Category: 3. Business

  • TTFields Plus Chemo Improves QOL, Delays Time to Pain Deterioration in Locally Advanced Pancreatic Adenocarcinoma

    TTFields Plus Chemo Improves QOL, Delays Time to Pain Deterioration in Locally Advanced Pancreatic Adenocarcinoma

    TTFields Plus Chemo in Pancreatic
    Adenocarcinoma | Image Credit: ©
    Ashling Wahner & MJH Life Sciences Using AI

    Tumor-treating fields (TTFields) administered in conjunction with gemcitabine plus nab-paclitaxel (Abraxane) led to an improvement in global health status (GHS) and significantly delayed time to pain deterioration and opioid use compared with gemcitabine plus nab-paclitaxel alone in patients with locally advanced pancreatic adenocarcinoma, according to data from an analysis of the phase 3 PANOVA-3 trial (NCT03377491) presented at the 2025 ESMO Gastrointestinal Cancers Congress.1

    Findings showed that based on responses to the EORTC QLQ-C30 questionnaire, patients treated with TTFields plus chemotherapy (n = 285) experienced a median time to deterioration of GHS of 7.1 months (95% CI, 5.7-9.4) compared with 5.7 months (95% CI, 4.1-7.4) for those given gemcitabine plus nab-paclitaxel alone (n = 286; HR, 0.77; 95% CI, 0.61-0.97; P = .023).

    Per responses to the EORTC QLQ-C30 and PAN26 questionnaires, time to deterioration was significantly longer in the TTFields arm for most symptoms, including nausea/vomiting (P = .021), appetite loss (P = .017), constipation (P = .004), diarrhea (P = .023), bloating (P = .034), digestive symptoms (P = .005), taste loss (P = .047), flatulence (P = .015), and weight (P = .002). Statistical significance was not reached for indigestion (P = .155) and altered bowel habit (P = .085); however, both trended in favor of the TTFields regimen.

    Notably, no significant difference in general symptoms was observed between the 2 arms, per responses to EORTC PAN26.

    Patients treated in the TTFields arm experienced a median time to deterioration of pain of 10.1 months (95% CI, 8.0-11.6) per the EORTC QLQ-C30 questionnaire vs 7.4 months (95% CI, 5.9-9.0) in the control arm (HR, 0.70; 95% CI, 0.54-0.89; P = .003). The median time to deterioration of pancreatic pain per the EORTC PAN26 questionnaire was 14.7 months (95% CI, 12.0-16.5) vs 10.2 months (95% CI, 8.8-12.2), respectively (HR, 0.69; 95% CI, 0.52-0.90; P = .006).

    “These QOL data, together with the overall survival [OS] benefit and lack of exacerbation of systemic toxicity related with chemotherapy, [position] TTFields as a new potential standard for patients with locally advanced pancreatic cancer,” lead study author Teresa Macarulla, MD, PhD, an attending physician in the Gastrointestinal Tumors Unit at Vall d’Hebron Hospital and a clinical researcher in the Gastrointestinal Tumor Program at Vall d’Hebron Oncology Institute in Barcelona, Spain, said during a presentation of the data.

    PANOVA-3 Efficacy Findings

    Findings from the phase 3 study shared the 2025 ASCO Annual Meeting showed that the addition of TTFields to gemcitabine and nab-paclitaxel improved overall survival (OS) vs chemotherapy alone, meeting the primary end point (HR, 0.82; 95% CI, 0.68-0.99; P = .039).2 Patients in the TTFields group achieved a median OS of 16.2 months (95% CI, 15.0-18.0) compared with 14.2 months (95% CI, 12.8-15.4) for those given chemotherapy alone.

    The median pain-free survival was 15.2 months (95% CI, 10.3-22.8) in the TTFields arm vs 9.1 months (95% CI, 7.4-12.7) in the control arm (HR, 0.74; 95% CI, 0.56-0.97; P = .027).

