, levels of the protein in brown fat rose 90-fold after a day in the cold. [32] The body clock, cold and fat in the diet each control it. [32]

    Why it matters — The lead scientist says it could point to a new kind of obesity or diabetes treatment that changes when the body burns fuel. [32] It has been shown only in mice so far. [32]

  32. 33

    Brain blood vessels and autism, in mice

    Researchers at The Ottawa Hospital reversed some autism-like behaviours in mice by fixing the cells that line the brain's blood vessels. [33] The mice lack a small piece of chromosome 16, one of the commonest genetic changes seen in autism. [33] Those cells had too little ATP, a molecule that carries energy, and switching on a receptor called P2Y2 restored the mice's behaviour. [33] The study was published in Neuron. [33]

    Why it matters — No drug treatment exists for autism symptoms, the researchers note. [33] The senior author says the road from this finding to trials in people is long. [33]

02 Lesson why it matters

Why a new medicine reaches one country years before another

Each country's regulator approves a medicine separately, so it arrives first where its maker tested and applied first, and where the regulator said yes.

The twist

A medicine does not arrive everywhere at once. Each country's regulator has to say yes on its own. The order follows where the maker ran its tests and applied first.

The picture

Ebvallo, one cell treatment for a deadly complication of a common virus. Europe has allowed it since late 2022, while the US regulator has refused it twice.

How it works

  1. Each country has its own regulator, and a medicine needs a separate yes from each one
  2. A company tests a new medicine where testing is fast and cheap, and applies there first
  3. Each regulator reads the results its own way, and can ask for more or say no
  4. So one country can have a medicine for years while another is still waiting
  5. Now the US is trying to win drug testing back from China and Australia

The same force, elsewhere today

Where this chain is also running, in today's other stories.

  • AstraZeneca's two lung cancer pills

    The pair was approved in China first, after a Chinese trial. Only now has AstraZeneca applied in the US.

  • Ebvallo's third try in the US

    Europe has allowed it since 2022. The FDA has refused it twice, the first time over how it is made, so US patients are still waiting.

  • US plans faster drug trials

    Drugmakers can start trials six to 12 months sooner in Australia. The US health department's new programme is meant to bring that testing back to the US.

  • China pitches its drugmakers in Shanghai

    Abbisko ran a trial for Germany's Merck KGaA in 11 months, and drugs designed in China now make up about a third of all drugs in development.

Where you've seen this

New cars

a model must pass each country's own safety tests before it can go on the road there

Films

each country's ratings board must classify a film before cinemas there can show it

Food additives

a sweetener can be allowed in one country and banned in the next

The catch

Arriving later is not always worse. A regulator that waits may be catching a real problem, as the FDA said it was the first time, over how Ebvallo is made.

And the whole of it

A patient in one country can be waiting for a medicine that a patient in another country already takes. Neither of them chose the order, and neither can see the trials, filings and rules that set it.

03 Truth what's really going on

What is really going on

The FDA approved a heart valve that can grow with a child on evidence from 62 children followed for six months to a year. So far only the FDA and Edwards, the company that holds the approval, have described those results. [1][2] Several of the day's other stories are about where drugs get tested: the US health department wants trials back from China and Australia, where testing is quicker and cheaper. [5][7]

Why it works on us — A first-ever treatment for children with heart defects is easy to cheer, which makes the small study and the short follow-up easy to skip.

Who gains

  • Edwards Lifesciences — It holds the first US approval for a valve built to grow with a child, adding to its devices for children born with heart defects. [2]
  • Regeneron — Sanofi pays it $1 billion up front, with up to $7 billion more if the drugs pass set tests, while Regeneron leads the research. [3][4]
  • Medicare Advantage insurers such as UnitedHealth and Humana — They raise members' out-of-pocket costs and cut extras such as dental money in 2027, to lift profits that investors said were too low. [16]
  • Drug companies in China — Drugs designed in China draw more than half of all licensing and partnership deals, STAT reports. [7]
  • AstraZeneca and HUTCHMED — If the FDA agrees, their two-pill combination can replace chemotherapy for some lung cancers that grew despite Tagrisso. [11]

Who pays

  • Older Americans on Medicare Advantage — They face higher out-of-pocket costs, less money for dental work and narrower choices of doctors in 2027. [16]
  • People in Nebraska applying for Medicaid — Fourteen percent of new applicants and 7% of those renewing were turned down or lost cover under the work rule. [7]
  • Disabled Americans — A shorter US health survey would drop questions on hearing, thinking and wheelchairs, so they may be counted even less. [15]
  • Baiga families in Balaghat, India — Their children fell ill far from care: the nearest state hospital is about 70km away, along tracks that turn to mud in the monsoon. [22]
  • Sanofi — It pays $1 billion now for antibodies with no substantial data yet, as Dupixent's patents near their end. [3][4]

What nobody knows yet

Open questions from across today’s stories — ours included.

  • 01

    How long the Autus valve lasts, and how many times it can be widened.

    Only two children have had their valves widened so far, and the FDA calls that experience limited. Edwards plans to follow the children for 10 years. [1][2]

  • 02

    What the valve will cost, and who will pay for it.

    Neither the FDA nor Edwards has given a price for the valve. [1][2]

  • 03

    Whether independent doctors will report the same results.

    Every account of the study we could find came from the FDA or from Edwards. One trial surgeon quoted by Edwards has had travel and lodging paid by the company. [2]

  • 04

    How much money SURPASS will get.

    The US health department's announcement did not say how much funding the new programmes have. [6]

  • 05

    Whether Sanofi and Regeneron's four new antibodies work.

    Only one has reached human testing, and an RBC Capital Markets analyst said there is no substantial data yet. [3]

  • 06

    Why daraxonrasib stops working in nearly every patient.

    The clues so far come from a preliminary study of 66 patients, presented at a conference. [9]

  • 07

    Whether the cold-virus treatment really helps pancreatic cancer patients live longer.

    Its survival gain passed the main test in one count of 96 patients but not in the full count of 101, and the authors say a larger, blinded trial is needed. [10]

  • 08

    What exactly killed each of the 32 children in Balaghat.

    Officials link most of the deaths to measles and malaria, but the BBC reports that the precise cause of every death is less certain. [22]

  • 09

    Why the US health department dropped the disability questions.

    It said the redesign was driven by the cost of collecting data, and would not say why those questions were struck. [15]

  • 10

    How well Invivyd's antibody prevents Covid.

    The part of STAT's report that could be read covers side effects only. [13]

04 Hope carry this

In the US, children born with a faulty pulmonary valve can now get a replacement that doctors widen with a balloon as they grow. All 62 children in its study came through the operation, and none died.

Also true today

  • Five years after getting immunotherapy before surgery, about 98 in 100 people with advanced melanoma whose tumours had mostly died by the time of the operation were still alive.
  • Mirum's Atebrioz is now approved in the US for FOP, an ultra-rare bone disease, for people aged 12 and over.
  • Dried mRNA vaccines kept all their strength after more than two months at body temperature, in tests on rodents and monkeys.
  • In the Edinburgh group of a worldwide trial of a hormone gel for men, 40 couples had no pregnancies.

Across the beats