Biotech, in brief

The US Food and Drug Administration (FDA), the US drug regulator, approved Onswik on Thursday 24 September. It is an insulin for adults with type 2 diabetes, injected under the skin once a week, on the same day each week. [1]

Onswik is made by Eli Lilly, the US drugmaker that also sells the weight-loss shot Zepbound. Lilly says it will be on sale in the United States in the coming months, in a pre-filled pen in two strengths. [2][4]

Type 2 diabetes means the body does not make enough insulin, or does not use it well, so sugar stays in the blood. Insulin moves that sugar out of the blood and into cells. [1]

Many people with type 2 diabetes inject a long-acting insulin every day. Lilly says a weekly shot cuts more than 300 injections a year. [2]

The approval rests on four trials with more than 3,400 adults. Onswik was compared with two daily insulins, glargine and degludec, and patients kept their other diabetes drugs. [1][2]

In all four trials Onswik lowered A1c, a measure of average blood sugar over months, about as much as the daily insulins did. It was tested to be no worse than them, not better. [1][3]

It is not for type 1 diabetes, where the body makes no insulin at all. In those patients the FDA saw a higher risk of severe low blood sugar, which can cause seizures, unconsciousness or death. [1][2]

The most common side effects are low blood sugar, allergic reactions, reactions where the needle goes in, itching, swelling and weight gain. The label also warns about dosing mistakes and accidental overdose. [1]

Onswik is the second weekly insulin approved in the United States. The first, Novo Nordisk's Awiqli, was approved in March. [1][3]

Novo Nordisk, the Danish drugmaker, is Lilly's main rival in diabetes and obesity. Lilly's two big diabetes and weight-loss drugs sold $27.6 billion in the first half of 2026, against about $15.7 billion for Novo's. [4]

Onswik was already approved in Europe, Japan and Mexico before the US decision. [2]

The same week Novo agreed to pay up to 1.17 billion euros for a coating technology to make its own injections monthly or every three months. [6]

Why it matters. Watch what Lilly charges for Onswik and whether US insurers list it beside the daily insulins; the next test is whether patients on it outside a trial keep their blood sugar as steady as those inside one.

Novo Nordisk, the Danish maker of Ozempic and Wegovy, agreed on Thursday to license a drug-coating technology from Nanexa, a small Swedish company. [4][6] The coating, PharmaShell, is an ultra-thin layer on each drug particle that dissolves slowly, so the drug enters the blood over a long time. [5][6] Novo may use it on up to five drugs for obesity, type 2 diabetes and related diseases, aiming at shots given monthly or every three months. [5][7] Up to 615 million euros is paid up front and on development goals, and neither company has said what the upfront part is. [5] Nanexa's shares more than doubled on Friday morning. [6]

Why it matters. Novo's weekly shots face Lilly's daily pill and a US patent on its best-seller that ends in 2032, so it is now selling how rarely a patient injects. [4] Lilly signed a similar deal with Camurus last year. [5]

Genentech, the US arm of the Swiss drugmaker Roche, is paying Earendil Labs $55 million up front to design bispecific antibodies for cancer. [8] A bispecific antibody is one molecule that grabs two targets at once, for instance a cancer cell and an immune cell. [8] Earendil designs antibodies with AI software and will run the early trials before handing the drugs to Genentech. [8] Payments could pass $1.5 billion if the drugs keep passing tests. [8] Sanofi has paid Earendil $285 million across two earlier deals, and the company raised $787 million in March. [8]

Why it matters. Sanofi, WuXi XDC and now Genentech have all paid a startup that made its name only in the past 18 months for designs rather than make them in-house. [8] It is the same trade as Novo and Nanexa: the big company pays a little for the idea, and most of the money arrives only if it works.

Merck, the US drugmaker, and Daiichi Sankyo of Japan withdrew their US application for ifinatamab deruxtecan this week. [9] The drug was under review for small-cell lung cancer that had grown back after chemotherapy, an aggressive form of the disease. [9] It is an antibody-drug conjugate: an antibody that finds the cancer cell and carries a dose of chemotherapy into it. [9] It is the second of three drugs in the pair's 2023 partnership, worth up to $22 billion, to have a US application pulled. [9] A larger trial against chemotherapy is nearly fully enrolled and will be the basis for a new application. [9]

Why it matters. People whose small-cell lung cancer has come back have few treatments, and now wait for the larger trial. [9] The first drug pulled from this partnership went after it failed to extend patients' lives. [9]