    Trial Background and QOL Objectives

    Investigators of PAVOVA-3 enrolled patients at least 18 years of age with previously untreated locally advanced pancreatic adenocarcinoma confirmed via biopsy.1 Patients needed to have a life expectancy of at least 3 months and an ECOG performance status of 0 to 2. Key exclusion criteria comprised prior palliative treatment to the tumor, the presence of an implanted medical device in the torso, and known allergies to medical adhesives, hydrogel, or chemotherapies.

    Patients were randomly assigned 1:1 to receive TTFields at 150 kHz for 18 hours per day in combination with 1000 mg/m2 of gemcitabine and 125 mg/m2 of nab-paclitaxel, with both chemotherapies given on days 1, 8, and 15 of each 28-day cycle; or the same chemotherapy regimen without TTFields. Patients were stratified by region and ECOG performance status.

    Follow-up visits occurred every 4 weeks, and CT scans were given once every 8 weeks. Along with the primary end point of OS, secondary end points included progression-free survival (PFS), local PFS, overall response rate, 1-year OS rate, QOL, pain-free survival, resectability rate, and safety.

    The median age was 67 years (range, 31-90) in the TTFields arm vs 67.5 years (range, 40-88) in the chemotherapy arm. Additionally, 51.6% of patients in the TTFields arm were male vs 43.7% of patients in the control arm. Most patients were White (TTFields arm, 70.9%; control arm, 71.3%), had an ECOG performance status of 1 (58.2%; 57.0%), had a body mass index below 25 kg/m2 (58.2%; 60.8%), and had a target lesion site at the head of the pancreas (50.2%; 51.7%). Macarulla noted that the majority of patients had moderate CA19-9 levels between 38 and 1000 U/mL (49.1%; 53.1%) or high CA19-9 levels above 1000 U/mL (30.9%; 27.6%).

    Predefined QOL end points included assessments using the EORTC QLQ C-30 and PAN26 questionnaires, along with HRQOL deterioration-free survival. Time to first opioid use was a post hoc secondary end point.

    Data on Opioid Use

    Findings from the post hoc analysis demonstrated that the median time to opioid use in the intention-to-treat (ITT) population was 7.1 months (95% CI, 6.2-9.3) in the TTFields arm vs 5.4 months (95% CI, 4.1-6.9) in the chemotherapy arm (HR, 0.80; 95% CI, 0.65-1.00; P = .046).

    In the modified ITT population, which patients who received at least 1 full cycle of gemcitabine plus nab-paclitaxel (both arms) and at least 28 days of TTFields (for the experimental arm), TTFields plus chemotherapy (n = 198) produced a median time to opioid use of 9.3 months (95% CI, 7.1-11.0) vs 6.7 months (95% CI, 5.1-8.2) for chemotherapy alone (n = 207; HR, 0.73; 95% CI, 0.56-0.94; P = .014).

    In the ITT population, 50% of patients in the TTFields arm and 49% of patients in the control arm received any opioids at least once. Within these populations, strong opioids were given to 80% and 82% of patients, respectively. Weak opioid use was recorded in 33% of patients who used opioids in the experimental arm vs 28% in the control arm.

    In the modified ITT population, any opioid use was reported in 52% of patients in the TTFields arm and 53% of patients in the control arm. For those in the TTFields group, strong and weak opioids were given to 75% and 38% of patients, respectively. These respective rates were 81% and 33% in the control arm.

