Latest news with #FDA-compliant
Associated Press
2 days ago
- Business
- Associated Press
Global Technologies, LTD Announces Strategic Pivot and New Agreements in Health & Wellness Sector
Greensboro, NC, June 04, 2025 (GLOBE NEWSWIRE) -- Global Technologies, LTD (OTCPK: GTLL), a public, multi-operational company focused on innovation in health and wellness, recently announced corporate developments and commercial milestones signaling a bold pivot in strategy and leadership. Over the past 90 days, GTLL has responded proactively to external FDA regulatory shifts that disrupted several industry sectors, including GLP-1 compounding and semaglutide supply. These changes catalyzed GTLL's sharpened focus on the digital health and wellness market, prompting operational streamlining and a commitment to scalable, revenue-focused platforms—particularly through its newly launched subsidiary, Primecare Supply, LLC. Launch of Primecare Supply and Execution of Key Agreements As disclosed in its May 30, 2025 Form 8-K filing, GTLL formally launched Primecare Supply, LLC and executed two transformative commercial agreements: These agreements position Primecare—and GTLL—at the forefront of compliant pharmaceutical distribution and digital wellness innovation. Leadership Appointments and Strategic Realignment In line with the Company's refined strategy, H. Wyatt Flippen has been officially appointed Chairman of the Board in addition to his role as Chief Executive Officer. Concurrently, GTLL has removed the President of its clean energy subsidiary, GOe3, LLC, to allow for a full transition away from non-core operations in the EV sector. 'We are building a business that's leaner, more focused, and directly aligned with FDA-compliant pharmaceutical distribution and digital wellness innovation,' said Flippen. 'These agreements and leadership changes reflect our resolve to reduce complexity, expand into higher-growth sectors, and deliver long-term shareholder value.' A Clearer Path Ahead GTLL is aggressively expanding its offerings in consumer-facing wellness plans and therapeutic products, leveraging both traditional partnerships and digital infrastructure. The Company is now fully aligned around the growth of its Primecare platform and related ventures, with future announcements anticipated regarding new reseller relationships, patient outreach programs, and proprietary health technologies. About Global Technologies, LTD Global Technologies, LTD (OTCPK: GTLL) is a public, multi-operational company committed to building scalable businesses in digital health, wellness, and technology. Through acquisitions, strategic licensing, and integrated platforms, GTLL delivers innovative solutions to improve lives and expand shareholder value. Forward Looking Statements: Statements made in this press release that express the Company or management's intentions, plans, beliefs, expectations or predictions of future events, are forward-looking statements. The words 'believe,' 'expect,' 'intend,' 'estimate,' 'anticipate,' 'will' and similar expressions are intended to further identify such forward-looking statements, although not all forward-looking statements contain these identifying words. Those statements are based on many assumptions and are subject to many known and unknown risks, uncertainties and other factors that could cause the Company's actual activities, results or performance to differ materially from those anticipated or projected in such forward-looking statements. The Company cannot guarantee future financial results; levels of activity, performance or achievements and investors should not place undue reliance on the Company's forward-looking statements. No information contained in this press release should be construed as any indication whatsoever of the Company's future financial performance, future revenues or its future stock price. The forward-looking statements contained herein represent the judgment of the Company as of the date of this press release, and the Company expressly disclaims any intent, obligation or undertaking to update or revise such forward-looking statements to reflect any change in the Company's expectations with regard thereto or any change in events, conditions or circumstances on which any such statements are based. No information in this press release should be construed as any indication whatsoever of the Company's future revenues or results of operations. Investor Contact: Wyatt Flippen, CEO and Chairman of the Board [email protected]
USA Today