The FDA approved Merck's Welireg with Eisai's Lenvima on Thursday for advanced clear-cell kidney cancer that has grown despite an immune-boosting drug such as Keytruda. [10][3] In a 747-patient trial the pair held the cancer back for a median 14.6 months, against 10.6 months on cabozantinib, the drug it was compared with. [10] Patients on the pair lived a median 33.7 months against 28.6, but that gap was not statistically significant, so it may be chance. [10] It is the latest of several approved uses for Welireg, which sold $470 million in the first half of 2026. [3]

Why it matters. It gives kidney cancer patients a next step after immunotherapy stops working, on evidence about delaying the cancer rather than about living longer. [10]

The FDA approved lirafugratinib, sold as Lyrfigtu by Elevar Therapeutics, on 23 September. [11] It is for cholangiocarcinoma, a cancer of the bile ducts, in patients whose tumour carries a fault in a gene called FGFR2 and who have already had chemotherapy. [11] The pill blocks the faulty FGFR2 signal that tells those cells to keep growing. [11] In a trial of 116 patients with no comparison group, tumours shrank in 46%, and the shrinkage lasted a median 11.8 months. [11] The label warns of eye damage and high phosphate levels. [11]

Why it matters. For a cancer with few options, the regulator accepted tumour shrinkage in a single-arm trial as proof. Whether patients live longer has not been shown. [11]

A federal jury in California sided on Thursday with Nektar Therapeutics in its 2023 lawsuit against Eli Lilly. [3] Nektar said Lilly had undermined an autoimmune drug the two were developing together after Lilly bought a rival treatment in a company takeover. [3] The jury awarded Nektar $90 million, far below the nearly $1 billion it had asked for. [3] Nektar told regulators the verdict is still subject to post-trial proceedings. [3]

Why it matters. Small companies license drugs to big ones and then depend on the big partner's attention. [3] A jury agreed Lilly fell short, and priced the harm at about a tenth of what Nektar asked. [3]

ADARx Pharmaceuticals, a San Diego company with 100 staff, priced its Nasdaq share sale on Thursday night at $17 a share, the top of its range, and sold more shares than planned. [12] It raised $446.3 million, against the $350 million it had expected. [12][13] AbbVie, a large US drugmaker that paid ADARx $335 million last year for options on its drugs, agreed to buy up to $100 million of shares alongside. [12][13] ADARx makes siRNA drugs, which stop a cell making a harmful protein by blocking the instructions for it. [12]

Why it matters. Biotech listings are the strongest part of this year's US share-sale market, though Electra, which listed a week earlier, has fallen about 21% since. [13]

Scientists at nChroma Bio in Boston and institutes in Milan reported on 21 September a one-time therapy that switches off the hepatitis B virus without cutting DNA. [14] Hepatitis B infects more than 250 million people and hides in liver cells as small loops of DNA, so today's daily drugs rarely clear it. [14] The therapy uses a disabled CRISPR enzyme to carry chemical tags onto the virus's genes, which silences them. [14] One injection worked in human liver cells and in mice, with minimal side effects in monkeys. [14] A human trial in Hong Kong and New Zealand gave its first dose in January. [14]

Why it matters. Cutting DNA can raise cancer risk in people with hepatitis B, so a tag instead of a cut matters most for exactly these patients. [14] No human results exist yet.

Doctors at Washington University in St Louis and 14 other centres used CRISPR to remove a protein called CD33 from donor stem cells. [15] They transplanted the cells into 30 adults with acute myeloid leukaemia or a related bone marrow disease. [15] CD33 sits on those cancer cells but also on healthy blood cells, so drugs aimed at it usually damage both. [15] All 30 transplants took hold by day 28, and patients then got a CD33-targeting drug without the usual collapse in blood counts. [15] Seven patients died, four from the cancer and three from transplant complications. [15]

Why it matters. Vor Biopharma funded the trial, published in Nature Medicine. [15] It clears a path for CAR-T cell therapy against these cancers, which has failed so far because the target sits on healthy cells too. [15]

Researchers at Mount Sinai in New York reported in two papers, in Cell and Cell Stem Cell, how APOE4, the strongest genetic risk factor for Alzheimer's disease, harms the brain. [16] The gene turns pericytes, cells that keep small blood vessels stable, into scar-forming cells that thicken the vessels and speed the build-up of amyloid, the protein clumps that current drugs target. [16] Blocking a protein called TGF-beta protected the pericytes and reversed the vessel damage in mice. [16]

Why it matters. It suggests blood-vessel damage in Alzheimer's is a cause that could be treated, not a late effect. [16] It has only been shown in mice.

