Biotech, in brief

A person in Washington state, in the US, has died of bird flu caught from infected dairy cows. [1]

It is the first bird flu death in the US in a year. [1]

The person lived in Yakima County and had other health problems. [2] They were taken to hospital very ill, and died on Sunday, 1 November. [2]

The CDC says the risk to the general public is low. [1]

Disease trackers call this exposure: being close to a germ. [1] The more animals carry bird flu, the more chances people get to catch it. [1]

Yakima has 33 infected herds. [2] All 3 people infected there caught it from cows at a dairy. [1]

A child who sits beside more coughing classmates is more likely to catch a cold.

Yakima County officials released no other details about the person who died. [1]

Their work puts them close to infected cows, which officials say makes them the people most at risk. [2]

Whether more people in Yakima County will catch bird flu.

The third case there was found only on Sunday, and health workers are still finding and watching the close contacts of all 3. [2]

The FDA, the US drug regulator, gave a tentative approval to a cheap copy of an HIV prevention shot. [3]

The shot, lenacapavir, is given once every 6 months and protects almost completely against catching HIV. [3]

Gilead Sciences, which sells the original in the US as Yeztugo, won FDA approval for it last year. [3]

The copy is made by Dr Reddy's, one of the world's biggest makers of generic, or copied, medicines. [3]

Dr Reddy's plans to start shipping the shot next month. [3] Global health groups have pushed to get it to poorer countries as fast as possible. [3]

It will cost $40 a person a year, about the same as daily HIV prevention pills. [3]

The approval is a key step to widening use in dozens of low- and middle-income countries, STAT reports. [3]

AP reports the copy is meant for 120 low- and middle-income countries. [30]

The FDA calls an approval tentative when a copy meets its standards but the original is still under patent. [30]

So Dr Reddy's copy cannot be sold in the US. [30] But FDA approval can speed approval in many other countries. [30]

A finished film can still wait for the date it is allowed into cinemas.

Carolyn Amole, of the Clinton Health Access Initiative, says the money to buy it for everyone is not there yet. [30]

Why the FDA can stop one trial and move its own deadline

A new drug must pass separate checks: safe to test, works, made right

The FDA answers each check when it comes up, not all at the end

A worry about one trial stops only that trial: a partial hold

Major new data during a review moves the decision date by 3 months

So each answer moves a company's money and a patient's wait

The FDA can stop one trial of a drug while its other trials go on. It can also move its own decision date when new data arrives during a review.

How far three companies' shares fell after an FDA answer in the past few days. Agios fell nearly 18%.

The FDA stopped only the US trial that would enrol children, because its worry was about young bodies, and Bright Minds' running trials go on.

Agios sent safety data the FDA had asked for, the FDA counted it a major change, and the decision date moved 3 months to 1 February 2027.

The FDA accepted uniQure's application and set 1 May, but it still plans to ask outside experts before it decides.

The FDA gave Dr Reddy's copy a tentative approval, a step short of a full one, and that step opens shipments to poorer countries.

Many of these answers stay private: Bright Minds learned the scope of its hold from an email, and the FDA's formal letter has not been sent yet.

A US child with severe seizures, a sickle cell patient waiting until February and a Huntington's family waiting until May all depend on one agency's calendar.

It becomes a supplier of a shot that global health groups are pushing to get into poorer countries quickly. [3]

How fast the cheap HIV shot will reach the people who need it.

The part of STAT's report we could read gives no countries and no numbers for the first shipments. [3]

Dr Reddy's, one of the world's biggest makers of copied medicines, won a tentative US approval for its copy of lenacapavir, an HIV prevention shot given every 6 months. It plans to start shipping next month at $40 a person a year.

The FDA will decide by 1 May whether to approve uniQure's gene treatment for Huntington's disease. [6]

Huntington's is an inherited brain disease that kills, and no treatment has yet been shown to slow it. [6]

The treatment is given in 1 dose, by brain surgery, into a deep part of the brain called the striatum. [6]

In November 2025 the FDA told uniQure its data might not be enough for approval. [6]

The agency changed course after Vinay Prasad, the official who opposed the application, resigned this year. [6]

The FDA also plans to ask outside experts to discuss it at a meeting, with no date set yet. [6]

uniQure's chief executive said Huntington's families have "waited generations for a treatment that changes the course of this devastating disease". [6]

Geneticists call this gene silencing: stopping a gene from making its protein. [6]

The harmful protein in Huntington's comes from the huntingtin gene. [6] So silencing that gene cuts the protein at its source. [6]

Turning off a dripping tap works better than mopping the floor again and again.

