Biotech, in brief

The FDA, the US medicines regulator, approved Hibsago on Tuesday 20 October, an injection made by GSK, the British drugmaker, for long-term hepatitis B. [1][2]

Hepatitis B is a virus that infects the liver. Over years it can scar the liver, which doctors call cirrhosis, and raise the risk of liver cancer. [1]

More than 250 million people live with it worldwide, about 1.7 million of them in the US. [2][3]

Today's hepatitis B pills suppress the virus but rarely get rid of it, so many people take them for life. [2]

With those pills, only 1% to 4% of patients reach what doctors call a 'functional cure'. [2] That means no virus and no HBsAg in the blood for at least 24 weeks after all treatment stops. [3]

Hibsago is the first antisense drug the FDA has approved for hepatitis B: a short strand of genetic material that sticks to the virus's instructions. [1][2]

That blocks the virus from making copies of itself and its surface protein, HBsAg, which shows up in the blood. [1]

Patients get the injection under the skin for up to 24 weeks, beside their usual pills, then keep the pills for at least 24 more weeks. [1]

In two trials, 24% of people on Hibsago met the rules to stop all hepatitis B medicine. None on a dummy injection did. [1]

Twenty-four weeks after stopping everything, 19% still had the virus under control and no HBsAg in their blood. [1]

Across the trials that was 233 of 1,220 people on the drug and none of 614 on placebo. Among people who started with less HBsAg, 26% reached it. [3]

It is only for adults without cirrhosis whose virus is already kept low by pills and whose HBsAg is at or below a set level, measured with an approved test. [1]

The drug carries a boxed warning, the FDA's strongest kind, for serious liver reactions and for low platelet counts, which can cause dangerous bleeding. [1]

Ionis Pharmaceuticals, a US company, invented the drug and licensed it to GSK in 2019. Ionis gets 10% to 12% of sales as royalties. [3]

Why it matters. The next tests are the US price, which GSK has not given, and the reviews in China and Europe. [2] GSK expects key decisions in several countries in the coming months. [3]

Nigeria confirmed its first Ebola case of this outbreak on Tuesday, in a woman in Abuja, its capital, who had arrived from Uganda. [4] She fell ill on 7 October and spent several days in a private hospital before Ebola was found. [5][4] Health Minister Muhammad Ali Pate said 44 of her contacts have been identified. [4] Uganda, declared free of Ebola in August, says she only passed through after a business trip to eastern Congo. [4][5] The outbreak began in Congo in May and has killed more than 4,600 people. [6]

Why it matters. Nigeria is Africa's most populous country, and the head of the Africa CDC, the continent's public health agency, called this the most widely spread Ebola outbreak on record. [4][5] In 2014 Nigeria stopped an Ebola outbreak after 20 cases. [7]

Kenya has now confirmed nine Ebola cases, all linked to its first patient, a man who travelled from Congo and died two weeks ago. [8] They are four of his relatives, three health workers and a hospital cleaner. [8] On Tuesday Patrick Amoth, Kenya's health director-general, said the eight patients were improving. [8] Ebola can take up to 21 days to show, and 134 of 135 listed contacts are in quarantine. [8] Kenya's doctors' union says border posts are short of staff and hospitals need more protective gear. [8]

Why it matters. On Monday the US told its citizens to reconsider travel to Kenya, and a Kenyan court has halted a quarantine centre the US built at a Kenyan air base. [8][9] Jennifer Nuzzo, a pandemic researcher at Brown University in the US, says US aid cuts leave countries less prepared for outbreaks. [9]

ICER, a US non-profit that judges whether drug prices match the health they buy, reported on Tuesday on 26 drugs approved from 2022 to 2025. [10] Two in three launched far above its limit for good value. [10] After inflation, the median net launch price rose from $190,000 in 2022 to $257,000 in 2025, partly because of one-time gene and cell therapies. [10] ICER said two drugs, Insmed's Brinsupri for a lung disease and Merck's Winrevair for high blood pressure in the lungs, would need discounts of about 90%. [10]

Why it matters. ICER said four in ten prescriptions for these drugs were turned down, and people on Medicare, the US scheme for older people, fared worse. [10] Drugmakers call its method flawed, though the UK's NICE uses a similar one. [10]

