Biotech, in brief

The US health department said on Wednesday that pharmacies may now make 6 untested peptide injections. [4]

Peptides are short chains of amino acids, the building blocks of proteins. [1]

The FDA, the US drug regulator, has never approved these 6 as safe and effective. [2]

The people who inject these peptides carry the risk, and evidence on their safety is thin. [3]

A public comment period of 2 weeks follows once the plan is formally published. [4]

The department says it may revisit the policy if safety or quality problems appear. [1]

This week the US health secretary, Robert F.

Kennedy Jr, let pharmacies make six untested peptide injections that most FDA scientists had opposed, through a policy written in his own office. [2][4]

Calling the peptide policy a matter of "patient choice and freedom" turns a question about evidence into a question about liberty, so objecting sounds like taking something away. [5]

They may now sell six peptides that were illegal for them to make, without the FDA's drug review. [3]

They take products whose safety the FDA's own scientists said was unproven. [2][3]

How many people the six compounded peptides will help or harm.

None has passed an FDA review, and pharmacies have only now been told to report side effects. [2][6]

Whether pharmacies can make enough to pull buyers off the grey market.

Only small pharmacies are covered, and one pharmacy boss says they will not meet demand. [3]

Eli Lilly, a big US drugmaker, said its experimental weekly shot retatrutide beat Novo's Ozempic. [9]

The final trial gave almost 1,300 adults with type 2 diabetes the drugs for 80 weeks. [7]

Average blood sugar readings fell 2.2 points on retatrutide and 1.8 points on Ozempic. [7]

People on the top dose lost 20.9% of their weight, against 9.4% on Ozempic. [8]

More people quit for side effects: 7.9% on the top dose, 2.7% on Ozempic. [8]

Lilly plans to ask the FDA to approve the drug early in 2027. [7]

Full results have not yet been shown at a meeting or in a journal. [8]

One analyst expects yearly sales of $15 billion in 2032, when Ozempic's US patent ends. [9]

One analyst says the trial win justifies a premium price for retatrutide before Ozempic's US patent ends in 2032. [9]

Its Ozempic lost a head-to-head trial on both blood sugar and weight. [7]

How well retatrutide does in full, and over years.

Lilly has given only headline numbers from an open-label trial, where patients knew which drug they got. Full results are still to be shown. [7][8]

In July, US health officials planned to ban a strong opioid chemical made from kratom. [10]

Kratom is a Southeast Asian plant sold in US shops as an energy booster and painkiller. [10]

Officials said the ban was crucial "to avoid an imminent hazard to public safety". [10]

On 9 October, Kennedy said his department would allow some levels of the chemical. [10]

The New York Times says the change followed lobbying by a big kratom distributor's manager. [10]

That manager, David Gabbay, and his wife gave about $2.9 million to Republicans this year. [10]

He faces wrongful-death lawsuits over products found to contain the chemical. [10]

The Times says allowing some of it in "natural" products could help him in court. [10]

Why the US health secretary can overrule his own drug experts

US law hands drug decisions to the health secretary

He passes them to the FDA, whose scientists weigh the evidence

That hand-over is a habit, not a rule he must keep

So he can take a decision back and sign it himself

The scientists' view then becomes advice he can set aside

FDA scientists decide most US drug questions only because the health secretary lets them. When he wants a different answer, he can write it himself.

On the peptides, the people who review drug evidence and the person who signed the policy came down on opposite sides.

Officials called a ban on a strong kratom chemical urgent in July, and the health secretary loosened it himself in October.

The department's leaders, not outside researchers, chose what the overdose numbers were said to mean, and credited their own administration.

An overruled decision can still be right, and expert advice can be wrong; what changes is who answers for it if it goes badly.

People who inject a peptide this winter, pharmacists deciding whether to make one, and FDA reviewers who said no are all inside one decision.

Allowing some of the chemical in natural products could help him against wrongful-death lawsuits, the New York Times reports. [10]

Whether lobbying changed the kratom decision.

The New York Times reports the change followed a distributor's lobbying. Kennedy says his department followed the science. [10]

The FDA has proposed taking Tavneos, a drug for a rare blood-vessel disease, off the market. [11]

In the disease, the immune system attacks blood vessels, often damaging the kidneys and lungs. [11]

The FDA believes staff at its original maker, ChemoCentryx, manipulated data in the key trial. [11]

The FDA also cites reports of serious, sometimes fatal, liver injury. [11]

Amgen, which bought ChemoCentryx and sells Tavneos for $220,000 a year, says it works. [11]

The European Union has pulled it, and Britain says it will too. [11]

Patients may lose a drug meant to cut their need for steroids. [11]

A court hearing on 29 October weighs a $69 million settlement with the maker's investors. [11]

The drug costs $220,000 a year and sold nearly half a billion dollars in 2025. [11]

They may lose a drug meant to spare them steroids if the FDA pulls it. [11]

Whether Tavneos works at all.

