Biotech, in brief

Moderna and Merck released the full results of their final-stage melanoma trial on Thursday, two days early, after the data leaked on social media. [2][3]

Melanoma is a skin cancer, and the 1,137 patients in the trial had already had their tumour removed by surgery but were at high risk of it coming back. [4][1]

Each patient got Keytruda, Merck's immune drug, for about a year, and two in three also got intismeran, a vaccine made for that one person. [4]

To make it, the tumour's genes are read and up to 34 of its own mistakes are written into mRNA, which teaches the immune system to hunt cells carrying them. [2][1]

Adding the vaccine cut the risk of the cancer returning or death by 42% after a typical 24.6 months of follow-up. [4][5]

After two years, 82 in 100 patients on the pair were alive and free of melanoma, against 70 in 100 on Keytruda alone. [3][1]

The risk of the cancer spreading to distant organs, or death, fell 38%: 88.5% stayed clear of that, against 80.2%. [3][4]

For the first six months, patients relapsed at about the same rate with or without the vaccine. From six months on, after the course of injections, a planned extra analysis found the risk 58% lower. [4]

Nobody knows yet whether patients live longer, because the trial has not run long enough to count deaths properly. [6][4]

Fever hit 52% of vaccine patients and injection-site pain 51%, but serious side effects were close: 14.2% with the vaccine, 13.4% without. [4][3]

Investors had expected a cut of 40% to 50%, so Moderna's shares fell nearly 25% and Merck's about 1%. [2]

The companies are talking to drug regulators, and the results have been accepted by the New England Journal of Medicine. [4][6]

Why it matters. The trial keeps running to count deaths, and the next test is whether the people given the vaccine also live longer; Merck and Moderna say an early look leans their way but is not settled. [4][6]

The US Treasury, the US government's finance department, proposed rules on Thursday that add biotechnology to the industries where American investment in China can be banned. [7][8] They come from the COINS Act, a US law passed in December 2025. [8] Taking a stake in a Chinese biotech or forming a joint venture with one would be covered, though shares bought on a stock market and deals under $50,000 would not. [7][8] Ordinary deals to license a single Chinese drug would not. [7][8] Comments close on 7 December. [8]

Why it matters. Pfizer and other big drugmakers had pushed to keep licensing deals open, and the draft does that. [8] Deals with a share stake, like Pfizer's $100 million stake in China's 3SBio last year, would be banned, and China proposed its own limits on selling biotech platforms abroad last week. [7][32]

Prime Medicine, a US biotech company, said this month that it has treated the first person in a trial that edits DNA directly inside the body with prime editing, the journal Nature reported. [9] Prime editing can rewrite, add or remove short stretches of DNA, more precisely than standard CRISPR, which is often used to switch genes off. [9] The patient has Wilson disease, where a faulty gene called ATP7B stops the liver clearing copper, which then damages the liver and nerves. [9] The company expects first results next year. [9]

Why it matters. The only gene-editing medicine approved in the US, Casgevy, edits a patient's cells outside the body and puts them back. [9] Editing inside the body could be cheaper and faster, but carries different risks, a University of Wisconsin engineer told Nature. [9]

The FDA, the US drug regulator, gave accelerated approval on Wednesday to AstraZeneca's Ultomiris for adults with IgA nephropathy, a rare disease in which the immune system inflames the kidneys. [10] In the trial, Ultomiris cut the protein leaking into urine by 43.4% against a dummy drug after 34 weeks. [10] An accelerated approval rests on an early sign like that one. [10] The trial runs to 106 weeks to show whether the drug really slows the loss of kidney function. [10]

Why it matters. AstraZeneca says more than 200,000 people in the US have the disease, and about half of those with high urine protein or weak kidneys risk kidney failure within 10 years. [10] Full approval depends on the longer result. [10]

AbbVie, a large US drugmaker, said on Thursday that its experimental drug lutikizumab passed a final-stage trial in hidradenitis suppurativa, a long-lasting disease that causes painful lumps and abscesses in the skin. [11] In the 1,400-patient trial, 31.4% of people on weekly injections saw their lumps and abscesses fall by at least three-quarters after 16 weeks. [11] On a dummy injection, 23.4% did. [11] Side effects were about the same in both groups. [11]

Why it matters. The result missed what investors had hoped for, and experts doubt it can compete with the treatment patients already get, STAT reported. [11] The drug helped about 8 more people in every 100 than the dummy injection did. [11]

Africa CDC, the African Union's public health agency, called an emergency meeting of health ministers for 28 October, after Ebola reached a third region of Africa. [13][14] Switzerland's government said on Thursday that the patient in Nigeria, the Ugandan-born wife of a Swiss diplomat, was probably infected while travelling in Uganda. [12] Uganda says it has no Ebola cases. [12] The WHO and Africa CDC said they had no confirmed sign she had been to Congo, where the outbreak began in May. [12]

