FDA to offer faster drug reviews to companies promoting ‘national priorities'
WASHINGTON (AP) — U.S. regulators will begin offering faster reviews to new medicines that administration officials deem as promoting 'the health interests of Americans,' under a new initiative announced Tuesday.
Food and Drug Administration Commissioner Marty Makary said the agency will aim to review select drugs in one to two months. FDA's long-standing accelerated approval program generally issues decisions in six months for drugs that treat life-threatening diseases. Regular drug reviews take about 10 months.
Since arriving at the FDA in April, Makary has repeatedly told FDA staff they need to 'challenge assumptions' and rethink procedures. In a medical journal commentary published last week, Makary suggested the agency could conduct 'rapid or instant reviews,' pointing to the truncated process used to authorize the first COVID-19 vaccines under Operation Warp Speed.
For the new program, the FDA will issue a limited number of 'national priority vouchers' to companies 'aligned with U.S. national priorities,' the agency said in a statement. The special designation will give the selected companies access to extra FDA communications, streamlined staff reviews and the ability to submit much of their product information in advance.
Speeding up drug approvals has long been a priority of the pharmaceutical industry, which has successfully lobbied Congress to create a variety of special programs and pathways for faster reviews.
Many aspects of the plan announced Tuesday overlap with older programs. But the broad criteria for receiving a voucher will give FDA officials unprecedented discretion in deciding which companies can benefit from the fastest reviews.
'The ultimate goal is to bring more cures and meaningful treatments to the American public,' Makary said in a statement.
Makary previously said the FDA should be willing to ease its scientific requirements for certain drugs, for instance, by not always requiring randomized studies in which patients are tracked over time to track safety and effectiveness. Such trials are generally considered the gold standard of medical research, though the FDA has increasingly been willing to accept smaller, less-definitive studies for rare or life-threatening diseases.
In several recent cases, the FDA has faced criticism for approving drugs based on preliminary data that didn't ultimately show benefits for patients.
The push to rapidly accelerated drug approvals is the opposite approach that Makary and his boss, Health Secretary Robert F. Kennedy Jr., have taken on vaccines.
Promising a 'return to gold-standard science,' Kennedy previously announced that all new vaccines would have to be compared to placebo, or a dummy shot, to win approval. Kennedy and Makary also have announced a stricter policy on seasonal updates to COVID-19 shots, saying they will have to undergo new testing before they can be approved for use in healthy children and most adults.
___
The Associated Press Health and Science Department receives support from the Howard Hughes Medical Institute's Science and Educational Media Group and the Robert Wood Johnson Foundation. The AP is solely responsible for all content.
Hashtags
Try Our AI Features
Explore what Daily8 AI can do for you:
Comments
No comments yet...
Related Articles
Yahoo
6 minutes ago
- Yahoo
Sword Health Now Valued At $4 Billion, Announces Expansion Into Mental Health Services
Sword Health announced Tuesday that it had raised $40 million in a recent funding round, giving it a $4 billion valuation. Founded in 2015, the healthcare startup has focused on helping people manage chronic pain at home. Using AI tools, the platform connects users with expert clinicians who then provide patients with tools for digital physical therapy, pelvic health, and overall mobility health. However, the company says this new round of funding will largely go towards developing a mental health arm of its program called Mind. Don't Miss: Maker of the $60,000 foldable home has 3 factory buildings, 600+ houses built, and big plans to solve housing — Peter Thiel turned $1,700 into $5 billion—now accredited investors are eyeing this software company with similar breakout potential. Learn how you can "Today, nearly 1 billion people worldwide live with a mental health condition. Yet care remains fragmented, reactive, and inaccessible," Sword said in the announcement. "Mind redefines mental health care delivery with a proactive, 24/7 model that integrates cutting-edge AI with licensed, Ph.D-level mental health specialists. Together, they provide seamless, contextual, and responsive support any time people need it, not just when they have an appointment." Sword CEO Virgílio Bento told CNBC, "[Mind] really a breakthrough in terms of how we address mental health, and this is only