Latest news with #North America
Times
4 days ago
- Business
- Times
Hvivo blames US trade disruption for halving in share price
Uncertainty caused by trade disruption in the United States and an adverse funding environment has resulted in the cancellation of a big contract for Hvivo, sending shares in the tester of infectious and respiratory disease products sharply lower. The Aim-listed group said that one of its clients had cancelled a 'significant' contract and another had postponed a smaller one, which Hvivo believes was a result of 'current uncertainties in the pharmaceuticals industry', particularly in the US. This had led to an increase in cancellations and delays of clinical trials across the industry, the company said, also citing a 'continued depressed biotech financing market'. Hvivo infects volunteers with safe doses of virus agents then quarantines them before testing the efficacy of vaccines and antivirals in so-called human challenge trials. The company, formerly known as Open Orphan and once a large holding in Woodford Capital's Equity Income Fund, provides clinical development services to clients that include a number of the world's biggest biopharmaceutical groups, such as Pfizer. It said it had £47 million of revenue contracted for the present financial year, including cancellation and postponement fees, and anticipated further contract wins over the course of the year. The company warned, however, that if these contract wins did not materialise then it was likely that the group would fall to a mid-single-digit operating loss for the year. All but one of the contacts for 2025 have started, Hvivo said, giving management confidence that 'there is a low risk of any further cancellations'. Shares in Hvivo more than halved in value during morning trading before paring some losses. They ended the day down 7½p, or 46.3 per cent, at 8¾p. • Biotech boss takes clinical approach to acquiring unloved assets Dr Yamin 'Mo' Khan, chief executive at Hvivo, said: 'Whilst we are disappointed to have received notification from these clients due to matters beyond our control, we still remain confident in the continued growth of human clinical trials and the overall prospects of Hvivo as we also continue to diversify our revenue streams.' Analysts at Shore Capital said concerns of a slowdown in the contract research organisation sector had also been flagged by Hvivo's larger peers, who have cited more cautious spending and clients delaying their decision making. 'Some of the negative narrative towards vaccines from Trump appointees at the US health department and the US Food and Drug Administration has clearly been an added cause for concern,' Sean Conroy, an analyst at Shore Capital, said. 'We would still caution against forming any endemic view towards vaccine development and the longer-term prospects of the human clinical trial business.'
Bloomberg
5 days ago
- Business
- Bloomberg
Where Does Trump's Trade War Go With Tariffs in Legal Limbo?
By , Josh Wingrove, Shawn Donnan, and Laura Curtis Updated on Save The US Court of International Trade ruled May 28 that the vast majority of President Donald Trump's tariffs were issued illegally and ordered them blocked, which would deliver a blow to a key pillar of his economic agenda. A day later, an appeals court gave Trump's administration a temporarily reprieve from the ruling while weighing a longer-lasting hold. In a unanimous ruling by a panel of three judges, the New York-based trade court concluded that Trump wrongfully invoked an emergency law to justify the levies. It was a rare rebuke as the courts tend to defer to the president on trade matters.
South China Morning Post
6 days ago
- Business
- South China Morning Post
US court blocks Trump's ‘Liberation Day' tariffs
In a setback to US President Donald Trump's trade strategy, a US federal court has blocked his sweeping 'Liberation Day' tariffs, ruling that he overstepped his authority in using emergency powers to impose hefty levies on all US trading partners. Advertisement 'The court does not read [the International Emergency Economic Powers Act] to confer such unbounded authority and sets aside the challenged tariffs imposed thereunder,' a three-judge panel of the New York-based US Court of International Trade said in its verdict in a lawsuit brought by five American businesses. This marks the first major legal challenge to Trump's tariffs, and the unfavourable ruling potentially upends his broader trade strategy. In April, Trump invoked IEEPA, which allows the president to impose economic measures during a national emergency, to address an 'unusual and extraordinary threat'. In statements related to a similar case before the same panel on Friday, US Commerce Secretary Howard Lutnick and Secretary of State Macro Rubio urged the court to uphold the tariffs, arguing that striking them down would embarrass the US and motivate other countries to retaliate. Advertisement More to follow...
