US regulator approves GSK's immune drug Jemperli for one kind of rectal cancer, so some patients can skip surgery, radiation and chemotherapy

The rest of the day

19 more stories on this beat.

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

1. 02

   Disc's sun-pain drug passes its final trial

   Disc Medicine, a US biotech, said on Monday its pill bitopertin met all its goals in a final-stage trial. [4][5] It treats EPP, a rare inherited disease in which a substance called PPIX builds up in the blood and makes sunlight painful. [4][5] On the drug, PPIX fell about 46%, against about 4% on a dummy pill. [4] Patients spent 12.2 more hours a month in light without pain. [5] The FDA refused the drug in February, because earlier trials had not shown that lower PPIX meant more time in the sun. [4]

   Bitopertin46%

   Dummy pill4%

   Why it matters — Disc plans to apply again by the end of the year and expects an answer by mid-2027. [4][5] Its shares rose more than 35% on the news. [4]

2. 03

   Merck KGaA buys Silence for $1.3 billion

   Merck KGaA, a German drugmaker, agreed on Monday to buy Silence Therapeutics, a British biotech, for about $1.3 billion in cash. [6][8] It pays $20 a share, 130% above Friday's closing price, or 82% above the average of the past 30 days. [7][8] Silence's main drug, divesiran, is for polycythemia vera, a rare blood cancer in which the bone marrow makes too many red blood cells. [7] The drug switches off a liver protein so less iron reaches the marrow, which then makes fewer red cells. [7] In a mid-stage trial, 88% of patients responded. [7]

   Why it matters — Divesiran would compete with Mimrylo, a weekly injection from Takeda and Protagonist approved in August, and would be given every three months. [7][8] Merck must still pay for a final trial; Silence had $72 million in cash in June. [6]

3. 04

   Roche pays Hansoh $400 million for cancer drugs

   Roche, the Swiss drugmaker, will pay Hansoh, a Chinese drug company, $400 million up front and $110 million after a year, the two said on Monday. [9] Up to $15 billion more depends on the drugs passing tests and selling. [9] The deal covers antibody-drug conjugates, medicines that use an antibody to carry a poison to cancer cells. [9] Hansoh will take two early drugs, and others aimed at targets Roche picks, through first human tests. [9] Roche then develops them everywhere except Greater China. [9]

   Why it matters — It is Roche's sixth deal with a Chinese drugmaker since late August, more than any rival this year, BioPharma Dive counts. [10] Neither company has said which diseases the drugs are for. [10]

4. 05

   Gilead's colitis pill passes a mid-stage test

   Gilead Sciences, a large US drugmaker, said its daily pill emvistegrast helped people with ulcerative colitis, a long-lasting inflammation of the large bowel. [11] In a trial of 238 adults, 31% on the top dose were in remission after 12 weeks, against 8% on a dummy pill. [11] The pill blocks a protein that guides certain immune cells into the gut. [11] Entyvio, a best-selling drug from Takeda, blocks the same protein but is given by drip or injection. [11] Gilead plans a final-stage trial in 2027. [11]

   Top dose31%

   Dummy pill8%

   Why it matters — A pill would be easier to take than a drip, but the two drugs have never been tested against each other. [11] 78% of the patients had not failed an advanced treatment before, so harder cases are still untested. [11]

5. 06

   AbbVie's two-drug mix beats Skyrizi in Crohn's

   AbbVie, a US drugmaker, tested a mix of its drug Skyrizi and a second antibody, trosunilimab, in 300 people with Crohn's disease, a long-lasting gut inflammation. [12] After 12 weeks, 30.2% on the mix showed little or no damage when the gut was checked with a camera. [12] That compared with 21.3% on Skyrizi alone and 18% on trosunilimab alone. [12] Skyrizi blocks one inflammation signal, IL-23, while trosunilimab blocks the gut-guiding protein that Gilead's pill also targets. [11][12] Three in four patients had already failed another advanced treatment. [12]

   The mix30.2%

   Skyrizi alone21.3%

   Trosunilimab alone18%

   Why it matters — Skyrizi brought AbbVie $10 billion in the first half of 2026. [12] A 2,000-patient trial that includes the mix began in July. [12]

6. 07

   A lung cancer vaccine lifts one-year survival

   OSE Immunotherapeutics, a French biotech, said on Monday its cancer vaccine Tedopi helped people whose lung cancer had grown after first treatment. [21] In a mid-stage trial of 106 patients in France, Italy and Spain, 47% given Tedopi with chemotherapy were alive after a year. [21] With Tedopi and the immune drug nivolumab, 46% were. [21] On chemotherapy alone, 29% were. [21] Only patients with a common immune type, HLA-A2, could join. [21]

