TIME100 Most Influential Companies 2025: Gilead
It's been more than four decades since the first cases of HIV emerged, and while there are effective drug treatments to control the virus, there's still no vaccine. But it turns out that an anti-HIV drug, injected twice a year, could be just as effective as a vaccine in protecting people from getting infected, according to strong results from studies published in 2024.
Leading HIV treatment developer Gilead's scientists spent 20 years developing lenacapavir, an antiviral drug that targets a specific protein on the virus' shell. Vaccines have similarly targeted other outer viral proteins, and the idea is that priming the immune system to recognize this part of HIV can help it to generate defenses against the virus if someone is later exposed. Lenacapavir was already approved to treat HIV, and in June the FDA also approved it as a preventive therapy. Widespread use of the medication could bring the world closer to ending the HIV epidemic.
The company's CEO Dan O'Day says Gilead is equally committed to ensuring that those who are at highest risk of getting infected with HIV have access to the drug. He signed a voluntary licensing agreement in 2024 that allows half a dozen generic manufacturers to make lenacapavir for 120 low and middle income countries, where HIV remains a significant threat. Close to 40 million people have HIV or AIDS globally, but a disproportionate number—about two-thirds—live in subsaharan Africa. 'Not that many companies focus on virology,' he says. 'And if we are going to produce a drug, and put our blood, sweat and tears into it, then it's got to end up in everybody's hands who can use it.'
Expanding on its expertise in immune-based treatments—the company's remdesivir was the first antiviral approved to treat COVID-19—O'Day says Gilead is also developing treatments for blood and solid cancers as well as autoimmune diseases. 'We are in build mode, but it is already a significant part of our company and the fastest-growing part of the company today,' he says of the cancer projects. 'I expect five years from now you will see Gilead making a bigger impact across the world, in a variety of disease states.'
Try Our AI Features
Explore what Daily8 AI can do for you:
Comments
No comments yet...
Related Articles
Yahoo
an hour ago
- Yahoo
ONWARD Medical Files 510(k) with US FDA for ARC-EX System Home Use and Submits CE Mark Application
FDA 510(k) application submitted to allow marketing of the ARC-EX® System for home use in the United States CE Mark application filed with notified body to enable commercialization of the ARC-EX System in the European Union and other countries EINDHOVEN, the Netherlands, July 01, 2025 (GLOBE NEWSWIRE) -- ONWARD Medical N.V. (Euronext: ONWD and US OTCQX: ONWRY), the leading neurotechnology company pioneering therapies to restore movement, function, and independence in people with spinal cord injury (SCI) and other movement disabilities, today announced the submission of two major regulatory applications for its ARC-EX System. The Company has submitted a 510(k) application to the US Food and Drug Administration (FDA) seeking clearance to expand its indication for home use. In parallel, ONWARD has filed an application with the notified body for CE Mark certification in accordance with the European Union Medical Device Regulation (MDR) to enable commercialization of the ARC-EX System in the EU. Completed in June, these submissions represent significant milestones as the Company advances its mission to bring breakthrough therapies to people with SCI around the world. The ARC-EX System is the first and only FDA-cleared technology indicated to improve hand sensation and strength after SCI. Following the successful initial phase of its US launch to clinics, ONWARD is pursuing FDA clearance to expand marketing of the ARC-EX System for use at home. Strong early demand and positive feedback from users suggest the Company is on track to meet its 2025 expectations. Clearance for home use would significantly broaden access to this innovative technology. Simultaneously, ONWARD is preparing for the commercialization of the ARC-EX System through its CE Mark submission. Once approved, the ARC-EX System would be available in the European Union and other countries recognizing CE Marking. 'These two submissions are further evidence of our ability to execute against our innovation roadmap,' said Dave Marver, Chief Executive Officer of ONWARD Medical. 'Gaining regulatory authorization for ARC-EX in Europe and broadening the ARC-EX label in the US will greatly expand the market while offering improved and more convenient access for those with SCI.' Earlier this year, ONWARD also announced the publication of positive results from the investigator-sponsored Pathfinder2 Study in Neuromodulation: Technology at the Neural Interface. This peer-reviewed paper further expands the body of clinical evidence supporting the ARC-EX System. The one-year trial demonstrated that ARC-EX Therapy combined with activity-based rehabilitation delivered significant functional improvements when administered to people with SCI in community-based rehabilitation centers. Participants experienced continued gains in upper body strength, trunk control, and balance after one year of treatment, with no plateau in therapeutic benefit1. About ONWARD Medical ONWARD Medical is the leading neurotechnology company pioneering therapies to restore movement, function and independence in people with spinal cord injury and other movement disabilities. Building on more than a decade of scientific discovery, preclinical research, and clinical studies conducted at leading hospitals, rehabilitation clinics, and neuroscience laboratories, the Company has developed ARC Therapy, which has been awarded ten Breakthrough Device Designations from the US FDA. The Company's ARC-EX System is cleared for commercial sale in the US. In addition, the Company is developing an investigational implantable system called ARC-IM with and without an implanted brain-computer interface (BCI). Headquartered in the Netherlands, the Company has a Science and Engineering Center in Switzerland and a US office in