    Disclosures: Macarulla reported serving in a consulting or advisory role for Sanofi/Aventis, Celgene, Roche, QED Therapeutics, Baxter, Incyte, Servier, Lilly, Ipsen, AstraZeneca, MSD, Eisai, Prime Oncology, Ability Pharma, Advance Medical, BioLineRX, Zymeworks, Aptitude Health, Basilea, Medscape, Novocure, Paraxel, Ellipses Pharma, Janssen, MFAR, Marketing Farmacéutico & Investigación Clínica, Amgen, Esteve, Arcus Biosciences, Boehringer Ingelheim, Taiho/Keylates, Alligator Bioscience, PEGASCY, Astellas Pharma, and Revolution Medicines; receiving institutional research funding from Celgene, Agios, ASLAN Pharmaceuticals, Bayer, Roche, Genentech, AstraZeneca, Immunomedics, Lilly, Merrimack, Millennium, Novocure, Pfizer, Pharmacyclics, AbbVie, Ability Pharma, Amc Medical Research, Amgen, Armo Biosciences, Basilea Pharmaceutica International, Beigene, Keralty Group, BiolineRx, Blueprint Medicines, Boston Biomedical, Bristol Myers Squibb (BMS), Cantargia AB, Eisai, Erytech Pharma, Fibrogen, Halozyme, Incyte, Ipsen, Loxo, Medimmune, Merck Sharp & Dohme, Nelum Corp, Novartis, OncoMed, VCN Biosciences, and Zymeworks; and receiving coverage of travel, accommodations, and expenses from Merck, H3 Biomedicine, Sanofi, Celgene, Servier, Prime Oncology, Incyte, and AstraZeneca.

    References

    1. Macarulla T, Picozzi V, Chandana S, et al. PANOVA-3: pain and quality of life outcomes with tumor treating gields (TTFields) therapy in patients with locally advanced pancreatic adenocarcinoma (LA-PAC). Presented at: 2025 ESMO Gastrointestinal Cancers Congress; July 2-5, 2025; Barcelona, Spain. Abstract LBA3.
    2. Picozzi V, Babiker HM, Chandana SR, et al. PANOVA-3: Phase 3 study of tumor treating fields (TTFields) with gemcitabine and nab-paclitaxel for locally advanced pancreatic ductal adenocarcinoma (LA-PAC). J Clin Oncol. 2025;43(suppl 17): LBA4005. doi:10.1200/JCO.2025.43.17_suppl.LBA4005

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  • Huntsman to Discuss Second Quarter 2025 Results on August 1, 2025 :: Huntsman Corporation (HUN)

    Huntsman to Discuss Second Quarter 2025 Results on August 1, 2025 :: Huntsman Corporation (HUN)

    THE WOODLANDS, Texas, July 3, 2025 /PRNewswire/ — Huntsman Corporation (NYSE: HUN) will hold a conference call on Friday, August 1, 2025, at 10:00 a.m. ET to discuss its second quarter 2025 financial results. Following some opening remarks, the call will move into a question and answer session.

    The earnings press release, including financial statements and segment information, will be distributed after the market closes on Thursday, July 31, 2025. The earnings slide presentation and prepared remarks will be available at www.huntsman.com/investors after the market closes on Thursday, July 31, 2025.

    Webcast link:
    https://event.choruscall.com/mediaframe/webcast.html?webcastid=5R7ztW5k

    Participant dial-in numbers:
    Domestic callers:                    (877) 402-8037
    International callers:                (201) 378-4913

    The conference call will be accessible via the webcast link and Huntsman’s investor relations website, www.huntsman.com/investors. Upon conclusion of the call, the webcast replay will be accessible via Huntsman’s website.

    About Huntsman:
    Huntsman Corporation is a publicly traded global manufacturer and marketer of differentiated and specialty chemicals with 2024 revenues of approximately $6 billion. Our chemical products number in the thousands and are sold worldwide to manufacturers serving a broad and diverse range of consumer and industrial end markets. We operate more than 60 manufacturing, R&D and operations facilities in approximately 25 countries and employ approximately 6,300 associates within our continuing operations. For more information about Huntsman, please visit the company’s website at www.huntsman.com.

