Russia warns NATO about preemptive strikes

 The Russian Foreign Ministry issued a statement on Monday regarding NATO's comments about possible "preemptive strikes" against Russia. The ministry said the remarks are an "extremely irresponsible step, demonstrating the alliance's readiness to continue escalating." It warned NATO that it should be "aware of the ensuing risks and potential consequences, including for the alliance members themselves."

NATO Military Committee Chair Giuseppe Cavo Dragone said in an interview with the Financial Times on Sunday that the alliance is considering "more aggressive" actions against Russia's hybrid warfare. He said deterrence, including retaliation and preemptive strikes, should be analyzed "deeply" if NATO comes under more pressure from Russia. However, he noted that such strikes are "further away from our normal way of thinking and behavior" and that legal and jurisdictional frameworks must be taken into account.

https://breakingthenews.net/Article/Russia-warns-NATO-about-preemptive-strikes/65273182

Burry says Tesla is 'ridiculously overvalued'

 Short seller Michael Burry just took a swipe at another richly valued stock: Tesla (TSLA).

Burry, who rose to fame shorting the housing market during the 2008 financial crisis, dubbed the EV maker as "ridiculously overvalued" in a Substack post on Sunday. Business Insider was first to report on Burry's latest missive.

His post took aim at the "tragic algebra" of stock-based compensation, and Tesla was an example. Tesla dilutes its stock by 3.6% a year, he said, and offers no buybacks.

"Tesla's market capitalization is ridiculously overvalued today and has been for a good long time," Burry said, adding that CEO Elon Musk's $1 trillion dollar pay package will dilute Tesla stock even further. Last month, Tesla shareholders approved the controversial pay package at its shareholder meeting.

Burry added another dig at Tesla's various pivots as the automaker pushed deeper into other areas of tech.

"As an aside, the Elon cult was all-in on electric cars until competition showed up, then all-in on autonomous driving until competition showed up, and now is all-in on robots — until competition shows up," Burry wrote in parentheses.

Burry did not disclose any position in Tesla stock.

Last month, the short seller took a sizable short position in both Nvidia (NVDA) and Palantir (PLTR) stock via put options, which investors typically buy if they are betting on a stock to fall.

Burry also subsequently deregistered his hedge fund, Scion Capital, and took to Substack to post his views.

Noted short seller Jim Chanos told Yahoo Finance's Laura Bratton that he also had concerns about Nvidia's use of vendor financing to boost sales, which Burry complained about as well.

Both Chanos and Burry have held Tesla short positions at points in the past.

Musk has in the past slammed short sellers of Tesla stock, most recently warning Bill Gates to close out his short position "soon."

While Burry warns about Tesla's valuation, Wall Street has become increasingly bullish.

Last week, Melius Research tabbed the EV maker a "must own" due to its autonomy efforts and as CEO Elon Musk talked up its chipmaking progress, which followed Stifel the week before upping its price target and reiterating Tesla's Buy rating, citing Tesla's strength in full self-driving (FSD) and its robotaxi service.

https://finance.yahoo.com/news/michael-burry-says-tesla-is-ridiculously-overvalued-slams-musk-pay-package-150113993.html

US announces zero tariff pharmaceutical deal with Britain

The UK and the US have agreed a deal to keep tariffs on UK pharmaceutical shipments into America at zero.


Under the agreement the UK will pay more for medicines through the NHS in return for a guarantee that US import taxes on pharmaceuticals made in the UK will remain at zero for three years.

The deal comes after US President Donald Trump threatened to raise tariffs to as high as 100% on branded drug imports.

Pharmaceuticals are one of the UK's biggest exports to the US, which is also the biggest market by far for big UK drugmakers including GSK and AstraZeneca.

Earlier this year, US president Donald Trump announced massive increases to taxes on goods imported to the country, which he argued would create jobs and boost American manufacturing.


The White House exempted pharmaceuticals from that round of tariffs, and later signed a deal with the UK to remove some trade barriers between the countries and reduce levies on most goods exported to the US to 10%. But pharmaceuticals remained a big unknown.

The White House has repeatedly threatened to raise tariffs on medicines, citing concerns about the country's reliance on medicines made overseas.

Trump has also argued that US consumers effectively subsidise medicines for other developed countries by paying premium prices for those drugs, pushing for other countries to pay more.

White House spokesman Kush Desai said the agreement with the UK was a "historic step towards ensuring that other developed countries finally pay their fair share".

Under the terms set out on Monday, the UK will increase the price threshold at which it deems new treatments to be too expensive by 25%.

The UK will also increase the overall amount the NHS spends on medicines, with a target to increase that spending from 0.3% of GDP to 0.6% of GDP over the next 10 years.

The amount drug companies must pay back to the NHS to ensure the health system does not overspend its allocated budget will be capped at 15% - last year, drug companies had to pay back more than 20%.

In exchange, UK medicine exports will be protected from tariff increases for the next three years.

