Latest news with #JohnFoley
Irish Examiner
22-05-2025
- Politics
- Irish Examiner
Donegal man facing deportation from US waiting three years for green card
A Donegal man facing deportation from the US has been on the waiting list for consideration for a green card for more than three years. The 40-year-old man, who has been living in the US for more than 15 years after overstaying on a travel visa, was awaiting judgement on a petition for legal residency with the US Citizenship and Immigration Service — the sister agency of America's Immigration and Customs Enforcement agency (ICE). The man was recently apprehended by ICE on the back of an historic driving offence and taken into custody at an immigration detention centre. He is expected to be deported in the coming days. Should that come to pass, he will be banned from re-entering the US for 10 years. The man's status as having entered America on a travel visa waiver programme, which was voided when he overstayed the 90 days visiting period, means that he can be subjected to immediate deportation without the need for due process. His legal counsel, experienced Boston immigration lawyer John Foley, said that the man has all but accepted that his deportation is now inevitable. Petition Mr Foley said that an extended wait for a green card petition is not unusual. He said he had been confident that the man's application for legal status would be approved given he has two American-born children — sons aged nine and 10. 'It is not unusual that the process could take that long, but it is unusual that ICE wouldn't let it be adjudicated upon," Mr Foley said. It's a long runway, but I was pretty confident that he would be approved He said that he had sought for his client, who runs a construction company with a handful of employees, to be allowed wear an ankle bracelet in order that he could stay free and manage his business while awaiting the result of his petition, but to no avail. 'ICE locally said no. They no longer have any flexibility,' Mr Foley said, adding that the immigration enforcement system 'has never been this rigorous, this aggressive, or frankly this scary'. Describing the current aggressive crackdown on illegal immigration within the US as 'heartless, mean-spirited and un-American", Mr Foley said the current situation would have been 'unthinkable 112 days ago'. 'This situation, like so much under the Trump administration, is a lose-lose for everyone — but particularly so for my client's young family,' he said.
Irish Times
20-05-2025
- Politics
- Irish Times
Donegal man to be deported from US following driving charge after more than 15 years in Boston
A Donegal man living in Boston for more than 15 years is facing imminent deportation to Ireland after being detained by US immigration officials for violating his visa waiver. The 40-year-old man, who has two American-born children aged nine and 10 and has built a successful business in the Boston area, was recently arrested and brought to a detention centre run by US Immigration and Customs Enforcement (ICE) following a driving-related conviction. He did not want to be identified. The man's lawyer John Foley, an experienced immigration attorney in Boston, said he pushed for the release of his client with an ankle bracelet and 24/7 monitoring but officials declined, saying that they had no discretion in the case. READ MORE 'No matter what I said, it didn't matter. What I am shocked about is how there is no movement at all; there was no discretion at all,' said Mr Foley. 'Never say never but before I went in, I thought there was a 10 per cent chance [of his release]. Now it is 1 per cent.' The Irish man originally travelled to the US on the visa waiver programme – under which visitors to the US can stay for tourism reasons for up to 90 days without a visa – in his early 20s and did not return home. Undocumented immigrants who overstay the period of the visa waivers are left in a precarious legal position if apprehended by immigration officials as they have no recourse to the judicial process and face immediate processing for deportation. [ Deportation anxiety in Irish America: 'I would have a clean slate before travelling' Opens in new window ] There has been a renewed crackdown by the US government on undocumented immigrants since president Donald Trump took office in January. Mr Trump has pledged to carry out the largest deportation effort in US history, promising to deport all foreign people living in the country without permission. Mr Foley said his client from Donegal was now coming to terms with the inevitability of deportation at some stage over the next 10 days. 'They will take him to the airport in chains and shackles and when the flight boards they will take the handcuffs off and allow him to leave on his own,' said the lawyer. 