Telix is buying ITM for at least $1.65 billion, a month after the US regulator turned down ITM's cancer drug over how it is made

The rest of the day

22 more stories on this beat.

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

1. 02

   FDA advisers review a blood test for many cancers

   A panel of outside experts that advises the FDA meets on 23 September to review Grail's Galleri. [4] It is a blood test for adults aged 50 and over that looks for signs of many kinds of cancer at once. [4] In Grail's two big studies, it flagged 32% to 35% of the cancers diagnosed within a year. [4] Of the people it flagged, 66% to 77% turned out to have cancer. [4] About one healthy person in 500 got a false alarm. [4] FDA documents posted before the meeting suggest a favourable view, with one oddity, STAT reported. [5]

   32 of 100

   cancers the test flagged, of every 100 diagnosed within a year in England's NHS-Galleri trial

   Why it matters — Galleri is already sold through laboratories, and FDA approval would be expected to help it get paid for by Medicare and other insurers. [5] Grail's own document says people should keep having their usual screening, because the test misses most cancers. [4]

2. 03

   First win in a late-stage Sjogren's trial

   Amgen said its drug dazodalibep improved Sjogren's disease more than a dummy drug in a final-stage trial of 651 people. [6] Sjogren's is a disease in which the immune system attacks the glands that make tears and saliva, and it can affect the whole body. [6] There is no medicine approved in the US specifically for it. [6] The trial measured overall disease activity after 48 weeks, and Amgen has not yet given the scores. [6] A second final-stage trial, in people with milder disease, is still running. [6]

   Why it matters — Novartis and Sanofi have each dropped a Sjogren's drug in recent years, and Astellas stopped one in April. [6] Patients now mostly get general anti-inflammatory drugs to ease the symptoms. [6]

3. 04

   US weighs letting drug deals with China continue

   The US Treasury is drafting rules that would probably let US drugmakers keep licensing new medicines from Chinese companies, Reuters reported, citing unnamed sources. [11] Deals on germs or biotechnology that could be made into weapons would be excluded. [11] Licensing deals for Chinese biotech drugs were worth $115 billion last year, according to the research firm GlobalData. [11] The rules come under a 2025 US law that screens investment in sensitive technology in certain countries, and a drug industry group is lobbying over them. [5] They are not final, and could change if President Trump weighs in. [11]

   Why it matters — Pfizer and other big drugmakers argued that limits would cut US companies off from a fast-growing source of new medicines. [11] Some smaller biotech companies and two Michigan members of Congress want the deals restricted, saying they help China lead in biotechnology. [11]

4. 05

   A gene-targeted ALS drug passes its big trial

   Ulefnersen, a drug for a rare form of ALS, slowed the disease in a final-stage trial of 89 people, its makers Otsuka and Ionis said. [8] ALS destroys the nerve cells that control muscles. [8] This form, caused by faults in a gene called FUS, is about 0.6% of cases and can kill younger patients within two years. [8] The drug lowers the amount of the harmful FUS protein, and patients did better than on a dummy drug on function and survival after 72 weeks. [8] Otsuka, a Japanese drugmaker, will take it to regulators. [8]

   Why it matters — The market is tiny: analysts at Guggenheim expect Ionis to earn only about $14 million a year from it by 2030. [8] The drug was designed for ALS with one genetic cause, not for ALS in general. [8]

5. 06

   Hives drug wins two late-stage trials

   Celldex said its antibody barzolvolimab beat a dummy injection in two final-stage trials with 1,939 people who have chronic hives with no known cause. [7] The drug blocks a signal that mast cells, the immune cells behind hives and swelling, need to survive. [7] In people not helped by the standard injection Xolair, 55% on the lower dose were fully clear at 12 weeks in one trial, against 9% on a dummy. [7] In the other trial the figures were 42% against 15%. [7] Two patients had a severe allergic reaction, and 16% left the trials, mostly by choice. [7]

   Lower dose of barzolvolimab55.3%

   Dummy injection9.3%

   Why it matters — The same drug failed a trial in a different itchy skin disease in July, so this is a recovery for the company. [7] Celldex plans to ask the FDA for approval in 2027. [7]

6. 07

   Novo sets out its plans, and shares fall

   Novo, the Danish maker of Ozempic and Wegovy, laid out its plans to 2030 to investors on Monday, and its shares fell 8%. [9] The US patent on semaglutide, the ingredient in both drugs, runs out in 2032, which its chief executive called the elephant in the room. [9][10] Novo expects its sales to grow at about the same rate as other big drugmakers until 2030. [10] It aims for more than $23 billion of sales from drugs in its pipeline by 2035, allowing for some to fail, and plans to buy companies as well as invent. [9]