The FDA believes the key trial's data were manipulated, while Amgen and one university registry study say the drug works. [11]

From Thursday, the US will block goods from BGI Group, a big Chinese gene-sequencing company. [12]

The ban also covers two companies it controls, BGI Genomics and MGI Tech. [12]

US officials say the firms use or support forced labour in Xinjiang, in China's far west. [12]

They point to the firms' genetic testing in Xinjiang, home to the persecuted Uyghur people. [12]

BGI said it "has not engaged in any form of forced labor". [12]

China's commerce ministry called the ban "political manipulation". [12]

The ban lands weeks before Xi Jinping and Donald Trump are due to meet in Shenzhen. [12]

Last week the US Treasury also proposed limits on US investment in Chinese biotech. [12]

Africa's Ebola outbreak has reached 10,091 cases, and 10,060 of them are in Congo. [13]

Congo counts 4,887 deaths, close to half of everyone infected. [14]

This strain, called Bundibugyo, has no approved vaccine or medicine. [14]

Cases have also been found in Uganda, Kenya and Nigeria. [13]

Jean Kaseya, head of Africa's disease agency, said it could reach Britain and other countries. [13]

He said "We want all countries to know that they are not safe" without preparation. [13]

Vaccine trials against this strain should report in three to six months, he said. [13]

Health workers in Congo have struck over unpaid wages and missing protective gear. [13]

Unpaid wages and missing protective gear have led to strikes. [13]

Whether any vaccine protects against the Bundibugyo strain of Ebola.

Trials have only just begun, and Africa CDC expects results in three to six months. [13][14]

US overdose deaths fell 27% in 2024, and early figures for 2025 show another drop. [15]

On Tuesday, the US health department credited both Trump administrations for the fall. [15]

It cited two new reports written by its own officials and staff. [15]

Epidemiologist Nabarun Dasgupta said the fall began years ago, with many states peaking during Covid. [15]

He gives credit to Trump's first term, Biden's term and Trump's second. [15]

His report points to changes in the drug supply, drug users and harm-reduction work. [15]

Experts warn planned cuts to Medicaid, US public health cover for the poor, could undo progress. [15]

The department's leaders, not outside researchers, chose what the overdose numbers were said to mean, and credited their own administration.

The same department had loosened a kratom ban it called urgent in July, after a distributor's lobbying, and credited its own administration for fewer overdose deaths. [10][15]

US overdose deaths fell 27% in 2024, and early figures for 2025 show another drop.

Scientists compared 189 bowel cancer tumours from patients aged 29 to over 90. [16]

Of those, 54 came from people under 50 and 135 from older patients. [18]

Bowel cancer is now the leading cause of cancer death in US adults under 50. [16]

Younger patients' tumours held more connective-tissue cells than cancer cells. [16]

Researcher Ana Anderson said these cells "can form a shield that protects the tumor". [17]

They can calm the immune system and block chemotherapy drugs from reaching cancer cells. [16]

The team could not say why young people's tumours look different. [17]

Young patients, though otherwise healthy, often do badly on standard treatment. [16]

Why bowel cancer is rising in people under 50.

The tumour study found how young patients' cancers differ, but not what causes them. [17]

A trial called PHERGain tested skipping chemotherapy for some women with HER2-positive early breast cancer. [19]

These tumours make too much of a growth protein, HER2, and are 15-20% of breast cancers. [19]

One group got two targeted drugs, and a scan after two rounds checked the response. [19]

Only women whose tumours did not respond, or were not gone at surgery, then had chemotherapy. [19]

After five years, 89.5% of the 267 women in that group were alive without invasive cancer. [19]

Among 86 who responded and never had chemotherapy, the figure was 92.4%. [19]

The authors warn the 92.4% group was not chosen at random, so it cannot prove cause. [19]

Tumour DNA found in the blood flagged women more likely to relapse. [19]

In a breast cancer trial, 92.4% of the 86 women whose tumours were gone by surgery after two targeted drugs, and who never had chemotherapy, were alive without invasive cancer five years later.

GSK, Britain's second-biggest drugmaker, said vaccine sales fell 2% to 2.6 billion pounds last quarter. [20]

Sales of Arexvy, its vaccine against the lung virus RSV, fell 24%. [20]

Its shingles vaccine Shingrix fell 5%, while meningitis vaccine sales rose 12%. [20]

Chief executive Luke Miels said Arexvy still leads Pfizer's rival vaccine on market share. [20]

GSK is cutting about 1,200 vaccine jobs in Belgium as it automates. [20]

Studies of Shingrix against heart attacks and dementia report in 2027 and 2029. [20]

"We're trying to demonstrate causation," Miels said of the dementia link. [20]

Scientists deliberately infected 45 healthy adults with a weakened dengue virus. [21]

Dengue, or break-bone fever, infects an estimated 100 to 400 million people a year. [21]