Boston, Massachusetts. The Company is listed on Euronext Paris, Brussels, and Amsterdam (ticker: ONWD) and its US ADRs can be traded on OTCQX (ticker: ONWRY). For more information, visit and connect with us on LinkedIn. To be kept informed about the Company's technologies, research studies, and the availability of therapies in your area, please complete this webform. For Media Inquiries: Sébastien Cros, VP communications media@ For Investor Inquiries: investors@ Disclaimer Certain statements, beliefs, and opinions in this press release are forward-looking, which reflect the Company's or, as appropriate, the Company directors' current expectations and projections about future events. By their nature, forward-looking statements involve several risks, uncertainties, and assumptions that could cause actual results or events to differ materially from those expressed or implied by the forward-looking statements. These risks, uncertainties, and assumptions could adversely affect the outcome and financial effects of the plans and events described herein. A multitude of factors including, but not limited to, delays in regulatory approvals, changes in demand, competition, and technology, can cause actual events, performance, or results to differ significantly from any anticipated development. Forward-looking statements contained in this press release regarding past trends or activities should not be taken as a representation that such trends or activities will continue in the future. As a result, the Company expressly disclaims any obligation or undertaking to release any update or revisions to any forward-looking statements in this press release as a result of any change in expectations or any change in events, conditions, assumptions, or circumstances on which these forward-looking statements are based. Neither the Company nor its advisers or representatives nor any of its subsidiary undertakings or any such person's officers or employees guarantees that the assumptions underlying such forward-looking statements are free from errors nor does either accept any responsibility for the future accuracy of the forward-looking statements contained in this press release or the actual occurrence of the forecasted developments. You should not place undue reliance on forward-looking statements, which speak only as of the date of this press release. Trademarks: ONWARD, ARC-EX, ARC-IM, ARC-BCI, and the stylized O-Logo are proprietary and registered trademarks of ONWARD Medical. Unauthorized use is strictly prohibited. 1ARC-EX Indication for Use (US): The ARC-EX System is intended to deliver programmed, transcutaneous electrical spinal cord stimulation in conjunction with functional task practice in the clinic to improve hand sensation and strength in individuals between 18 and 75 years old that present with a chronic, non-progressive neurological deficit resulting from an incomplete spinal cord injury (C2-C8 inclusive). Other Investigational Products: All other ONWARD Medical devices and therapies including ARC-IM and ARC-BCI are investigational and not available for commercial in to access your portfolio
Medscape
an hour ago
- Medscape
BCG Revaccination Fails to Prevent Sustained TB Infection
TOPLINE: Bacille Calmette-Guérin (BCG) revaccination showed no efficacy in preventing sustained Mycobacterium tuberculosis infection compared with placebo in adolescents, with similar rates of QuantiFERON-TB (QFT) test conversion from negative to positive. METHODOLOGY: In a previous trial, BCG revaccination did not prevent primary M tuberculosis infection but did reduce the risk for sustained infections, prompting further study in a wider population. Researchers conducted a phase 2b, randomized study to evaluate the efficacy of BCG revaccination for the prevention of sustained M tuberculosis infection in South Africa. A total of 1836 adolescents (age, 10-18 years), who tested negative for HIV and had negative QFT test results at screening, were randomly assigned to receive either the BCG vaccine or placebo and were followed up for a median of 30 months. A sustained M tuberculosis infection was defined as a sustained QFT test conversion from negative to positive (≥ 0.35 IU/mL interferon gamma), occurring any time after the first negative QFT test, followed by positive tests confirmed at 3 and 6 months. The primary endpoint was sustained QFT test conversion, and the secondary endpoints were the safety and reactogenicity of BCG revaccination. TAKEAWAY: BCG revaccination showed no protective effect against sustained M tuberculosis infection, with similar QFT test conversion rates in the vaccine and placebo groups (hazard ratio, 1.04; P = .58), with a vaccine efficacy of -3.8% (95% CI, -48.3 to 27.4). The frequencies of antigen-specific CD4 T cells expressing various cytokines were higher in the BCG revaccination group than in the placebo group, and they remained higher than those at baseline even 6 months postvaccination. Most adverse events were mild to moderate. Serious adverse events occurred in 0.3% of participants in each group and were unrelated to the vaccine or placebo, with no deaths or treatment discontinuations. IN PRACTICE: 'Although this trial does not allow us to draw firm conclusions on the efficacy of BCG revaccination for the prevention of disease, the lack of vaccine efficacy with respect to prevention of infection probably decreases the likelihood of BCG revaccination conferring protection against disease,' the study authors wrote. SOURCE: The study was led by Alexander Schmidt, MD, Gates Medical Research Institute, Cambridge, Massachusetts. It was published online on May 7, 2025, in The New England Journal of Medicine. LIMITATIONS: Enrollment was paused for 4 months due to the COVID-19 pandemic, which may have contributed to a lower incidence of QFT test conversions. DISCLOSURES: The study was supported by the Gates Foundation. One author reported being an employee of the Gates Medical Research Institute. Some authors reported being employees of pharmaceutical companies such as GSK, Pfizer, and Third Rock Ventures, LLC, and owning stocks in these companies. This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication.