   Why it matters — Novo has lost ground to Eli Lilly, whose drug Zepbound beat Wegovy for weight loss in a head-to-head trial. [10] The same day Novo said its newer drug CagriSema beat Zepbound in another trial, though against a lower dose of Lilly's drug. [10]

7. 08

   More drug companies line up to sell shares

   Iambic Therapeutics, which designs cancer drugs with AI and is backed by the chipmaker Nvidia, filed to list on the US Nasdaq stock market. [12] It has raised about $461.8 million from investors since 2019. [12] Its most advanced drug, for tumours driven by a gene called HER2, is in a first safety trial. [13] Retension Pharmaceuticals and TRex Bio filed on Friday, and ADARx began pitching its share sale to investors. [12] On the same day, AbbVie signed a research deal with Iambic. [12][15]

   Why it matters — One analyst said this year's rush of listings has been helped by big drugmakers buying up young companies. [12] Eli Lilly has already said it may buy shares in TRex, whose drug it licensed in 2023. [14]

8. 09

   Roche's weight-loss drug tested in diabetes

   Roche said its weekly injection enicepatide cut blood sugar in a mid-stage trial in people with type 2 diabetes. [16] HbA1c, a measure of average blood sugar, fell 2.65 points on the top dose after 48 weeks. [16] Weight fell by 15.5%, with no sign yet of levelling off. [16] Roche got the drug by buying Carmot Therapeutics for $2.7 billion, and 2% of patients stopped because of side effects. [16]

   Why it matters — Lilly's Mounjaro lowered HbA1c by up to 1.8 points in its own trial, but the trials ran for different lengths, so the numbers cannot be compared directly. [16] Roche wants to become one of the three biggest companies in obesity drugs. [16]

9. 10

   Vertex kidney drug cuts protein in urine

   Vertex said its pill inaxaplin cut protein leaking into the urine in a mid-stage trial for kidney disease driven by a gene called APOL1. [17] In 22 people with milder leaking, it fell by 42.7% on average after 13 weeks. [17] In 17 people who also had type 2 diabetes, it fell by 17.3%. [17] A larger trial has finished enrolling, and early results are due next year. [17]

   Why it matters — If the larger trial is positive, Vertex could ask the FDA for a faster, conditional approval. [17] Vertex says the group in that larger trial covers about 150,000 people in the US and Europe. [17]

10. 11

    Viking tests fewer weight-loss injections

    Viking Therapeutics said people kept most of the weight they lost on its drug VK2735 when injections were spaced out. [18] After 21 weeks of weekly doses, people had lost 16% to 19% of their weight. [18] Moved to one injection every two weeks, they kept 90% of that loss on average; moved to monthly injections, 85%. [18] Viking's shares rose sharply on the news. [18]

    Why it matters — Weight-loss drugs have to be taken for good to keep weight off, and many people stop taking them. [18] Fewer injections could make staying on the drug easier. [18]

11. 12

    A bipolar drug calms mania within days

    Johnson & Johnson said Caplyta reduced manic symptoms in people with bipolar I disorder after three weeks in a final-stage trial, compared with a dummy drug. [15] Bipolar I is a mental illness defined by manic episodes, sudden swings in mood and behaviour. [15] Some improvements showed up within three days. [15] Caplyta is already approved for schizophrenia, bipolar depression and major depression, but not for mania. [15]

    Why it matters — J&J paid nearly $15 billion last year for the company that made Caplyta. [15] A second final-stage trial in mania is still running. [15]

12. 13

    FDA rewrites its rule on animal testing

    The FDA issued a final rule saying the safety of drugs and biological medicines can be tested with methods other than animals where appropriate. [19] The rule replaces the words 'animal tests' with 'nonclinical tests' in its regulations. [19] It is the second package of this kind announced this year by the US health department. [19] Health secretary Robert F. Kennedy Jr. said it moves research toward human biology. [19]

    Why it matters — Kennedy said researchers have been kept dependent on animal testing when better tools exist. [19] The department says it is paying to develop testing methods based on human biology. [19]

13. 14

    FDA accepts a wearable sensor for trials

    The FDA accepted a proposal to use a wearable movement sensor to measure foot drop in people with a nerve disease called CMT1A. [20] Foot drop means being unable to lift the front of the foot, which disturbs walking. [20] The sensor records it during a six-minute walk at clinic visits. [20] It is the first such digital tool for a rare nerve disease accepted into this FDA programme. [20]

    Why it matters — CMT1A gets slowly worse over years, so trials need a way to measure small changes. [20] The sensor is meant to track that change as a trial result. [20]

14. 15

    The FDA nominee faces senators

    Heidi Overton, nominated to lead the FDA, goes before the US Senate health committee on Thursday for her confirmation hearing. [25] Two former FDA commissioners, Scott Gottlieb and Mark McClellan, wrote in support of her. [25] They noted that more early human trials now begin in China than in the US. [25] In February, the FDA's leaders at the time argued that one large final trial, instead of two, should be the usual standard for approval. [26]

