Breaking right now on Morning News Now, former Prince Andrew under arrest. The ex-royal taken into custody early this [music] morning amid growing scrutiny over his relationship with Jeffrey Epstein. More on his arrest, the [music] allegations, and what could come next.Also, new developments in day 19 of the search for Nancy [music] Guthrie. Investigators now zeroing in on partial DNA found in Guthri's home. They're also working to recover more video from surveillance cameras from the night she went missing ...

Core Viewpoint - The FDA has agreed to review Moderna's experimental mRNA flu shot, reversing its earlier decision, which has surprised both Wall Street and the medical community [1][2]. Group 1: FDA Review and Approval Process - The FDA is expected to make a decision on the flu shot by August 5, which is crucial for Moderna's plans to introduce the vaccine for the upcoming influenza season [2]. - Moderna aims for full approval of the flu shot for adults aged 50 to 64 and accelerated approval for those aged 65 and older, which will require a post-marketing study to confirm benefits [5]. - The FDA's acceptance of the modified application follows a "constructive" meeting where Moderna proposed a revised regulatory approach addressing previous criticisms [4][5]. Group 2: Clinical Trial and Regulatory Concerns - The FDA had previously criticized Moderna's choice of comparator in its phase three trial, stating it did not reflect the best standard of care in the U.S. [6]. - Moderna contends that FDA guidelines do not mandate the use of the highest-dose vaccine as a comparator and argues that the agency's prior communications supported their trial design [8]. - The decision to initially refuse the application was influenced by the FDA's top vaccine regulator, who has advocated for stricter vaccine regulations [9][10]. Group 3: Market Reaction and Company Outlook - Following the announcement of the FDA's review, shares of Moderna increased by over 6% [3]. - The successful introduction of the flu vaccine is integral to Moderna's goal of achieving financial break-even by 2028 [2].

FDA reverses course and will review Moderna's mRNA flu vaccine, the company says https://t.co/jykQnuHtBx https://t.co/WOW8LeSJZS ...

FDA reverses course and will review Moderna's mRNA flu vaccine, the company says https://t.co/SpvmnBCYzC https://t.co/bYWc18XVQa ...

In the race to lead the innovation narrative, the US healthcare industry needs to actively consider systemic changes to contend with the growing competition from China, say industry experts. At the glitzy event organised by the lobbying group PhRMA on 17 February in Washington DC, several administration leaders mingled with leading pharma and biotech executives to discuss the latest trends and challenges in the pharmaceutical sector. The chief topic on the agenda for all was China; with PhRMA and others ...

分组1: Shopify Earnings Report - Shopify reported a 31% year-over-year revenue growth, maintaining the same growth rate as the previous year, with merchandise volume through the platform growing by 29% for the full year [1][2] - The company authorized a new $2 billion buyback and provided first-quarter guidance that exceeded analyst expectations [1] - Despite strong overall metrics, Shopify missed earnings per share (EPS) estimates by a few cents, and free cash flow margin contracted slightly [1][2] 分组2: Market Reaction and Analyst Insights - The stock initially rose 13% in pre-market trading but fell 6% by the end of the day, indicating a negative market reaction following the conference call [1] - Analysts raised concerns about "agentic commerce," a trend that could significantly impact e-commerce and Shopify's future, as AI technology evolves to handle transactions on behalf of consumers [2][3] - There is uncertainty regarding how agentic commerce will affect Shopify, with some analysts viewing the market's reaction as more of a jitter than a fundamental shift in the investment thesis [3][4] 分组3: Moderna FDA Challenges - Moderna faced a setback as the FDA refused to consider its recent flu vaccination for approval, which is critical for funding its pipeline of cancer and rare disease treatments [7][8] - The FDA's decision was based on issues with the methods used in Moderna's late-stage clinical trials, but the vaccine has shown greater efficacy compared to traditional flu vaccines [8][12] - Moderna has a robust pipeline with over 50 candidates, and while the flu vaccine setback is significant, it is not seen as a death blow for the company's overall strategy [8][10] 分组4: Regulatory Environment and Future Outlook - The current administration's cautious attitude towards vaccines, particularly mRNA vaccines, raises questions about future approvals and the regulatory landscape for Moderna [12] - Analysts suggest that Moderna may need to retool its late-stage trials, which could delay progress but is not expected to derail the company's broader goals [12] - The lack of regulatory clarity is a concern for companies like Moderna, as it complicates planning and investment in research and development [12]

