An influential vaccine panel’s task force will be led by a member who has previously expressed distrust in the Covid vaccine, weeks after a shooting on the US Centers for Disease Control and Prevention was fueled by Covid misinformation https://t.co/YczVp7bkv6 ...

.@MikeBloomberg: The president who sped the development of the Covid vaccine might do the same for a cancer cure — if his health secretary gets out of the way (via @opinion) https://t.co/g1nOXDmzX7 ...

The Food and Drug Administration is considering revoking Pfizer Inc.’s authorization to sell its Covid vaccine for children under the age of 5, a move that would leave healthy kids with no available shots https://t.co/epTXYQQ1Ei ...

Core Viewpoint - Moderna has lowered its 2025 revenue outlook due to delays in vaccine shipments to the U.K., while still beating Wall Street expectations for the second quarter as it implements cost-cutting measures [1][2]. Revenue Outlook - The company now expects full-year revenue to be between $1.5 billion and $2.2 billion, a decrease of $300 million at the top end of the range [2]. - The delay in shipping spring Covid boosters to the U.K. has shifted deliveries to the first quarter of 2026, but the overall contract value remains unchanged [3]. Second Quarter Performance - Moderna reported second-quarter sales of $142 million, a 41% decline from the same period last year, primarily due to decreasing Covid vaccine sales [4]. - The revenue from the Covid vaccine accounted for $114 million of the total, surpassing analysts' expectations of $89 million [5][7]. - The company's vaccine for respiratory syncytial virus had negligible sales, falling short of the expected $5.9 million [5]. Financial Losses - Moderna posted a net loss of $825 million, or $2.13 per share, for the second quarter, an improvement from a net loss of $1.3 billion, or $3.33 per share, in the same quarter last year [5][6]. - The loss per share was better than the expected loss of $2.97 [7]. Cost Management - The company's efforts to cut costs resulted in a 27% reduction in second-quarter operating expenses, which fell to $1.1 billion from $1.6 billion year-over-year [6].

Moderna is cutting about 10% of its workforce, part of an effort by the struggling biotech company to reduce spending as sales of its Covid vaccine decline https://t.co/Cl8KeUal81 ...

>> All right. Welcome back everybody. FDA Commissioner Doctor Marty Makary is in New York City today on a listening tour.He's going to be meeting with CEOs of major pharma and biotech companies. Doctor Makary joins us on set before he does that. And welcome.It's great to see you. >> Great to be with you all. >> So let's talk a little bit.First of all, why you're here in New York City. Who are you going to be speaking to. What what what's the point.Or I guess listening not speaking. >> Yeah. So look, there's ...

FDA Focus & Policy Changes - FDA commissioner highlights efforts to rebuild public trust through radical transparency, emphasizing that the government is not your doctor and advocating for individual consultations with healthcare providers [4] - The agency is taking an evidence-based approach to vaccine recommendations, particularly regarding boosters for young, healthy individuals, citing concerns about myocarditis risks and questioning the need for repeated doses without sufficient clinical trials [6][7] - FDA aims to ensure vaccines are available to those who want them, emphasizing the decision is between individuals and their doctors, separate from insurance coverage policies [9][10] - FDA is committed to determining the safety and effectiveness of submitted applications, moving away from rubber-stamping vaccines without clinical trials, especially for young, healthy individuals [12][13] Streamlining Drug Approval & Innovation - FDA is addressing the root causes of health issues, including environmental exposures and chemicals in food, and is inventorying over 1,000 chemicals banned in Europe but present in the US food supply [17] - The agency is working to remove all nine petroleum-based food dyes from the US food supply by next year and is seeking innovation in baby formula, addressing the lack of updates to the FDA recipe in 30 years [18] - FDA is questioning why it takes ten years for a drug to come to market and is implementing programs to reduce animal testing, replace it with computational modeling and organ-on-a-chip technology, and expedite decision-making processes [19][20] - The agency is piloting a priority pathway to potentially reduce decision times to weeks instead of a year and is exploring the use of AI in the review process [20] - FDA is making drug rejection letters public in real-time to increase transparency and predictability for drug developers and investors [21][39] National Priorities & Post-Market Surveillance - FDA is prioritizing large unmet public health needs, domestic manufacturing, and drug affordability as national priorities, aiming to lower drug prices for Americans [23][24][25] - The agency is establishing a post-market surveillance program using big data to monitor drugs immediately after approval, aiming to detect potential issues earlier and potentially change the threshold for approval, especially for rare diseases [26][27] - FDA is interested in seeing cures for type one diabetes, more effective cancer therapies, a universal flu shot, and treatments for neurodegenerative diseases [29][30] FDA Restructuring & Efficiency - FDA has not laid off scientific reviewers or inspectors but has implemented early retirements and is actively hiring scientific reviewers [31][32] - The agency is consolidating redundant services and addressing the "empire building culture" within its centers to improve efficiency and accountability [33][34] - FDA is consolidating its ten different adverse event reporting systems into one to create a better user interface and database for post-market surveillance of drugs [35][36]

US regulators approved Moderna’s Covid vaccine for children, a positive sign for the company amid Robert F. Kennedy Jr.’s policy positions that have led to restricted access to the shots for kids https://t.co/nIBtdAkS25 ...

The House Judiciary Committee subpoenaed a former Pfizer executive, demanding he address allegations of deliberately delaying positive news from the company’s Covid vaccine study until after the 2020 election https://t.co/vUf0tiatFl ...

Group 1 - Proactive provides fast, accessible, informative, and actionable business and finance news content to a global investment audience [2][3] - The company focuses on medium and small-cap markets while also covering blue-chip companies, commodities, and broader investment stories [3] - Proactive's news team delivers insights across various sectors including biotech, pharma, mining, natural resources, battery metals, oil and gas, crypto, and emerging technologies [3] Group 2 - Proactive employs technology to enhance workflows and has a forward-looking approach to technology adoption [4] - The company utilizes automation and software tools, including generative AI, while ensuring all content is edited and authored by humans [5]