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GlobalData

Pharma

Cell and gene therapy manufacturers turn to specialist automation partners, says GlobalData

Cell and gene therapy manufacturers are partnering with specialist technology companies to address the challenges associated with scaling complex therapies. Recent collaborations between developers, contract development and manufacturing organizations (CDMOs), and automation companies demonstrate how robotics, digital systems, and advanced manufacturing platforms are being integrated into production workflows to support more scalable and efficient manufacturing, […]
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FDA regenerative medicine approvals gain momentum, reveals GlobalData

Following several years of limited activity, FDA approvals for regenerative medicines have accelerated, culminating in a record eight approvals in 2024. Recent findings also highlight a surge in regenerative medicine advanced therapy (RMAT) designations, which, together with a robust late-stage pipeline, suggests that FDA approval activity for regenerative medicine products is likely to remain elevated […]
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Niktimvo approval in Australia reinforces momentum for macrophage-targeted cGVHD therapies, says GlobalData

Australia’s Therapeutic Goods Administration (TGA) approved Niktimvo (axatilimab) for chronic graft-versus-host disease (cGVHD) in May 2026, making Australia the first market outside the US to authorize the therapy. The decision strengthens the role of macrophage-targeted treatments for heavily pretreated patients, while highlighting reimbursement, real-world adoption, and earlier-line evidence as key factors shaping its long-term clinical […]
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Dimerix’s DMX-652 acquisition to bolster kidney disease therapy development, says GlobalData

Dimerix recently announced the acquisition of DMX-652 from Mission Therapeutics, adding a Phase II-ready acute kidney injury (AKI) program with a differentiated mechanism. The acquisition expands Dimerix beyond its late-stage focal segmental glomerulosclerosis (FSGS) asset. The company already has a late-stage rare kidney disease asset in FSGS, so adding DMX-652 creates a continuum from acute […]
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MASH market growth in India hinges on awareness-led strategies, says GlobalData

Non-cirrhotic metabolic dysfunction-associated steatohepatitis (MASH) market in India is entering a new phase, with awareness-driven strategies expected to play a pivotal role in improving diagnosis, treatment access, and patient outcomes. The expanded approval of semaglutide for adults with MASH and fibrosis stages F2–F3 marks a significant development, while rising diagnosed prevalence and growing awareness initiatives […]
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China’s biotech rise to face challenges from US policy responses, says GlobalData

China is emerging as a global biotechnology innovation hub, but its growing influence is facing political and regulatory scrutiny from the US. The US policy response reflects concerns around its competitiveness and technological leadership, rather than the country’s scientific capability alone, says GlobalData, a leading intelligence and productivity platform. China’s scientific progress was on display […]
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Siegfried and Lonza lead four-way CDMO race in outsourced HPAPI manufacturing, says GlobalData

Known for their low-dose therapeutic efficacy and high target affinity, high-potency active pharmaceutical ingredients (HPAPIs) are in high demand by biopharma companies, which often outsource their production. Approximately 41% of innovator and biosimilar HPAPIs come from contract development and manufacturing organizations (CDMOs). With strategic acquisitions and expansions of HPAPI facilities reshaping the HPAPI outsourcing market, […]
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EU approval of Arrowhead’s Redemplo to expand FCS treatment options, says GlobalData

Arrowhead Pharmaceuticals has recently announced that the European Commission has granted marketing authorization for Redemplo (plozasiran), an innovative apolipoprotein C III (apoC-III) inhibitor that is already approved in the US for the treatment of adults with familial chylomicronemia syndrome (FCS). The approval was supported by Phase III data demonstrating substantial reductions in triglyceride levels and […]
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Diagnosed incident cases of hepatocellular carcinoma across 8MM to reach 370,000 in 2034, forecasts GlobalData

The diagnosed incident cases of hepatocellular carcinoma (HCC) in the eight major markets (8MM*) are projected to increase at an annual growth rate (AGR) of 2.06%, from over 306,000 in 2024 to approximately 370,000 by 2034, according to  GlobalData, a leading intelligence and productivity platform. GlobalData’s latest report, “Hepatocellular Carcinoma (HCC): Epidemiology Report and Forecast”, […]
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Diagnosed prevalent cases of overweight and obesity across 7MM to reach over 260 million in 2035, forecasts GlobalData

The diagnosed prevalent cases of overweight and obesity combined in the seven major markets (7MM*) are set to increase at an annual growth rate (AGR) of 0.61%, from over 245 million in 2025 to 260 million in 2035, forecasts GlobalData, a leading intelligence and productivity platform. GlobalData’s latest report, “Overweight and Obesity: Epidemiology Report and […]
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FDA-awarded RMAT designations continue to surge in 2025, reveals GlobalData

Since the FDA first awarded a regenerative medicine advanced therapeutic (RMAT) designation in 2017, activity in this space remained relatively modest until 2023. However, the number of RMAT designations increased sharply in 2024, reaching a record of 48 RMAT designations in 2025, reflecting the expanding regenerative medicine landscape and suggesting that a larger number of […]
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Europe–US new drug manufacturing outsourcing gap widens, reveals GlobalData

Contract manufacturing facilities located in the US and Europe provide biopharma companies with strategic options to diversify supply chains, access specialized technologies, and speed time-to-market for new drugs. Outsourced dose manufacturing for innovator drugs and biosimilars approved in the US and Europe (the EU and UK) has traditionally oscillated between the two geographies, but there […]
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MSCopilot Detect emerges as early contender for scalable remote MS monitoring, says GlobalData

Digital biomarkers are gaining momentum in multiple sclerosis (MS) care, with new findings highlighting the potential of smartphone-based assessments to transform disability monitoring. Early evidence supporting MSCopilot Detect use underscores growing industry efforts to enable scalable, remote, and standardized disease assessment, a shift that could reshape clinical  patient monitoring, and the evaluation of MS disease […]
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Real-world data point to patient experience as next battleground for anti-CD20 therapies in RMS, says GlobalData

As real-world evidence (RWE) increasingly shapes competition in the relapsing multiple sclerosis (RMS) market, TG Therapeutics is leaning on patient-reported outcomes to carve out space for Briumvi (ublituximab) in a crowded anti-CD20 monoclonal antibody (mAb) field. There is growing importance on patient-centered outcomes as manufacturers seek competitive advantage beyond comparable clinical efficacy in MS treatment, […]
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Produodopa’s positive RWE for Parkinson’s disease to boost clinician confidence in crowded levodopa market, says GlobalData

At the European Academy of Neurology (EAN) 2026 virtual congress, AbbVie presented new 12-month interim data from the ROSSINI study, supporting the real-world safety and effectiveness of Produodopa in patients with advanced Parkinson’s disease. Sustained improvements were observed across motor fluctuations, non-motor symptoms, and selected quality-of-life outcomes. Positive real-world evidence (RWE) for Produodopa could boost […]
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China’s first dual BAFF/APRIL therapy approval signals new phase of competition in IgA nephropathy market, says GlobalData

China’s approval of the first dual BAFF/APRIL-targeting therapy for IgA nephropathy marks a significant shift in a treatment landscape long constrained by limited disease-modifying options and reliance on corticosteroids. The milestone highlights the growing role of innovative biologics in addressing persistent unmet needs, while underscoring the increasing influence of Chinese biopharma innovation in a competitive […]
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