    Social Media:
    Twitter: www.twitter.com/Huntsman_Corp
    Facebook
    : www.facebook.com/huntsmancorp
    LinkedIn
    : www.linkedin.com/company/huntsman

    Forward-Looking Statements: 
    Certain information in this release constitutes forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. These statements are based on management’s current beliefs and expectations. The forward-looking statements in this release are subject to uncertainty and changes in circumstances and involve risks and uncertainties that may affect the company’s operations, markets, products, services, prices and other factors as discussed under the caption “Risk Factors” in the Huntsman companies’ filings with the U.S. Securities and Exchange Commission. Significant risks and uncertainties may relate to, but are not limited to, volatile global economic conditions, cyclical and volatile product markets, disruptions in production at manufacturing facilities, reorganization or restructuring of Huntsman’s operations, including any delay of, or other negative developments affecting the ability to implement cost reductions, timing of proposed transactions, and manufacturing optimization improvements in Huntsman businesses and realize anticipated cost savings, and other financial, economic, competitive, environmental, political, legal, regulatory and technological factors. The company assumes no obligation to provide revisions to any forward-looking statements should circumstances change, except as otherwise required by applicable laws.

     

    View original content to download multimedia:https://www.prnewswire.com/news-releases/huntsman-to-discuss-second-quarter-2025-results-on-august-1-2025-302497851.html

    SOURCE Huntsman Corporation


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  • Sidley Advises Athora on £5.7 Billion Acquisition of Pension Insurance Corporation Group Limited | News

    Sidley Advises Athora on £5.7 Billion Acquisition of Pension Insurance Corporation Group Limited | News

    Sidley is acting as counsel for Athora Holding Ltd. (Athora), a leading European savings and retirement services provider, in its approximately £5.7 billion acquisition of Pension Insurance Corporation Group Limited (PICG), a specialist insurer of UK defined benefit pension schemes.

    Athora, which is supported by Apollo Global Management and Athene Holdings, has approximately €76 billion in assets under management and administration (on behalf of 2.8 million policyholders) and when combined with PICG will have approximately €137 billion in assets under management and administration. Following completion, which is expected in early 2026, PICG will become Athora’s first UK subsidiary and serve as its UK insurance platform, complementing its presence in the Netherlands, Belgium, Italy, and Germany.

    The cross-practice, cross-jurisdictional Sidley team was led by partners Perry Shwachman, Ramy Wahbeh, and Sean Carney and counsel Florian Kamp, with support from associates Stanley Amoah, Andrew Lecky, Silvia Maglio, and JD Heinz. Also serving on the Athora team were partners Paige Levitt, James Phythian-Adams, Jason Menzies, Matthew Shankland, Alastair Hopwood, James Wood, and Patrick Harrison, counsel Ed Perry, and associate Jacqueline Noel.

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  • US Earnings Will Start to Show the Impact of Trump’s Tariffs

    US Earnings Will Start to Show the Impact of Trump’s Tariffs

    “Early earnings results offer conflicting messages on the margin outlook,” Kostin writes. “Companies have so far only announced modest price increases this year, although increases have been larger among firms most exposed to tariffs.”

    On the other hand, if companies themselves have to absorb a larger-than-expected share of the cost of tariffs, their profit margins will come under pressure. Revisions to analysts’ consensus estimates of corporate margins suggest that some companies may not be able to fully offset the impact of tariffs.

    Some companies will be able to tap into built-up inventories to minimize the hit to their margins from tariffs. The aggregate S&P 500 inventory-to-sales ratio was largely unchanged in the first quarter of 2025, but some companies built up their inventories before tariffs were implemented

    How are US tariffs impacting corporate earnings and profitability?

    Analysts also expect the growth in earnings-per-share, a key measurement of companies’ profitability, to drop off this quarter. The consensus estimate among analysts sees S&P 500 companies’ earnings-per-share growth decelerating to 4% this quarter relative to the same quarter last year—down from 12% in the first quarter. On a sequential basis, consensus forecasts imply that margins contracted by 50 basis points to 11.6% from 12.1%. 

    “We expect the S&P 500 in aggregate will beat the low bar set for the second quarter,” Kostin writes.

    The outlook for demand, meanwhile, still appears solid. Goldman Sachs Research expects nominal GDP in the US to grow at an average rate of 4.5% year-on-year in 2025. It also forecasts positive real income and spending growth for companies across all income cohorts. And sales revision breadth, which measures the difference between the number of companies with upward and downward revisions to their future sales estimates, has jumped back into positive territory after a sharp decline in April.