A second infection is often worse, because old antibodies can help the virus grow. [21]

The volunteers had none, one, or more than one past dengue infection. [21]

Those whose antibodies helped the virus most had the most virus in their blood. [21]

Antibodies against one viral protein, called NS1, went with less virus and more balanced responses. [21]

The work could guide vaccines that protect against all 4 dengue strains. [21]

It was a small early-stage trial, using a weakened virus in a controlled setting. [21]

Epic Systems, which sells hospital record software, holds data on some 8 in 10 Americans. [22]

A STAT investigation says Epic selectively blocks rival software from reaching that data. [22]

Executives at 12 companies on Epic's own app store said it undercut their businesses. [22]

They cite denied data links, negative rumours and high fees for access. [22]

Epic says it offers more data connections than US law requires. [22]

The company takes in more than $6.5 billion a year. [22]

Some hospital executives say this keeps the most useful new software out of hospitals. [22]

Twelve on Epic's own app store say Epic undercut them by denying data access or charging high fees. [22]

Whether Epic's limits on rival apps break any law.

STAT's sources say Epic blocks rivals, and Epic says it gives more data access than US law requires. [22]

Flagship Pioneering, which creates biotech start-ups, merged three of them into Etcelera Therapeutics. [23]

The three had raised $374 million from investors before the merger. [23]

Etcelera says its AI tools can help predict which drugs might fail in human tests. [23]

It uses "perturbation data", showing how a cell reacts when a gene is silenced. [23]

Its first drug programmes are for blood disorders such as myelofibrosis. [23]

No new money was announced with the launch. [23]

AI drug companies have struggled on stock markets, and critics say some overstate AI. [23]

Astellas Pharma bought an option on DAX-044, an early cancer drug from Australian biotech Audax. [24]

An option lets Astellas decide later whether to license the drug. [24]

The drug is built to carry IL-12, an immune protein, into cancer cells. [24]

Astellas will pay $285 million upfront and in option fees. [24]

Another $1.05 billion could follow if the drug hits set goals. [24]

Human testing should begin in 2027, Astellas said. [24]

Most of the money is paid only if the drug meets set goals. [24]

It pays $285 million now, and the $1.05 billion more only if the drug meets set goals. [24]

Fierce Biotech, a trade news site, counts 10 biotech closures so far in 2026. [25]

That compares with 16 in 2025 and 27 in 2023. [25]

Job cuts have also settled down after reaching worrying heights in 2025. [25]

Investors still favour firms with trial data over riskier early bets. [25]

Adecto, a Boston cancer start-up founded in 2014, closed after failing to raise money. [25]

Its chief, Nora Mineva, said the company "simply ran out of financial runway". [25]

Each closure leaves its staff hunting for work in a tight job market. [25]

Fierce Biotech counts 10 biotech companies shut down so far this year, against 16 in 2025 and 27 in 2023.

The Western Isles board prescribes weight-loss and diabetes jabs at nearly 3 times Scotland's next-highest rate. [26]

The figures come from a report by the ABPI, which represents drug companies. [26]

Shetland, another island board, had the lowest rate in Scotland. [26]

The authors note that a few prescriptions swing the rate for small island populations. [26]

The Western Isles say they set up a route to these drugs earlier than others. [26]

Fewer than 800 Scots had received the jabs for weight loss so far. [26]

A doctors' body called the lack of access "discriminatory against obese people". [26]

Danish-led scientists found ageing muscles lose cardiolipin, a fat that keeps cells' energy makers working. [27]

Lowering it in young mice switched their muscles to slower fibres, as in old age. [27]

The switch seems to protect muscle cells from damage, not to be a failure. [27]

"The fiber switch is not the muscle failing," said lead author Fabian Finger. [27]

Restoring cardiolipin to about two-thirds of normal began reversing muscle wasting in mice. [27]

Giving the mice antioxidants made their muscles worse, not better. [27]

The key experiments were in mice; human samples only showed cardiolipin falls with age. [27]

A drug that steadies cardiolipin, elamipretide, is already approved for one rare disease. [27]

University of Utah scientists found how the heart burns sugar and lactate at the same time. [28]

In most tissues, burning more of one fuel makes it harder to burn the other. [28]

A molecule called MCT1 carries lactate into the cell's energy makers, keeping the two apart. [28]

Mice without working MCT1 developed heart failure faster when their hearts were stressed. [28]

"This appears to be a critical backup system for heart function," said Gregory Ducker. [28]

The work was in mice, though MCT1 also sits in human heart cells. [28]

The team hopes future drugs could help failing hearts use lactate better. [28]

Rockefeller University researchers redesigned a microscope to watch nerve cells deep in living mouse brains. [29]

Light scatters in brain tissue, which makes deep cells hard to see. [29]

The new system records single cells about 2 mm down, without removing tissue above. [29]