15-05-2025
- USA Today
An estimated $60K in cigarettes seized from cruise passengers in California
An estimated $60K in cigarettes seized from cruise passengers in California Show Caption Hide Caption FDA proposes cutting nicotine in cigarettes by more than half The FDA has proposed caps on nicotine in cigarettes. The potential rule could reduce the concentration of nicotine in cigarettes by more than half. Scripps News CBP confiscated approximately 750 cartons of illicit cigarettes from two cruise passengers in Long Beach. The cigarettes, lacking necessary permits and FDA-compliant labels, were discovered in the passengers' luggage after arriving from Ensenada, Mexico. The estimated value of the contraband cigarettes is $59,920, and they will be destroyed. U.S. Customs and Border Protection seized nearly 750 cartons of illegally imported cigarettes from two cruise passengers in Long Beach, California. Officers found the cigarettes, including Newport 100s, Marlboro Red, Marlboro Silver and other varieties, in 10 pieces of luggage during an April 17 inspection, according to a May 14 news release. The couple had arrived from Ensenada, Mexico on a cruise. The agency did not identify the travelers or the cruise line they were sailing with. 'Large quantities of cigarettes are considered 'commercial' not personal use; therefore, an importer permit from the U.S. Alcohol and Tobacco Tax and Trade Bureau (TTB) is required,' CBP said in the release. 'In addition, tobacco product labels must meet FDA standards, such as including nicotine warnings and accurate product descriptions.' The two women had receipts for the cigarettes but could not show the required permits. CBP estimated the cartons – which will be destroyed under the agency's supervision – to be valued at $59,920. 'Selling illegally imported cigarettes could yield high profits for underground vendors due to the low cost of cigarettes when purchased overseas and the evasion of taxes owed upon import,' added Africa R. Bell, CBP Port Director of Los Angeles/Long Beach Seaport. 'This type of scheme not only evades revenue owed to the United States but may be harmful to the American consumer.' The news comes after CBP said in late April that officers had seized close to 72 grams of heroin mixed with fentanyl from a cruise passenger arriving in Galveston, Texas. Nathan Diller is a consumer travel reporter for USA TODAY based in Nashville. You can reach him at ndiller@
Yahoo
13-05-2025
- Business
- Yahoo
OncoCyte Corp (OCX) Q1 2025 Earnings Call Highlights: Strategic Advances in Transplant Testing ...
Release Date: May 12, 2025 For the complete transcript of the earnings call, please refer to the full earnings call transcript. OncoCyte Corp (NASDAQ:OCX) has finalized its clinical trial design and received central IRB approval, marking a significant milestone in its strategic pivot towards transplant rejection testing. The company is on track to submit a data package to the FDA by the end of the year, with FDA approval targeted for the first half of 2026. There is strong interest from top transplant centers in the US and Germany to participate in the clinical trial, representing nearly 10% of US transplant volumes. OncoCyte Corp (NASDAQ:OCX) has successfully expanded its RUO assay to 10 sites across the US, Germany, UK, Switzerland, Austria, and Southeast Asia, with researchers exploring new applications for the tests. The company reported Pharma Services revenue of $2.1 million, exceeding expectations and extending its cash runway, with gross margins of 62%. Pharma Services revenue is situation-driven and expected to vary, with Q2 revenue anticipated to be less than $500,000, highlighting potential revenue volatility. The company's oncology pipeline, while promising, is still in the early stages compared to its transplant focus, indicating a longer timeline for revenue generation in this area. OncoCyte Corp (NASDAQ:OCX) is undergoing a corporate rename, which, although budget-conscious, may cause temporary brand recognition challenges. The company anticipates a couple of quarters with increased cash burn due to clinical trial costs and FDA-compliant software development, impacting financial stability. There is uncertainty regarding the speed at which transplant centers will adopt the new test post-FDA approval, as these centers are generally risk-averse and may require time to integrate new technologies. Warning! GuruFocus has detected 6 Warning Signs with OCX. Q: Can you expand on the interest from a larger