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GlobalData

Pharma

FDA reversal on Moderna’s mRNA-1010 can transform the seasonal influenza vaccines market, says GlobalData

The US Food and Drug Administration’s (FDA) decision to review Moderna’s mRNA-1010, with a Prescription Drug User Fee Act (PDUFA) date set for 05 August 2026, signals a pivotal inflection point for the seasonal influenza vaccines market. If approved, the candidate will introduce the first mRNA-based flu vaccine, potentially redefining production timelines, strain matching precision, […]
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Systemic lupus erythematosus and lupus nephritis market to reach $5.9 billion in 7MM by 2034, forecasts GlobalData

The systemic lupus erythematosus (SLE) and lupus nephritis (LN) market across the seven major markets (7MM*) is forecast to grow from $2.4 billion in 2024 to $5.9 billion in 2034, at a compound annual growth rate (CAGR) of 9.6%, according to GlobalData, a leading intelligence and productivity platform. GlobalData’s latest report, “Systemic Lupus Erythematosus and […]
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Global pain market presents significant opportunities for novel mechanisms and modalities, says GlobalData

There is a lack of diversity within the current pain market, with non-steroidal anti-inflammatory drugs (NSAIDs) and opioids dominating the market. With 98% of currently marketed drugs for pain being generics, the pain market provides significant opportunities for innovation and development, according to GlobalData, a leading intelligence and productivity platform. GlobalData’s latest report, “Global Pain […]
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Pricing and reimbursement delays critical headwind for biopharmaceutical industry innovation, finds GlobalData

Delays in turning approved medicines into revenue, driven by pricing and reimbursement (P&R) processes, have emerged as one of the most critical challenges facing the pharmaceutical industry over the next year. Industry professionals now rank pricing pressure alongside innovation-led trends, underscoring growing concerns that tougher price controls and policy shifts could erode revenues, slow launches, […]
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Insmed’s treprotinil palmitil phase III study signals potential shift in progressive pulmonary fibrosis treatment, says GlobalData

At the 44th annual J.P. Morgan Healthcare conference, Insmed delivered one of the most closely watched updates in the respiratory space, detailing its clinical and commercial plans for 2026. Among the highlights was the company’s announcement to launch a Phase III study for its treprostinil palmitil inhalation powder (TPIP) in progressive pulmonary fibrosis (PPF) during […]
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Eliquis sales to fall by 15.2% in 2026 as European patent expiry nears, forecasts GlobalData

Global sales of Bristol Myers Squibb’s (BMS) and Pfizer’s drug Eliquis (apixaban) are projected to decline by 15.2% in 2026 due to the loss of its European market exclusivity on May 19, 2026, according to GlobalData, a leading intelligence and productivity platform. According to GlobalData’s Pharmaceutical Intelligence Center Sales and Forecast Database, the BMS-Pfizer alliance […]
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Diagnosed prevalent cases of systemic lupus erythematosus across 7MM to reach over 640,000 in 2034, forecasts GlobalData

The diagnosed prevalent cases of systemic lupus erythematosus (SLE) in the seven major markets (7MM*) are set to increase at an annual growth rate (AGR) of 1.17% from over 575,000 in 2024 to 640,000 in 2034, forecasts GlobalData, a leading intelligence and productivity platform. GlobalData’s latest report, “Systemic Lupus Erythematosus and Lupus Nephritis: Epidemiology Forecast […]
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Nucala approval for COPD in China expands precision therapy access with lower eosinophil cutoff, says GlobalData

GSK’s Nucala (mepolizumab) has recently received approval in China as add-on maintenance treatment for adults with inadequately controlled chronic obstructive pulmonary disease (COPD), expanding the shift in treatment access by allowing use at a lower blood eosinophil threshold. The decision broadens eligibility for biologic therapy, strengthens competition in China’s emerging precision COPD market, says GlobalData, […]
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US CMS selects GlobalData’s POLI database as price source for MFN pricing under GLOBE and GUARD price models for Medicare