It's estimated that the COVID-19 vaccine saved up to 15 million lives worldwide during the pandemic. One of the main reasons the COVID vaccine was so successful is is because some of it used mRNA technology. And let's not forget, in 2020, Donald Trump was touting the COVID vaccines and mRNA and Operation Warp Speed as among one of the greatest accomplishments of his first term.But this time around, Trump's Health and Human Services, led by anti-vaccine Secretary Robert F. Kennedy Jr. ., is walking its suppo ...

THE FOOD AND DRUG THE UNITED STATES, THE ADMINISTRATIONOTIFIED THE PHARMACEUTICAL COMPANY MODERNA ON TUESDAY THAT IT WOULD NOT THE F .D .A. GAVE FOR REFUSING TO REVIEW THE VACCINE WAS THAT IN THE CLINICAL TRIAL MODERNA COMPARED IT'S EXPERIMENTAL VACCINE TO THAT OF A PRODUCT THAT THE FDA DID NOT CONSIDER THE BEST ON THE MARKET. MODERNA'S LEADERS SAY THE REFUSAL COMES OUT OF THE BLUE AS THE COMPANY HAD PREVIOUSLY THEY COMMUNICATED WITH FDA OFFICIALS ABOUT ITS STUDY.JOINING US NOW THE THE PRESIDENT OF MODERNA, ...

Core Viewpoint - Moderna Inc. is facing significant challenges, particularly with its mRNA flu vaccine, which has impacted its financial outlook and stock performance [2][5]. Financial Performance - Analysts predict an earnings per share (EPS) loss of $2.60 for the upcoming quarterly earnings, with projected revenue of $624 million [1][6]. - The company has a negative P/E ratio of -5.07, indicating current earnings struggles, while its price-to-sales ratio of 7.13 suggests investor confidence in its sales potential [3]. - Moderna's enterprise value to sales ratio stands at 6.95, reflecting a valuation perspective that still sees potential in the company's sales capabilities [3]. Financial Health - Moderna exhibits a low debt-to-equity ratio of 0.079, indicating conservative debt usage [4][6]. - The company has a strong current ratio of 3.93, suggesting good short-term financial health and the ability to cover current liabilities with assets [4][6]. - However, the negative earnings yield of -19.72% highlights ongoing profitability challenges [4]. Regulatory Challenges - The FDA's refusal to review Moderna's application for its new mRNA flu vaccine has resulted in a nearly 10% drop in the company's stock [2][6]. - Despite the FDA's decision, no safety or efficacy issues were raised, and Moderna is actively seeking a Type A meeting to address the concerns related to trial design [2]. Strategic Initiatives - Moderna is continuing its vaccine development efforts and is seeking approvals in the European Union, Canada, and Australia [5].

Core Viewpoint - The U.S. Food and Drug Administration (FDA) has declined to review Moderna's application for a new flu vaccine utilizing mRNA technology, which was awarded a Nobel Prize [1] Group 1: Company Impact - Moderna's application for a flu vaccine based on mRNA technology has been rejected by the FDA, which may hinder the company's expansion into the flu vaccine market [1] - The refusal from the FDA could impact Moderna's stock performance and investor sentiment, as the company seeks to diversify its vaccine portfolio beyond COVID-19 [1] Group 2: Industry Implications - The decision by the FDA raises questions about the regulatory landscape for mRNA vaccines in the broader vaccine industry, potentially affecting other companies exploring similar technologies [1] - The rejection may slow down the adoption of mRNA technology in flu vaccines, which could have implications for public health strategies and vaccine development timelines [1]