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GlobalData

Pharma

Shionogi’s cefiderocol shows improved outcomes with early use in treating gram-negative infections, reports GlobalData

Japan-based Shionogi has shared new real-world evidence showing its antibiotic cefiderocol leads to better outcomes when used early to treat serious gram-negative bacterial infections. Presented at European Society of Clinical Microbiology and Infectious Diseases (ESCMID) Global 2025 conference in Vienna, the Retrospective Cefiderocol Chart Review (PROVE) study found that earlier use of cefiderocol, rather than […]
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Global divide emerges among physicians over patient choice in biologics vs. biosimilars, reveals GlobalData

Physician attitudes toward patient choice between the use of biologics and biosimilars vary widely across global markets, revealing deep-rooted cultural and systemic differences. While nearly half of (49%) physicians support patient involvement in treatment decisions, enthusiasm ranges from strong backing in China to notable skepticism in Germany and France—underscoring the growing but uneven shift toward […]
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Innovent’s Sycume to transform thyroid eye disease treatment landscape in China and Asia, says GlobalData

Innovent Biologics has recently received approval for Sycume (teprotumumab biosimilar) to treat thyroid eye disease (TED) in China. It is the country’s first insulin-like growth factor 1 receptor (IGF-1R) monoclonal antibody approved for TED by the National Medical Products Administration (NMPA). It represents a significant breakthrough and has the potential to transform the standard of […]
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COPD market to surpass $30.2 billion in 7MM in 2033, driven by biologics and precision medicine, forecasts GlobalData

The chronic obstructive pulmonary disease (COPD) market across the seven major markets (7MM*), is projected to grow from $11.6 billion in 2023 to $30.2 billion in 2033, representing a compound annual growth rate (CAGR) of 10%, driven by the entry of biologics into the treatment landscape and the continued integration of precision medicine approaches, forecasts […]
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Remegen eyes competitive DMT market as telitacicept shows promise in gMG, says GlobalData

At the recently held 2025 American Academy of Neurology (AAN) meeting, Remegen presented positive Phase III results for telitacicept in patients with AChR+ or MuSK+ generalized myasthenia gravis (gMG). The B cell-targeting therapy demonstrated a favorable efficacy and safety profile over 24 weeks, showing clinically meaningful improvement. These findings position telitacicept as a potential challenger […]
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OX40 inhibitors may transform atopic dermatitis landscape, says GlobalData

The atopic dermatitis (AD) treatment landscape is witnessing intensified competition with several novel therapies nearing market entry. While biologics like dupilumab have already transformed care, emerging drug classes such as OX40 inhibitors are showing promise in clinical trials. Their potential for long-lasting efficacy and favorable safety profiles may significantly advance treatment options for moderate-to-severe AD […]
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Axsome Therapeutics’ AXS-05 challenges current standard of care as promising non-antipsychotic for Alzheimer’s agitation, says GlobalData

At the recently held American Academy of Neurology (AAN) 2025 annual meeting, Axsome Therapeutics presented promising data for AXS-05 (bupropion + dextromethorphan) in treating agitation associated with Alzheimer’s disease (AD). With a novel, non-antipsychotic mechanism and a favorable safety profile, AXS-05 addresses a critical unmet need in managing distressing behavioral symptoms, potentially reshaping the current […]
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DHTs promise detection of disease progression in early PD patients receiving symptomatic treatment, says GlobalData

At the recently held AD/PD 2025 International Conference on Alzheimer’s and Parkinson’s Diseases, Roche outlined the effectiveness of digital health technologies (DHTs) in providing more sensitive measures of disease progression in early Parkinson’s disease (PD). There are no pathological or imaging-based biomarkers to measure a PD patient’s progression. Instead, physicians rely on clinical examinations and […]
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Roche’s Brainshuttle technology promises next generation of amyloid beta mAbs, says GlobalData

At the recently held AD/PD 2025 International Conference on Alzheimer’s and Parkinson’s Diseases, Roche presented interim trial data for its novel anti-amyloid monoclonal antibody (mAb), trontinemab, to clinically validate its proprietary Brainshuttle technology for the treatment of prodromal or mild to moderate Alzheimer’s disease (AD). The presentation showcased promising results from early clinical experience, with […]
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Prasinezumab hints PD progression delay as assessed by time-to-event, says GlobalData

At the recently held AD/PD 2025 International Conference on Alzheimer’s and Parkinson’s Diseases (PD), Roche announced topline results of prasinezumab in patients with early Parkinson’s disease (PD) on stable symptomatic treatment (PADOVA [NCT04777331]). The presentation highlighted the potential of prasinezumab at delaying PD motor progression as assessed with time-to-event endpoints, says GlobalData, a leading data […]
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Alzheon’s valiltramiprosate poised to meet high unmet need for MCI APOE4 homozygotes, says GlobalData

At the recently held AD/PD 2024 International Conference on Alzheimer’s and Parkinson’s Diseases (PD), Alzheon presented promising Phase III APOLLOE4 trial results for its drug ALZ-801 (valiltramiprosate) in treating mild cognitive impairment (MCI) in APOE4 homozygous patients, highlighting its potential to meet the high unmet need for a safe, effective treatment in this population, says […]
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Job cuts at US health agencies raise concerns over drug approvals and supply chain stability, reveals GlobalData

The widespread job cuts and regulatory shifts at key US health agencies, including the Food and Drug Administration (FDA) and the Centers for Disease Control and Prevention (CDC), are fueling concerns over potential delays in drug and medical device approvals. These developments could destabilize the pharmaceutical supply chain and drive companies to prioritize markets outside […]
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Bavarian Nordic’s Jynneos highlights unmet need for mpox prevention in HIV patients, says GlobalData

A recent study reveals that a single dose of Bavarian Nordic’s Jynneos vaccine demonstrated 58% overall effectiveness in preventing mpox infection. Among the participants without HIV, effectiveness rose to 84%, while those with HIV showed only 35% effectiveness. These findings underscore the critical need for enhanced mpox prevention strategies for vulnerable, high-risk populations, particularly those […]
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AGA new UC guidance will reshape market access and therapeutic competition, says GlobalData

The American Gastroenterological Association (AGA) has recently released a major update to its clinical guideline for the pharmacological management of moderate-to-severe ulcerative colitis (UC). The new “living” guideline strongly recommends the early use of biologics and small-molecule therapies following 5-ASA failure, a significant departure from the traditional step-up approach. It marks a turning point in […]
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Pharma majors expand US manufacturing amid tariff pressures as BRICS boost biosimilar access, reveals GlobalData

Major pharmaceutical companies including Eli Lilly, Pfizer, and Merck are ramping up manufacturing investments in the US to navigate the evolving trade tariffs and capitalize on domestic tax incentives. While this strategic shift supports supply chain resilience, it may also elevate production costs and drug prices—raising concerns around affordability as emerging markets pursue regulatory reforms […]
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