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The U.S. Food and Drug Administration (FDA) no longer requires new drugs to be tested in animals before being approved. Thanks to a law passed in December 2022 (opens in new tab) , the agency now has the option to approve drugs that are tested in only non-animal studies, including those that use lab-grown tissues or computer models, before being tested in clinical trials with humans. 

But is that safe, and will it happen any time soon? For now, no one should expect a dramatic shift in how drug developers bring medicines to market, experts told Live Science.

“I think it’s going to be a while before this actually gets implemented in full force,” Vivek Gupta (opens in new tab) , an associate professor of industrial pharmacy at St. John’s University told Live Science. Gupta is also the scientific founder of PulmoSIM Therapeutics, a subsidiary of VeriSIM Life that develops therapies for rare and progressive respiratory diseases. 

That’s because, although promising non-animal models have recently been developed, these technologies are “still in their infancy,” Jim Newman (opens in new tab) , communications director at Americans for Medical Progress, which advocates for the use of animal research, wrote in a Feb. 1 statement (opens in new tab) . 

Related: Why do medical researchers use mice? 

Previously, the FDA typically required drugs be tested in one rodent and one nonrodent species, before they were moved into human trials, Science reported (opens in new tab) . These animal tests help reveal how drugs break down in the body, whether they reach the tissues they’re intended to target and whether they exert the intended effects on those tissues — without having harmful side effects. But they’re not perfect: more than 90% of drugs that pass initial animal tests end up being unsafe or ineffective in humans, according to a 2019 review in the journal Translational Medicine Communications (opens in new tab) .

Research groups developing alternatives to animal testing aim to find different models that capture this same information, or better yet, ones that accurately predict exactly how a drug will behave in people. 

Dr. Donald Ingber (opens in new tab) , the founding director of the Wyss Institute for Biologically Inspired Engineering at Harvard University, agreed with Gupta’s assessment that the implementation of the new law will be gradual. “It’ll still be a while, I think, before we really see the impact of this,” Ingber told Live Science.

One of the biggest hurdles will be convincing drug developers to adopt new, non-animal testing methods, he said. The companies will want to see evidence that the models show equivalent or superior performance to animal testing, and reassurance that the FDA views the tests as robust before they heavily invest in new technology. Once they do, that will provide the FDA with more evidence that these tests can replace animal testing.

“I think it’s going to happen over the next couple years, one by one, drugs including data from these models,” said Ingber, whose lab develops “organ chips” — small devices that contain living human tissues and flowing fluids that mimic the inner workings of full-size organs. These organ chips, which can be used in drug testing, are being commercialized by Emulate, a biotech company of which Ingber is a board member.

This is an example of the “Organ Chip” platform developed at the Wyss Institute and subsequently licensed to Emulate, Inc. (Image credit: Harvard’s Wyss Institute)

Still, replacing animal models with organ chips will “occur gradually,” as each system will have to be validated for a specific purpose, to show how a drug is absorbed by the colon or whether it damages heart cells, for example, Ingber wrote in his review. 

What’s more, “true validation of their use as animal replacements will require large-scale evaluation involving hundreds of devices of the same design carried out using the same protocols,” a feat that will require regulatory agencies and drug companies to work together to standardize their validation methods and performance criteria, he added.

Related: Tiny ‘hearts’ self-assemble in lab dishes and even beat like the real thing

Other promising alternatives to animal testing are organoids, or 3D clusters of lab-grown cells that can mimic key biological features of full-size organs. These organized clumps, often derived from stem cells and grown on physical scaffolding, are especially useful for observing cell- and tissue-level drug responses, as well as assessing how well drugs latch onto their molecular targets, Ingber said.

“In the same ballpark” of organoids are spheroids — simpler 3D clusters of cells that are often used to model cancerous tumors, Gupta said. Gupta, who studies lung cancer, works with spheroids grown from primary cell lines, which are populations of cells sampled directly from human patients and can only replicate a few times; that’s in contrast to so-called immortalized cell lines, which can be grown indefinitely. 