Why it matters. The Bundibugyo strain behind this outbreak kills about half of those infected and has no approved vaccine or treatment, and about 4,700 people have died, Africa CDC counts. [12] Kenya says it has now traced all 135 contacts of its first case. [12]

The CDC, the US national public health agency, added a third measles death this year to its count on Wednesday, but would not say in which state it happened. [15] A spokesperson for the US health department cited privacy laws, and two law professors told the Guardian that naming a state would identify nobody. [15] US cases rose 8% in a week to 4,410, nearly double last year's total. [15] In September the CDC switched from a system that reports deaths quickly to the national health statistics office, and has not given a clear reason. [15]

Why it matters. Pennsylvania alone has reported six deaths linked to measles, five of them confirmed, so the national count trails what one state says. [15] Paul Offit, an infectious diseases doctor at the Children's Hospital of Philadelphia, said that makes risk hard to judge. [15]

Roche, the Swiss maker of medicines and diagnostic tests, said on Thursday that its sales rose 7% to 16.1 billion Swiss francs, about $19.6 billion, in the third quarter, beating analysts' estimates. [16] It kept its forecast for the year. [17] Its allergy and asthma drug Xolair sold 848 million francs, below estimates of over 900 million, and a cheaper US copy of it launched this month. [16] Ocrevus and Tecentriq, two more of its best sellers, face copies by 2030. [16]

Why it matters. Roche is counting on giredestrant, a breast cancer pill with a US decision due by 18 December, and on obesity drugs to replace those sales. [16][17] An analyst at Jefferies, an investment bank, said the underlying numbers looked like a miss. [16]

The FDA has accepted a new application for Biohaven's drug Vyglxia, which it turned down last November, the company said on Thursday. [18] The drug is for spinocerebellar ataxia, a group of rare inherited diseases where nerve damage slowly takes away balance, coordination and speech. [18] Its studies suggested the drug might slow the disease by as much as 70%. [18] The FDA found the key experiment unconvincing, partly because of how it was designed. [18]

Why it matters. A panel of outside experts will meet, and a decision is due in the first three months of 2027. [18] If approved, it would be the first medicine sold for the disease, and Biohaven's shares rose about 25%. [18]

Lycia Therapeutics, a California drug company co-founded by Nobel Prize winner Carolyn Bertozzi, raised nearly $318 million by selling shares to the public for the first time. [19] It sold about 3 million more shares than it had planned, and its shares begin trading on the Nasdaq exchange on Friday. [19] Its drugs grab harmful proteins outside cells and pull them inside to be destroyed. [19] Two are in early trials, for allergies and Graves' disease, with data expected in 2027. [19]

Why it matters. About two-thirds of drug company share sales this year have raised more than $250 million, BioPharma Dive counts. [19] Its first results in patients are not due until 2027. [19]

Apothecary Pharma, a US compounding pharmacy, has recalled 22 batches of its copy of tirzepatide, the active ingredient in Eli Lilly's weight-loss drug Zepbound. [20] It said it could not fully guarantee the medicine's safety. [20] Compounding pharmacies mix their own versions of drugs, and many began selling cheaper copies when Zepbound and Novo Nordisk's Wegovy ran short. [20] The shortages ended, but firms kept selling copies by tailoring doses to each patient, which US law allows. [20]

Why it matters. About 20% of Americans on these drugs use a copy, a Gallup survey found. [20] Lilly and Novo have sued to stop the copies, and the recall could support their claim that copies are less safe. [20]

Some US online clinics that treat addiction have begun prescribing weight-loss drugs like Ozempic, branded and copied, for alcohol and other addictions, STAT reported. [21] The US regulator has not approved them for that, so this is off-label use: a drug prescribed for an illness it was not approved for. [21] Eli Lilly is testing a new drug, brenipatide, in alcohol addiction, and Altimmune is testing one called pemvidutide. [21]

Why it matters. No new medicine for alcohol addiction has been approved in the US in two decades. [22] The clinics are prescribing before the US regulator has approved any of these drugs for addiction. [21][22]

The Health Committee, a cross-party group of British MPs, said on Thursday that hundreds of thousands more people in England should get the weight-loss injection Mounjaro on the NHS. [23] The NHS plans to give it to 220,000 people by 2028, about 6% of those eligible. [23] More than a million people already pay for such jabs privately. [23] Treating all 2.8 million eligible people at once would cost an estimated 15.2 billion pounds over five years. [23]

Why it matters. The committee says a two-tier system is forming, where only people who can pay get good access, and wants a crackdown on unlicensed jabs sold online. [23] The NHS is reviewing its 12-year rollout plan. [23]

