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GlobalData

Pharma

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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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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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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Japan to rejuvenate pharma landscape with new Government fund and policy reforms, says GlobalData

Japan’s Ministry of Health, Labor, and Welfare (MHLW) announced a new 10 year government fund in January 2025 to support innovative drug development. The initiative signals a stronger push towards pro-innovation policies, aiming to strengthen drug discovery capabilities and build a more resilient pharmaceutical ecosystem in the country, says GlobalData, a leading data and analytics […]
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South Korea and China stand at forefront of degrader antibody-conjugate development in oncology and other indications, says GlobalData

The emergence of degrader-antibody conjugates (DACs) has attracted much attention, with a potential to transform the precision medicine landscape. DACs aim to address the limitations of traditional antibody-drug conjugates (ADCs) that combine the specificity of antibodies with the potency of protein degraders. DACs represent an emerging class of targeted therapy, with South Korea and China […]
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FDA drug approvals drop 15.44%, but smaller pharma leads innovation, reveals GlobalData bio/pharmaceutical outsourcing report

Innovator and biosimilar drug approvals by the FDA have declined by 15.44%, from 149 in 2023 to 126 in 2024. Despite this downturn, the landscape of pharmaceutical innovation remains vibrant, particularly among smaller companies, which are making significant strides in addressing unmet medical needs, says GlobalData, a leading data and analytics company. GlobalData’s Bio/Pharmaceutical Outsourcing […]
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Blood cancers dominate CAR-T pipeline, reveals GlobalData

Chimeric antigen receptor T-cell (CAR-T) therapeutics have emerged as a dominating cancer treatment within cell and gene therapies (CGT). The CAR-T landscape is dominated by blood cancers, with industry leaders like Bristol Myers Squibb at the forefront of this revolution, driving advancements that have the potential to redefine treatment paradigms for blood cancers, such as […]
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NHS approval of endometriosis therapy Ryeqo enhances patient care, eases healthcare strain, says GlobalData

The National Health Service (NHS) in England has approved Gedeon Richter’s Ryeqo, the first long-term pill available for endometriosis for patients who have exhausted all other treatment options. The approval addresses the long-standing gap in long-term treatment options for endometriosis, improving overall disease management while easing the burden on healthcare resources, says GlobalData, a leading […]
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IA-2A positivity could help develop effective intervention strategies in type 1 diabetes progression, says GlobalData

A recent study published in Springer Medizin has identified insulinoma-associated protein 2 autoantibody (IA-2A) positivity as a significant biomarker for disease progression in individuals at risk of type 1 diabetes (T1D). The findings are particularly relevant as the T1D market undergoes a transformation driven by advancements in predictive diagnostics and disease-modifying therapies. This discovery enhances […]
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Lerodalcibep could become key option for patients requiring additional LDL-C reduction beyond existing therapies, says GlobalData

LIB Therapeutics (LIB) recently announced that the FDA has accepted its Biologics License Application (BLA) for lerodalcibep, a novel therapy designed to lower low-density lipoprotein cholesterol (LDL-C) in patients with atherosclerotic cardiovascular disease (ASCVD) or those at high or very high risk of developing ASCVD. If approved, lerodalcibep could be a key treatment option for […]
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Sionna Therapeutics’ NBD1 stabilizers hold potential to differentiate from Vertex’s existing therapies in cystic fibrosis, says GlobalData

Sionna Therapeutics has recently raised $191 million through its initial public offering (IPO), marking a step forward in its efforts to develop treatments for cystic fibrosis (CF). With Vertex Pharmaceuticals maintaining a dominant position in the CF treatment landscape through its CFTR modulator franchise, Sionna is looking to introduce its NBD1 stabilizers, SION-719 and SION-451, […]
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