GlobalData
GlobalData

Pharma

Sugemalimab approval in China makes it only second drug approved globally for ENKTL, says GlobalData

CStone Pharmaceuticals’ sugemalimab (Cejemly) has been approved by the China National Medical Products Administration (NMPA) for the treatment of relapsed or refractory extranodal natural killer/T-cell lymphoma (r/r ENKTL) in October 2023. With this approval, sugemalimab becomes the first anti-PD-1/PD-L1 monoclonal antibody approved for r/r ENKTL globally and is expected to boost CStone’s presence in the […]
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FDA’s Fast Track designation for Altimmune’s pemvidutide reinforces use of GLP-1RAs in NASH, says GlobalData

In October 2023, the FDA granted Fast Track designation for Altimmune’s incretin mimetic, pemvidutide, in non-alcoholic steatohepatitis (NASH). Pemvidutide is a glucagon-like peptide 1 (GLP-1) glucagon receptor (GCGR) dual agonist peptide (GLP-1R/GCGR) currently in Phase IIb development for NASH (IMPACT trial) and for obesity (MOMENTUM trial). The Fast Track designation is supported by the data […]
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Vertex Pharmaceuticals poised for dominance in global gene therapy market with first CRISPR approval, says GlobalData

Following the news that the UK Medicines and Healthcare Products Regulatory Agency has granted conditional marketing authorization to Vertex Pharmaceuticals and CRISPR Therapeutics‘ Casgevy, marking the world’s first approval of a CRISPR-based gene editing therapy; Joselia Carlos, Medical Device Analyst at GlobalData, offers her view: “The approval of Casgevy for sickle cell anemia (SCA) and […]
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Vast majority of healthcare professionals believed that COVID-19 had greatest impact on digital transformation, reveals GlobalData survey

Globally, 71% of healthcare industry professionals expressed that the COVID-19 pandemic had the greatest impact on digital transformation in the healthcare sector during the last few years, among other macro events, according to a survey* by GlobalData, a leading data and analytics company. GlobalData’s latest Thematic Intelligence report, ‘Digital Transformation and Emerging Technologies in the […]
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First-in-class DLL3-targeting BiTE could be the next big player in small-cell lung cancer treatment, says GlobalData

Small cell lung cancer (SCLC), comprising 15% of lung tumors, is a highly aggressive form of malignancy. However, tarlatamab, a bispecific T-cell engager (BiTE) developed by Amgen, recently demonstrated potentially registrational data at the European Society for Medical Oncology (ESMO) 2023 Congress from the Phase II DeLLphi-301 trial.  The drug may become a promising lifeline […]
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Penbraya approval sparks shift to pentavalent meningococcal vaccines in US market, says GlobalData

Pfizer has recently announced the FDA approval of Penbraya, the first and only pentavalent vaccine for coverage against the most common serogroups causing meningococcal disease in people aged 10 to 25 years. The pentavalent vaccine has potential to enhance the level of protection against serious and life-threatening meningococcal infections in adolescents and young adults, says […]
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AnaptysBio’s generalized pustular psoriasis drug pipeline agent Imsidolimab poses challenge to Boehringer Ingelheim’s Spevigo, says GlobalData

AnaptysBio‘s groundbreaking Phase III trial results for imsidolimab, a novel inhibitor, bring renewed hope to patients battling Generalized Pustular Psoriasis (GPP). With a promising safety and tolerability profile, imsidolimab could potentially emerge as a vital treatment option for GPP, presenting a significant challenge to the current leader in the field, Boehringer Ingelheim‘s Spevigo, according to […]
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Bristol Myers Squibb’s Opdivo sales to reach $14 billion by 2028, forecasts GlobalData

On 30 October, the European Medicines Agency (EMA) announced that it has validated the application of Bristol Myers Squibb’s Opdivo for the front-line treatment of metastsic urothelial carcinoma in combination with standard-of-care (SOC) cisplatin-based chemotherapy. The news comes on the heels of  Phase lll CheckMate-901 results presented recently at the European Society for Medical Oncology’s […]
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Novartis eyes HR+/HER2- early breast cancer market with NATALEE trial success, says GlobalData

The hormone receptor-postivie (HR+), human epidermal growth factor receptor 2-negative (HER2-) breast cancer (BC) market has seen promising results with the advent of cyclin dependent kinase 4/6 (CDK4/6) inhibitors in recent years. These inhibitors, when used in combination with endocrine therapies (ET), have had extensive clinical success in extending survival benefit in the first-line treatment […]
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