Yahoo
22-05-2025
- Health
- Yahoo
ZEVASKYN Approval Positions Abeona as Emerging Player in Dystrophic Epidermolysis Bullosa Market
Approximately a year after the FDA rejected its previous approval submission, Abeona announced that the agency had approved ZEVASKYN, its autologous cell-based gene therapy for both adult and pediatric patients with RDEB. This approval marks Abeona's entry into the commercial gene therapy market for dystrophic epidermolysis bullosa. LAS VEGAS, May 22, 2025 /PRNewswire/ -- Dystrophic epidermolysis bullosa (DEB) is one of the main subtypes of epidermolysis bullosa, a group of genetic skin disorders characterized by varying degrees of fragility in the skin and mucous membranes. This fragility occurs due to the absence, deficiency, or malfunction of proteins critical to maintaining skin structure. In the 7MM, approximately 6,500 diagnosed prevalent cases of DEB were recorded in 2023, with the United States accounting for about 50% of these cases. Currently, there is no cure for DEB. Management is primarily supportive, focusing on wound care, controlling pain and itching, preventing infections, providing nutritional assistance, and addressing complications that may arise. Learn more about the DEB therapeutic market @ Dystrophic Epidermolysis Bullosa Treatment Market As of now, only four therapies, namely FILSUVEZ (Chiesi Farmaceutici), VYJUVEK (Krystal Biotech), JACE (Japan Tissue Engineering), and recently approved ZEVASKYN (Abeona Therapeutics), have been approved for treating DEB, leaving a significant unmet need for effective and targeted dystrophic epidermolysis bullosa treatments. FILSUVEZ (oleogel-S10), developed by Chiesi Farmaceutici, is a plant-based medicinal product derived from birch bark triterpenes. It was granted EU-wide marketing authorization on June 21, 2022. In December 2023, the FDA approved FILSUVEZ topical gel for the treatment of partial-thickness wounds in patients aged six months and older with Junctional or Dystrophic Epidermolysis Bullosa (JEB and DEB). VYJUVEK (beremagene geperpavec), developed by Krystal Biotech, is a topical, repeat-dose gene therapy intended to deliver two functional copies of the COL7A1 gene directly to DEB wounds. It received FDA approval in May 2023 for use in DEB patients aged six months and older. The Marketing Authorization Application (MAA) for VYJUVEK has been validated by the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) and is currently under review. JACE, developed by Japan Tissue Engineering, is a combination product featuring a human autologous epidermal cell sheet created using Green's technique. In December 2018, Japan's Ministry of Health, Labour and Welfare (MHLW) granted additional approval for JACE, expanding its use to include both JEB and DEB. Dive deep into the treatment for dystrophic epidermolysis bullosa @ Dystrophic Epidermolysis Bullosa Drugs Market Recently, in April 2025, Abeona Therapeutics Inc. announced that the FDA had approved ZEVASKYN (pz-cel), marking it as the first and only autologous, gene-modified cell therapy for treating wounds in both adult and pediatric patients with recessive dystrophic epidermolysis bullosa (RDEB)—a severe, inherited skin disorder with no known cure. ZEVASKYN is currently the only FDA-approved therapy for RDEB wounds that works with just a single application. The approval was granted based on results from the Phase III VIITAL study (NCT04227106), a multi-center, randomized, intrapatient-controlled trial. The study successfully met its two main goals, showing significant wound healing (50% or more from baseline) and a reduction in pain, as measured by the Wong-Baker FACES scale, at six months post-treatment. ZEVASKYN is anticipated to become available in Q3 2025 through ZEVASKYN Qualified Treatment Centers (QTCs)—specialized facilities across the U.S. with expertise in treating epidermolysis bullosa and administering cell and gene therapies, ensuring broad patient access. To know more about the treatment for dystrophic epidermolysis bullosa in children, visit @ Dystrophic Epidermolysis Bullosa Drugs Companies across the globe are diligently working toward the development of novel DEB treatment therapies with considerable amount of success over the years. Some of the drugs in the pipeline include Dabocemagene autoficel (Castle