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Pharma

BioCardia eyes heart failure space in Japan with CardiAMP Cell Therapy System, says GlobalData

BioCardia has recently completed the submission of CardiAMP Cell Therapy System to Japan’s Pharmaceutical and Medical Device Agency (PMDA) towards approval for the indication of ischemic heart failure (HF) with reduced ejection fraction. If approved, CardiAMP would be a minimally invasive stem cell therapy option for patients with ischemic systolic HF, says GlobalData, a leading […]
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NMPA approval for first BCMA CAR-T Therapy paves way for more multiple myeloma cell therapies, says GlobalData

Approval to dramatically change CAR-T therapies landscape GlobalData forecasts Fucaso sales to reach $69 million in 2029 Manufacturing and logistical challenges may impact commercial success Nanjing Iaso Biotherapeutics and Innovent Biologics have received China National Medical Product Administration (NMPA) approval for Fucaso (equecabtagene autoleucel) as a treatment for patients with relapsed or refractory multiple myeloma […]
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Diagnosed incident cases of venous thromboembolism across 7MM set to reach 1.69 million in 2032, forecasts GlobalData

The burden of diagnosed incident cases of venous thromboembolism (VTE) in the 7MM* is expected to increase at an annual growth rate (AGR) of 1.50% from 1.47 million in 2022 to 1.69 million cases in 2032, forecasts GlobalData, a leading data and analytics company. GlobalData’s latest report, “Venous Thromboembolism: Epidemiology Forecast to 2032,” estimates that […]
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Eli Lilly obesity drug retatrutide trials set to challenge weight loss results seen with other GLP-1RAs, says GlobalData

Eli Lilly’s retatrutide garnered interest recently following the release of results, which set a record for percentage body weight loss in the obesity space. Retatrutide, which is currently in development for obesity, type 2 diabetes (T2D), and non-alcoholic fatty liver disease (NAFLD), is of special interest due to addressing the need for improved efficacy within […]
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Amneal Parkinson’s drug IPX203 needs to compete with novel subcutaneous levodopa delivery systems post FDA CRL, says GlobalData

Following the news that Amneal Pharmaceuticals received a complete response letter (CRL) from the FDA, concerning its new drug application for IPX203 (carbidopa/levodopa) as a treatment for Parkinson’s disease (PD); Christie Wong, Neurology Analyst at GlobalData, a leading data and analytics company, offers her view: “Although levodopa has been the gold standard for patients with […]
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Soliris approval for MG will allow AstraZeneca play key role in rare disease treatment ecosystem in China, says GlobalData

AstraZeneca’s Soliris (eculizumab) was approved in China in June 2023 for the treatment of adults with refractory generalised myasthenia gravis (gMG) who are anti-acetylcholine receptor antibody positive. MG patients in China will now finally have access to this novel targeted therapy as part of an expanded treatment algorithm. This will allow AstraZeneca to play a […]
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Bad clinical practices overshadow BioXcel positive results for Igalmi in Alzheimer’s agitation, says GlobalData

Following the news that BioXcel Therapeutics announced positive top-line results from TRANQUILITY II (NCT05271552), a Phase III study of Igalmi (dexmedetomidine sublingual film) for the acute treatment of agitation episodes associated with Alzheimer’s disease (AD); Philippa Salter, Senior Neurology Analyst at GlobalData, offers her view: “Although the clinical trial met its primary endpoint for the […]
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Inflammatory bowel disease treatments reach inflection point requiring active comparators, says GlobalData

At Digestive Disease Week (DDW) 2023, a comment was made following a presentation discussing the preliminary induction findings from QUASAR (NCT04033445), the Phase IIb/III trial evaluating Janssen’s guselkumab (GUS) in ulcerative colitis (UC). A member of the audience questioned the talk’s overall conclusion that GUS is a “great therapy”. This individual’s comment reflects an overarching […]
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Rystiggo will need excellent marketing strategy to fully compete in myasthenia gravis space, says GlobalData

The FDA has recently approved UCB’s subcutaneous formulation of rozanolixizumab-noli, branded as Rystiggo, for use in myasthenia gravis (MG). The approval of Rystiggo comes six months after the FDA accepted UCB’s priority review application, making it the first approved treatment for MG. It is indicated for both anti-acetylcholine receptor (AChR) and anti-muscle-specific tyrosine kinase (MuSK) […]
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Zolbetuximab niche patient target in gastric cancer will limit its potential in Japan, says GlobalData

Astellas Pharma recently filed new drug application (NDA) in Japan for zolbetuximab, a novel chimeric immunoglobulin G1 antibody highly specific for Claudin 18 isoform 2 (CLDN18.2) for the first-line treatment of gastric cancer patients. Following approval, the drug is expected to have limited potential in the first-line treatment setting, considering the clinical success of its […]
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