    How are tariffs impacting capital expenditures and investment?

    Tariffs and policy uncertainty don’t appear to have substantially dampened companies’ investment spending plans. Goldman Sachs economists found in a recent report that analysts raised capital spending expectations overall, when measured by weighted average.

    However, those estimates for capital spending vary widely by company. Revisions to companies’ spending plans have been greatest for the sectors and stocks most exposed to the continuing development of AI, such as utilities (which provide power for data centers) and information technology. By contrast, analysts have cut capital expenditure estimates in most other sectors. Economists at Goldman Sachs Research found that capital expenditure estimates have been lowered for companies more affected by policy uncertainty, tariffs, and potential retaliatory tariffs.

    What is the forecast for the S&P 500?

    In total, Goldman Sachs Research forecasts that S&P 500 earnings-per-share will grow 7% in 2025 to $262. That’s slightly above the median strategist 2025 forecast for a 6% increase to $260.

    The team’s estimate incorporates a modest drag on economic growth and a one-time boost to inflation from tariffs, which is likely to weigh on some sectors. But this is expected to be offset by growth in certain sectors such as information technology, communication services, and healthcare.

    Kostin’s team forecasts that the S&P 500 will return 5% over the next 12 months, reaching 6500.

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  • Autonomous Vehicle Market Is Forecast to Grow and Boost Ridesharing Presence

    Autonomous Vehicle Market Is Forecast to Grow and Boost Ridesharing Presence

    Key determinants in whether that forecast proves too ambitious or too conservative include the pace at which AV providers can scale their operations and the degree of competition. Our researchers say they will continue to monitor whether improving AI training technology and models, as well as simulation tools, will lead to an increased number of AV tech providers over time.

    But there are early signs of AV scaling success. Data shows that consumers are gravitating toward AVs in select rideshare markets where they are available. The safety record of Waymo, a self-driving technology company, so far is also encouraging. The company’s studies show that its vehicles had far fewer airbag deployment crashes and injury-causing crashes as compared to human drivers.

    How expensive will autonomous vehicles be?

    As AVs increase their scale, their costs are coming down. Each successive generation of AVs is incorporating more purpose-built hardware. For example, one company was able to greatly decrease the number of installed cameras as it transitioned from its fifth-generation model to the sixth. Those kinds of improvements are helping to significantly reduce the average cost of an AV in the US. That said, AV costs in the US will likely remain above AV costs in China, which launched the technology earlier and where market economics are different.

    Driving costs per mile are also on the decline. Enabled in part by lower hardware costs, depreciation costs per mile could drop from about 35 cents in 2025 to 15 cents in 2040 for a representative AV, our researchers estimate. Insurance costs are expected to decline from 50 cents a mile to about 23 cents over the same timeframe.

    Other big savings could be realized as AV companies are able to rely on fewer remote operators, who don’t directly drive the vehicles but act as a safety net by providing virtual assistance in navigating complex or ambiguous situations. Our team predicts one remote operator could manage 35 cars by 2040, up from 10 in 2030 and only three at present.

    Will drivers pick robotaxis over car ownership?

    As AVs and robotaxis proliferate, will people stop buying cars? Delaney and his colleagues conclude that view is probably too negative, given that the per-mile cost of owning and operating a personal vehicle in the US is at most a little over $1, compared with more than $2 per mile for the average rideshare.

    As AV costs continue to decline over the next decade or two, they believe users may choose to own an AV rather than rent one for a ride, particularly if they can sleep and engage in other activities while they’re traveling.

    “Importantly, this aligns with the ambitions of several manufacturers”, they write in the report. “However, we think AV shipments in the US for the next 3-5 years will be mostly or entirely for commercial applications.”