   Tedopi + chemo47%

   Tedopi + nivolumab46%

   Chemo alone29%

   Why it matters — A final trial of Tedopi against chemotherapy is recruiting, with results expected in early 2028. [21] Full results will be shown at ESMO, Europe's big cancer meeting, in Madrid on 25 October. [21]

7. 08

   AstraZeneca's stomach cancer drug extends survival

   AstraZeneca, the British drugmaker, said its drug Sone-Ve helped people with advanced stomach cancer live longer in a final-stage trial. [22] It was tested in patients whose cancer had grown after earlier treatment. [22] The drug carries a poison to cells that show CLDN18.2, a protein found on many stomach cancers. [22] About 60% of these patients carry enough of the protein to qualify. [22] AstraZeneca says it is the first final-stage trial of such a drug to show a survival gain in this group. [22]

   Why it matters — The survival numbers are not public yet; they come at ESMO, which runs from 23 to 27 October. [22] Until then, nobody outside the company can judge how much longer patients lived.

8. 09

   An eye cancer drug pair shrinks more tumours

   IDEAYA Biosciences, a US biotech, and Servier, a French drugmaker, released trial results on Monday for darovasertib, a drug given with an older one, crizotinib. [23] It treats uveal melanoma that has spread, a rare cancer that starts in the eye. [23] In a mid-stage trial, tumours shrank in 22.1% of patients overall. [23] Older treatments shrink them in about 5%, the companies say. [23] Half the patients lived at least 13.4 months. [23]

   Why it matters — The trial had no comparison group, so its numbers are set against past studies, which put survival at about 12 months for patients treated first. [23] Diarrhoea hit 82% of patients and nausea 76%. [23]

9. 10

   Trump orders an NIH division for women's health

   US President Donald Trump signed an order on Monday to create a women's health division at the NIH, the US government's medical research agency, within 90 days. [13] Melania Trump, the first lady, announced it. [13] A White House task force led by Susie Wiles, the chief of staff, was due to meet for the first time the same day. [13] Details of the new division were not disclosed. [13] Since 2025, NIH grants that used the word women have faced special reviews. [13]

   Why it matters — Women have more bad reactions to drugs than men, partly because research has studied them less, a 2025 review found. [13] The new division sits beside the NIH's existing Office of Research on Women's Health rather than replacing it. [13]

10. 11

    A face photo predicts cancer survival

    Researchers at Mass General Brigham, a Boston hospital group, trained a computer on 40 million face photos and then taught it to predict how long cancer patients live. [14] In 3,820 cancer patients, 64 of the 122 with the highest risk scores died within 90 days of their photo. [14] The study came out on Monday in Lancet Digital Health, a medical journal. [14] The model learned mostly from white patients in the Boston area. [14] It is not yet ready for use in clinics. [14]

    64 of 122

    died within 90 days

    Why it matters — A bioethics professor at New York University warns that insurers or employers could use a tool like this to judge people. [14] A wrong score could also mean a sick person is not offered care. [14]

11. 12

    A hair-loss pill passes a second final trial

    Veradermics, a US biotech, said on Monday its pill for male-pattern baldness passed a second final-stage trial. [10] The pill is a slow-release form of minoxidil, a cheap hair-growth drug that is widely sold as a copy. [10] In the first trial it regrew more hair than a dummy pill over six months. [10] An analyst at Cantor Fitzgerald, an investment bank, called the new results consistent and slightly better. [10]

    Why it matters — Some investors doubt people will pay for it when cheap minoxidil already exists. [10] The same analyst argues that a version approved by the FDA could still sell fast. [10]

12. 13

    Nouscom raises $135 million for a cancer-prevention vaccine

    Nouscom, a Swiss start-up, raised $135 million from investors to keep testing NOUS-209, a vaccine that teaches the immune system to find and kill abnormal cells. [10] It is aimed at people with Lynch syndrome, an inherited condition that raises the risk of cancer. [10] The vaccine is in an early trial. [10] Data at this week's ESMO meeting suggest it might help prevent some tumours. [10] M Ventures and Revelation Partners led the round. [10]

    Why it matters — Lynch syndrome comes from faulty genes for repairing DNA, the same fault that marks the rectal tumours Jemperli now treats. A vaccine would aim to act before any cancer has formed.