Robert F. Kennedy Jr., the US health secretary, said on Tuesday the Trump administration wants a regulated market for peptides. [11] Peptides are short chains of the building blocks of proteins, promoted on social media for pain, muscle growth and beauty with little evidence from human studies. [11] The ones under review are not approved by the FDA as safe or effective. [11] Last Thursday the FDA sent the US president's office a plan that could let pharmacies mix some more easily, with no details published. [12] 'Americans are going to be buying these anyway,' Kennedy said. [11]

Why it matters. In July the FDA's outside advisers backed loosening the rules on six of seven peptides, against the advice of FDA staff. [11] Hims & Hers, a US online health company, has said it plans to sell peptides if the rules allow. [12]

Rapport Therapeutics, a Boston drug company, said its pill RAP-219 beat a dummy pill in about 250 adults with bipolar mania, the high phase of bipolar disorder. [13] After three weeks, scores on a 60-point symptom scale fell by 15.4 points on the drug and 12.3 on placebo. [13] The 3.1-point gap only just counted as more than chance. [13] Last month Rapport's chief executive had called a 4-point gap the level that matters to patients. [14] Rapport plans two final-stage trials from late 2027. [13]

Why it matters. The pill was built for epilepsy and calms a protein found mostly in the brain areas where seizures start. [13] Side effects were mild to moderate, and analysts at Raymond James said the bipolar drugs that work best are the ones patients stay on. [13]

KFF Health News, a US health news service, reported on Tuesday that Americans are travelling to China for cancer medicines and trials they cannot get at home. [26] One New York woman, whose lung cancer had spread to her brain, takes sunvozertinib, a pill made by Shanghai's Dizal Pharmaceutical, which her son brings back from Shanghai. [26] The FDA licensed it in July 2025, but it was still not on sale in the US in mid-October. [26] Her son knows of at least 30 Americans who have gone for it. [26]

Why it matters. China ran as many as 46% of the new drugs tested worldwide in 2025, the report says. [26] Two US lawmakers want the US Treasury to clear every US drug deal with a Chinese firm, and AstraZeneca plans to sell sunvozertinib in the US by early 2027. [26]

Radical Numerics, an AI start-up, said on Tuesday it had treated a patient with a virus designed by AI, the first time this has been done, it says. [15] The virus is a phage, a kind of virus that kills bacteria, and it was given for a deadly bacterial infection. [15] The company says the FDA authorised the trial. [15] It gave no details about the patient or the doctors, citing confidentiality, and its report has not been checked by outside scientists. [15]

Why it matters. Phages can sometimes clear infections that antibiotics no longer can. [15] Until the patient's outcome is published, nobody outside the company can tell whether the AI-designed virus worked.

Novo Nordisk, the Danish maker of Wegovy, said women on its newer weekly injection, CagriSema, lost 25% of their weight on average after 68 weeks. [16] Women on placebo lost 3%. [16] The figure covers 2,309 women in a final-stage trial of more than 3,400 adults. [16] Across everyone, the drug's average loss was 22.7%, below the 25% Novo had aimed for. [16] Novo said analyses done after a trial ends only raise ideas that need more study. [16]

Why it matters. Novo is counting on CagriSema to win back ground lost to Eli Lilly, and Wegovy's patents run out after 2030. [16] A US decision on approving CagriSema is expected by the end of this year. [16]

Lycia Therapeutics, a California drug company founded by Nobel Prize winner Carolyn Bertozzi, set a price range on Tuesday for its first sale of shares. [17] It plans to sell 14.7 million shares at $16 to $18 each, valuing it at up to $938 million. [17] Its lead drug, LCA-0061, is built to remove IgE, the antibody behind allergic reactions; Lycia says today's drug Xolair only blocks it. [18] LCA-0061 is in an early trial for food allergy. [17]

Why it matters. Lycia expects about $80 million of the money to take LCA-0061 through a mid-stage trial. [18] Health companies have carried this autumn's US share sales, and City Therapeutics and Iambic listed last week. [17]

The FDA approved on Monday the first generic copy of Climara Pro, a skin patch changed once a week to treat menopause symptoms. [19] It holds two hormones, an oestrogen and a progestogen. [19] It is only for women who still have a womb, because the second hormone lowers a risk to the womb's lining from oestrogen alone. [19] It also helps prevent bone thinning after menopause. [19] New CDC figures show 15.6% of US women aged 40 to 60 with menopause symptoms take a prescription medicine for them. [20]

