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GlobalData

Pharma

ImmunoACT to lead journey of indigenous CAR-T cell therapy in India but market access a key hurdle, says GlobalData

Immunoadoptive Cell Therapy Private Limited (ImmunoACT)’s NexCAR19 (actalycabtagene autoleucel) chimeric antigen receptor T-cell (CAR-T) therapy was approved in October by the Central Drug Standards Control Organisation (CDSCO) of India for the treatment of relapsed or refractory (r/r) B-cell lymphomas and leukemia. With the approval, ImmunoACT is set to lead the journey of indigenous CAR-T cell […]
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Bio-Thera favourably positioned for monetization of Tofidence biosimilar in US, says GlobalData

Roche’s primary patents for Actemra/RoActemra (tocilizumab) have already expired in major markets, including Europe and the US. In September 2023, the FDA approved Tofidence (tocilizumab-bavi, BIIB00) as the first biosimilar referencing the IL-6 receptor antagonist tocilizumab for the treatment of rheumatoid arthritis (RA), polyarticular juvenile idiopathic arthritis, and systemic juvenile idiopathic arthritis. Tofidence is the […]
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FDA rejection to delay Lebrikizumab chances to enter atopic dermatitis market, says GlobalData

The FDA recently rejected Eli Lilly’s biologic license application (BLA) for their anti-interleukin (IL) -13, lebrikizumab, which is in development for the treatment of atopic dermatitis (AD). This news will likely delay lebrikizumab’s entry into the US market and therefore affects the agent’s chances to compete directly with agents such as Sanofi and Regeneron’s first-to-market […]
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Record number of RSV designations awarded in 2022, says GlobalData

In 2022, global regulatory authorities awarded a record 10 review designations for respiratory syncytial virus (RSV)-indicated drugs. This surge acted as a precursor for the RSV-marketed drug landscape in 2023, which has seen several novel drug launches, particularly in the field of preventative treatments, says GlobalData, a leading data and analytics company. RSV, a common […]
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Golidocitinib’s anti-tumor efficacy in PTCL will pave way for new treatment approach in China, says GlobalData

Dizal (Jiangsu) Pharmaceutical Co Ltd’s golidocitinib was granted priority review designation by the China National Medical Products Administration (NMPA) in September 2023. As a result, golidocitinib is expected to evolve as a potential therapeutic option for peripheral T-cell lymphoma (PTCL), a type of non-Hodgkin lymphoma (NHL) in China upon receiving regulatory approval, says GlobalData, a […]
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Gaucher Disease Awareness Month highlights serious unmet need from lack of neuronopathic therapies, says GlobalData

In the midst of International Gaucher Disease Awareness Month, which is observed in October every year, GlobalData sheds light on a critical issue within the Gaucher disease landscape: the significant lack of neuronopathic therapies. Gaucher disease, a rare inherited metabolic disorder caused by mutations in the GBA1 gene, poses challenges for patients and physicians, especially […]
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GlobalData forecasts multiple myeloma dendritic cell therapy sales across 8MM to reach $62 million in 2031

A promising dendritic cell (DC) therapy currently in clinical trials is displaying the potential to revolutionize the multiple myeloma treatment paradigm. If successful, its growth will be facilitated by an increasing embrace of personalized medicine for the research and development of DC therapies. Against this backdrop, the multiple myeloma dendritic cell therapy sales across the […]
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Physicians using AI in clinical practice see lack of in-person interaction as major concern, finds Globaldata

Artificial intelligence (AI) algorithms can analyze vast amounts of patient data, identify patterns and trends, and make predictions based on this information. This technology can help doctors make more accurate diagnosis, recommend the most effective treatment, and even predict patient outcomes. While AI holds the potential to enhance patient care, it is accompanied by a […]
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Ionis’ Olezarsen holds potential to overcome dyslipidemia unmet needs, says GlobalData

In September 2023, Ionis Pharmaceuticals unveiled positive Phase III clinical data for olezarsen, a ligand-conjugated antisense (LICA) designed to inhibit apolipoprotein C-III (apoC-III). Phase III studies showed a significant reduction in triglycerides in patients with familial chylomicronemia syndrome (FCS) taking 80mg of olezarsen monthly for six months. The drug holds the potential to overcome dyslipidemia […]
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Diakonos Oncology’s dendritic cell vaccine shows promise despite development hurdles, says GlobalData

Cellipoint Bioservices entered an agreement with Diakonos Oncology in October 2023 for the development and manufacturing of DOC1021, an autologous dendritic cell (DC) vaccine. The collaboration was announced after Diakonos Oncology revealed promising results of the ongoing Phase I trial evaluating DOC1021 in newly diagnosed patients with glioblastoma multiforme (GBM) administered following surgical intervention and […]
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Supernus’ SPN-830 will face fiercely competitive Parkinson’s market if approved by FDA, says GlobalData

Supernus Pharmaceuticals recently announced that it has resubmitted a New Drug Application (NDA) for its subcutaneous apomorphine infusion device (SPN-830) for the continuous treatment of motor fluctuations in Parkinson’s Disease (PD). However, as advancement in drug formulations and delivery systems is one of the most rapidly changing areas in PD treatment, SPN-830 is set to […]
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AstraZeneca’s Tagrisso to lead lung cancer small molecule market with over $7 billion sales by 2029, says GlobalData

In the ever-evolving landscape of oncology, small-molecule drugs are carving a significant niche in lung cancer treatment. In 2015, AstraZeneca’s Tagrisso  achieved landmark approval from the FDA following the results of the Phase III AURA trial. This approval marked a significant advancement in the treatment of metastatic EGFR T790M mutation-positive non-small cell lung cancer (NSCLC). […]
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Alvotech’s AVT05 emerges as leading contender for Simponi biosimilar in rheumatoid arthritis, says GlobalData

The patent for Janssen’s second-generation, tumour necrosis factor-alpha (TNF)-a inhibitor Simponi (golimumab), is scheduled to expire in 2024 and in 2025 in the US and EU, respectively. As patent expiration approaches, strategic activity within this space indicates that the landscape is shifting. In May 2023, Alvotech and Advanz Pharma announced an extended strategic partnership with […]
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