After 4 years, the trial's main measure showed a 44% slowing that was not statistically clear. [6] A measure of everyday function showed 61%. [6]

uniQure plans to start screening patients for a US trial of about 200 people by the end of 2026. [6]

The FDA accepted uniQure's application and set 1 May, but it still plans to ask outside experts before it decides.

The FDA is reviewing its treatment under priority review, which brings a decision sooner. [6]

When outside experts will discuss uniQure's Huntington's treatment, and what they will say.

uniQure says only that the FDA will tell it when a meeting is set. [6]

The FDA agreed to review uniQure's gene treatment for Huntington's disease, an inherited brain disease that no treatment has yet been shown to slow. It will decide by 1 May.

The FDA moved its decision on Agios's sickle cell pill, mitapivat, from 1 November to 1 February 2027. [7]

People with sickle cell disease, an inherited blood disorder, suffer painful attacks called pain crises. [7]

The FDA asked for more safety data, to decide whether the pill needs a special safety plan. [7]

Agios sent about 9 months of new safety data on 19 October, which the FDA counted as a major change. [7]

In the main trial, 41% of 138 patients on the pill had more haemoglobin, the oxygen carrier in blood. [7] Only 3% of 69 on a dummy pill did. [7]

Agios's shares fell nearly 18% on Friday, from $37.23 to $30.55. [7]

The pill is already sold for thalassaemia, another blood disorder, under the name Aqvesme. [7]

Investors worry the delay shrinks Agios's lead over Novo Nordisk, which plans to file a rival drug this quarter. [7]

Under PDUFA, a US law on drug review fees, the FDA sets a date to decide each drug. [7]

When a company sends major new data during a review, the FDA can add 3 months. [7]

Hand your teacher extra pages the night before marking, and your mark comes back later.

The pill did not clearly cut pain crises: 2.6 a year on it against 3.1 on a dummy pill. [7]

Agios sent safety data the FDA had asked for, the FDA counted it a major change, and the decision date moved 3 months to 1 February 2027.

Its launch for sickle cell could slip by about 3 months, an analyst at Leerink Partners says. [7]

The FDA has stopped a planned US trial of BMB-101, a seizure drug from Bright Minds Biosciences. [8]

The trial was for severe epilepsies called developmental and epileptic encephalopathies, and would have enrolled children. [8]

The FDA pointed to harm seen in mice, and too little data on how the drug acts in young bodies. [8]

The company announced the hold on Monday. [9] Its shares fell 49% before trading opened, to $28. [8]

Earlier, 11 patients on the drug had 73.1% fewer seizures over 3 months. [8] Days later, in January, Bright Minds raised $175 million. [8]

Bright Minds says trials already running are not affected, so only the new US trial waits. [8]

Drug regulators call this a partial clinical hold: one trial is stopped while the drug's others go on. [8]

Here the worry was about young bodies, so the trial that would enrol children was the one stopped. [8]

A referee can send one player off while the match carries on.

Bright Minds' account rests on an FDA email; the FDA's formal letter is due within 30 days. [8]

The FDA stopped only the US trial that would enrol children, because its worry was about young bodies, and Bright Minds' running trials go on.

The trial that would have given them BMB-101 cannot start until the FDA lifts the hold, and Bright Minds cannot say when. [8]

Whether the harm seen in mice was caused by BMB-101.

Bright Minds says the finding was by chance, and the FDA has not published its own reasoning. [8]

Karyopharm Therapeutics, a US maker of a blood cancer drug, filed for bankruptcy on Monday so it can sell itself. [11]

It used Chapter 11, a US court process that shields a company from its lenders while it reorganises. [11]

Ayrmid, an Irish company with 2 approved blood-disease treatments, will be the first bidder in a court-run auction. [10]

In 2025 Karyopharm sold about $115 million of its drug, Xpovio, and lost $196 million. [11]

In May the FDA withdrew Xpovio's fast approval for a type of lymphoma, a blood cancer. [10] In July it failed a big trial in womb cancer. [10]

Its shares fell 83% to 11 cents, valuing the whole company at $2.5 million. [11]

Karyopharm says the process will not disrupt its work or its support for patients. [12]

Ayrmid's chief executive, Joe Wiley, said it wants to "continue delivering important therapies to patients in need". [11]

Investors call the months a company's cash will last its runway. [10]

Karyopharm spent more than Xpovio brought in, and early this year it said its cash would last only to mid-2026. [11]

Pocket money that runs out before Friday means borrowing, or selling something.

