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Pharma

FDA approval of Blujepa and Nuzolvence signal new era in treatment of gonorrhea, says GlobalData

Following the news that the FDA has approved GSK’s Blujepa (gepotidacin) and Innoviva’s Nuzolvence (zoliflodacin) for the treatment of uncomplicated urogenital gonorrhea in adults and adolescents:  Fiona Chisholm, Associate Director of Infectious Diseases at GlobalData, a leading data and analytics company, offers her view: “Blujepa and Nuzolvence are the first drugs from new antibiotic classes […]
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Diagnosed prevalent cases of diabetic macular edema (DME) across 7MM to reach 3.46 million in 2034, forecasts GlobalData

The diagnosed prevalent cases of diabetic macular edema (DME) in the diabetes population across the seven major markets (7MM*) are expected to increase at an annual growth rate (AGR) of 1.99% from 2.89 million in 2024 to 3.46 million in 2034, forecasts GlobalData, a leading data and analytics company. GlobalData’s report, “Diabetic Macular Edema (DME) […]
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Priligy to get first mover advantage as CAR-T therapy for pediatric r/r B-cell acute lymphoblastic leukemia in China, says GlobalData

China is making significant strides in CAR-T innovation. Recently, Chongqing Precision Biotech Co., Ltd. received approval for Priligy (priscabtagene autoleucel) to treat pediatric and adolescent patients aged 3 to 21 years with CD19-positive relapsed/refractory B-cell acute lymphoblastic leukemia (r/r B-ALL). With this approval, Priligy is expected to gain a first-mover advantage as a CAR-T therapy […]
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Cell and gene therapy investments shift as budgets tighten and big pharma recalibrates towards strategic acquisitions, says GlobalData

The cell and gene therapy (CGT) sector is undergoing a transition as companies navigate a more selective and strategy-driven funding landscape, according to an analysis by the Pharma Strategic Intelligence team at GlobalData, a leading data and analytics company. While venture capital (VC) investment in CGTs has declined in recent years after a peak during […]
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CKD-HPT, HP, and HK market to reach $4 billion across 7MM by 2034, forecasts GlobalData

The chronic kidney disease (CKD)-hyperparathyroidism (HPT), hyperphosphatemia (HP), and hyperkalemia (HK) market across the seven major markets (7MM*) is forecast to grow at a compound annual growth rate (CAGR) of 4.4% from $2.6 billion in 2024 to $4 billion in 2034, according to GlobalData, a leading data and analytics company. GlobalData’s latest report “Hyperparathyroidism, Hyperphosphatemia, […]
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Ivonescimab to emerge as China’s first potential bispecific immuno-oncology therapy in TNBC landscape, says GlobalData

Akeso Inc’s Idafang (ivonescimab) received Breakthrough Therapy Designation (BTD) in China in November 2025 for triple-negative breast cancer (TNBC). As a result, ivonescimab, an investigational monoclonal antibody (mAb) currently in a Phase III trial, is positioned to become the first potential bispecific next-generation immuno-oncology (IO) agent as first-line treatment for TNBC in China, according to […]
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FDA signals strong regulatory push for precision oncology as ADC review designations hit record high in 2024, says GlobalData

The FDA is accelerating its support for precision cancer therapies, awarding a record 63 review designations to antibody drug conjugates (ADCs) in 2024, nearly double the previous year’s peak of 35. This sharp rise underscores the agency’s strengthened intent to speed market access for high-value oncology innovations and reflects surging confidence in ADC technology, according […]
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Merck’s acquisition of Cidara highlights potential of strain-agnostic influenza prophylactics, says GlobalData

Following the news that Merck & Co. (Merck) has agreed to acquire Cidara Therapeutics (Cidara) for $9.2 billion; Fiona Chisholm, Associate Director of Infectious Diseases at GlobalData, a leading data and analytics company, offers her view: “The acquisition strengthens and diversifies Merck’s infectious disease portfolio, a strategic move that aligns with the company’s goals to […]
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PDE inhibitors dominate pipeline assets in respiratory indications, says GlobalData

The landscape of phosphodiesterase 3/4 (PDE3/4) inhibitors is experiencing a significant transformation in 2025, driven by advances in clinical research, new product approvals, and increased market interest. Dual PDE3/4 inhibitors are emerging as a promising therapeutic drug class with the potential to address unmet needs in the respiratory medicine, especially for patients with chronic obstructive […]
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US tariff and pricing reforms drive pharma localization and spur outsourcing-led investment shifts, says GlobalData

Escalating US tariff and pricing reforms are pushing pharmaceutical companies to localize manufacturing and rethink their investment priorities, fueling a surge in outsourcing-led strategies and targeted acquisitions. The recent deals in obesity and liver disease, Pfizer’s purchase of Metsera and Roche’s acquisition of 89bio, underscore how dealmaking is increasingly shaped by policy incentives, tariff exposure, […]
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Sutaray NMPA approval marks major milestone in China HER2-positive breast cancer market, says GlobalData

The National Medical Products Administration (NMPA) in China has recently approved Sichuan Kelun Biotech Biopharmaceutical’s Sutaray (trastuzumab botidotin) for the treatment of adult patients with unresectable or metastatic HER2-positive breast cancer (BC). The move marks a pivotal advance in the nation’s oncology market as domestic innovation accelerates in high-need breast cancer segments, says GlobalData, a […]
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Glaukos’ Epioxa to redefine treatment for keratoconus after a decade without new therapies, says GlobalData

FDA’s recent approval for Epioxa (IVMED-80) marks a landmark moment in ophthalmology, introducing the first and only incision-free, topical drug therapy for keratoconus. Developed by Glaukos Corporation, Epioxa is expected to transform keratoconus care from a procedure-based model to a pharmacologic one, emphasizing accessibility and patient comfort after nearly a decade without new treatment options, […]
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Metsera takeover battle reflects Novo Nordisk and Pfizer push to challenge Lilly’s obesity drug dominance, says GlobalData

Following the news that Novo Nordisk made an unsolicited acquisition bid for US-based obesity biotech Metsera Therapeutics, which was subsequently rejected by Pfizer, but designated by Metsera as a “Superior Company Proposal” to the one previously agreed between Metsera and Pfizer: Jay Patel, Senior Pharma Analyst at GlobalData, a leading data and analytics company, offers […]
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Armata AP-SA02 shows promise for SAB in Phase IIa trial, underscoring growing potential of phage therapy, says GlobalData

Armata Pharmaceuticals’ investigational phage therapy, AP-SA02, demonstrated earlier resolution in patients with Staphylococcus aureus bacteremia (SAB) in a Phase IIa trial, reinforcing the growing clinical promise of bacteriophage-based treatments. The findings highlight the therapy’s potential to address antibiotic resistance and provide a new treatment option for patients with serious bloodstream infections, says GlobalData, a leading […]
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Novartis strengthens IgAN position with Fabhalta trial results, says GlobalData

Novartis recently announced positive final results from the Phase III APPLAUSE-IgAN clinical trial, demonstrating that Fabhalta (iptacopan) significantly slows kidney function decline in adults with IgA nephropathy (IgAN). The results establish Fabhalta as the first and only approved complement inhibitor for the progressive autoimmune kidney disease, strengthening Novartis’ position in the IgAN space, says GlobalData, […]
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