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Moderna says FDA refuses to review its application for experimental flu shot

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Moderna says FDA refuses to review its application for experimental flu shot


The Food and Drug Administration has refused to start a review of Moderna‘s application for its experimental flu shot, the company announced Tuesday, in another sign of the Trump administration’s influence on tightening vaccine regulations in the U.S. 

The company’s stock fell roughly 7% in after-hours trading Tuesday.

Moderna said the move is inconsistent with previous feedback from the agency from before it submitted the application and started phase three trials on the shot, called mRNA-1010. The drugmaker said it has requested a meeting with the FDA to “understand the path forward.” 

Moderna noted that the agency did not identify any specific safety or efficacy issues with the vaccine, but instead objected to the study design, despite previously approving it. The company added that the move won’t impact its 2026 financial guidance.

Moderna’s jab showed positive phase three data last year, meeting all of the trial goals. At the time, Moderna said the stand-alone flu shot was key to its efforts to advance a combination vaccine targeting both influenza and Covid-19.

The announcement follows sweeping changes to U.S. immunization policy over the past year under Health and Human Services Secretary Robert F. Kennedy Jr., a prominent vaccine skeptic. 

Moderna on Tuesday specifically pointed to the FDA’s top vaccine regulator, Vinay Prasad, who returned to the agency in August after being ousted. Prasad, who heads the agency’s Center for Biologics Evaluation and Research, or CBER, has been vocal about tightening regulations for vaccines and recently linked child deaths to Covid shots. 

In a letter signed by Prasad on Feb. 3, he said the sole reason why the FDA refused to review the application was because of how the clinical trial on the shot was designed.

The agency specifically took issue with Moderna’s decision to compare its product to a standard, approved flu shot, arguing that it “does not reflect the best-available standard of care.” As a result, the FDA said the study did not meet its definition of an “adequate and well-controlled” trial.

Moderna disputes that reasoning, noting that FDA rules and guidance do not actually require trials to use the most advanced or highest-dose vaccine as a comparator in clinical studies. 

“This decision by CBER, which did not identify any safety or efficacy concerns with our product, does not further our shared goal of enhancing America’s leadership in developing innovative medicines,” Moderna CEO Stéphane Bancel said in a release. “It should not be controversial to conduct a comprehensive review of a flu vaccine submission that uses an FDA-approved vaccine as a comparator in a study that was discussed and agreed on with CBER prior to starting.”

Moderna said it expects the earliest approval for its flu shot to be in late 2026 or late 2027, pending regulatory reviews in the U.S., Europe, Canada and Australia.

The FDA said it does not comment on regulatory communications to individual sponsors.



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JPMorgan CEO Jamie Dimon in annual letter cites risks in geopolitics, AI and private markets

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JPMorgan CEO Jamie Dimon in annual letter cites risks in geopolitics, AI and private markets


JPMorgan Chase CEO Jamie Dimon is calling for a broad recommitment to American ideals as his bank navigates geopolitical uncertainty, a teetering economy and the revolutionary impact of artificial intelligence.

Dimon in his annual letter to shareholders, published Monday, noted the country’s 250th anniversary as “the perfect time to rededicate ourselves to the values that made this great nation of ours — freedom, liberty and opportunity.”

“The challenges we all face are significant. The list is long but at the top are the terrible ongoing war and violence in Ukraine, the current war in Iran and the broader hostilities in the Middle East, terrorist activity and growing geopolitical tensions, importantly with China,” Dimon said. “Even in troubled times, we have confidence that America will do what it has always done — look to the values that have defined our singular nation and sustained our leadership of the free world.”

Dimon, the longtime leader of the world’s largest bank by market cap, is among the most outspoken of U.S. corporate leaders. His annual letter offers not only a matter of record for his firm’s performance, but also sweeping perspectives on the global state of affairs.

In Monday’s letter, Dimon noted headwinds including global conflicts, persistent inflation, private market upheaval and what he called “poor bank regulations.”

Dimon said that while regulations like those put in place after the 2008 financial crisis “accomplished some good things … they also created a fragmented, slow-moving system with expensive, overlapping and excessive rules and regulations — some of which made the financial system weaker and reduced productive lending.”

He specifically cited negative consequences of capital and liquidity requirements, the current construction of the Federal Reserve’s stress test and a “badly handled” process at the Federal Deposit Insurance Corp.

Dimon also said JPMorgan’s reaction to revised proposals for Basel 3 Endgame and a global systemically important bank, or GSIB, surcharge — issued by U.S. regulators last month — were “mixed.”

“While it was good to see that the recent proposals for the Basel 3 Endgame (B3E) and GSIB attempted to reduce the increase in required capital from the 2023 proposals, there are still some aspects that are frankly nonsensical,” Dimon said.

The CEO said with the aggregate proposed surcharges of about 5%, the bank would need to hold “as much as 50% more capital across the vast majority of loans to U.S. consumers and businesses when compared with a large non-GSIB bank for the same set of loans.”

“Frankly, it’s not right, and it’s un-American,” he said.