Although often more difficult to obtain than immortal cells, primary cells better capture what happens in a human patient, Gupta explained. RELATED STORIES—Fatal ‘brain-eating’ amoeba successfully treated with repurposed UTI drug

—Does medicine really expire?

—New Alzheimer’s drug slightly slows cognitive decline. Experts say it’s not a silver bullet. 

Alongside these models constructed from cells are those built using computers. For instance, scientists have built computer models to assess drug toxicity — one model, described in a 2018 report in the journal Frontiers in Physiology (opens in new tab) , predicts whether a given drug could have toxic effects on the heart. 

“As the AI-based models become more and more robust, as more and more data gets fed into them, I think they are able to provide a fairly accurate prediction,” Gupta said. Perfecting these AI-based models will be essential in getting rid of the early stage animal tests that assess how drugs get broken down in the body and interact with different tissues, he said.  

As more drug developers invest in and perfect organ chips, organoids and AI-based models the need for animal studies may gradually shrink. In the meantime, “I think the FDA will be happy to review the data,” Ingber said. “If they see data that they believe are convincing, they can use it,” he said.

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Donald Trump announces sweeping global trade tariffs – including 10% on UK imports

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Donald Trump announces sweeping global trade tariffs - including 10% on UK imports

Donald Trump has announced a 10% trade tariff on all imports from the UK – as he unleashed sweeping tariffs across the globe.

Speaking at a White House event entitled “Make America Wealthy Again”, the president held up a chart detailing the worst offenders – which also showed the new tariffs the US would be imposing.

“This is Liberation Day,” he told a cheering audience of supporters, while hitting out at foreign “cheaters”.

Follow live: Trump tariffs latest

He claimed “trillions” of dollars from the “reciprocal” levies he was imposing on others’ trade barriers would provide relief for the US taxpayer and restore US jobs and factories.

Mr Trump said the US has been “looted, pillaged, raped, plundered” by other nations.

President Donald Trump holds a signed executive order during an event to announce new tariffs in the Rose Garden of the White House, Wednesday, April 2, 2025, in Washington. (AP Photo/Evan Vucci)
Image:
Pic: AP

His first tariff announcement was a 25% duty on all car imports from midnight – 5am on Thursday, UK time.

Mr Trump confirmed the European Union would face a 20% reciprocal tariff on all other imports. China’s rate was set at 34%.

The UK’s rate of 10% was perhaps a shot across the bows over the country’s 20% VAT rate, though the president’s board suggested a 10% tariff imbalance between the two nations.

It was also confirmed that further US tariffs were planned on some individual sectors including semiconductors, pharmaceuticals and critical mineral imports.

Please use Chrome browser for a more accessible video player

Trump’s tariffs explained

The ramping up of duties promises to be painful for the global economy. Tariffs on steel and aluminium are already in effect.

The UK government signalled there would be no immediate retaliation.

Business and Trade Secretary Jonathan Reynolds said: “We will always act in the best interests of UK businesses and consumers. That’s why, throughout the last few weeks, the government has been fully focused on negotiating an economic deal with the United States that strengthens our existing fair and balanced trading relationship.

“The US is our closest ally, so our approach is to remain calm and committed to doing this deal, which we hope will mitigate the impact of what has been announced today.

“We have a range of tools at our disposal and we will not hesitate to act. We will continue to engage with UK businesses including on their assessment of the impact of any further steps we take.

“Nobody wants a trade war and our intention remains to secure a deal. But nothing is off the table and the government will do everything necessary to defend the UK’s national interest.”

Please use Chrome browser for a more accessible video player

Who showed up for Trump’s tariff address?

The EU has pledged to retaliate, which is a problem for Northern Ireland.

Should that scenario play out, the region faces the prospect of rising prices because all its imports are tied to EU rules under post-Brexit trading arrangements.

It means US goods shipped to Northern Ireland would be subject to the EU’s reprisals.

The impact of a trade war would be expected to be widely negative, with tit-for-tat tariffs risking job losses, a ramping up of prices and cooling of global trade.