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  • Is There Really an Electrification Race for the US and Western Automakers to Lose? – autoevolution

    1. Is There Really an Electrification Race for the US and Western Automakers to Lose?  autoevolution
    2. Trump’s Policy Bill Could Put the U.S. Further Behind China  The New York Times
    3. Trumponomics 2.0 will erode the foundations of America’s prosperity  The Economist
    4. China, Lawsuits, and the “One Big, Beautiful” Bill  Financial Sense
    5. Is the Republican Party a Chinese Communist Conspiracy?  The American Prospect

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  • A Closer Look at Nipocalimab’s Impact on Myasthenia Gravis Care: Constantine Farmakidis, MD

    A Closer Look at Nipocalimab’s Impact on Myasthenia Gravis Care: Constantine Farmakidis, MD

    The April 30 FDA approval of nipocalimab-aahu (Imaavy; Johnson & Johnson) for generalized myasthenia gravis (gMG) in adult and pediatric patients 12 years or older marked a significant advancement in treating this chronic neuromuscular disease. To break down what this means for these patients and clinicians, The American Journal of Managed Care® (AJMC®) spoke with Constantine Farmakidis, MD, a neuromuscular specialist and associate professor at the University of Kansas Medical Center, whose expertise lies in MG and related neuromuscular junction disorders.

    Farmakidis explains how nipocalimab—a neonatal Fc receptor (FcRn) blocker—works to rapidly reduce harmful antibodies driving gMG symptoms and offers a targeted alternative to broad immunosuppressants. He discusses key findings from the pivotal Vivacity-MG3 (NCT04951622) trial, including early symptom relief and sustained benefits, while addressing practical considerations like administration and safety. Notably, nipocalimab’s approval covers a broad patient population, both anti–acetylcholine receptor positive (AChR+) and anti–muscle-specific kinase antibody positive (MuSK+) subtypes, as well as adolescents.

    Read on for insights into how nipocalimab fits into the evolving gMG treatment landscape and its potential to improve daily function for patients with this challenging condition.

    This transcript has been lightly edited for clarity.

    AJMC: Can you briefly explain the mechanism of action of FcRn blockers, such as nipocalimab, and why this class of medications is particularly effective in treating gMG?

    Farmakidis: Nipocalimab is a neonatal FcRn blocker that inhibits the recycling and recirculation of immunoglobulin G (IgG) antibodies and ultimately leads to a broad knockdown of IgG levels in the body. Myasthenia gravis is an IgG autoantibody–mediated disease—and in patients who have gMG, nipocalimab broadly decreases their IgG levels—but this also includes disease-causing IgG autoantibodies like the AChR antibody and the MuSK antibody. It is through this antibody removal mechanism that nipocalimab treats MG.

    The phase 3 Vivacity-MG3 study of nipocalimab in patients with gMG was pivotal, showing that treatment with nipocalimab leads to improved disease control and that the medication is well tolerated in a broad population of patients.

    There is another category of recently developed biologic agents that treat MG by inhibiting the terminal portion of the complement system. There is no evidence to date that FcRn blockers are more effective than terminal complement inhibitors for MG treatment.

    AJMC: Mechanistically, what differentiates nipocalimab from other currently approved FcRn inhibitors for gMG?

    Farmakidis: Nipocalimab is a fully human, nonglycosylated IgG1 isotype monoclonal antibody that blocks the neonatal Fc receptor. Rozanolixizumab (Rystiggo; UCB) is a humanized monoclonal antibody that is also designed to block the neonatal FcRn and inhibit antibody recycling; it is of the IgG4 isotype.

    Efgartigimod (Vyvgart; Argenx), unlike nipocalimab and rozanolixizumab, is not a full antibody but a portion of an antibody known as a fragment. This drug is derived from the Fc fragment portion of an IgG1 humanized antibody that is also a neonatal FcRn blocker.

    AJMC: Nipocalimab is described as immunoselective, sparing other adaptive and innate immune functions. How does this characteristic differentiate its safety and tolerability profile?

    Farmakidis: Nipocalimab is intended to knock down IgG antibody levels. This could be anticipated to interfere with antibody-mediated or humoral immunity. However, clinical trial data indicate mild suppression of humoral immunity. On the other hand, nipocalimab and other neonatal FcRn blockers do not interfere with the complement system or interfere with cell-mediated immunity, as can be seen with other immunosuppressant medications such as prednisone.