Gilead Sciences, a large US drugmaker, agreed to pay $45 million to settle claims brought by the Texas attorney general. [24] The state said Gilead paid kickbacks that swayed prescriptions paid for by Texas Medicaid, its health cover for people on low incomes. [24] A whistleblower said Gilead paid another company to hire nurses who recommended its drugs. [24] The suit also said Gilead offered doctors free support services so they would prescribe its drugs. [24]

Why it matters. It is the latest drugmaker settlement with Texas over how drugs are marketed. [24] The case grew from whistleblower suits filed nearly a decade ago against several drugmakers. [24]

The FDA launched a programme on Thursday to help develop medicines and devices for the brain and nerves, called the Neuroscience Advancement and Innovation Nexus. [25] Its first project, the Alzheimer's Prevention Accelerator, will look at how to run trials of drugs that delay or prevent Alzheimer's disease, including which patients to enrol and which results should count. [25] The FDA says brain drugs are hard to test because diseases like Alzheimer's develop over many years. [25]

Why it matters. The programme joins the FDA's centres for drugs, for biologics (medicines made from living things) and for devices and also covers psychiatric illness, addiction and pain. [25] Acting FDA Commissioner Kyle Diamantas called Alzheimer's one of the most urgent public health challenges. [25]

The Institute for Protein Design at the University of Washington and Nvidia, which makes the chips most AI runs on, released RFD4-Proteina, a free AI model that designs new proteins. [26] It works out a protein's chain of building blocks and its shape at the same time as the molecule the protein must hold. [26] Its makers say it succeeds five to 10 times more often than earlier models, and works five to 10 times faster. [26]

Why it matters. Possible uses include proteins that block a disease or detect it in a test, and any lab can build on an open model. [26] The speed and success figures come from the developers' own benchmark tests. [26]

PerturbAI, which published an atlas of brain cells earlier this year, and OpenAI, the maker of ChatGPT, described a system of thousands of AI agents. [27] They sort through large lab experiments and suggest what to test next. [27] Run on PerturbAI's atlas, the system finished in 32 minutes and recovered the study's conclusions without seeing the paper. [27] In blind comparisons, biologists preferred its reports to a single AI's 45 times out of 60. [27]

Why it matters. The results are in a preprint, a paper not yet checked by other scientists. [27] The test used one dataset, PerturbAI's own. [27]

Scientists at ETH Zurich, a Swiss university, built an implant the size of a USB stick that removes sugar from the blood with electricity, and tested it in mice, a study in the journal Science reports. [28] Gold and platinum on its surface turn glucose into gluconate, which the body burns or passes out in urine. [28] In obese mice with diabetes it brought blood sugar under control within an hour and held it there for six weeks. [28] Linked to a phone and a glucose monitor, it ran by itself for two weeks. [28]

Why it matters. It has been tested only in mice. [28] An outside chemist said long-term safety, and removing enough glucose for a human body, are the next hurdles. [28]

Researchers at Oxford Population Health, part of the University of Oxford, measured more than 6,000 proteins in blood taken from 982 men who later got prostate cancer and 1,573 men picked at random. [29] The men were followed for about 16 years. [29] Twelve proteins were linked to cancers found more than 15 years after the blood was taken, and seven to aggressive cancer. [29] One, GZMK, is made by immune cells, a hint that the immune system may hold the cancer back for years. [29]

Why it matters. Most links were modest, and the proteins are not ready to use as a test. [29] Prostate cancer is the most commonly diagnosed cancer in men worldwide. [29]

Researchers at WEHI, an Australian medical research institute, found that immune cells called gamma delta T cells can find and kill small cell lung cancer, a form fewer than 7% of patients survive for five years. [30] Patients whose tumours held more of these cells tended to live longer. [30] In mini tumours grown from patients' tissue, two approved drugs, tarlatamab and zoledronate, made the cells kill more cancer. [30] The study is in the journal Cancer Cell. [30]

Why it matters. This cancer usually hides from the immune cells that most immune drugs depend on, and these cells appear able to see through that. [30] The drug results come from lab dishes, not from patients. [30]

Researchers at Albert Einstein College of Medicine, Institut Pasteur and LSU Health Shreveport mapped, almost atom by atom, how the Andes virus grabs human cells. [31] Andes is a hantavirus, caught from rodents, that can cause a life-threatening lung illness and, unlike most hantaviruses, can pass between people. [31] Its spike holds a human protein called PCDH1 in a deep pocket formed by four copies of one viral protein. [31] Most antibodies are too bulky to reach inside. [31]

Why it matters. The team says thin, long molecules might reach into the pocket and block infection, and plans to test that idea. [31] It is lab work on the virus's structure, not yet a treatment. [31]