'His main worry is his family, then his business, which is operational. He has family to go back to in Ireland but he came to Boston as a young guy and built up a business here. He hasn't been back to Ireland in 16 years.' A colleague of Mr Foley's is representing another Irishman who is also being detained by ICE and is facing deportation under visa waiver violations. Mr Foley is expecting more undocumented Irish in Boston and other Irish-American communities to be apprehended by ICE in the months ahead. He described the mood among the undocumented community in Boston as one of 'real fear.' 'Before they leave the house they are looking up and down the street. They might spend nights in different places,' he said. Mr Foley said a state prosecutor told him recently that witnesses were not showing up as witnesses because there was 'a fear of being any place where they could be approached by ICE'. He said that people who overstay a visa waiver had no rights to 'judicial processing', especially if 'they have any kind of criminal charge hanging over them; it doesn't even have to be a conviction'. 'One guy told me he was screwed by a boss who didn't give him overtime and he can't say anything in case that boss makes a phone call,' said Mr Foley. 'In the past ICE didn't respond to those one-off calls. Now, they do.' As Trump's deportations begin, what now for the undocumented Irish? Listen | 23:49
Yahoo
29-03-2025
- General
- Yahoo
Independent Lancashire garden centre with café named among UK's best
An independent garden centre in Lancashire has been named among the best in the UK in a list by The Telegraph. Independent garden centres across the UK feature in the list and if you're looking for somewhere to buy your plants and veggies this spring, look no further. That's because Holden Clough is flying the flag for Lancashire with it being the only garden centre in the county to be mentioned among the best. The garden centre has plenty to offer including fruit trees, bulbs, interior accessories and you can even stop at the café for refreshments, The Telegraph explained. The newspaper said: 'This almost century-old nursery in the beautiful Ribble Valley has dramatically expanded over the past decade under horticulturalist and grower John Foley, whose family first took over in 1978. 'Plants are propagated and raised outside in growing fields on site, so they should cope with the toughest conditions. "The nursery stocks fruit trees, shrubs, perennials and topiary alongside perennials, bulbs and annual bedding, which is all laid out in the original Frame Yard with its 1920s growing frames. 'Via their Wonder Garden project, the team will tailor-make garden borders and ship all the plants. "There are extensive areas of interior accessories, indoor plants, tools and seeds, along with a busy café and workshops.' You can see the full list of the UK's best independent garden centres via The Telegraph's website. The garden centre in Bolton-by-Bowland has been well praised by visitors too with some sharing their experiences on Google Reviews and given it a collective rating of 4.6 stars. Recommended reading: 'Huge' Lancashire garden centre with 70-year history among the best in the UK Inside the Lancashire village steeped in history and among best UK places to live What Lancashire locals love about the county from the food to the countryside One visitor said: 'The perfect cafe, set in a very pretty garden centre and gift shop. Well worth visiting if you are in the area. 'We had coffee, and lunch, and both were excellent. Plenty of vegetarian options on the menu, and a choice of non-dairy milk alternatives on offer.' Another shared: 'A fabulous independent garden centre located in the beautiful Ribble valley! There were a great selection of Christmas interiors and decorations, and very different from other shops. 'The cafe was lovely and we had a ginger cake and coffee! Can't wait to come back when we are in the area again!'
Associated Press
18-02-2025
- Business
- Associated Press
TG Therapeutics Announces Schedule of Data Presentations for BRIUMVI® (ublituximab) in Multiple Sclerosis at the Americas Committee for Treatment and Research in Multiple Sclerosis Annual Forum
NEW YORK, Feb. 18, 2025 (GLOBE NEWSWIRE) -- TG Therapeutics, Inc. (NASDAQ: TGTX), today announced the schedule of presentations highlighting data from the ULTIMATE I & II Phase 3 trials and the ENHANCE Phase 3b trial evaluating BRIUMVI® (ublituximab-xiiy) in patients with relapsing forms of multiple sclerosis (RMS) to be presented at the upcoming Americas Committee for Treatment and Research in Multiple Sclerosis (ACTRIMS) annual forum, being held February 27 – March 1, 2025, in West Palm Beach, Florida. Abstracts are now available online and can be accessed on the ACTRIMS meeting website at Details of the upcoming presentations are outlined below. Presentation Date/Time: Thursday, Feb. 27, 2025/6:45pm – 7:30pm ET Session: Poster Session 1 Abstract Number/Poster Number: 509/P107 Lead Author: Dr. John Foley – Rocky Mountain Multiple Sclerosis, Salt Lake City, Utah Presentation Date/Time: Thursday, Feb. 27, 2025/6:00pm – 6:45pm ET Session: Poster Session 1 Abstract Number/Poster Number: 301/P194 Lead Author: Nancy Monson Ph.D. - University of Texas Southwestern Medical Center, Dallas, TX OTHER BRIUMVI RELATED