The sale is expected to close in early 2027. [11]

As first bidder it sets the starting price for Xpovio, a cancer drug already on sale, which it can add to its own blood-disease medicines. [10]

How much Ayrmid will pay for Karyopharm.

The terms of its offer were not disclosed, and other bidders can still join the court-run auction. [10]

STAT, a US health news site, spent 8 months looking into a fertility treatment sold to women over 40. [13]

The treatment, mitochondrial replacement or MRT, puts a woman's DNA into a donor's egg with its own centre removed. [13]

Mitochondria are the tiny energy factories in cells, and the donor eggs' are younger. [13]

MRT was first built to stop rare mitochondrial diseases passing from mothers to children. [13]

It is illegal in the US. [13] IFG, a company near Chicago, connects women to clinics abroad, such as one in Albania. [13]

A Dutch woman called Wendy paid more than $30,000. [13] Her pregnancy test came back negative. [13]

The average age of IFG's MRT patients rose from 39.2 in 2022 to 45.6 in 2025. [13]

Women paid tens of thousands of dollars for a treatment with no published proof it helps them. [13]

Research seen by STAT shows older women's infertility mostly has causes other than worn-out mitochondria. [13]

So giving an egg younger mitochondria leaves those other causes in place, and MRT fails for most older women. [13]

A new battery will not fix a phone whose screen is broken.

IFG says it is not a clinic and promised no one a pregnancy. [13] After STAT's questions, it removed MRT from its website. [13]

STAT also got unpublished data from a Ukrainian clinic that once did the most MRT. [14] Its reporter calls the results "the strongest refutation" of MRT for age-related infertility. [14]

Outside the FDA's reach, a US company, IFG, sold older women an unproven fertility treatment through clinics abroad, and stopped advertising it only after STAT's questions. [13]

One woman's contract with IFG cost $20,000 before medicines and donor eggs, for a treatment that research shows fails for most older women. [13]

How many babies have been born after MRT.

Industry insiders estimate up to 200, IFG claimed 34 by February 2025, and IFG declined to give newer figures. [13]

Congo's Ebola outbreak had killed 5,372 people by Friday, figures released on Sunday show. [15]

Just over half of the people diagnosed with it die: 51.6%. [15]

Congo had 10,414 confirmed cases by 30 October. [15]

It is caused by Bundibugyo, a rare kind of Ebola with no approved vaccine or medicine. [16]

On day 187 of this outbreak there were 10,060 cases. [19] West Africa's 2014 outbreak had 544 by day 186. [19]

Kenya and Uganda have each had 2 deaths, Africa CDC, the continent's health agency, says. [16]

The outbreak has spread beyond Congo, with cases in Uganda, Kenya and Nigeria. [15]

Epidemiologists count an outbreak as under control when 95% of new cases come from known contacts. [19]

In Congo about 80% of new cases come from chains of spread nobody was tracking. [15]

A teacher can stop a cold spreading only if she knows who sat next to the sick child.

Part of the latest jump in deaths came from correcting old records, not from a single bad day. [15]

Many of the sick never reach care: at least half of the deaths were in people never admitted to a treatment centre, AP reports. [19]

How many Ebola infections in Congo nobody has found.

The counts include only confirmed cases, and tracers have lost track of most chains of spread. [15]

2 people suspected of having Ebola in north-eastern Nigeria tested negative twice, Nigeria's disease agency said on Monday. [17]

Nigeria confirmed its first Ebola case in more than a decade on 23 October. [17]

That case is a 42-year-old Swiss woman who had been to Uganda. [17] She and her husband went home to Switzerland on 26 October. [17]

Nigeria is Africa's most populous country. [16] Both suspected cases were in its north-east, away from the first case in Abuja, the capital. [17]

Outbreak teams call this isolation and contact listing: keep a possible case apart, and list everyone they met. [17]

Nigeria kept the 2 people apart and listed their contacts until 2 rounds of tests came back. [17]

A child with a rash stays home until the doctor says it is not catching.