Why it matters. The FDA said the copy is meant to make the treatment cheaper and easier to get. [19] By the CDC's count, about one in six women with symptoms gets prescription treatment. [20]

The FDA published final guidance on Tuesday for apps that drug companies offer with prescription medicines. [21] An app tied to a device, such as one paired with an asthma inhaler, should generally be described on the drug's official label. [21] A standalone app, such as a dose reminder, goes on the label only if the company shows it is needed for safe use or brings a real health benefit. [21] Most of what such apps show patients will be treated as advertising. [21]

Why it matters. The guidance says what companies must send the FDA when their apps tell patients things, a question left open for years. [21] An FDA official said these apps are moving from dose reminders to tools that adapt to each patient. [21]

A trial in China has reported long-term survival results for entinostat, a breast cancer pill, in a journal from the Nature group. [22] The 354 patients had advanced hormone-sensitive breast cancer that kept growing on hormone therapy. [22] Those given entinostat with the hormone pill exemestane lived a median 38.6 months, against 29.2 months on exemestane and a dummy pill. [22] But the gap was not statistically significant, so it may be chance. [22]

Why it matters. The same trial had already shown the cancer stayed in check longer, 6.3 months against 3.7, and China's regulator approved the drug. [22] Severe side effects hit 65.5% of the patients taking it. [22]

Scientists at City of Hope, a US cancer centre, have found in mice one way radiation for lung cancer harms healthy lung. [23] Radiation raised a signalling protein, interferon-beta, which turned protective immune cells into ones that cause inflammation. [23] Blocking that signal during radiation cut inflammation and scarring in the mice. [23] Human immune cells showed similar changes in the lab. [23] The study was published in Nature Communications. [23]

Why it matters. More than 70% of people with lung cancer get radiation at some point, and up to 20% are left with lasting breathing trouble. [23] This is a mouse study, and most things that work in mice never work in people.

Pfizer has ended a mid-stage trial of PF-06835375, an antibody for immune thrombocytopenia, or ITP. [24] ITP is an illness in which the body's own immune system leaves too few platelets, the blood cells that help it clot. [24] The 61-patient trial began in 2022. [24] Pfizer called the ending 'a business decision' not based on safety, and would not say whether all work on the drug has stopped. [24]

Why it matters. The drug is still listed on Pfizer's website for ITP and for lupus. [24] A trial stopped this way may never show whether the drug worked for the people who took part.

The US National Science Foundation, which funds basic research, has not opened applications for its Major Research Instrumentation grants, due to open on 15 October. [25] The grants pay up to $4 million for costly shared machines, such as microscopes, lasers and computer clusters. [25] In 2025 the agency suspended the same round, so this is the second year it has stalled. [25] A spokesperson said the agency is updating the programme but gave no date. [25]

Why it matters. One scientist said it is often the only option for researchers without money from the NIH, the US medical research funder. [25] A single proposal takes 30 to 40 hours to write, and universities run their own contests before applying. [25]

A 43-year-old man in Abu Dhabi no longer needs regular blood transfusions after gene therapy, the UAE's state news agency reported on Tuesday. [28] He has thalassaemia, an inherited blood disorder in which the body lacks haemoglobin, the protein that carries oxygen in the blood. [28] He had needed transfusions every three to four weeks. [28] Doctors collected his own stem cells, changed their genes and put them back. [28]

Why it matters. A haematologist at Yas Clinic said gene therapy helps patients who have no matching bone marrow donor. [28] It is one patient, and he remains under medical watch, so how long the benefit lasts is not yet known. [28]

The UAE will ban vets from using ciprofloxacin, an antibiotic, from 1 November, its drug regulator, the Emirates Drug Establishment, said. [29] Ciprofloxacin belongs to a group of antibiotics classed as critically important for treating serious human infections such as sepsis and pneumonia. [29] Vets give it to dogs and cats for skin and bladder infections. [29] Nine products are affected, and sellers must withdraw their stocks before the ban starts. [29]

Why it matters. The regulator said using the drug in animals can help bacteria learn to resist it, weakening it for people. [29] Drug resistance contributed to more than 4.7 million deaths worldwide in 2021, by the WHO's estimate. [29]