A CAR-T therapy from Gilead Sciences, the US drugmaker, produced responses in all 38 patients with hard-to-treat multiple myeloma in a phase 1 trial reported in the New England Journal of Medicine. [16] CAR-T takes a patient's own immune cells, engineers them in a lab to hunt a protein on the cancer, and returns them to the body. [16] Nearly 80% had no detectable cancer; more than half showed no progression two years on, and 65% were alive after three years. [16] Phase 1 trials test safety, so larger trials are under way to confirm this. [16]

Why it matters. Multiple myeloma is a blood cancer that keeps coming back, and a treatment that holds it off for years in most patients would change what those patients can expect. [16] The number is 38 people, and severe side effects were uncommon. [16]

Researchers at MIT found a way to identify senescent cells, old cells that have stopped dividing but refuse to die, without destroying them, in a study in Nature Aging. [16] They used Raman microscopy, which reads a cell's chemistry with light, together with the cell's gene activity, to find a unique signature for these cells. [16] The work was in mouse cells, and the team is now adapting it for human tissue. [16] It is part of a US National Institutes of Health programme on cell senescence. [16]

Why it matters. Senescent cells feed inflammation and age-related disease, and drugs to remove them need a way to find them first. [16]

The chairs of nine drugmakers, including AstraZeneca, GSK, Novo Nordisk, Novartis, Roche and Sanofi, published an open letter on Tuesday. [17] It asks the European Union and its governments to spend more on medicines, run trials faster and protect patents. [17] They said Europe's share of global drug research has fallen to 31% from 43% in 1990, and its share of commercial trials has halved to 9% in a decade. [17] About 40% of new therapies never reach European patients, they said. [17] Europe spends about 1% of GDP on medicines, against 2% in the United States. [17]

Why it matters. The companies are asking governments for more spending and faster approvals, and they have already delayed some European launches with an eye on US pricing rules. [17]

Lepu Biopharma, a Chinese drugmaker, is suing an adviser named Zhang in a New York federal court. It hired her in December 2024 to find Western partners for its obesity and diabetes drugs. [18] Lepu says Zhang and her team worked at the same time for rival Chinese companies while holding Lepu's confidential data. [18] Zhang made her name at Hengrui, where she set up the first 'NewCo' deal: a Chinese company spins early drugs into a new Western firm and keeps a stake. [18] Her lawyers say her firm was an independent contractor and owed Lepu no such duty. [18]

Why it matters. These deals are how Western investors reach Chinese drugs early; Chinese assets have produced 15 of them this year, and this case tests who owes loyalty to whom inside one. [18]

Indivior, the maker of the opioid-addiction treatment Sublocade, has returned all rights from an eight-year partnership with Addex Therapeutics, a Swiss biotech, Addex said. [19] The two had worked since 2018 on drugs that turn up a brain receptor called GABAB to treat addiction; the first candidate failed and Indivior took on a second in 2024. [19] Indivior is cutting research ahead of its planned merger with Supernus. [19] Addex says it now holds one of the broadest portfolios against that receptor and may seek a new partner. [19]

Why it matters. A merger at the big partner ends the small company's programme. [19] Addex gets its drug back, and loses the money that was developing it.

Eric Dube, chief executive of Travere Therapeutics, is stepping down. Bradley Campbell, who led Amicus Therapeutics through its $4.8 billion sale to BioMarin, takes over on 1 December. [20] Dube renamed the company from Retrophin, which was founded by Martin Shkreli, and won US approval in 2023 for Filspari, a drug for the rare kidney disease IgA nephropathy. [20] He stays on as an adviser until February 2027. [20] Campbell spent 20 years at Amicus and took it from one product to two, with a Pompe disease treatment approved in 2023. [20]

Why it matters. Filspari was approved on an accelerated basis, so Travere still has to confirm it works, and the new chief's job is that and the sales. [20]

Anthropic, the company behind the Claude AI models, said on 23 September that Claude had discovered a new enzyme system with repeated DNA sequences it called reminiscent of CRISPR. [21] CRISPR is the gene-editing tool copied from a bacterial defence against viruses, and its discoverers won a Nobel prize in 2020. [21] New Scientist's assessment is that the two discoveries are not comparable, and that at best the find is another gene-editing tool. [21]

Why it matters. AI companies are now announcing biology findings directly, and the specialist press is grading them. [21]