    Why it matters — The FDA has since published draft guidance on the one-trial idea, which is not yet final. [26] How much evidence a company must gather before a drug reaches patients depends on it. [26]

15. 16

    A drug-coated balloon approved for blocked stents

    The FDA approved Cordis's Selution balloon for heart arteries that narrow again inside a stent, a metal tube put in earlier to hold them open. [21] The balloon coats the artery wall with sirolimus, a drug usually given to stop the body rejecting a transplanted organ. [21] It leaves no new metal behind. [21] About 10% of the roughly one million US artery-opening procedures a year treat this re-narrowing. [21]

    Why it matters — Doctors often have to put a second stent inside the first one when this happens. [21] The approval rested on a study of more than 400 patients, and a 960-patient trial in small arteries has finished enrolling. [21]

16. 17

    Boehringer pays for AI-found cancer targets

    Boehringer Ingelheim, a German drugmaker, signed a deal worth up to $1 billion with Envisagenics, a New York company. [22] Envisagenics uses AI to screen more than 14 million ways cells edit gene messages. [22] It looks for protein versions made only by tumours, which a drug could hit while sparing healthy tissue. [22] Its chief executive said the money will take its own brain drug into human trials. [22]

    Why it matters — Neither company gave the split between money paid now and money paid later. [22] Boehringer can choose targets and license them for itself alone. [22]

17. 18

    A pill plus radiation in lung cancer

    A final-stage trial registered in China tested aumolertinib, a pill that blocks a faulty EGFR gene, with radiotherapy for lung cancer that cannot be operated on. [24] It was compared with chemotherapy plus radiotherapy. [24] Half the patients on the pill went 34 months before their cancer grew, against 7.4 months on chemotherapy. [24] The trial stopped early with only 43 of a planned 98 patients, partly because it enrolled slowly. [24]

    Aumolertinib pill with radiation34 months

    Chemotherapy with radiation7.4 months

    Why it matters — Chemotherapy with radiation has been the standard for this stage of lung cancer. [24] A trial this small cannot yet show a clear difference in how long people live. [24]

18. 19

    Lexeo buys a rare-disease pipeline for $8m

    Lexeo Therapeutics bought four drugs for Friedreich's ataxia from Mantle for $8 million. [23] Friedreich's ataxia is an inherited disease that destroys balance and coordination and affects about one American in 50,000. [23] About 80% of patients develop heart muscle disease. [23] The lead drug improved a 93-point disease rating by 6 points in 11 patients in early testing. [23]

    Why it matters — Lexeo already has a gene therapy for the same disease in a late-stage trial. [23] It has money to run until 2028. [23]

19. 20

    A team of AI agents proposes a lung-cancer drug

    Scientists at Stanford University built a 'virtual biotech' of up to 37,000 AI agents that split drug-discovery work between them, reported in the journal Science. [27] It studied more than 55,000 past clinical trials. [27] It found that drugs aimed at proteins active in only certain cell types were nearly 50% likelier to reach the market. [27] It also proposed an antibody carrying a cancer drug to a protein called CD276 in lung tumours. [27]

    Why it matters — None of its predictions has been tested in a lab, let alone a trial, other scientists pointed out. [27] It is a test of whether AI can speed up the early, slow part of making a drug. [27]

20. 21

    Designing safer psychedelic-like drugs

    Researchers mapped two serotonin receptors, the docking points that psychedelic drugs act on, in the journal Nature Communications. [28] One, called 2A, is behind the effects doctors want; the other, 2B, causes side effects. [28] Using that map, they designed a compound that switches on 2A and blocks 2B. [28] Images of the molecule in place confirmed how it works. [28]

    Why it matters — The authors say avoiding the 2B receptor is critical for safe medicines inspired by psychedelics. [28] This was laboratory work, not a test in people. [28]

21. 22

    A blood test for stomach and bowel cancer

    Researchers tested blood for 28 sugar-coated protein fragments in 550 people, half with stomach or bowel cancer and half healthy. [29] A computer model using them picked out 77.3% of the cancers and wrongly flagged 18.4% of the healthy people. [29] It did less well on early cancers. [29]

    Why it matters — About one healthy person in five was wrongly flagged, against about one in 500 for Galleri. [4][29] It compared known patients with healthy people, which is not the same as screening the general public. [29]

22. 23

    FDA clears a quick COVID test

    The FDA cleared the latest version of Aptitude's Metrix, a small molecular test for COVID. [30] It was paid for partly by BARDA, the US health department's fund for emergency medical products. [30] It arrives before the US ends emergency approvals for COVID tests on 26 December. [30]

    Why it matters — Tests already shipped under the emergency rules can still be used until they expire, the company said. [30] Aptitude is also seeking clearance for a combined COVID and flu test. [30]