Research for the Institute for Public Policy Research has suggested more than 25,000 direct jobs in the UK car manufacturing industry alone could be at risk from the tariffs on car exports to the US.

The Society of Motor Manufacturers and Traders (SMMT) had said the tariff costs could not be absorbed by manufacturers and may lead to a review of output.

The tariffs now on UK exports pose a big risk to growth and the so-called headroom Chancellor Rachel Reeves was forced to restore to the public finances at the spring statement, risking further spending cuts or tax rises ahead to meet her fiscal rules.

Read more:
What do Trump’s tariffs mean for the UK?
The rewards and risks for US as trade war intensifies

A member of the Office for Budget Responsibility (OBR), David Miles, told MPs on Tuesday that US tariffs at 20% or 25% maintained on the UK for five years would “knock out all the headroom the government currently has”.

But he added that a “very limited tariff war” that the UK stays out of could be “mildly positive”.

He said: “There’s a bit of trade that will get diverted to the UK, and some of the exports from China, for example, that would have gone to the US, they’ll be looking for a home for them in the rest of the world.

“And stuff would be available in the UK a bit cheaper than otherwise would have been. So there is one, not central scenario at all, which is very, very mildly potentially positive to the UK. All the other ones which involve the UK facing tariffs are negative, and they’re negative to very different extents.”

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Politics

‘My lawyers are ready’ for questions about corruption claims, ex-minister tells Sky News

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'My lawyers are ready' for questions about corruption claims, ex-minister tells Sky News

Tulip Siddiq has told Sky News her “lawyers are ready” to handle any formal questions about allegations she is involved in corruption in Bangladesh.

Asked whether she regrets apparent links with the Bangladeshi Awami League political party, Ms Siddiq said “why don’t you look at my legal letter and see if I have any questions to answer… [the Bangladeshi authorities] have not once contacted me and I’m waiting to hear from them”.

The London MP resigned as a Treasury minister in January after being named in several corruption inquiries in Bangladesh.

In her first public comments since leaving government, Ms Siddiq said “there’s been allegations for months on end and no one has contacted me”.

Last month, the interim leader of Bangladesh told Sky News the MP had “wealth left behind” in the country “and should be made responsible”.

Lawyers acting for Ms Siddiq wrote to the Bangladeshi Anti Corruption Commission (ACC) several weeks ago saying the allegations were “false and vexatious”.

The letter said the ACC must put questions to Ms Siddiq “by no later than 25 March 2025” or “we shall presume that there are no legitimate questions to answer”.

More on Bangladesh

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Staff from the NCA visited Bangladesh as part of initial work to support the interim government in the country.

In a post online today, the former minister said the deadline had expired and the authorities had not replied.

Sky News has approached the Bangladeshi government for comment.

The allegations against Ms Siddiq are focused on links to her aunt Sheikh Hasina – who served as the prime minister of Bangladesh for 20 years.

Ms Hasina was forced to flee the country in August following weeks of deadly protests.

She is accused of becoming an autocrat, with politically-motivated arrests, extra-judicial killings and other abuses allegedly happening on her watch. Hasina claims it’s all a political witch hunt.

Electrocuted on their genitals and mouths sewn up: Inside Bangladesh’s ‘death squad’ jails

Ms Siddiq was found to have lived in several London properties that had links back to the Awami League political party that her aunt still leads.

She referred herself to the prime minister’s standards adviser Sir Laurie Magnus who said he had “not identified evidence of improprieties” but added it was “regrettable” Ms Siddiq had not been more alert to the “potential reputational risks” of the ties to her aunt.

Ms Siddiq said continuing in her role would be “a distraction” for the government but insisted she had done nothing wrong.

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World

Donald Trump announces sweeping global trade tariffs – including 10% on UK imports

Published

on

By

Donald Trump announces sweeping global trade tariffs - including 10% on UK imports

Donald Trump has announced a 10% trade tariff on all imports from the UK – as he unleashed sweeping tariffs across the globe.