PRESENTATIONS: Presentation Date/Time: Friday, Feb. 28, 2025/6:45pm – 7:30pm ET Session: Poster Session 2 Abstract Number/Poster Number: 510/P425 Lead Author: Dr. John Foley – Rocky Mountain Multiple Sclerosis, Salt Lake City, Utah Presentation Date/Time: Thursday, Feb. 27, 2025/6:00pm – 6:45pm ET Session: Poster Session 1 Abstract Number/Poster Number: 516/P048 Lead Author: Ferhan Qureshi - Octave Bioscience, Menlo Park, CA Following the presentations, the data presented will be available on the Publications page, located within the Pipeline section, of the Company's website at ABOUT THE ULTIMATE I & II PHASE 3 TRIALS ULTIMATE I & II are two randomized, double-blind, double-dummy, parallel group, active comparator-controlled clinical trials of identical design, in patients with RMS treated for 96 weeks. Patients were randomized to receive either BRIUMVI, given as an IV infusion of 150 mg administered in four hours, 450 mg two weeks after the first infusion administered in one hour, and 450 mg every 24 weeks administered in one hour, with oral placebo administered daily; or teriflunomide, the active comparator, given orally as a 14 mg daily dose with IV placebo administered on the same schedule as BRIUMVI. Both studies enrolled patients who had experienced at least one relapse in the previous year, two relapses in the previous two years, or had the presence of a T1 gadolinium (Gd)-enhancing lesion in the previous year. Patients were also required to have an Expanded Disability Status Scale (EDSS) score from 0 to 5.5 at baseline. The ULTIMATE I & II trials enrolled a total of 1,094 patients with RMS across 10 countries. These trials were led by Lawrence Steinman, MD, Zimmermann Professor of Neurology & Neurological Sciences, and Pediatrics at Stanford University. Additional information on these clinical trials can be found at (NCT03277261; NCT03277248). ABOUT BRIUMVI® (ublituximab-xiiy) 150 mg/6 mL Injection for IV BRIUMVI is a novel monoclonal antibody that targets a unique epitope on CD20-expressing B-cells. Targeting CD20 using monoclonal antibodies has proven to be an important therapeutic approach for the management of autoimmune disorders, such as RMS. BRIUMVI is uniquely designed to lack certain sugar molecules normally expressed on the antibody. Removal of these sugar molecules, a process called glycoengineering, allows for efficient B-cell depletion at low doses. BRIUMVI is indicated for the treatment of adults with relapsing forms of multiple sclerosis (RMS), to include clinically isolated syndrome, relapsing- remitting disease, and active secondary progressive disease. A list of authorized specialty distributors can be found at IMPORTANT SAFETY INFORMATION Active Hepatitis B Virus infection A history of life-threatening infusion reaction to BRIUMVI WARNINGS AND PRECAUTIONS Infusion Reactions: BRIUMVI can cause infusion reactions, which can include pyrexia, chills, headache, influenza-like illness, tachycardia, nausea, throat irritation, erythema, and an anaphylactic reaction. In MS clinical trials, the incidence of infusion reactions in BRIUMVI-treated patients who received infusion reaction-limiting premedication prior to each infusion was 48%, with the highest incidence within 24 hours of the first infusion. 0.6% of BRIUMVI-treated patients experienced infusion reactions that were serious, some requiring hospitalization. Observe treated patients for infusion reactions during the infusion and for at least one hour after the completion of the first two infusions unless infusion reaction and/or hypersensitivity has been observed in association with the current or any prior infusion. Inform patients that infusion reactions can occur up to 24 hours after the infusion. Administer the recommended pre-medication to reduce the frequency and severity of infusion reactions. If life-threatening, stop the infusion immediately, permanently discontinue BRIUMVI, and administer appropriate supportive treatment. Less severe infusion reactions may involve temporarily stopping the infusion, reducing the infusion rate, and/or administering symptomatic treatment. Infections: Serious, life-threatening or fatal, bacterial and viral infections have been reported in BRIUMVI-treated patients. In MS clinical trials, the overall rate of infections in BRIUMVI-treated patients was 56% compared to 54% in teriflunomide-treated patients. The rate of serious infections was 5% compared to 3% respectively. There were 3 infection-related deaths in BRIUMVI-treated patients. The most common infections in BRIUMVI- treated patients included upper respiratory tract infection (45%) and urinary tract infection (10%). Delay BRIUMVI administration in patients with an active infection until the infection is resolved. Consider the potential for increased immunosuppressive effects when initiating BRIUMVI after immunosuppressive therapy or initiating an immunosuppressive therapy after BRIUMVI. Hepatitis B Virus (HBV) Reactivation: HBV reactivation occurred in an MS patient treated with BRIUMVI in clinical trials. Fulminant hepatitis, hepatic