    Constantine Farmakidis, MD | Image Credit: University of Kansas Medical Center

    AJMC: The Vivacity-MG3 trial demonstrated rapid IgG reduction and symptom relief as early as week 2. How clinically meaningful is this swift onset of response for patients and their management?

    Farmakidis: Clinical trial data for nipocalimab in MG show both early drops in serum IgG levels and simultaneous improvement in disease control, as seen in MG clinical trial outcome measures. This is encouraging, because traditional medications like immunosuppressants or steroids can take months to show effect, although it should be noted that each patient will have an individualized response to an FcRn blocker, and both the clinical effect and time of onset of any benefit may not match aggregated clinical trial results.

    AJMC: How should clinicians interpret the observed changes in Myasthenia Gravis Activities of Daily Living (MG-ADL) and Quantitative Myasthenia Gravis (QMG) scores seen in the Vivacity-MG3 trial in terms of their tangible impact on patients’ daily functioning and quality of life?

    Farmakidis: A 2-point change in the MG-ADL scale is considered clinically significant, while a 3-point change in the QMG score is generally considered clinically significant. The clinical trial in myasthenia gravis showed statistically significant improvement in the nipocalimab-plus-standard-of-care group vs those who only received standard of care for both the MG-ADL and QMG outcome measures.

    AJMC: Considering the inclusion of patients refractory to standard of care in Vivacity-MG3, what do these findings reveal about nipocalimab’s potential role in managing treatment-resistant gMG?

    Farmakidis: Individual outcomes with nipocalimab therapy for patients who previously were treatment refractory cannot be projected from the aggregate outcomes of a clinical trial with about 75 patients in each of the nipocalimab and placebo groups. However, since this was a positive trial in a group of patients with gMG who were on background treatments and still had moderate to severe symptoms, this could be taken as an indication that nipocalimab is a promising treatment option for patients.

    AJMC: What are the practical administration considerations for nipocalimab, particularly for diverse patient populations such as adolescents or those with mobility limitations?

    Farmakidis: Nipocalimab is administered as an intravenous (IV) infusion every 2 weeks. Patients should be able to travel or obtain transportation to an infusion center, although it is possible that nipocalimab may become available through home infusions as well. Individuals should also have veins that are consistently accessible or be amenable to port placement or an equivalent medical device that allows for consistent and uncomplicated IV access.

    AJMC: What realistic day-to-day functional improvements can patients anticipate with nipocalimab therapy?

    Farmakidis: Patients with MG can have ocular, lower face, limb, and respiratory muscle weakness. Any of these can improve if the individual patient is responsive to nipocalimab.

    AJMC: The open-label extension data indicate sustained disease control with benefits lasting up to 20 months (72 weeks). Could you discuss the clinical importance of this long-term durability for managing gMG’s fluctuating and often unpredictable nature?

    Farmakidis: The treatment goal in MG is to first achieve disease control and then to have disease control be durable. The open-label extension data for nipocalimab in MG showed evidence of durable disease control. This is a very encouraging finding.

    AJMC: What further insights do you anticipate from even longer-term data?

    Farmakidis: Postapproval clinical data are likely to provide critical information about the long-term safety and tolerability of nipocalimab.

    AJMC: Given its favorable safety profile, what are the key adverse effects and monitoring requirements clinicians and patients should be aware of when using nipocalimab?

    Farmakidis: Infections were not observed at a higher rate in the nipocalimab group vs the placebo group. However, given nipocalimab’s immune-driven mechanism of action, it remains important to monitor patients for severe infections. There are other adverse effects listed in the product insert, and these should also be monitored as well.

    AJMC: Nipocalimab’s approval now encompasses the broadest FcRn-treated population, including both anti–AChR+ and anti–MuSK+ subtypes, as well as adolescents. Can you discuss the clinical significance of having a single FcRn inhibitor for this expanded population, how it impacts current treatment paradigms, and your confidence in its use for adolescents?

