Biotech, in brief

Kenya confirmed a second Ebola case on 14 October: a 39-year-old man who is a close relative of the country's first patient. [1][2]

He was already in quarantine and checked every day when fever, tiredness and joint pain began on 13 October. [2] Two laboratories in Kenya confirmed the virus. [2]

Kenya's health ministry says the two cases are linked and it has found no spread in the wider community. [1][2]

The first patient, a Kenyan businessman who fell ill in Congo, flew to Nairobi on 3 October and died there on 5 October. [1][3]

Kenya has listed 128 people who were near the first patient. [2] By 13 October it had found 113, and 108 are in quarantine in Kenya with checks every day for 21 days. [2]

Five of those contacts are abroad, and their countries have been told. [2] Another 15 are still being looked for. [2]

Quarantine staff and health workers who met the second man after he fell ill are now being checked too. [2]

Kenya has kept travel, trade and public gatherings open. [1][2] Before the first case, the WHO says, Kenya's readiness score rose from 66% in May to 82% in July. [6]

In Congo, where this outbreak was declared in May, confirmed cases have passed 9,000 and deaths 4,000, across seven provinces. [5]

About one in three new cases in recent weeks were people who died in their communities, outside any treatment centre, the WHO's manager for the outbreak said. [4] That means cases are not being found while the patients are alive. [4]

This outbreak is Bundibugyo, a rarer kind of Ebola with no approved vaccine or medicine, and it kills about half the people it infects. [4][7]

A vaccine trial against it is due to start in Congo this month. [5] Until then, front-line volunteers get Ervebo, a vaccine made for a different kind of Ebola, called Zaire. [5]

Why it matters. Watch the 108 people in quarantine and the 15 not yet found: a case outside that list would be the first sign that Kenya's tracing has missed someone. [2]

The FDA, the US medicines regulator, on 14 October approved Anktiva for adults with high-grade papillary bladder cancer that BCG did not stop. [8] Papillary tumours grow like small fingers from the bladder lining, and BCG is a treatment put into the bladder to rouse the immune system against the cancer. [8] The FDA ran no new trial for this group. [8] It used Anktiva's earlier trial in a flat kind of tumour, where no high-grade cancer could be found afterwards in 62% of 77 patients, and judged the two cancers alike. [8]

Why it matters. These patients had no approved treatment made for them after BCG failed. [8] The FDA says it may judge future bladder cancer drugs the same way, and the label warns that delaying bladder surgery can let the cancer spread. [8]

The FDA launched a Rare Disease Framework Initiative on 14 October to rethink how rare-disease drugs are tested and approved. [9] A rare disease often has too few patients for a large trial. [9] The FDA says only about 5% of rare conditions have an approved treatment. [9] It promises rules fitted to each disease and to the evidence a small group can give, and will hear patients and companies at a public meeting on 28 October. [9]

Why it matters. US Health Secretary Robert F. Kennedy Jr. says the aim is to remove unnecessary barriers. [9] What changes in practice is not yet written: the FDA lists new guidance, changed regulations and staff training as possibilities. [9]

Guinea-Bissau's health minister, Quinhin Nantote, said on 13 October that his ministry never approved a trial in 14,000 newborns that the US government would help fund. [36] Half would get the hepatitis B vaccine at birth, and half would wait six weeks. [36] US Health Secretary Robert F. Kennedy Jr. has championed the study. [36] A Danish ethics committee voted last week to let it go ahead after members were told Guinea-Bissau had approved it, and at least four members resigned. [36]

Why it matters. Hepatitis B is widespread in Guinea-Bissau, and catching it as a child can cause lifelong harm. [36] The US health department told Reuters the study has not been approved. [36]

CVS Pharmacy agreed to pay the US government $315 million to settle claims that it filled unnecessary prescriptions for opioids, which are addictive painkillers, the US Justice Department said on 13 October. [20] Prosecutors said CVS also billed Medicare, the US health plan for older people, for those prescriptions. [20] CVS admitted no wrongdoing and says it strongly disagrees. [20] It must set up a hotline for reporting suspicious dispensing and watch its pharmacies' patterns. [20]