Business and Trade Secretary Peter Kyle said the deal "guarantees that UK pharmaceutical exports – worth at least £5bn a year - will enter the US tariff free, protecting jobs, boosting investment and paving the way for the UK to become a global hub for life sciences."


In the 12 months to the end of September, the UK exported £11.1bn worth of medicines to the US, making up 17.4% of all goods exports in that period, according to the Department for Business and Trade.

The pressure from the US had intensified a long-running row between the industry and UK government over spending levels and approval rates.

Health Secretary Wes Streeting said in August that he was not prepared to let drug companies "rip off" the UK, after talks between the government and pharmaceutical firms over the cost of medicines broke down.

But subsequently Science Minister Sir Patrick Vallance told the BBC he accepted that the NHS needed to spend more on medicines after seeing its spending on drugs shrink as a percentage of its budget over the last 10 years.

Meanwhile, several large pharma investments in the UK have been paused or cancelled over the last 18 months while both GSK and AstraZeneca have recently announced multi-billion-dollar investments in the US.

In mid-September, British pharmaceutical giant GSK pledged to invest $30bn (£22bn) in research and manufacturing in the US over the next five years.

A week before GSK's US investment announcement, US pharmaceutical company Merck - which is called MSD in Europe – revealed it was scrapping its planned £1bn expansion of its UK operations.

Shortly after, AstraZeneca also announced it was pausing a planned £200m investment in a Cambridge research facility. In July, AstraZeneca said it would invest $50bn on medicine manufacturing and research and development in the US.

William Bain, head of trade policy at the British Chambers of Commerce, said he was pleased to see that the protections from US tariffs that UK officials had promised earlier this year had been delivered.

"This deal is a real win. It will promote exports, boost investment, and enhance UK competitiveness as a production and innovation base for world-leading medicines and treatments," he said.


The White House had launched a formal investigation into pharmaceutical imports and their effect on national security in April, taking the first step towards tariffs.

In September in a Truth Social post, Trump threatened to raise tariffs on branded drugs - a small subset of the medicine that the US imports - to 100%, but the White House did not put the plan into effect, citing negotiations with manufacturers.

In announcing the new agreement, the UK government said it was the only country in the world to have secured a zero percent tariff rate for pharmaceutical shipments.

European officials have previously said they believed their exports would be protected by terms agreed over the summer, which would cap tariffs at 15%.

US Health Secretary Robert Kennedy Jr said Americans "should not pay the world's highest drug costs for medicines they helped fund".

"This agreement with the United Kingdom strengthens the global environment for innovative medicines and brings long-overdue balance to U.S.–U.K. pharmaceutical trade," he said in a statement.

https://www.bbc.com/news/articles/cn0k520v4xro

'WHO backs use of GLP-1 therapies for obesity, warns access will remain limited'

Fewer than one in 10 people who could benefit from obesity jabs like Wegovy are able to get them, warns the World Health Organization as it releases its first guidance on the drugs.

With more than one billion people worldwide now obese, it is calling for more widespread and fairer access to GLP-1 medication.

According to projections, more than two billion will be obese by 2030 unless action is taken.

High costs, limited production capacity, and supply-chain constraints are major barriers to universal access to the injections that can help people shift significant weight, says WHO.


It has already added them to its "essential" medicines list that countries are advised to provide.

WHO director-general Tedros Adhanom Ghebreyesus said: "Our new guidance recognises that obesity is a chronic disease that can be treated with comprehensive and lifelong care.

"While medication alone won't solve this global health crisis, GLP-1 therapies can help millions overcome obesity and reduce its associated harms."

WHO says these drugs, sometime called skinny jabs, represent a new chapter in the gradual conceptual shift in how society approaches obesity, from a "lifestyle condition" to a complex, preventable, and treatable chronic disease.

It says the drugs can be taken long-term - for six months or more - but must be prescribed along with advice on diet and exercise, so that people can keep the weight off.

Too few people around the world can access them, says WHO. "Our greatest concern is equitable access," said Tedros.


Even under the current best projected scenario, the production of GLP-1 therapies could only cover around 100 million people - less than 10% of those who need them, according to the WHO.

The guideline calls on countries and companies to expand access, through strategies such as voluntary licensing - where a pharmaceutical company grants permission for others to make affordable non-brand versions of its patented drug.

A patent on semaglutide - the core ingredient of Novo Nordisk's Wegovy - is due to expire in several countries in 2026, meaning other drug-makers will soon be free to produce and sell cheap versions in places like India, Canada, China, Brazil and Turkey.

WHO says countries must also create healthier environments to promote good health and prevent obesity.

GLP-1 drugs mimick a natural hormone to slow digestion, curb appetite and increase feelings of fullness so people eat less.


In the UK, the injections are prescription only medicines, which means they can only be prescribed by a healthcare professional for a person who clinically needs it.

Some are available on the NHS, but more are sold privately.

There is a black market and to be safe people should avoid buying from unregulated sellers such as beauty salons or via social media.

People typically start to lose weight within a few weeks of starting on the weekly injections.