Creek Biosciences), ABCB5+ MSCs (RHEACELL), and ALLO-ASC-SHEET (Anterogen), among others. Discover which therapies are expected to grab major DEB therapeutics market share @ Dystrophic Epidermolysis Bullosa Drugs Market D-Fi, also referred to as FCX-007 (dabocemagene autoficel), is an investigational autologous gene therapy designed to treat dystrophic epidermolysis bullosa (DEB). It involves using the patient's own dermal fibroblasts, which are genetically engineered using a self-inactivating (SIN) lentiviral vector carrying the COL7A1 gene to produce type VII collagen (COL7). The therapy is delivered via intradermal injection directly into the superficial papillary dermis of persistent wounds, where COL7 helps form anchoring fibrils essential for skin integrity. ABCB5-positive mesenchymal stem cells (ABCB5+ MSCs) represent a novel and promising therapeutic option for DEB. These cells possess anti-inflammatory properties through interaction with immune cells, triggering their reprogramming. Administered systemically via infusion, ABCB5+ MSCs migrate to wound sites, reduce inflammation, and aid in tissue repair by releasing and depositing type VII collagen. This therapy targets both external and internal wounds and has received Orphan Drug Designation (ODD) from both the FDA and EMA for the treatment of RDEB. RHEACELL is currently running a Phase III clinical trial to evaluate the effectiveness of ABCB5+ MSCs in patients with RDEB. Discover more about DEB drugs in development @ Dystrophic Epidermolysis Bullosa Clinical Trials The anticipated launch of these emerging dystrophic epidermolysis bullosa treatments are poised to transform the market landscape in the coming years. As these cutting-edge therapies continue to mature and gain regulatory approval, they are expected to reshape the dystrophic epidermolysis bullosa market landscape, offering new standards of care and unlocking opportunities for medical innovation and economic growth. DelveInsight estimates that the dystrophic epidermolysis bullosa market size in the 7MM is expected to grow from USD 550 million in 2023 at a significant CAGR by 2034. According to DelveInsight's analysis, the growth of the dystrophic epidermolysis bullosa market is expected to be mainly driven by increasing prevalence, patient awareness, and robust clinical pipeline during the forecast period (2025–2034). DelveInsight's latest published market report titled Dystrophic Epidermolysis Bullosa Market Insight, Epidemiology, and Market Forecast – 2034 will help you to discover which market leader is going to capture the largest market share. The report provides comprehensive insights into the dystrophic epidermolysis bullosa country-specific treatment guidelines, patient pool analysis, and epidemiology forecast to help understand the key opportunities and assess the market's underlying potential. The dystrophic epidermolysis bullosa market report proffers epidemiological analysis for the study period 2020–2034 in the 7MM, segmented into: Diagnosed Prevalent Cases of DEB Age-Specific Cases of DEB Type-specific Cases of DEB Severity-specific Cases of DEB The report provides an edge while developing business strategies by understanding trends shaping and driving the 7MM dystrophic epidermolysis bullosa market. Highlights include: 10-year Forecast 7MM Analysis Epidemiology-based Market Forecasting Historical and Forecasted Market Analysis upto 2034 Emerging Drug Market Uptake Peak Sales Analysis Key Cross Competition Analysis Industry Expert's Opinion Access and Reimbursement Download this dystrophic epidermolysis bullosa market report to assess the epidemiology forecasts, understand the patient journeys, know KOLs' opinions about the upcoming treatment paradigms, and determine the factors contributing to the shift in the dystrophic epidermolysis bullosa market. Also, stay abreast of the mitigating factors to improve your market position in the dystrophic epidermolysis bullosa therapeutic space. Related Reports Recessive Dystrophic Epidermolysis Bullosa Pipeline Recessive Dystrophic Epidermolysis Bullosa Pipeline Insight – 2025 report provides comprehensive insights about the pipeline landscape, pipeline drug profiles, including clinical and non-clinical stage products, and the key RDEB companies, including Abeona Therapeutics, Inc., Castle Creek