On trade and geopolitics

Dimon identified geopolitical tensions as the primary risk facing his bank, namely the wars in Ukraine and Iran and their impacts on commodities and global markets — deeming war “the realm of uncertainty.”

“The outcome of current geopolitical events may very well be the defining factor in how the future global economic order unfolds,” he said. “Then again, it may not.”

He also cited a “realignment of economic relations in the world” brought on by U.S. trade policy. U.S. President Donald Trump has made tariffs a signature policy of his second term in office, introducing higher duties on dozens of trade partners and import categories.

“The trade battles are clearly not over, and it should be expected that many nations are analyzing how and with whom they should create trade arrangements,” Dimon said. “While some of this is necessary for national security and resiliency, which are paramount, it is hard to figure out what the long-term effects will be.”

On private markets

Dimon also spoke to recent upheaval in the private markets, as fears around loans made to software firms spur massive redemption requests at private credit funds.

“By and large, private credit does not tend to have great transparency or rigorous valuation ‘marks’ of their loans — this increases the chance that people will sell if they think the environment will get worse — even if actual realized losses barely change,” Dimon said.

The executive added that actual losses are already higher than they should be relative to the environment.

“However this plays out, it should be expected that at some point insurance regulators will insist on more rigorous ratings or markdowns, which will likely lead to demands for more capital,” he said.

On AI

Dimon reiterated Monday that the pace of AI adoption is unlike any technology that came before it. He said while its implementation will be “transformational,” it remains to be seen how the AI revolution will unfold.

“Overall, the investment in AI is not a speculative bubble; rather, it will deliver significant benefits. However, at this time, we cannot predict the ultimate winners and losers in AI- related industries,” Dimon said.

“We will not put our heads in the sand. We will deploy AI, as we deploy all technology, to do a better job for our customers (and employees),” he wrote.

JPMorgan has been at the forefront of Wall Street firms introducing AI at every level of its business. Last year, JPMorgan Chief Analytics Officer Derek Waldron gave CNBC an early demonstration into how it’s using agentic AI to speed up work and improve results for customers and shareholders.

In February, Dimon said AI was reshaping JPMorgan’s workforce and that the bank had “huge redeployment plans” for employees.

“We have focused on some of the ‘known and predictable’ and some of the ‘known unknown’ events,” he said. “But huge technological shifts like AI always have second- and third-order effects as well that can deeply impact society. … We should be monitoring for this kind of transformation, too.”

— CNBC’s Leslie Picker and Ritika Shah contributed to this report.

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Gold price rises up Rs1,100 per tola in Pakistan – SUCH TV

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Gold price rises up Rs1,100 per tola in Pakistan – SUCH TV



The prices of gold increased in the local market on Monday, with 24-karat gold per tola rising by Rs1,100 to settle at Rs491,462 compared to Rs490,362 on the previous trading day, according to rates issued by the All Pakistan Sarafa Gems and Jewellers Association.

Similarly, the price of 10 grams of 24-karat gold increased by Rs943 to Rs421,349 from Rs420,406, whereas 10 grams of 22-karat gold went up by Rs864 to Rs386,250 against Rs385,386.

In the international market, the price of gold increased by $11 to $4,687 per ounce from $4,676.

Meanwhile, the price of silver per tola decreased by Rs 50 to Rs 7,744 from Rs 7,794, while the price of 10 grams of silver declined by Rs 43 to Rs 6,639 from Rs 6,682.

The price of silver in the international market also decreased by $0.50 to $72.60 per ounce from $73.10.



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Aurobindo Pharma gets board nod for Rs 800 crore share buyback plan – The Times of India

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Aurobindo Pharma gets board nod for Rs 800 crore share buyback plan – The Times of India


Hyderabad: Aurobindo Pharma’s board on Monday approved a Rs 800 crore share proposal to buy back up to 54.23 lakh fully paid-up equity shares of the company of face value Rs 1 each at Rs 1,475 a share.The proposed buyback, which is subject to regulatory and statutory approvals, represents up to 0.93% of the total number of equity shares in the company’s total paid-up equity share capital.The Hyderabad-based generics drug maker informed the bourses that April 17, 2026, has been fixed as the record date to determine shareholder eligibility and entitlement for the buyback, which will be carried out through the tender offer route on a proportionate basis, in line with SEBI’s Buyback Regulations and the Companies Act.All eligible equity shareholders, including promoters and promoter group entities holding shares on the record date, will be entitled to participate in the offer for which the company has already constituted a buyback committee.The company also said the board or buyback committee may increase the buyback price and correspondingly reduce the number of shares to be bought back up to one working day before the record date but the overall size will remain unchanged.The Rs 800 crore buyback size excludes transaction costs and related expenses such as brokerage, taxes, filing fees, legal charges and publication expenses, it said.The latest buyback comes less than two years after the last buyback offer aggregating to Rs 750 crore that was made at Rs 1,460 a piece in August 2024 by the company.As of December 31, 2025, promoters and promoter group entities held 51.82% stake in the company, mutual funds 19.52%, foreign portfolio investors 13.94%, insurance companies 5.50%, and public shareholders and others 7.93%.



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