Research suggests people may put most of the weight back on within a year of stopping the medication though, as their normal food cravings return.

Being overweight or obese increases your risk for developing health problems, such as diabetes, heart disease, stroke, and certain cancers.

Obesity affects people in every country and was associated with 3.7 million deaths worldwide in 2024, according to the WHO.

https://www.bbc.com/news/articles/cze8n0753zzo

Merck Drug Gets Fast-Track Designation from FDA for Alzheimer's Treatment

 Merck’s investigational antibody MK-2214 has received fast-track designation from the FDA for the treatment of Alzheimer’s disease.

MK-2214 targets phosphorylated serine 413 tau (pS413), a marker of abnormal protein accumulation in the brain, according to a Dec. 1 news release from the company. The designation was announced alongside the first-in-human phase 1 trial data to be presented at the Dec. 1-4 Clinical Trials on Alzheimer’s Disease 2025 event in San Diego. The data supported dose selection for an ongoing phase 2 trial.

Merck also shared early clinical results for MK-1167, a separate Alzheimer’s drug candidate that modulates the alpha-7 nicotinic acetylcholine receptor. That drug is being studied in a phase 2 trial.

MK-2214 is being developed in collaboration with Teijin Pharma.

https://www.beckershospitalreview.com/pharmacy/merck-alzheimers-drug-granted-fda-fast-track-designation/

Is FDA about to restrict vaccination even further?

 Reports have emerged that Vinay Prasad, head of the FDA's Center for Biologics Evaluation and Research (CBER), is planning to tighten up the regulations surrounding vaccines after concluding that COVID-19 shots resulted in the deaths of 10 children.

The source of the reports is an internal email to CBER staff in which Prasad said that, in a "profound revelation," the US medicines regulator will "for the first time […] acknowledge that COVID-19 vaccines have killed American children."

The memo – first revealed on X.com by a PBS journalist and subsequently obtained by various news agencies – also said: "Healthy young children who faced tremendously low risk of death were coerced, at the behest of the Biden administration, via school and work mandates, to receive a vaccine that could result in death."

Prasad said in the email that the FDA is looking into a new approval process for vaccines that will require more evidence of their safety and efficacy before they can be cleared for marketing, particularly if they are to be used in pregnant women, which has raised fears of a slowdown in the development of new vaccines for the US market.

He also said there would be a re-examination of annual flu shot policies, calling it an "evidence-based catastrophe," and limits on the administration of combination vaccines, in a new signal of an increasingly vaccine-sceptic stance at the agency under Health and Human Services (HHS) Secretary, Robert F Kennedy Jr, a prominent figure in the anti-vaccine movement.

Prasad said that a review had revealed at least 10 children had died "after and because of" a COVID-19 vaccine, citing data reported to the Vaccine Adverse Event Reporting System (VAERS) on 96 deaths between 2021 and 2024, but did not provide any details about the cases or the circumstances behind their deaths.

In an autocratic move that is increasingly familiar among federal agencies under the Trump administration, Prasad also said that anyone who disagreed with the new regulatory direction should resign.

In the summer, the FDA imposed new restrictions on who can access COVID-19 vaccines, saying that new jabs would only be approved for those over 65 or those at high risk due to other conditions. Previously, they were available to everyone over six months of age under emergency authorisations.

A few weeks later, the CDC's Advisory Committee on Immunization Practices (ACIP) stopped short of requiring prescriptions for a COVID jab, but did indicate they should be used only after discussions between a patient and doctor.

The ACIP is scheduled to meet later this week and has vaccine risk monitoring and the childhood and adolescent immunisation schedule on its agenda, along with a full day on hepatitis B vaccines, having previously postponed a vote on banning the dose administered at birth.

Meanwhile, mRNA-based COVID vaccines had stronger warnings added to their labels earlier this year, and Kennedy cancelled $500 million of federal funding for mRNA vaccine projects, to the delight of vaccine sceptics.

Last month, to the consternation of medical and autism advocacy groups, the CDC also changed wording on its website to suggest vaccines may cause autism, despite decades of research refuting such a link.

https://pharmaphorum.com/news/fda-about-restrict-vaccination-even-further

Trump urges Israel to keep 'strong' dialogue with Syria

 United States President Donald Trump urged Israel in a Truth Social post on Monday to "maintain a strong and true dialogue with Syria," noting that nothing should "interfere" with the Middle Eastern country's "evolution into a prosperous state."

The US president also remarked how Washington was "very satisfied" with the "results" displayed by Syria's new government. "One of the things that has helped them greatly was my termination of very strong and biting sanctions — I believe this was truly appreciated by Syria, its Leadership," he stated.

In addition, Trump hoped Israel and Syria would "have a long and prosperous relationship together." In November, he hosted Syria's interim President, Ahmed al-Sharaa, at the White House amid strengthening relations between the two nations.

https://breakingthenews.net/Article/Trump-urges-Israel-to-keep-'strong'-dialogue-with-Syria/65275378