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GlobalData

Pharma

Everest Medicines Nefecon to transform IgAN treatment in China and Asia, says GlobalData

China-based Everest Medicines has recently launched Nefecon (budesonide DR) to treat primary immunoglobulin A nephropathy (IgAN) in China. It is the first approved medicine for IgAN by China’s National Medical Products Administration (NMPA). It represents an innovative treatment option for IgAN patients with more rapid disease progression compared to the American and European populations, says […]
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CAR T-cell assets for SLE and LN diseases hold potential for growth with China emerging as key player, says GlobalData

At the recent European Alliance of Associations for Rheumatology (EULAR) 2024 conference, industry sponsors presented preliminary data from ongoing, early-stage clinical trials evaluating CAR T-cell assets in autoimmune diseases, including systemic lupus erythematosus (SLE) and lupus nephritis (LN). While the overall results gave early indications of the potential ability of CAR T-cell assets in achieving […]
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FDA approval of CAPVAXIVE will enhance protection against pneumococcal disease in older adults, says GlobalData

The FDA has approved Merck’s CAPVAXIVE (pneumococcal 21-valent conjugate vaccine, originally known as V116), for the prevention of invasive pneumococcal disease and pneumococcal pneumonia in adults aged 18 years and older. This is the first pneumococcal vaccine that is specifically designed to protect against serotypes which particularly infect older adults. The vaccine will likely become […]
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Niemann Pick Type C market sales across 3MM to reach $220 million in 2031, forecasts GlobalData

Niemann Pick Type C (NPC) is a rare progressive genetic disorder, characterized by the accumulation of dysfunctional proteins causing lysosomal function impairment. Patients can experience diverse symptoms, from hepatosplenomegaly, to neurological disorders, to respiratory failure. New medicines for NPC are expected to launch in the three major markets (3MM: US, Germany and UK) in the […]
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Bayer’s BAY2927088 to face intense competition in EGFR-mutant but limited competition in HER2-exon 20 mutant NSCLC market in China, says GlobalData

Bayer AG’s BAY2927088 recently received the Breakthrough Therapy designation from the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) in China. Following approval, BAY2927088 is expected to face intense competition in the epidermal growth factor receptor (EGFR)-mutant non-small cell lung cancer (NSCLC) but limited competition in the human epidermal growth factor […]
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Vertex could solidify dominance in cystic fibrosis market with vanza triple approval, says GlobalData

With the submission of regulatory marketing applications for its once-daily vanzacaftor triple, also known as the vanza triple program (vanzacaftor/tezacaftor/deutivacaftor) with the European Medicines Agency (EMA) and the US FDA, Vertex Pharmaceuticals is expected to hold its lead in the development of therapies for the treatment of cystic fibrosis (CF). Approval and success of vanza […]
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Beacon Therapeutics’ AGTC-501 holds potential to become first gene therapy in XLRP space, says GlobalData

Beacon Therapeutics initiated the final leg of the race for its lead asset, AGTC-501 (laruparetigene zovaparvovec), announcing recently that the company has treated its first patient in the pivotal trial, VISTA. Currently, the only retinitis pigmentosa therapy on the market is Spark Therapeutics’ Luxturna (voretigene neparvovec), a retinoid isomerohydrolase activator, indicated for patients with confirmed […]
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Tapinarof may mark Dermavant’s first atopic dermatitis approval, says GlobalData

Dermavant’s VTAMA (tapinarof), a nonsteroidal, topical AhR-modulating agent, achieved positive Phase III trial results in atopic dermatitis patients aged two and above, leading to FDA acceptance of its supplemental new drug application (sNDA). The promising results may bring Dermavant’s VTAMA closer to market authorization and will be its first atopic dermatitis marketed drug, subject to […]
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China’s Innovent holds potential to change pancreatic cancer treatment landscape with bispecific antibody IBI389, says GlobalData

China-based Innovent Biologics recently presented Phase I study results of its first-in-class anti-CLDN18.2/CD3 bispecific antibody (IBI389) for the treatment of advanced pancreatic cancer at the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting. Preliminary results from the Phase I study (NCT05164458) of IBI389 demonstrated promising efficacy in pancreatic ductal adenocarcinoma (PDAC) and the bispecific […]
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Moderna’s COVID-19/influenza vaccine phase III data highlights potential of mRNA technology for infectious diseases, says GlobalData

Moderna has announced positive Phase III data for its COVID-19/influenza combination vaccine, mRNA-1083. The investigational combination mRNA vaccine generated statistically significant higher immune responses in relation to the licensed comparator vaccines used in the randomized, observer-blind, active control study among 8,000 adults aged 50 years and older. This development comes less than two weeks after […]
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China leads APAC in institute-led clinical trials, reveals GlobalData

With the evolving landscape of drug development and innovations, several institutes are serving as catalysts by partnering with pharmaceutical companies to drive progress at various stages of research and development. These collaborations are particularly significant in advancing clinical trials, a critical step in drug development. Against this backdrop, within the Asia-Pacific (APAC) region, China leads […]
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BIOSECURE Act forces US pharma to reevaluate China manufacturing reliance, says GlobalData

As the BIOSECURE Act progresses through the US legislative process, the US pharmaceutical industry finds itself at a crossroads. With heavy reliance on Chinese contract manufacturers, US companies are reevaluating their partnerships amidst the proposed regulations aimed at safeguarding national security interests. While the Act remains a topic of debate, some anticipate potential onshoring benefits, […]
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Roche’s Vabysmo further showcases stronghold across wAMD and DME spaces, says GlobalData

Roche has recently presented post-hoc analysis results of the TENAYA (NCT03823287) and LUCERNE (NCT03823300) trials of Vabysmo (faricimab), a VEGF and Ang2 inhibitor, at the Association for Research in Vision and Ophthalmology (ARVO) conference. The data not only showcases Vabysmo’s efficacy in wet age-related macular degeneration (wAMD) and diabetic macular edema (DME) but also the […]
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Biosimilar market poised for significant growth in the coming years, says GlobalData

The rise of biologics has revolutionized treatments for traditionally hard-to-treat diseases, leading to the growth of the biosimilar market. As more biologics lose patent protection, the influx of biosimilars is set to expand, offering cost-effective alternatives and significantly impacting their respective markets. This dynamic shift promises broader access to critical therapies, according to GlobalData, a […]
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