Why it matters. Prosecutors said CVS tied staff pay to targets that put profit before patient safety. [20] Opioids killed nearly 80,000 people in the US in 2023. [20]

Arrowhead Pharmaceuticals said on 14 October that its experimental drug ARO-MAPT cut tau by 73% on average after 105 days at the highest dose. [11] Tau is a protein that clumps in the brains of people with Alzheimer's disease. [11] The drug silences the gene that makes tau, and it reached the brain from an injection under the skin. [11] The trial was in about 64 healthy volunteers and mainly tested safety. [11]

Why it matters. Lowering tau has not yet been shown to slow Alzheimer's, an analyst at the bank Stifel cautioned. [11] The next part of the trial adds people with mild Alzheimer's. [11]

Verastem Oncology's shares rose 18% on 14 October after early results for its pill VS-7375. [12] It targets G12D, the most common change in KRAS, a gene that can get stuck telling cells to grow. [13] Tumours shrank in four of eight pancreatic cancer patients on their second treatment, and in 43% of 23 lung cancer patients. [13] The study is early and small, and Verastem plans three final-stage trials. [12]

Why it matters. FDA papers suggest Revolution Medicines' approved pill Rasonque works less well against G12D, which leaves room for a rival. [12] Verastem also sold $250 million of new shares the same day. [12]

Scientists say a website taking public comments on a change to how the US National Institutes of Health (NIH) scores grant applications shut hours before its 13 October deadline. [23] The NIH is the US government's main funder of medical research. [23] The change would sort applications into three broad groups and keep each one's exact score secret. [23] Some researchers say that could let politics shape which projects get money. [23]

Why it matters. The US Congress already stopped an earlier plan to let political appointees pick grant winners, which is on hold until at least December. [23] The NIH did not immediately answer Scientific American's questions. [23]

Three former heads of the FDA criticised the Trump administration's staff cuts at a STAT conference in Boston on 14 October. [24] Robert Califf said DOGE, Elon Musk's cost-cutting team, "will go down as one of the biggest disasters in American history". [24] DOGE cut 3,500 FDA workers, and more left under Marty Makary, the FDA head who resigned in May. [24] Ned Sharpless said companies now meet more junior, less experienced drug reviewers. [24]

Why it matters. Scott Gottlieb, FDA head in Trump's first term, joined the criticism but praised the agency's current acting leaders. [24] The agency still has no confirmed commissioner. [24]

Britain's prime minister, Andy Burnham, announced a brain cancer review and a new national clinical lead after meeting swimmer Archie Goodburn, 25. [10] Goodburn has three brain tumours that surgeons cannot remove, and had appealed on TV for more research. [10] Prof Anthony Chalmers of the University of Glasgow will review progress since 2018. [10] Burnham also asked the MHRA, Britain's medicines regulator, to finish reviewing rare-condition medicine rules in two years, not three. [10]

Why it matters. Goodburn says trials run in other countries are not reaching UK patients. [10] Health Secretary Yvette Cooper will lead a drive to get more people onto clinical trials. [10]

Gilead Sciences, a large US drugmaker, will pay Vir Biotechnology $90 million up front to design three T-cell engagers, drugs that direct immune cells to destroy cancer cells. [14] Vir's versions carry masks that keep them switched off until they reach a tumour, to cut side effects. [14] All three will aim at solid tumours whose targets have not been named. [15] Vir can also get $45 million in early payments and up to $1.74 billion more if the drugs pass tests and sell. [14]

Why it matters. Most of the $1.9 billion headline is paid only if the drugs succeed. [14] Vir's chief executive says deals like this pay for its own drugs without selling more shares. [14]

Zealand Pharma, a Danish company developing weight-loss drugs, will pay Generate Biomedicines $30 million up front to design protein drugs for obesity and related diseases. [16] Generate uses AI to design proteins that act on more than one target. [16] It could earn up to $35 million in early payments and nearly $1.2 billion more if products are made and sold. [16] Zealand's two lead weight-loss drugs, partnered with Roche and Boehringer Ingelheim, are in final-stage trials. [16]