Biosciences, LLC., RHEACELL GmbH & Co. KG, among others. Dystrophic Epidermolysis Bullosa Pipeline Dystrophic Epidermolysis Bullosa Pipeline Insight – 2025 report provides comprehensive insights about the pipeline landscape, pipeline drug profiles, including clinical and non-clinical stage products, and the key DEB companies, including Phoenix Tissue Repair, Castle Creek Biosciences, Phoenicis Therapeutics, Aegle Therapeutics, RHEACELL GmbH & Co. KG, Anterogen Co., Ltd., Abeona Therapeutics, Inc., InMed Pharmaceuticals, BridgeBio Inc., Eloxx Pharmaceuticals, Relief Therapeutics, Quoin Pharmaceuticals, among others. Epidermolysis Bullosa Market Epidermolysis Bullosa Market Insights, Epidemiology, and Market Forecast – 2034 report deliver an in-depth understanding of the disease, historical and forecasted epidemiology, as well as the market trends, market drivers, market barriers, and key epidermolysis bullosa companies including Abeona Therapeutics, Castle Creek Biosciences, RHEACELL, Ishin Pharma, Holostem Terapie Avanzate, BridgeBio (Phoenix Tissue Repair), InMed Pharmaceuticals, Shionogi, Anterogen, among others. Epidermolysis Bullosa Pipeline Epidermolysis Bullosa Pipeline Insight – 2025 report provides comprehensive insights about the pipeline landscape, pipeline drug profiles, including clinical and non-clinical stage products, and the key epidermolysis bullosa companies, including Abeona Therapeutics, InMed Pharmaceuticals, BioMendics, RHEACELL, Castle Creek Biosciences, BPGbio, Eloxx Pharmaceuticals, Phoenicis Therapeutics, Aegle Therapeutics, Amryt Pharma, among others. About DelveInsight DelveInsight is a leading Business Consultant and Market Research firm focused exclusively on life sciences. It supports pharma companies by providing comprehensive end-to-end solutions to improve their performance. Get hassle-free access to all the healthcare and pharma market research reports through our subscription-based platform PharmDelve. Contact Us Shruti Thakur info@ +14699457679 Logo: View original content: SOURCE DelveInsight Business Research, LLP 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
Reuters
22-05-2025
- Business
- Reuters
Canada's TD Bank profit falls on hit from higher bad loan provisions
May 22 (Reuters) - TD Bank ( opens new tab reported a fall in second-quarter profit on Thursday, as the Canadian lender stockpiled money to cover for potential bad loans in an uncertain economic environment. The results from the country's second-biggest bank offer a glimpse into the impact of the tariff chaos on the Canadian economy. Trade uncertainty is expected to result in higher credit losses and weaker loan growth as sentiment takes a hit from the changing outlook. In the second quarter, TD's provision for credit losses jumped to C$1.34 billion ($965.5 million) from C$1.07 billion a year earlier. "TD delivered strong results this quarter, with robust trading and fee income in our markets-driven businesses as well as deposit and loan growth in Canadian Personal and Commercial Banking," CEO Raymond Chun said in a statement. "We are operating in a fluid macroeconomic environment," Chun said. TD is also undergoing a broad-based strategic review as the new leadership looks to simplify the business and turnaround the bank after its anti-money laundering problems. Chun, a longtime TD Bank executive, took the helm in February. Meanwhile, TD's wholesale banking arm - which houses its capital markets and investment banking businesses - reported record revenue of C$2.13 billion, a 10% jump from a year earlier. Uncertainty stemming from U.S. trade policy injected heightened market volatility, spurring trading activity as investors aggressively rejigged their portfolios. Among transactions in the quarter, TD Securities was the lead left bookrunner on the $13.1 billion secondary offering of Charles Schwab (SCHW.N), opens new tab shares by TD, one of the largest equity market deals ever. TD kicks off the earnings season for Canadian lenders, with rival big banks set to report their results next week. The bank posted adjusted net income of C$3.63 billion, or C$1.97 per share, for the three months ended April 30, compared with C$3.79 billion, or C$2.04 per share, a year earlier. TD shares have gained 17.5% this year, outperforming rival banks. ($1 = 1.3878 Canadian dollars)