possible because we have AI." Users will be equipped with a wearable device called an M-band, which will measure their environmental and physiological signals so that experts can reach out proactively as needed. The program will also offer access to services like traditional talk therapy. Bento told CNBC that a human is "always involved" in patients care in each of its programs, and that AI is not making any clinical decisions. Trending: Maximize saving for your retirement and cut down on taxes: . For example, if a Sword patient has an anxiety attack, AI will identify it through the wearable and bring it to the attention of a clinician, who can then provide an appropriate care plan. "You have an anxiety issue today, and the way you're going to manage is to talk about it one week from now? That just doesn't work," Bento told CNBC. "Mental health should be always on, where you have a problem now, and you can have immediate help in the moment." According to Bento, Sword Mind already has a waiting list, and is being tested by some of its partners who appreciate it's "personalized approach and convenience." "We believe that it is really the future of how mental health is going to be delivered in the future, by us and by other companies," he told CNBC. "AI plays a very important role, but the use of AI — and I think this is very important — needs to be used in a very smart way." The rest of the cash raised in the funding round, which was led by General Catalyst, will go towards acquisitions, global expansion, and AI development, Sword Health says. Read Next: Here's what Americans think you need to be considered Shutterstock UNLOCKED: 5 NEW TRADES EVERY WEEK. Click now to get top trade ideas daily, plus unlimited access to cutting-edge tools and strategies to gain an edge in the markets. Get the latest stock analysis from Benzinga? APPLE (AAPL): Free Stock Analysis Report TESLA (TSLA): Free Stock Analysis Report This article Sword Health Now Valued At $4 Billion, Announces Expansion Into Mental Health Services originally appeared on © 2025 Benzinga does not provide investment advice. All rights reserved. Error in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
Forbes
3 hours ago
- Forbes
The Triple Threat Draining Workforce Productivity And Mental Health
Productivity and mental health are taking a hit for three reasons. Numbers never lie: it's why CEOs obsess over revenue targets, operational metrics, quarterly growth, and more. Yet beneath the spreadsheets and data dashboards lies an invisible crisis quietly eroding organizational strength and productivity: the deteriorating mental health and emotional resilience of today's workforce. A comprehensive 2025 State of the Workforce Report by meQuilibrium, surveying 5,477 employees across various industries, identified a troublesome "triple threat" that undermines employee performance and well-being: uncertainty, pessimism, and psychological disconnection. These aren't mere HR concerns; they're operational risks with quantifiable financial impacts. The data paints a clear picture: These challenges are silently sabotaging productivity, further inflating turnover costs, and increasingly impacting employee well-being. The Real Cost Of The Triple Threat Uncertainty alone led to a 68% increase in productivity impairment. Employees facing high uncertainty stress experience twice the risk of generalized anxiety disorders and nearly double the rate of burnout, costing American companies between $4,000 and $21,000 per employee annually, according to a study in the American Journal of Preventive Medicine. Pessimism compounds this impact significantly. Workers with negative job outlooks report a 64% decrease in productivity, alongside a staggering 128% higher risk of depression and 108% higher risk of anxiety compared to optimistic colleagues. The psychological disconnect further exacerbates productivity losses. Even employees displaying no signs of disconnect report an average productivity impairment of 29%, while severely disconnected employees experience impairment rates of up to 66%. This triple threat isn't fleeting; it's systemic and escalating, making employee mental health and emotional resilience one of your organization's significant, yet often overlooked, financial liabilities. Foundational Strategies To Improve Productivity And Mental Health A company thrives when its people thrive. Amid volatility and continuous disruptions, the greatest threat to any organization is a workforce characterized by stress, negativity, disengagement, and poor health. However, this crisis presents opportunities to cultivate resilience and strength. While each company is unique, these foundational actions can universally elevate employee well-being and productivity: Fitness offers more than aesthetics. It's a strategic investment. CEOs like Bob Iger strongly