failure, and death caused by HBV reactivation have occurred in patients treated with anti-CD20 antibodies. Perform HBV screening in all patients before initiation of treatment with BRIUMVI. Do not start treatment with BRIUMVI in patients with active HBV confirmed by positive results for HBsAg and anti-HB tests. For patients who are negative for surface premedantigen [HBsAg] and positive for HB core antibody [HBcAb+] or are carriers of HBV [HBsAg+], consult a liver disease expert before starting and during treatment. Progressive Multifocal Leukoencephalopathy (PML): Although no cases of PML have occurred in BRIUMVI-treated MS patients, JCV infection resulting in PML has been observed in patients treated with other anti-CD20 antibodies and other MS therapies. If PML is suspected, withhold BRIUMVI and perform an appropriate diagnostic evaluation. Typical symptoms associated with PML are diverse, progress over days to weeks, and include progressive weakness on one side of the body or clumsiness of limbs, disturbance of vision, and changes in thinking, memory, and orientation leading to confusion and personality changes. MRI findings may be apparent before clinical signs or symptoms; monitoring for signs consistent with PML may be useful. Further investigate suspicious findings to allow for an early diagnosis of PML, if present. Following discontinuation of another MS medication associated with PML, lower PML-related mortality and morbidity have been reported in patients who were initially asymptomatic at diagnosis compared to patients who had characteristic clinical signs and symptoms at diagnosis. If PML is confirmed, treatment with BRIUMVI should be discontinued. Vaccinations: Administer all immunizations according to immunization guidelines: for live or live-attenuated vaccines at least 4 weeks and, whenever possible at least 2 weeks prior to initiation of BRIUMVI for non-live vaccines. BRIUMVI may interfere with the effectiveness of non-live vaccines. The safety of immunization with live or live-attenuated vaccines during or following administration of BRIUMVI has not been studied. Vaccination with live virus vaccines is not recommended during treatment and until B-cell repletion. Vaccination of Infants Born to Mothers Treated with BRIUMVI During Pregnancy: In infants of mothers exposed to BRIUMVI during pregnancy, assess B-cell counts prior to administration of live or live-attenuated vaccines as measured by CD19+ B-cells. Depletion of B-cells in these infants may increase the risks from live or live-attenuated vaccines. Inactivated or non-live vaccines may be administered prior to B-cell recovery. Assessment of vaccine immune responses, including consultation with a qualified specialist, should be considered to determine whether a protective immune response was mounted. Fetal Risk: Based on data from animal studies, BRIUMVI may cause fetal harm when administered to a pregnant woman. Transient peripheral B-cell depletion and lymphocytopenia have been reported in infants born to mothers exposed to other anti-CD20 B-cell depleting antibodies during pregnancy. A pregnancy test is recommended in females of reproductive potential prior to each infusion. Advise females of reproductive potential to use effective contraception during BRIUMVI treatment and for 6 months after the last dose. Reduction in Immunoglobulins: As expected with any B-cell depleting therapy, decreased immunoglobulin levels were observed. Decrease in immunoglobulin M (IgM) was reported in 0.6% of BRIUMVI-treated patients compared to none of the patients treated with teriflunomide in RMS clinical trials. Monitor the levels of quantitative serum immunoglobulins during treatment, especially in patients with opportunistic or recurrent infections, and after discontinuation of therapy until B-cell repletion. Consider discontinuing BRIUMVI therapy if a patient with low immunoglobulins develops a serious opportunistic infection or recurrent infections, or if prolonged hypogammaglobulinemia requires treatment with intravenous immunoglobulins. Most Common Adverse Reactions: The most common adverse reactions in RMS trials (incidence of at least 10%) were infusion reactions and upper respiratory tract infections. Physicians, pharmacists, or other healthcare professionals with questions about BRIUMVI should visit ABOUT BRIUMVI PATIENT SUPPORT BRIUMVI Patient Support is a flexible program designed by TG Therapeutics to support U.S. patients through their treatment journey in a way that works best for them. More information about the BRIUMVI Patient Support program can be accessed at ABOUT MULTIPLE SCLEROSIS Relapsing multiple sclerosis (RMS) is a chronic demyelinating disease of the central nervous system (CNS) and includes people with relapsing- remitting multiple sclerosis (RRMS) and people with secondary progressive multiple sclerosis (SPMS) who continue to experience relapses. RRMS is the most common form of multiple sclerosis (MS) and is characterized by episodes of new or worsening signs or symptoms (relapses) followed by periods of