The US Centers for Medicare and Medicaid Services (CMS) announced that it will use leading intelligence and productivity platform GlobalData’s POLI database to verify prices in the reference countries and set maximum prices for prescription drugs under two Medicare price models based on International Reference Pricing (IRP). The two models, announced in late December 2025, […]
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Meta-analysis strengthens commercial case for broader ERA indication expansion, says GlobalData

A recent research study, conducted by Shi and colleagues and published in the Clinical Journal of the American Society of Nephrology, highlighted compelling evidence that endothelin receptor antagonists (ERAs) offer substantial therapeutic benefits for patients with chronic kidney disease (CKD) while clarifying their safety profile—particularly regarding fluid retention concerns. The meta-analysis strengthens the commercial case […]
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UK–US pharma policies and US manufacturing shape global investment strategies, says GlobalData

The recent UK–US policy developments are reshaping global pharmaceutical investment and launch strategies, as governments on both sides of the Atlantic seek to secure supply, attract capital, and accelerate patient access, says GlobalData, a leading intelligence and productivity platform. In December 2025, the UK announced a landmark pharmaceuticals agreement with the US, granting UK-made medicines […]
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Diagnosed prevalent cases of AMD in Italy projected to increase by 44.09% by 2034, forecasts GlobalData

Diagnosed cases of age-related macular degeneration (AMD) are accelerating across the seven major markets (7MM*), with Italy emerging as the fastest-growing hotspot as prevalence is set to rise more than 44% by 2034. This sharp uptick underscores how aging demographics, lifestyle risks, and chronic comorbidities are converging to intensify long-term pressure on ophthalmology care pathways […]
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Diagnosed incident cases of head and neck cancers in urban China to increase at 3.55% AGR during 2024-2034, forecasts GlobalData

Diagnosed incident cases of head and neck cancers (HNCs) are rising steadily across the eight major markets (8MM*), with urban China set to outpace all others as incidence grows at a 3.55% annual rate through 2034. This trend highlights a pivotal epidemiological transition, where aging populations and evolving risk factors are reshaping disease profiles and […]
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Regenxbio’s clemidsogene lanparvovec approval in Hunter syndrome depends on translating biomarkers to clinical outcomes, says GlobalData

Regenxbio’s clemidsogene lanparvovec has a plausible pathway to FDA approval in Hunter syndrome, although the decision will likely hinge on whether biomarker reductions can be convincingly linked to meaningful clinical outcomes, experts tell the Insights Investigative News team at GlobalData, a leading intelligence and productivity platform. Clemidsogene lanparvovec is a CNS-directed gene therapy designed to […]
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Biopharma enters 2026 with renewed and cautious optimism, says GlobalData

Against the backdrop of a turbulent year marked by both breakthrough and setbacks, the biopharmaceutical industry is entering 2026 with renewed confidence. Industry optimism and investment sentiment have strengthened, although cautiously, according to a new report by GlobalData, a leading intelligence and productivity platform. In 2025, the biopharmaceutical industry began the year with strong scientific […]
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PCSK9 approval marks shift to long-acting LDL-C control in high-risk cardiovascular patients, says GlobalData

Once monthly proprotein convertase subtilisin/kexin type 9 (PCSK9) therapy has moved into a new phase with FDA approval of LIB Therapeutics’ Lerochol for adults with hypercholesterolemia, including heterozygous familial hypercholesterolemia (HeFH). The approval highlights a clear industry shift toward long-acting, adherence-focused lipid-lowering options as payers, clinicians, and innovators prioritize sustained LDL-C control in high-risk cardiovascular […]
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US affordability reforms and multibillion-dollar manufacturing expansions to reshape global pharmaceutical strategy, says GlobalData

A wave of transformative US drug-pricing agreements and record manufacturing investments from leading biopharmaceutical companies is poised to reshape the global landscape for pharmaceutical access, production, and industrial policy, according to GlobalData, a leading data and analytics company. In November 2025, the Trump administration advanced its Most-Favored-Nation (MFN) pricing program through landmark agreements with Eli […]
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