advocate for fitness because it improves their mood, focus, emotional regulation, executive presence, and resilience. To build a health-driven culture, leaders must actively model wellness practices. Sleep is equally critical. Improved sleep and recovery improve individuals' decision-making and emotional regulation and reduce team volatility. Prioritizing a health-first culture also serves as a strong talent attractor and retention tool. Ambiguity breeds stress, especially with technological disruptions like AI, which create concerns about job stability. Clear and consistent communication significantly mitigates uncertainty. Leaders must frequently reiterate their vision in a way that integrates each person seamlessly. Also key is establishing priorities and performance expectations along with transparency in explaining the rationale behind decisions. Vulnerability and candor strengthen trust, which further reduces speculation and disengagement among employees and investors alike. Soft skills matter significantly, even in the data-driven corporate world. As highlighted in the report, empathetic managers reduce uncertainty stress by 37% and disconnect by nearly 50%. CEOs and senior leaders can actively cultivate empathy through the following: Better Mental Well-Being Equals Improved Productivity Addressing the triple threat isn't merely beneficial—it's critical. The modern workforce faces numerous challenges that threaten employees' mental health and productivity. With ongoing volatility and persistent uncertainty, investing in mental health and resilience becomes not just advantageous but essential. As technology democratizes and ceases to offer unique competitive advantages, the companies that will lead tomorrow are those who invest significantly in their people's well-being today.
Yahoo
5 hours ago
- Yahoo
Perspective Therapeutics Commences Recruitment for [212Pb]VMT-α-NET in the Third Dose Escalation Cohort of its Ongoing Phase 1/2a Clinical Trial
[212Pb]VMT-α-NET Phase 1/2a study is advancing into Cohort 3 with a fixed administered dose that is up to 20% higher (6 mCi) than the dose administered to patients in Cohort 2 Dosimetry sub-study analysis presented at the Society of Nuclear Medicine & Molecular Imaging (SNMMI) 2025 Annual Meeting to advance utility of dosimetry in clinical development when considered with clinical data On track to submit further clinical updates to scientific congresses in 2H 2025, including longer safety follow-up on all patients who have received at least one treatment of [212Pb]VMT-α-NET and anti-tumor activities in patients dosed to date who have had the opportunity to receive at least one scan after their full treatment SEATTLE, June 21, 2025 (GLOBE NEWSWIRE) -- Perspective Therapeutics, Inc. ("Perspective" or the "Company") (NYSE AMERICAN: CATX), a radiopharmaceutical company pioneering advanced treatments for cancers throughout the body, today announced that alignment was reached with the U.S. Food and Drug Administration (FDA) to open the third dosing cohort (Cohort 3) of its ongoing Phase 1/2a clinical trial for [212Pb]VMT-α-NET in patients with unresectable or metastatic somatostatin receptor 2 (SSTR2)-positive neuroendocrine tumors (NETs) who have not received prior radiopharmaceutical therapies (RPT). "We are excited to start exploring a higher dose level of VMT-α-NET after successfully completing an interaction with the FDA that was agreed prior to commencement of this trial," commented Markus Puhlmann, Chief Medical Officer of Perspective. "We are encouraged by the overall clinical profile observed at the second dose level of VMT-α-NET—including evidence of anti-tumor activity and primarily low-grade adverse events—and we believe it is important to assess whether a higher dose could further improve the therapeutic profile. Meanwhile, we remain committed to engaging with the FDA to evaluate the clinical utility of dosimetry estimates and analyses in the development of our proprietary RPTs." Patients in Cohort 3 will receive up to four fixed administered doses of [212Pb]VMT-α-NET at 6 mCi every eight weeks if they weigh more than 60kg (133lb), or 100μCi/kg of body weight if they weigh less than or equal to 60kg. Observations of dose limiting toxicities (DLTs) in up to eight patients within 42 days of the first treatment cycle will be used to assess whether this cohort of patients have received maximum tolerated dose (MTD) or maximum feasible dose (MFD). Once a safety monitoring committee (SMC) has reviewed the data from these initial patients, it may recommend exploring alternative dosing and/or recruit more patients into Cohort 3. Perspective is notifying sites that Cohort 3 is now open for recruitment. Patients currently being evaluated for entry into the study will enroll into Cohort 3 if they qualify. Pending feedback from sites on