    Farmakidis: In my view, it is significant that an additional drug such as nipocalimab is now approved for use in patients who are AChR antibody-positive and MuSK antibody-positive—essentially, the more options available, the better for patients. At this time there is no basis to say that nipocalimab may be superior to other FcRN blockers or terminal complement inhibitors, as no clinical trials have been done to compare the effectiveness of these drugs. As for the approval for adolescents, it is highly notable, as this is the first biologic agent approved in this age group. Here nipocalimab will provide an FDA-approved corticosteroid-sparing treatment option.

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  • Flash Report: June’s Unemployment Rate Falls as More People Find Jobs – Federal Reserve Bank of St. Louis

    1. Flash Report: June’s Unemployment Rate Falls as More People Find Jobs  Federal Reserve Bank of St. Louis
    2. Breaking: US Nonfarm Payrolls increase by 147,000 in June vs. 110,000 expected  FXStreet
    3. Solid US job growth masks loss of labor market momentum  Reuters
    4. U.S. payrolls increased by 147,000 in June, more than expected  CNBC
    5. July Non-Farm Payrolls preview  marketpulse.com

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  • Reconciliation Bill Closes Off Pathways to Keep Global Warming Below 1.5 C | Press Release

    “A little less than three years ago, we applauded the enactment of the Inflation Reduction Act because of all the benefits it promised to deliver,” said EESI President Daniel Bresette. “Unfortunately, the opposite applies to the reconciliation bill just passed by the Senate and House of Representatives so we have to condemn it. This legislation will increase household energy bills, put people out of work, and stall investments in clean energy technologies. Greenhouse gas emissions will increase as a result of this bill becoming law, essentially closing off the few remaining pathways to limit global warming to 1.5°C (2.7°F) to avoid the worst outcomes of climate change.”

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  • Gulf markets rally as non-oil growth, US-Vietnam tariff deal lift investor sentiment

    Gulf markets rally as non-oil growth, US-Vietnam tariff deal lift investor sentiment

    Major Gulf stock markets rebounded on Thursday, supported by steady non-oil private sector growth and renewed investor optimism following a trade agreement between the United States and Vietnam, just ahead of the July 9 tariff deadline.

    U.S. President Donald Trump signed a deal with Vietnam on Wednesday imposing a 20% tariff on exports to the United States — significantly lower than the previously threatened 46%. The move gave markets reason to hope the impact of the tariffs on global trade may be less severe than initially feared.

    Saudi Arabia’s benchmark index rose 1%, reaching its highest level in over a month, with almost all constituents posting gains. Saudi National Bank, the kingdom’s largest lender by assets, surged 4.1%, while oil giant Saudi Aramco added 0.9%.

    BlackRock Inc. was reportedly in talks with Aramco to divest its stake in the leasing rights of a natural gas pipeline network — a deal potentially worth billions of dollars, according to Bloomberg. Reuters could not independently verify the report.

    Retailer Fawaz Abdulaziz Al Hokair & Co. was the day’s top performer, jumping 9.9%, followed by Saudi Telecom, which rose 1.2%.

    Market optimism was also fueled by strong domestic data. Saudi Arabia’s non-oil private sector expanded at its fastest pace in three months in June, according to a new survey. The seasonally adjusted Riyad Bank Saudi Arabia Purchasing Managers’ Index rose to 57.2 from 55.8 in May, remaining well above the 50-point growth threshold.

    Dubai’s main index gained 1.4% to close at 5,748 — its highest in 17 years — with most sectors trading in positive territory. Emaar Properties climbed 3.7%, while tolls operator Salik advanced 3.4%.

    In Abu Dhabi, the benchmark index rose 0.6%, supported by gains across sectors. Presight AI surged 6%, reaching its highest level in nearly two years, while Space42 rose 4.3%.

    The UAE’s non-oil private sector also expanded steadily in June despite regional tensions, as companies ramped up output to clear backlogs, according to a separate survey released Thursday.

    Qatar’s main index added 0.6%, lifted by a 0.5% gain in Qatar National Bank.

     


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