13. 14

    Ultragenyx sells a second FDA fast pass

    Ultragenyx, a US rare-disease drugmaker, said last Wednesday it sold a priority review voucher for $203 million. [10] The voucher is an FDA fast pass, which its holder can use to get a quicker review. [10] Ultragenyx earned it when its gene therapy Fayuvi was approved. [10] Less than two weeks earlier it sold another voucher for $210 million. [10] The company has been weighing cuts since its drug for Angelman syndrome, a rare brain disorder, failed. [10]

    Why it matters — The two sales brought Ultragenyx $413 million without selling a medicine. [10] The buyer gets a quicker FDA decision on one of its own drugs, and the FDA's test for that drug stays the same.

14. 15

    Enlivex lays off 60% of its staff

    Enlivex, an Israeli biotech, is laying off 60% of its staff and stopping its early laboratory research. [15] It began the year with 34 full-time employees. [15] Managers take a 20% pay cut and the chief executive 40%. [15] The money goes to one mid-stage trial of allocetra, a cell treatment for knee osteoarthritis, the wear-and-tear arthritis of the knee. [15] Results are due in mid-2027. [15]

    Why it matters — Enlivex also keeps part of its money in prediction markets, websites where people bet on future events, which is unusual for a drug company. [15] Its future now rests on one trial in one disease.

15. 16

    UK Biobank to map the immune systems of 80,000 people

    UK Biobank, a British study holding health records and blood from half a million volunteers, will add detailed immune data. [16] IMU Biosciences, a London company, will profile blood from an initial 80,000 volunteers. [16] It aims to read more than 100 million immune data points from each sample. [16] Machines from Waters Corporation and Ultima Genomics, two instrument makers, will do the measuring. [16] The work starts this year. [16]

    Why it matters — UK Biobank's chief scientist says it will show which immune changes come before cancer, diabetes and dementia. [16] The data will be open to approved researchers. [16]

16. 17

    PacBio and Verily join DNA readings to medical records

    PacBio, which makes machines that read long stretches of DNA, signed a deal lasting several years with Verily Health, a health-data company. [17] Verily will combine PacBio's DNA readings with patients' medical records on its computer platform. [17] Long readings can catch large changes in DNA that shorter readings miss. [17] The data will be used for research and to train AI programs. [17] The deal was announced at ASHG, the yearly meeting of the American Society of Human Genetics. [17]

    Why it matters — Neither company gave the price, the customers or a timetable. [17] Verily names rare disease, cancer and brain disease as the areas it hopes to help. [17]

17. 18

    Stress restarts arthritis in mice

    Scientists at Chiba University in Japan found how stress can restart joint inflammation in mice whose arthritis had calmed down. [18] Stress switched on brown fat, a kind of fat that makes heat. [18] The fat released IL-6, an inflammation signal. [18] IL-6 made cells in the joint lining call in white blood cells, and the joint swelled again. [18] Blocking one receptor for stress hormones reduced the flare. [18] The study is in the journal Science Advances. [18]

    Why it matters — People with rheumatoid arthritis often report that stress makes it flare. [18] This was shown in mice, and most results in mice do not carry over to people.

18. 19

    A virus built to wake only inside tumours

    Researchers reported a virus that stays switched off until it reaches a tumour. [19] They fitted a cap onto VSV, a virus that infects livestock, so it cannot enter cells. [19] Enzymes common around tumours cut the cap off, and only then can the virus infect cancer cells. [19] Injected into the blood of mice, a version carrying an immune booster wiped out tumours without harming the rest of the body. [19] The paper is in Signal Transduction and Targeted Therapy, a Nature journal. [19]

    Why it matters — Viruses that kill cancer are already approved, but each must be injected straight into a tumour. [19] One that travels in the blood could reach tumours that have spread, though so far that has only been shown in mice.

19. 20

    A caffeine-flushing supplement has never been tested in people

    Scientific American looked at rutaecarpine, a plant extract sold online as a way to drink coffee late and still sleep. [20] It comes from a fruit used in traditional Chinese medicine. [20] In rats, it raises CYP1A2, a liver enzyme that breaks down caffeine. [20] It has never been through a human trial. [20] A 2024 study in mice and human cells suggests it could be dangerous taken with paracetamol, also called acetaminophen. [20]

    Why it matters — The same liver enzyme turns paracetamol into a substance that can damage the liver. [20] Sold as a supplement, it needs no FDA test for safety or effect in the US. [20]