Biotech, in brief

A committee of the European Medicines Agency, the EU's medicines regulator, recommended on Thursday 15 October that the EU approve Rasonque, a pancreatic cancer pill. [1][2]

The committee only advises. The European Commission, the EU's executive body, makes the final decision. [1]

Rasonque, also called daraxonrasib, is made by Revolution Medicines, a US drug company. It is taken by mouth once a day. [1]

It is meant for adults whose pancreatic cancer has spread and got worse after earlier treatment. [1]

It works by blocking RAS proteins. These proteins pass on signals that can make cancer cells keep growing. [1]

In a final-stage trial it nearly doubled the usual survival time for patients with an aggressive form of the disease, Bloomberg reported. [2]

Pancreatic cancer is often found only after it has spread. Chemotherapy is still the main treatment, and few options remain once it stops working. [1]

The US drug regulator, the FDA, approved the pill on 26 August for adults who had had at least one earlier treatment, or who cannot have combined chemotherapy. [3]

After the main trial results, demand was so strong that the FDA let patients get it through compassionate use, a route to unapproved drugs for the very ill. [1]

In the US a 30-day supply costs $39,800. [1]

Mark Goldsmith, the company's chief executive, said it will keep asking regulators in other countries to approve the pill. [1]

Why it matters. Watch whether the European Commission confirms its advisers' yes, the step that would let the pill be sold across the EU's 27 countries. [1][2]

Congo's national biomedical research institute confirmed on Sunday two Ebola cases, one of them a death, in North Ubangi province. [6] Reuters had first reported the cases on Thursday, before any official statement. [6] North Ubangi is the eighth province hit and borders the Central African Republic. [6] Congo's latest count is 9,415 cases and 4,536 deaths, with 67 new cases and 26 deaths in the 24 hours to 16 October. [6]

Why it matters. The outbreak is the worst in Congo's history, and health teams now face a province on the border with another country. [6] Most new cases are still in Ituri, in the east, which had 44 of the 67. [6]

Kenya confirmed its eighth Ebola case on Sunday, Patrick Amoth, the country's director-general for health, said. [4] The patient is a 49-year-old man who cleaned plates and bed linen for patients, not a health worker. [4] He had probably been exposed to Kenya's first case, a man who came from Congo and died in a Nairobi hospital on 5 October. [4] He fell ill on Saturday while already in quarantine, and his test came back positive on Sunday. [4] That day 38 people were tested, and he was the only positive. [4]

Why it matters. All of Kenya's cases are the Bundibugyo kind of Ebola, which has no approved vaccine or treatment. [5] Kenya's health ministry says there is no sign of the virus spreading in the wider public, and the second and third patients are stable and responding to treatment. [5]

Dexcom, a US maker of glucose monitors, said on 14 October that the New England Journal of Medicine had published its CONNECT trial of a skin sensor that reads blood sugar all day. [7] The trial screened 440 adults with type 2 diabetes who do not use insulin, at 22 US clinics. [7] Over 26 weeks, A1C, a measure of average blood sugar, fell 1.6 points from 8.8% in people wearing the monitor. That was 0.9 points more than with routine care, and 97% were still wearing the monitor at the end. [7]

Why it matters. Millions of people with type 2 diabetes do not use insulin, Dexcom says, and it is asking doctors and insurers to back monitors for them. [7] These figures come from the company's own announcement; the results were first shown at a diabetes meeting in June. [7]

Gabon, a country in central Africa, is trying to control the trade in iboga, a rainforest shrub, the Guardian reported on 18 October. [9] Its root bark is used in Bwiti, a spiritual tradition, and contains ibogaine, a drug being studied for addiction. [9] A decree in May made traditional knowledge of iboga national heritage and requires firms that sell it to share the benefits with Gabon. [9] On 18 September ministers adopted a draft ban on exporting iboga in any form. [9]

Why it matters. Interest grew after a US presidential order on 18 April named ibogaine, and Texas granted $50 million for a trial. [9] Ibogaine can also be made from a related tree, Voacanga africana, so a ban on iboga does not control the drug itself. [9]

Researchers in New York, the Netherlands and Austria found patterns of antibodies in blood that appeared up to ten years before people were diagnosed with inflammatory bowel disease. [8] That is a long-lasting inflammation of the gut, mainly Crohn's disease and ulcerative colitis. [8] The team tested 2,000 blood samples from 500 US military personnel; 400 later got one of the two diseases. [8] People who got Crohn's more often had antibodies against Epstein-Barr, the virus behind glandular fever. [8]

Why it matters. The study, in the journal Gut, shows a link, not a cause, and it still has to be checked in other groups of people. [8] An outside expert, James Lindsay of Barts Health, called it a research tool that is not ready for the clinic. [8]

Shares in Liquidia, a US drug company, rose about 25% in the five days after it settled six lawsuits with United Therapeutics, GEN reported. [11] They had fallen 57% on 30 September, after a US court found Liquidia's lung drug Yutrepia broke one of United's patents. [11] Liquidia pays $380.7 million and stops promoting Yutrepia to new patients with high lung blood pressure linked to scarred lungs. [11] It said Yutrepia's sales reached $222.7 million in July to September. [11]

Why it matters. Liquidia keeps selling the drug for the other main use, high blood pressure in the lungs' arteries, which already makes about 60% of its sales. [11] United Therapeutics sells Tyvaso, a rival inhaled drug, and its shares fell 3% that week. [11]

Diasome, a small company in New Orleans, says it is finishing plans for a final-stage trial of its insulin for type 1 diabetes, GEN reported. [10] Its insulin is wrapped in tiny fat particles that steer it to the liver, which controls how much sugar the body stores. [10] In a 25-week trial in 226 adults, it kept blood sugar about as well as a standard insulin. [10] Severe low blood sugar happened in five people on the standard insulin and none on Diasome's. [10]

Why it matters. Robert Geho, Diasome's chief executive, calls dangerously low blood sugar the biggest limit on how much insulin people can take safely. [10] The gap of five to none was not strong enough to rule out chance, and the company still has to discuss its final trial with the FDA. [10]

India will cut the prices of as many as 137 cancer drugs by 70%, its Ministry of Chemicals and Fertilizers said on Saturday. [12] The list includes immunotherapy drugs, which help the body's own defences attack a cancer, used for more than 20 kinds of cancer. [12] It also covers medicines for breast, prostate, colon, ovarian and cervical cancer. [12] The new prices start on 9 November, and wholesalers and shops may keep no more than 30% of the most a shop may charge. [12]

Why it matters. It widens the price controls India set in 2019 on 42 cancer drugs, which cut their prices by as much as 90%. [12] Reuters reports that the aim is to make cancer treatment more affordable. [12]

South Africa's health department confirmed four new mpox cases, taking the country's total since 1 January to 26. [13] Mpox is a virus that causes a rash and fever, and it spreads through close skin-to-skin contact. [13] Of the 26 cases, 18 were in the Western Cape, and 16 of those were caught inside the country. [13] Of 17 cases tested for their type, 13 were clade Ib and four clade IIb, two branches of the virus. [13]

Why it matters. All but one of the 26 patients are men, aged 23 to 50. [13] The department says it is tracing contacts with the National Institute for Communicable Diseases, and that mpox can be prevented and treated. [13]