pharma customer regarding oncology kits? A: Josh Riggs, CEO: The interest is primarily around Determa IO and its potential as a standalone PCR assay or in conjunction with a larger NGS panel. The data is seen as differentiating, especially in challenging cancers like colon cancer. Q: What are the next milestones for Determa IO, and when might it represent a tangible revenue opportunity? A: Josh Riggs, CEO: We submitted for reimbursement in December 2022 and are awaiting results. The SWAG study, involving 800 patients, is a significant milestone, with results expected towards the end of the year, potentially at the San Antonio Breast Cancer Symposium. Q: What feedback have you received from large US transplant centers about participating in your study? A: Josh Riggs, CEO: The centers are enthusiastic and eager to access the technology. They are interested in answering complex questions that are difficult with only send-out options. The partnership approach is fostering strong relationships. Q: How do you anticipate the iota model impacting market growth? A: Josh Riggs, CEO: The model is expected to increase demand for testing as more marginal organs are used, leading to more adverse events. This will drive the need for tools to manage patients, and we are hopeful that new drugs will mitigate some negative effects. Q: What is the focus of the final Q-sub meeting with the FDA, and what has been de-risked? A: Ecky Schutz, Chief Science Officer: We are submitting the CSA to the FDA and have had productive pre-meetings. The FDA has provided clear guidance on what they want to see, which we have incorporated into our QA. We are on track to submit by the end of the year. For the complete transcript of the earnings call, please refer to the full earnings call transcript. This article first appeared on GuruFocus. 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
Associated Press
20-04-2025
- Business
- Associated Press
DEA MARIJUANA SCAM: As DEA Cannabis Program Implodes This 4/20, MMJ Stands Alone in Pursuit of Real Medicine
MMJ's DEA lawsuit continues moving through the federal courts. The 8 organizations who have been issued DEA federal cannabis registrations since 2021, all are incapable of growing pharmaceutical-grade marijuana and 7 are now either inactive or bankrupt. WASHINGTON, DC / ACCESS Newswire / April 20, 2025 / As the nation marks April 20 or '4/20,' the unofficial cannabis holiday long associated with marijuana reform, cultural awareness, and patient advocacy, new revelations expose a scandal at the heart of America's DEA federal cannabis research policy. The 8 companies granted marijuana registrations by the U.S. Drug Enforcement Administration (DEA) since 2021, the only one, MMJ BioPharma Cultivation is actively pursuing FDA-compliant, pharmaceutical-grade marijuana development. The others are either inactive, bankrupt or never began cultivation at all. Despite being the only registrant aligned with federal pharmaceutical drug development standards, MMJ BioPharma's application has been delayed since 2018 - a staggering violation of the Medical Marijuana and Cannabidiol Research Expansion Act (MCREA), which requires the DEA to act within 60 days. 'This is not a backlog - this is a blockade. The DEA's inaction has destroyed scientific opportunities and patient hope. Seven years is not a delay - it's deliberate DEA obstruction' said Duane Boise, CEO of MMJ BioPharma Cultivation. 4/20: From Celebration to DEA Epitome Of Ineptitude April 20 has long been a symbol of cannabis progress and patient empowerment. But in 2025, it also marks the failure of America's regulatory framework due to bureaucrats at the DEA that have not delivered. Meet Thomas Prevoznik, Deputy Administrator, Matthew Strait, Deputy Administrator Policy and Aarathi Haig, DEA attorney now under investigation for ethical violations. While the DEA continues to posture about promoting research, the facts tell a different story: MMJ BioPharma Cultivation: Still Waiting While Others Vanish MMJ BioPharma is the only registrant to: Despite these accomplishments, the DEA has yet to issue MMJ's bulk manufacturing registration. DEA's Marijuana Research Program: A Roster of Failure Calls for Action on 4/20 In light of the program's implosion, MMJ BioPharma and patient advocates are calling for: 'On this 4/20, Americans should not be celebrating cannabis reform - they should be demanding accountability, Boise added. 'The DEA's marijuana program isn't just broken. It's a scam - and suffering patients are paying the price.' MMJ is represented by attorney Megan Sheehan. CONTACT: Madison Hisey [email protected] 203-231-8583 SOURCE: MMJ International Holdings press release