Associated Press
6 hours ago
- Associated Press
IBN Coverage: NRx Pharmaceuticals (NASDAQ: NRXP) Applies for FDA Commissioner's National Priority Voucher for IV Ketamine NRX-100
This article was published by IBN, a multifaceted communications organization engaged in connecting public companies to the investment community. LOS ANGELES, CA - June 30, 2025 ( NEWMEDIAWIRE ) - NRx Pharmaceuticals (NASDAQ: NRXP), a clinical-stage biopharmaceutical company developing innovative treatments for suicidal depression and PTSD, is accelerating its push toward regulatory approval of NRX-100, a preservative-free intravenous ketamine formulation. The company has filed an application under the newly created FDA Commissioner's National Priority Voucher ('CNPV') program, which promises significantly shortened review timelines for drugs that meet urgent U.S. health priorities ( ). The new CNPV program, announced by FDA Commissioner Marty Makary on June 17, is intended to bring promising treatments to market more quickly. Makary had previously identified psychedelic drugs for treatment of suicidal depression and PTSD as a national priority. For eligible drugs, the program… Read More NOTE TO INVESTORS: IBN is a multifaceted financial news, content creation and publishing company utilized by both public and private companies to optimize investor awareness and recognition. For more information, please visit Please see full terms of use and disclaimers on the InvestorBrandNetwork website applicable to all content provided by IBN, wherever published or re-published: The latest news and updates relating to NRXP are available in the company's newsroom at Forward Looking Statements Certain statements in this article are forward-looking, as defined in the Private Securities Litigation Reform Act of 1995. These statements involve risks, uncertainties, and other factors that may cause actual results to differ materially from the information expressed or implied by these forward-looking statements and may not be indicative of future results. These forward-looking statements are subject to a number of risks and uncertainties, including, among others, various factors beyond management's control, including the risks set forth under the heading 'Risk Factors' discussed under the caption 'Item 1A. Risk Factors' in Part I of the Company's most recent Annual Report on Form 10-K or any updates discussed under the caption 'Item 1A. Risk Factors' in Part II of the Company's Quarterly Reports on Form 10-Q and in the Company's other filings with the SEC. Undue reliance should not be placed on the forward-looking statements in this article in making an investment decision, which are based on information available to us on the date hereof. All parties undertake no duty to update this information unless required by law. About IBN IBN is a cutting-edge communications and digital engagement platform providing tailored Platform Solutions for select private and public companies. Over the course of 19+ years, IBN has introduced over 70 investor facing brands to the investment public and amassed a collective audience of millions of social media followers. These distinctive investor brands amplify recognition and reach as well as help fulfill the unique needs of our rapidly growing and diverse base of client-partners. IBN will continue to expand our branded network of influential properties as well as leverage the energy and experience of our team of professionals to best serve our clients. IBN's Platform Solutions provide access to: (1) our Dynamic Brand Portfolio (DBP) through 70+ investor facing brands; (2) article and editorial syndication to 5,000+ news outlets; (3) full-scale distribution to a growing Social Media Network (SMN) ; (4) a network of wire solutions via InvestorWire to effectively reach target markets and demographics; (5) Press Release Enhancement to ensure accuracy and impact; (6) a full array of corporate communications solutions; and (7) total news coverage solutions. For more information, please visit Please see full terms of use and disclaimers on the InvestorBrandNetwork website applicable to all content provided by IBN, wherever published or re-published: Media Contact IBN Los Angeles, California 310.299.1717 Office [email protected] View the original release on