recovery. It is estimated that nearly 1 million people are living with MS in the United States and approximately 85% are initially diagnosed with RRMS.1,2 The majority of people who are diagnosed with RRMS will eventually transition to SPMS, in which they experience steadily worsening disability over time. Worldwide, more than 2.3 million people have a diagnosis of MS.1 ABOUT TG THERAPEUTICS TG Therapeutics is a fully integrated, commercial stage, biopharmaceutical company focused on the acquisition, development and commercialization of novel treatments for B-cell diseases. In addition to a research pipeline including several investigational medicines, TG has received U.S. Food and Drug Administration (FDA) approval for BRIUMVI® (ublituximab-xiiy), for the treatment of adult patients with relapsing forms of multiple sclerosis (RMS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, as well as approval by the European Commission (EC) and the Medicines and Healthcare Products Regulatory Agency (MHRA) BRIUMVI to treat adult patients with RMS who have active disease defined by clinical or imaging features in Europe and the United Kingdom, respectively. For more information, visit and follow us on X (Formerly Twitter) @TGTherapeutics and on LinkedIn. BRIUMVI® is a registered trademark of TG Therapeutics, Inc. Cautionary Statement This press release contains forward-looking statements that involve a number of risks and uncertainties. For those statements, we claim the protection of the safe harbor for forward-looking statements contained in the Private Securities Litigation Reform Act of 1995. Any forward-looking statements in this press release are based on management's current expectations and beliefs and are subject to a number of risks, uncertainties and important factors that may cause actual events or results to differ materially from those expressed or implied by any forward- looking statements contained in this press release. In addition to the risk factors identified from time to time in our reports filed with the U.S. Securities and Exchange Commission (SEC), factors that could cause our actual results to differ materially include the below. Such forward looking statements include but are not limited to statements regarding the results of the ULTIMATE I & II Phase 3 studies, the ENHANCE Phase 3b study, and BRIUMVI as a treatment for relapsing forms of multiple sclerosis (RMS). Additional factors that could cause our actual results to differ materially include the following: the risk that the data from the ULTIMATE I & II or ENHANCE trials that we announce or publish may change, or the product profile of BRIUMVI may be impacted, as more data or additional endpoints are analyzed; the risk that data may emerge from future clinical studies or from adverse event reporting that may affect the safety and tolerability profile and commercial potential of BRIUMVI; the risk that any individual patient's clinical experience in the post-marketing setting, or the aggregate patient experience in the post-marketing setting, may differ from that demonstrated in controlled clinical trials such as ULTIMATE I and II; the risk that BRIUMVI will not be commercially successful; our ability to expand our commercial infrastructure, and successfully market and sell BRIUMVI in RMS; the Company's reliance on third parties for manufacturing, distribution and supply, and a range of other support functions for our commercial and clinical products, including BRIUMVI, and the ability of the Company and its manufacturers and suppliers to produce and deliver BRIUMVI to meet the market demand for BRIUMVI; the failure to obtain and maintain requisite regulatory approvals, including the risk that the Company fails to satisfy post-approval regulatory requirements; the uncertainties inherent in research and development; and general political, economic and business conditions, including the risk that the ongoing COVID-19 pandemic could have on the safety profile of BRIUMVI and any of our other drug candidates as well as any government control measures associated with COVID-19 that could have an adverse impact on our research and development plans or commercialization efforts. Further discussion about these and other risks and uncertainties can be found in our Annual Report on Form 10-K for the fiscal year ended December 31, 2022 and in our other filings with the U.S. Securities and Exchange Commission. Any forward-looking statements set forth in this press release speak only as of the date of this press release. We do not undertake to update any of these forward-looking statements to reflect events or circumstances that occur after the date hereof. This press release and prior releases are available at The information found on our website is not incorporated by reference into this press release and is included for reference purposes only. Investor Relations Media Relations: 1. MS Prevalence. National Multiple Sclerosis Society website. Accessed October 26, 2020. 2. Multiple Sclerosis International Federation, 2013 via Datamonitor p. 236.
