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Pharma

New GMP standards in India expose fault line between regulators and MSMEs, says GlobalData

India’s small drugmakers are sounding the alarm as new good manufacturing practice (GMP) and bio-equivalence mandates could deepen the divide between regulators and micro, small and medium enterprises (MSME). Their appeal to delay enforcement highlights growing concern that India’s drive for stricter quality standards, while well-intentioned, may strain smaller manufacturers, forcing consolidation, factory shutdowns, and […]
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Diagnosed prevalent cases of idiopathic pulmonary fibrosis to increase by 1.58% AGR in 7MM during 2024-34, forecasts GlobalData

The diagnosed prevalent cases of idiopathic pulmonary fibrosis (IPF) in the seven major markets (*7MM) are projected to increase from 199,146 in 2024 to 230,591 in 2034 at an annual growth rate (AGR) of 1.58%, forecasts GlobalData, a leading data and analytics company. GlobalData’s latest report, “Idiopathic Pulmonary Fibrosis (IPF) – Epidemiology Forecast to 2034,” […]
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06
Oct

uniQure’s gene therapy for Huntington’s disease holds blockbuster potential, says GlobalData

uniQure recently announced that its novel gene therapy, AMT-130 (ifezuntirgene inilparvovec), demonstrated statistically significant disease slowing in a Huntington’s disease (HD) pivotal trial. The results indicate that AMT-130 holds blockbuster potential in the disease space, according to GlobalData, leading data and analytics company. Pippa Salter, Managing Neurology Analyst at GlobalData, comments: “In a market where […]
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RSV Awareness Month 2025: Effective treatment still lacking despite recent breakthroughs in prophylaxis, says GlobalData

National Respiratory Syncytial Virus (RSV) Awareness Month is observed each October in the US, to align with the start of RSV season. The campaign highlights the global health and economic burden of RSV, which poses serious risks to infants, older adults, and immunocompromised individuals, and encourages the public to engage in preventative measures, including immunization. […]
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Understanding real-world microbiological outcomes will guide long-term CFTR modulator use in CF, says GlobalData

At the 2025 European Respiratory Society (ERS) International Congress in Amsterdam, researchers from Dalhousie University and the University of Toronto presented findings from a comprehensive, registry-based analysis examining the long-term clinical and microbiological impacts of cystic fibrosis transmembrane conductance regulator (CFTR) modulator therapy. The study, spanning data from 2019-2023 across Canadian and US cystic fibrosis […]
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Anbenitamab to gain competitive edge as first bispecific mAb in HER-positive gastric cancer market in China, says GlobalData

China’s National Medical Products Administration (NMPA) has recently accepted the New Drug Application (NDA) of Alphamab Oncology’s KN026 (anbenitamab). If approved, KN026 is expected to become the first bispecific monoclonal antibody (mAb) targeting HER2-positive gastric or gastroesophageal (GEJ) carcinoma and evolve as a potential treatment option in the gastric cancer landscape in China, says GlobalData, […]
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Breakthroughs in idiopathic pulmonary fibrosis may lead to first approval in years, says GlobalData

After years of limited progress, new treatments for idiopathic pulmonary fibrosis (IPF) are moving closer to approval. Boehringer Ingelheim’s nerandomilast has shown strong Phase III results and could secure approval later in 2025, while United Therapeutics’ inhaled treprostinil advances in late-stage trials, signaling a potential breakthrough for patients facing this debilitating lung disease, says GlobalData, […]
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FDA ends HAE drought with record approvals in 2025, reveals GlobalData

After four years of inactivity, the FDA approved three novel products for hereditary angioedema (HAE) in 2025. This bumper year increased the total number of marketed innovator drugs in the US to 11, introducing new mechanisms and modalities that broaden the treatment strategies available to patients, according to GlobalData, a leading data and analytics company. […]
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Pozelimab and cemdisiran combination holds potential to challenge existing complement inhibitors in MG market, says GlobalData

Regeneron recently announced exciting results from a Phase III clinical trial called NIMBLE, evaluating the efficacy and safety of pozelimab + cemdisiran combination therapy and cemdisiran monotherapy for adult patients living with generalized myasthenia gravis (gMG). The results showed that both cemdisiran monotherapy and pozelimab + cemdisiran combination therapy met their primary endpoints, displaying a […]
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World Sepsis Day 2025: Improved awareness, faster diagnosis, and investment in novel therapeutics key to tackle huge healthcare burden, says GlobalData

World Sepsis Day, which takes place annually on September 13, aims to raise awareness and understanding of this life-threatening condition. World Sepsis Day 2025 also marks one year since the launch of the 2030 Global Agenda for Sepsis by the Global Sepsis Alliance. This strategy aims to reduce the global incidence of sepsis by at […]
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Four drugs in race for first bispecific ADC approval, reveals GlobalData

Bispecific (bs) antibody drug conjugates (ADCs) are an emerging therapeutic approach that presents advantages over traditional ADCs. With 84% of bsADCs in the preclinical or discovery stages, the pipeline is still nascent. However, with four candidates in Phase III, the race for the first approval in this novel landscape is underway, according to GlobalData, a […]
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Semaglutide patent cliff to present substantial opportunity for companies in the Chinese generics market, says GlobalData

Semaglutide, marketed as Ozempic for diabetes and Wegovy for obesity, ranked among the top-selling drugs globally in 2024. While patents protect the drug until 2031-2032 in seven major markets, China’s patent expires much earlier, in March 2026. Chinese pharmaceutical companies are aggressively preparing their manufacturing capabilities and regulatory approvals to capitalize on this multi-billion-dollar market […]
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FDA acceptance of VCTE as trial endpoint can accelerate MASH drug development, says GlobalData

Following the news that the US FDA has accepted Echosens’ letter of intent to qualify liver stiffness measurement (LSM) by vibration-controlled transient elastography (VCTE) as a reasonably likely surrogate endpoint for metabolic dysfunction-associated steatohepatitis (MASH) trials with moderate-to-advanced fibrosis; Jay Patel, Senior Pharma Analyst at GlobalData, a leading data and analytics company, comments: “The announcement […]
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US eosinophilic esophagitis market to reach $1.19 billion by 2030, forecasts GlobalData

The US eosinophilic esophagitis (EoE) market is projected to grow from $202 million in 2020 to $1.19 billion in 2030, registering a compound annual growth rate (CAGR) of 19.4%, driven by the transition from off-label therapies to FDA-approved, patient-friendly options such as Sanofi/Regeneron’s Dupixent (dupilumab), Takeda’s Eohilia (budesonide oral suspension), and Ellodi Pharmaceuticals’ late-stage pipeline […]
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