Why it matters. Neither of those two drugs has impressed analysts so far, Fierce Biotech reports. [16] Zealand added small-molecule drugs in December and now adds proteins, beyond the peptides it has always made. [16]

Iambic Therapeutics, a US company that uses AI to find medicines, raised $150 million by selling shares at $16 each, and starts trading on the Nasdaq on Thursday. [17] Private investors have put $462 million into it since 2019. [17] Its leading drug, a cancer pill for tumours driven by a protein called HER2, is in early human tests, and a larger trial could start in 2027. [17] It is the 25th biotech to list its shares this year, BioPharma Dive counts. [17]

Why it matters. Several drug companies built on AI have struggled after going public. [17] Iambic's filing says its approach can disrupt how drugs are found, a claim its trials have not yet tested. [17]

Biomea Fusion's shares fell 30% to 87 cents on 14 October after early results for BMF-650, a pill that copies GLP-1, a gut hormone that makes people feel full. [18] In four groups, people lost 1.5% to 3.2% of their weight after 29 days. [18] In a fifth group the drug brought 6.1%, but the two people on dummy pills lost about as much. [18] Forty people took part in all. [18]

Why it matters. Eli Lilly's GLP-1 pill Foundayo was approved in April, so Biomea is late. [18] It argues that gentler weight loss with fewer stomach problems could still sell, and it is looking for a partner. [18]

Verdiva Bio, a British company that raised $410 million last year, has ended a trial of its weekly weight-loss pill VRB-101 after signing up 8 of the 120 people it wanted. [19] The trial tested whether people who lost weight on injections could switch to the pill and keep it off. [19] Verdiva said it changed plans because the market has moved. [19] It still tests the pill on its own, and a 206-person trial ended in July. [19]

Why it matters. Eli Lilly reported its own trial of switching people to its daily pill in December. [19] Verdiva has not yet said what the 206-person trial found. [19]

Liquidia will pay United Therapeutics about $380.7 million through 2027 to end six lawsuits over Yutrepia, Liquidia's inhaled lung drug. [21] Yutrepia treats high blood pressure in the lungs and competes with United Therapeutics' drug Tyvaso. [21] Liquidia will stop promoting it for lung pressure linked to scarred lungs, but keeps selling it for the main form of the disease. [21] Its shares jumped nearly 37% before the market opened on 14 October. [21]

Why it matters. Tyvaso now faces less competition among patients with scarred lungs. [21] Liquidia says it will pay from Yutrepia sales and the cash it holds. [21]

Genentech, part of the Swiss drugmaker Roche, settled its US patent lawsuit against India's Biocon over a copy of Perjeta, a breast cancer drug, Biocon said on 14 October. [22] A biosimilar is a close copy of a drug made from living cells, which cannot be copied exactly. [22] Perjeta earned Roche nearly 2.97 billion Swiss francs last year. [22] Biocon can launch its copy, Pebrilzo, in the UK and EU in early 2027, and in the US in the third quarter of 2028. [22]

Why it matters. US patients will wait about 18 months longer than European ones for this copy. [22] The other terms are secret. [22]

The Massachusetts Institute of Technology (MIT) enrolled nearly 500 fewer graduate students this autumn, a 20% drop from 2024, its president Sally Kornbluth said. [25] She blamed a $100 million cut in federal research awards to MIT. [25] Most graduate students are paid from such grants, so MIT admits fewer when it cannot be sure the money will last. [25] Other US universities have also cut graduate places. [25]

Why it matters. Kornbluth said she does not know when funding will recover. [25] A plan to give political appointees more control over NIH grants adds to the doubt. [25]

Only 705 people in Scotland had received weight-loss injections from the NHS by September 2026, a BBC freedom of information request found. [35] Mounjaro was approved there for weight loss in 2023 and Wegovy in 2024. [35] Fewer than half of Scotland's health boards offer them, and only in small pilot schemes. [35] At least 300,000 people are thought to buy them privately. [35]