Speaking at a White House event entitled “Make America Wealthy Again”, the president held up a chart detailing the worst offenders – which also showed the new tariffs the US would be imposing.

“This is Liberation Day,” he told a cheering audience of supporters, while hitting out at foreign “cheaters”.

Follow live: Trump tariffs latest

He claimed “trillions” of dollars from the “reciprocal” levies he was imposing on others’ trade barriers would provide relief for the US taxpayer and restore US jobs and factories.

Mr Trump said the US has been “looted, pillaged, raped, plundered” by other nations.

President Donald Trump holds a signed executive order during an event to announce new tariffs in the Rose Garden of the White House, Wednesday, April 2, 2025, in Washington. (AP Photo/Evan Vucci)
Image:
Pic: AP

His first tariff announcement was a 25% duty on all car imports from midnight – 5am on Thursday, UK time.

Mr Trump confirmed the European Union would face a 20% reciprocal tariff on all other imports. China’s rate was set at 34%.

The UK’s rate of 10% was perhaps a shot across the bows over the country’s 20% VAT rate, though the president’s board suggested a 10% tariff imbalance between the two nations.

It was also confirmed that further US tariffs were planned on some individual sectors including semiconductors, pharmaceuticals and critical mineral imports.

Please use Chrome browser for a more accessible video player

Trump’s tariffs explained

The ramping up of duties promises to be painful for the global economy. Tariffs on steel and aluminium are already in effect.

The UK government signalled there would be no immediate retaliation.

Business and Trade Secretary Jonathan Reynolds said: “We will always act in the best interests of UK businesses and consumers. That’s why, throughout the last few weeks, the government has been fully focused on negotiating an economic deal with the United States that strengthens our existing fair and balanced trading relationship.

“The US is our closest ally, so our approach is to remain calm and committed to doing this deal, which we hope will mitigate the impact of what has been announced today.

“We have a range of tools at our disposal and we will not hesitate to act. We will continue to engage with UK businesses including on their assessment of the impact of any further steps we take.

“Nobody wants a trade war and our intention remains to secure a deal. But nothing is off the table and the government will do everything necessary to defend the UK’s national interest.”

Please use Chrome browser for a more accessible video player

Who showed up for Trump’s tariff address?

The EU has pledged to retaliate, which is a problem for Northern Ireland.

Should that scenario play out, the region faces the prospect of rising prices because all its imports are tied to EU rules under post-Brexit trading arrangements.

It means US goods shipped to Northern Ireland would be subject to the EU’s reprisals.

The impact of a trade war would be expected to be widely negative, with tit-for-tat tariffs risking job losses, a ramping up of prices and cooling of global trade.

Research for the Institute for Public Policy Research has suggested more than 25,000 direct jobs in the UK car manufacturing industry alone could be at risk from the tariffs on car exports to the US.

The Society of Motor Manufacturers and Traders (SMMT) had said the tariff costs could not be absorbed by manufacturers and may lead to a review of output.

The tariffs now on UK exports pose a big risk to growth and the so-called headroom Chancellor Rachel Reeves was forced to restore to the public finances at the spring statement, risking further spending cuts or tax rises ahead to meet her fiscal rules.

Read more:
What do Trump’s tariffs mean for the UK?
The rewards and risks for US as trade war intensifies

A member of the Office for Budget Responsibility (OBR), David Miles, told MPs on Tuesday that US tariffs at 20% or 25% maintained on the UK for five years would “knock out all the headroom the government currently has”.

But he added that a “very limited tariff war” that the UK stays out of could be “mildly positive”.

He said: “There’s a bit of trade that will get diverted to the UK, and some of the exports from China, for example, that would have gone to the US, they’ll be looking for a home for them in the rest of the world.

“And stuff would be available in the UK a bit cheaper than otherwise would have been. So there is one, not central scenario at all, which is very, very mildly potentially positive to the UK. All the other ones which involve the UK facing tariffs are negative, and they’re negative to very different extents.”

Continue Reading

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