Yahoo
20-04-2025
- Business
- Yahoo
DEA MARIJUANA SCAM: As DEA Cannabis Program Implodes This 4/20, MMJ Stands Alone in Pursuit of Real Medicine
MMJ's DEA lawsuit continues moving through the federal courts. The 8 organizations who have been issued DEA federal cannabis registrations since 2021, all are incapable of growing pharmaceutical-grade marijuana and 7 are now either inactive or bankrupt. WASHINGTON, DC / / April 20, 2025 / As the nation marks April 20 or "4/20," the unofficial cannabis holiday long associated with marijuana reform, cultural awareness, and patient advocacy, new revelations expose a scandal at the heart of America's DEA federal cannabis research policy. The 8 companies granted marijuana registrations by the U.S. Drug Enforcement Administration (DEA) since 2021, the only one, MMJ BioPharma Cultivation is actively pursuing FDA-compliant, pharmaceutical-grade marijuana development. The others are either inactive, bankrupt or never began cultivation at all. Despite being the only registrant aligned with federal pharmaceutical drug development standards, MMJ BioPharma's application has been delayed since 2018 - a staggering violation of the Medical Marijuana and Cannabidiol Research Expansion Act (MCREA), which requires the DEA to act within 60 days. "This is not a backlog - this is a blockade. The DEA's inaction has destroyed scientific opportunities and patient hope. Seven years is not a delay - it's deliberate DEA obstruction" said Duane Boise, CEO of MMJ BioPharma Cultivation. 4/20: From Celebration to DEA Epitome Of Ineptitude April 20 has long been a symbol of cannabis progress and patient empowerment. But in 2025, it also marks the failure of America's regulatory framework due to bureaucrats at the DEA that have not delivered. Meet Thomas Prevoznik, Deputy Administrator, Matthew Strait, Deputy Administrator Policy and Aarathi Haig, DEA attorney now under investigation for ethical violations. While the DEA continues to posture about promoting research, the facts tell a different story: 7 of 8 registrants are non-operational or irrelevant to medical science The only viable pharmaceutical applicant MMJ remains blocked MCREA's 60-day deadline has been ignored for over 2,300 days MMJ BioPharma Cultivation: Still Waiting While Others Vanish MMJ BioPharma is the only registrant to: Submit FDA Investigational New Drug (IND) applications Receive FDA Orphan Drug Designation for Huntington's Disease Develop a THC/CBD softgel for Huntington's Disease and MS Build a federally compliant cultivation facility Complete and pass DEA pre-registration inspections DEA Issued Schedule 1 registration to MMJ Labs Despite these accomplishments, the DEA has yet to issue MMJ's bulk manufacturing registration. DEA's Marijuana Research Program: A Roster of Failure Company Status Notes MMJ BioPharma Cultivation ✅ Active Still waiting for DEA to issue registration; only company pursuing FDA clinical trials with softgel capsule Maridose (Maine) ❌ Inactive Not growing, only 1,100 sq ft of space Scottsdale Research Institute ❌ Inactive No marijuana being cultivated Bright Green Corp ❌Surrendered Never grew; relinquished registration Royal Emerald Pharmaceuticals ❌ Inactive Rumored bankruptcy Groff NA Hemplex ❌ Inactive Ceased operations University of Mississippi ⚠️ Poor Quality Substandard marijuana, decades-old monopoly BRC (Biopharmaceutical Research Co.) ⚠️ Limited Activity Growing a small number of plants, not FDA-focused Irvine Labs ⚠️ Limited Activity Minimal cultivation, no pharmaceutical output Calls for Action on 4/20 In light of the program's implosion, MMJ BioPharma and patient advocates are calling for: Immediate approval of MMJ BioPharma Cultivation's stalled application A DOJ Office of Inspector General investigation Full congressional oversight hearings A formal audit of all DEA marijuana registrants since 2021 "On this 4/20, Americans should not be celebrating cannabis reform - they should be demanding accountability, Boise added. "The DEA's marijuana program isn't just broken. It's a scam - and suffering patients are paying the price." MMJ is represented by attorney Megan Sheehan. CONTACT:Madison Hiseymhisey@ SOURCE: MMJ International Holdings Related Documents: Image 4-18-25 at 11.00 AM View the original press release on ACCESS Newswire Sign in to access your portfolio