Why it matters. Doctors call the gap discriminatory, because people who can pay get the drugs first. [35] A third of Scots are obese. [35]

Two hormone replacement therapy (HRT) patches used for menopause symptoms, Estradot and FemSeven Conti, are short across the UK, Northern Ireland's Department of Health told the BBC. [34] A special rule lets pharmacists hand over an alternative with the same active ingredient and dose, without a new prescription, until 8 January 2027. [34] A Belfast pharmacist warned women not to treat themselves. [34] Some women who switched report itchy skin or patches falling off. [34]

Why it matters. Women who found a patch that works must change brands mid-treatment. [34] A menopause charity says these shortages have gone on for years. [34]

Scientists at the University of California, San Francisco found antibodies that may set off early labour, they report in Nature Immunology. [30] They tested blood from more than 2,000 pregnant women. [30] Women who gave birth before 37 weeks had more antibody changes, and earlier. [30] One antibody blocks IL1RA, the body's brake on inflammation that can trigger contractions, and it damaged the placenta when injected into pregnant mice. [30]

Why it matters. About one in 10 babies is born too early, and being born early is the leading cause of newborn deaths worldwide. [30] The team says its blood test could lead to new ways to screen for the risk. [30]

A small first trial gave ten women with ovarian cancer a vaccine made for each one's own tumour, Nature Medicine reports. [32] The vaccines target neoantigens, changed proteins found only on that person's cancer cells. [32] They were given after chemotherapy, with an immune drug that blocks PD-1, a brake on immune cells. [32] There were no unexpected safety problems, and blood tests suggested the vaccine was working in six of the ten. [32]

Why it matters. Some tumours escaped by hiding the very targets the vaccine trained the body on. [32] The trial tested safety and whether the vaccines could be made and given, in ten women. [32]

A pill called VG-3927 was safe in a first human trial with 115 people, a paper in Science Translational Medicine reports. [29] It acts on TREM2, a switch on the brain's clean-up immune cells that helps them clear amyloid, a protein that clumps in Alzheimer's. [29] The pill reached the brain and changed a TREM2 marker in patients' spinal fluid. [29] In mice, a sister compound helped these cells clear amyloid. [29]

Why it matters. The approved Alzheimer's antibody drugs that clear amyloid help only modestly, so researchers are trying the brain's own immune cells instead. [29] This first human trial mainly tested safety, at doses up to 140 milligrams. [29]

Researchers at Cedars-Sinai in Los Angeles found that worn-out zombie cells, which stop dividing but do not die, carry a protein called PD-L2 that may hide them from the immune system. [28] These cells build up with age and release substances that cause inflammation. [28] In mice, blocking PD-L2 cut the number of these cells, and the mice handled sugar better and gripped harder. [28] Ageing human cells also made more PD-L2. [28]

Why it matters. This is a mouse result. [28] Whether blocking PD-L2 is safe or helps people has not been tested. [28]

A study in Nature found that water touching microplastics, tiny bits of plastic, turns chemically active and makes highly reactive molecules. [31] These can change nearby proteins and cell walls. [31] Breaking plastic up multiplies its surface: a credit card ground into 10-micron bits has over 200 times the surface area, said Columbia University chemist Wei Min. [31] Microplastics have been linked to heart attacks, strokes and dementia, without a known cause. [31]

Why it matters. This offers one possible reason for that harm. [31] Min says how it plays out in living human tissue is still unclear. [31]

iOnctura, a company spun out of the German drugmaker Merck KGaA, reported early results for its pill roginolisib in 44 patients with advanced cancers. [33] Twenty had uveal melanoma, a rare cancer at the back of the eye that often spreads to the liver. [33] Patients lived a median of 20.8 months, against about seven for past patients on immune drugs as a second treatment. [33] No patient had to stop or cut the dose. [33]

Why it matters. The comparison is with past patients, not a control group in the same trial. [33] Serious side effects hit three of the 44 patients. [33]