operationalizing enrollment into Cohort 3, an update on pace of recruitment will be provided in due course. About [212Pb]VMT-α-NETPerspective designed [212Pb]VMT-α-NET to target and deliver 212Pb to tumor sites expressing SSTR2. The Company is conducting a multi-center, open-label, dose-escalation, dose-expansion study ( identifier NCT05636618) of [212Pb]VMT-α-NET in patients with unresectable or metastatic SSTR2-positive neuroendocrine tumors who have not received a prior RPT. Interim update with a data cut-off date of April 30, 2025 were reported in an oral presentation at the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting in May 2025. Cohort 2 was reopened in August 2024. During 2H 2025, some of the 33 additional patients enrolled after the cohort reopened and through April 30, 2025 will have had the opportunity for at least 32 weeks of follow-up after their initial doses, sufficient time to receive at least one scan after their full treatment (up to four doses every eight weeks), if they receive all four doses of treatment per protocol. About Perspective Therapeutics, Therapeutics, Inc. is a radiopharmaceutical company pioneering advanced treatments for cancers throughout the body. The Company has proprietary technology that utilizes the alpha-emitting isotope 212Pb to deliver powerful radiation specifically to cancer cells via specialized targeting moieties. The Company is also developing complementary imaging diagnostics that incorporate the same targeting moieties, which provides the opportunity to personalize treatment and optimize patient outcomes. This "theranostic" approach enables the ability to see the specific tumor and then treat it to potentially improve efficacy and minimize toxicity. The Company's melanoma (VMT01), neuroendocrine tumor (VMT-α-NET), and solid tumor (PSV359) programs are in Phase 1/2a imaging and therapy trials in the U.S. The Company is growing its regional network of drug product finishing facilities, enabled by its proprietary 212Pb generator, to deliver patient-ready products for clinical trials and commercial operations. For more information, please visit the Company's website at Safe Harbor StatementThis press release contains forward-looking statements within the meaning of the United States Private Securities Litigation Reform Act of 1995. Forward-looking statements in this press release include statements concerning, among other things, the Company's ability to pioneer advanced treatments for cancers throughout the body; the Company's belief that it is on track to submit further clinical updates to scientific congresses in 2H 2025 and the planned content of such updates; the Company's ability to explore a higher dose level of VMT-α-NET; the Company's commitment to engage with the FDA to evaluate the clinical utility of dosimetry estimates and analyses in the development of its proprietary RPTs; the Company's expectation that patients currently being evaluated for entry into its VMT-α-NET study will enroll into Cohort 3 if they qualify; the ability of the Company's proprietary technology utilizing the alpha emitting isotope 212Pb to deliver powerful radiation specifically to cancer cells via specialized targeting moieties; the Company's prediction that the use of complementary imaging diagnostics that incorporate the same targeting moieties provides the opportunity to personalize treatment and optimize patient outcomes; the Company's belief that its "theranostic" approach enables the ability to see a specific tumor and then treat it to potentially improve efficacy and minimize toxicity; the Company's ability to grow its regional network of drug product finishing facilities, enabled by its proprietary 212Pb generator, to deliver patient-ready products for clinical trials and commercial operations; and other statements that are not historical fact. These forward-looking statements involve risks and uncertainties that could cause the Company's actual results to differ materially from the results described in or implied by the forward-looking statements. Certain factors that may cause the Company's actual results to differ materially from those expressed or implied in the forward-looking statements in this press release are described under the heading "Risk Factors" in the Company's most recent Annual Report on Form 10-K filed with the Securities and Exchange Commission (the "SEC"), in the Company's other filings with the SEC, and in the Company's future reports to be filed with the SEC and available at Forward-looking statements contained in this news release are made as of this date. Unless required to do so by law, we undertake no obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events, or otherwise. Media and Investor Relations Contacts: Perspective Therapeutics IR:Annie J. Cheng, CFAir@ Russo Partners, LLCNic JohnsonPerspectiveIR@