Both results were negative, so Nigeria still has just 1 confirmed Ebola case. [17]

The Independent Panel for Pandemic Preparedness and Response says the world is ignoring known disease threats such as mpox. [18]

Mpox, first found in people 50 years ago in West Africa, has spread to more than 82 countries. [18]

There were more than 14,000 confirmed cases and 50 deaths in the first 9 months of 2026. [18]

A target to vaccinate 6.4 million people across Africa was missed by far. [18]

Helen Clark, a panel member who has held senior UN roles, said preventable health emergencies are a sign of failure. [18]

The panel says weak local health care and missed warning signs let viruses spread beyond where they began. [18]

Why Africa fell so far short of its mpox vaccination target.

The panel blames too little preparation and investment, but the report as described gives no count of how many people were vaccinated. [18]

Pennsylvania's measles outbreak has reached 1,398 cases, the state health department says. [20]

Health workers have given 150,000 doses of MMR, the measles, mumps and rubella vaccine, since 1 August. [20]

The outbreak centres on Lancaster County's Amish, a religious group that keeps much of modern life away. [20]

A study found fewer than a third of Amish residents had the MMR vaccine. [20]

Almost two-thirds of Pennsylvania's cases are adults, the reverse of how measles usually spreads. [20]

US health secretary Robert Kennedy Jr says Governor Josh Shapiro's team politicised the outbreak. [20] Shapiro blames Kennedy for stoking vaccine doubt. [20]

In New York, 3 Amish schools face fines of $2,000 for each unvaccinated pupil. [20]

All 5 people who died in Pennsylvania were unvaccinated by choice or too young for the vaccine, a newspaper reported. [20]

Pennsylvania counts 5 measles deaths. [20] The CDC lists only 3 deaths across the whole US this year, out of 4,588 cases. [20]

How many Amish people in Lancaster County are vaccinated against measles.

The Amish are a religious group, so governments are not allowed to track it, says Steven Nolt, a historian of the Amish. [20]

Pennsylvania has given 150,000 doses of the measles vaccine since 1 August, more than 50,000 of them in October.

The FDA published final guidance, its official advice, for companies that make cell and gene therapies. [21]

It explains how to prove each batch is potent, strong enough to do its job, before a patient gets it. [21]

It replaces advice the FDA gave in 2011. [21]

Many of these treatments are made for just 1 person. [21]

Karim Mikhail, who runs the FDA's centre for biological medicines, said patients deserve to know the product will work. [21]

Patients getting these treatments often have cancers or rare diseases and no other option. [21]

Drugmakers call this potency testing: checking that each batch does what the medicine is meant to do. [21]

The raw materials vary, so batches of the same treatment can differ, and each must be checked. [21]

A baker tastes each batch of dough, because no two bags of flour are quite the same.

The FDA will explain the guidance in an online session on 10 December. [21]

Squeezing the leg bones of old mice twice a week for 4 months made them live nearly 3 months longer. [22]

That is about 9 extra years for a person. [22]

The study, led from Southern Medical University, was published in late October in Cell Metabolism, a journal. [22]

Bone cells called osteocytes sense being pushed and pulled, and then release proteins that slow ageing. [22]

Mice whose osteocytes could not sense force died 105.5 days earlier than normal mice. [22]

The squeezed mice also had stronger bones, faster reflexes and sharper minds. [22]

Exercise is linked to longer lives, but scientists "have yet to figure out how exactly this works". [22] Bones may be part of the answer. [22]

Biologists call this mechanosensing: cells reacting to being pushed or pulled. [22]

A protein called PIEZO1 lets bone cells feel force. [22] With it switched off, the mice aged faster. [22]

A doorbell rings only when someone presses it.

It has not been shown in people; a Mayo Clinic expert called it a proof of concept in mice. [22]

An experimental drug, cinaciguat, cut amyloid beta in the blood of old rats by about 50% in 2 weeks. [23]

Amyloid beta is a protein that builds up in the brains of people with Alzheimer's disease. [23]

LDL, the bad cholesterol, also fell to the levels of young rats. [23]

The study, by the University of Southern California, was published in the Journal of Biological Chemistry. [23]

Drugs aimed at the brain for Alzheimer's have failed about 98% of the time in trials. [23] Reaching the liver is much easier. [23]

The liver cleans the blood through tiny holes in the cells lining its blood vessels. [23]

With age the holes shrink, so more amyloid beta stays in the blood. [23] The drug reopened them. [23]

A drain clogged with hair empties the sink more slowly.

It has only been shown in rats so far. [23]

Swiss researchers built an implant that turns extra blood sugar into a substance the body passes out in urine. [24]

In diabetic mice it kept blood sugar in check for 6 weeks, and the mice lost weight. [24]