Sanofi, Regeneron's Itepekimab Delivers Mixed Results in Late-Stage Trials
Sanofi and Regeneron said that drug candidate Itepekimab met the primary goal in one of two chronic obstructive pulmonary disease phase 3 studies, but didn't hit the main objective of a second trial.
The French pharmaceutical company on Friday said that Itepekimab in former smokers with inadequately controlled chronic obstructive pulmonary disease met the primary endpoint of a statistically significant reduction in moderate or severe acute exacerbations compared to placebo of 27% at week 52.
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Associated Press
38 minutes ago
- Associated Press
IBN Coverage: NRx Pharmaceuticals (NASDAQ: NRXP) Files ANDA for Preservative-Free IV Ketamine
IBN published this article, a multifaceted communications organization engaged in connecting public companies to the investment community. LOS ANGELES, CA - June 5, 2025 ( NEWMEDIAWIRE ) - NRx Pharmaceuticals (NASDAQ: NRXP), has submitted an Abbreviated New Drug Application (ANDA) to the FDA for NRX-100, its preservative-free intravenous ketamine formulation aimed at approved indications such as anesthesia and pain management. With the U.S. ketamine market valued at $750 million and global demand projected to reach $3.35 billion by 2034, the company is seeking priority review amid an ongoing national shortage. NRx also plans to petition the FDA to mandate preservative-free ketamine formulations, citing safety concerns over benzethonium chloride. This filing complements its broader strategy to expand ketamine's label to include treatment for suicidal depression, backed by clinical data from more than 1,000 patients. To view the full press release, visit About NRx Pharmaceuticals, Inc. NRx Pharmaceuticals is a clinical-stage biopharmaceutical company developing therapeutics based on its NMDA platform for the treatment of central nervous system disorders, specifically suicidal bipolar depression, chronic pain, and PTSD. The Company is developing NRX-101, an FDA-designated investigational Breakthrough Therapy for suicidal treatment-resistant bipolar depression and chronic pain. NRx plans to file an NDA for Accelerated Approval for NRX-101 in patients with bipolar depression and suicidality or akathisia. NRX-101 additionally has potential to act as a non-opioid treatment for chronic pain, as well as a treatment for complicated UTI. NRx has recently initiated a New Drug Application filing for NRX-100 (IV ketamine) for the treatment of suicidal depression, based on results of well-controlled clinical trials conducted under the auspices of the US National Institutes of Health and newly obtained data from French health authorities, licensed under a data sharing agreement. NRx was awarded Fast Track Designation for development of ketamine (NRX-100) by the US FDA as part of a protocol to treat patients with acute suicidality. 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. 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Entrepreneur
an hour ago
- Entrepreneur
Manila-Based telehealth Startup &you Secures Pre- Seed Funding from International Investors
The company is launching with a focus on some of the most neglected and misunderstood health issues in Southeast Asia. But its broader ambition is to become the region's most seamless and trusted online healthcare platform — a market expected to surpass $22 billion by 2030, growing at a CAGR of over 18%. Opinions expressed by Entrepreneur contributors are their own. You're reading Entrepreneur Asia Pacific, an international franchise of Entrepreneur Media. &you ( a health tech startup founded by entrepreneur Emil Eriksen, has raised an undisclosed amount in pre-seed funding, backed by a strategic group of early investors in a round led by New York-based VC Everywhere Ventures. "Despite a dynamic global trade environment, the macro tailwinds behind Southeast Asia and the Philippines in particular are unquestionable. We believe in rising prosperity, the incredible power of an expanding middle class, and the demand that creates for quality healthcare products. We are excited to be investing in the Philippines for the fifth time," said Scott Hartley, co-founder and managing partner, Everywhere Ventures. The company is launching with a focus on some of the most neglected and misunderstood health issues in Southeast Asia. But its broader ambition is to become the region's most seamless and trusted online healthcare platform — a market expected to surpass $22 billion by 2030, growing at a CAGR of over 18%. Rebuilding Healthcare Starts with Restoring Trust In the Philippines, trust in the healthcare system is in short supply — and for good reason. Ninety percent of people self-medicate, not by choice but out of necessity. Seven in ten rural patients travel hours just to see a specialist. Half of Filipinos can't reach a clinic within 30 minutes, and 50% of families face financial hardship just trying to access basic care. For millions, traditional healthcare is either out of reach, unaffordable, or unreliable. That's the gap &you is stepping into — not just with technology, but with a new model built around clinical credibility, licensed care, and patient trust. Tech at its core — not layered on later While a few players already exist in the space, &you believe the current offerings fall short — especially in markets like the Philippines, where patients are often left with overpriced products, clunky apps, or worse: black-market alternatives. &you offers licensed doctor consultations and FDA-compliant treatments through a streamlined digital platform — no clinic visits required. &you is developing a fully localized end-to-end system — from mobile onboarding and medical intake to prescription and nationwide delivery — built specifically for Southeast Asia's infrastructure and behavior. The platform will use advanced technology to help users assess their health and connect them with licensed local doctors to create personalized treatment plans. "We're addressing unique regional challenges such as disrupted supply chains, user- unfriendly platforms, and a significant trust deficit. Our goal is to make getting help feel as easy and safe as ordering food," said Emil Eriksen, Founder of &you. A Homegrown Model with Global Standards Behind the scenes, &you works only with FDA-compliant partners and fully-licensed doctors, ensuring that all treatments are not only accessible but also safe and fully regulated. The company emphasizes user experience and clinical credibility — not just cheaper medicine. All &you orders are handled through carefully selected partners to ensure a smooth and confidential delivery experience. Early Traction Signals Big Demand Since launching just this April, &you has already seen rapid traction, with thousands of customers in the few month, and expects to scale quickly as awareness grows. The new funding will be used to scale engineering, expand local operations, and prepare for entry into new verticals in the next 12 months. "Healthcare doesn't work here the way it should," Eriksen says. "We're fixing that — one problem, one product, and one person at a time."
Washington Post
an hour ago
- Washington Post
Adventist HealthCare won't buy Howard U. Hospital, ending partnership
Howard University and Adventist HealthCare are ending discussions for the health care company to buy Howard's hospital after a five-year partnership, officials said Thursday. Adventist will phase out its management of the hospital by February. Howard, meanwhile, is looking for a new deal to manage the hospital, university and hospital officials said.
