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GlobalData

Pharma

Beacon Therapeutics AGTC-501 poses formidable challenge to Spark Therapeutics Luxturna in retinitis market, says GlobalData

Beacon Therapeutics’ gene therapy AGTC-501 (laruparetigene zovaparvovec) is in the spotlight with encouraging interim results from SKYLINE trial in the retinitis pigmentosa (retinitis) market. Offering a new mechanism of action, it presents a formidable challenge to Spark Therapeutics’ Luxturna (voretigene neparvovec-rzyl), the current frontrunner in gene therapy for retinitis. With promising safety profiles and ongoing […]
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Opportunities for cell and gene therapy landscape remain high but so does challenges, says GlobalData

Cell and gene therapies (CGTs) have been gaining traction within the medical community as treatment options that are expected to replace lifelong management of chronic diseases with fewer number of doses, which could offer significant benefits for both patients and strained healthcare systems. However, alongside these opportunities, regulatory barriers and cost concerns pose challenges to […]
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High ADHD comorbidity rates offer opportunity for pipeline products to capture market, says GlobalData

Attention-deficit/hyperactivity disorder (ADHD) is a clinically heterogenous neurodevelopmental disorder with high rates of comorbidity with other childhood-onset psychiatric disorders as well as learning disorders. As a result, pipeline products capable of targeting both ADHD and comorbid symptoms will have a competitive edge to capture a highly saturated ADHD market, says GlobalData, a leading data and […]
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Biogen needs Leqembi to be successful following discontinuation of Aduhelm, says GlobalData

Biogen’s stance at the upcoming AD/PD 2024 International Conference on Alzheimer’s disease (AD) and Parkinson’s disease (PD) that will be held on March 5-9 will demonstrate its future plans for AD following the discontinuation of Aduhelm (aducanumab), its anti-amyloid beta (Aβ) monoclonal antibody (mAb). Against this backdrop, the success of Leqembi (lecanemab) remains important for […]
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Novel approaches for amyotrophic lateral sclerosis will transform treatment landscape, says GlobalData

Innovative approaches are poised to revolutionize the treatment of amyotrophic lateral sclerosis (ALS), a challenging and rare disease. The current therapies have limitations in efficacy, prompting a surge in exploration of novel disease-modifying drugs (DMD). With 109 pipeline candidates in various stages of development, the ALS treatment landscape is primed for transformation, offering hope for […]
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Nezglyal remains promising therapy despite EMA’s market authorization refusal, says GlobalData

The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) recently recommended the refusal of the marketing authorization for Nezglyal (leriglitazone). Nezglyal is a novel orally bioavailable and selective peroxisome proliferator-activated receptor (PPAR) gamma agonist that is intended for the treatment of cerebral adrenoleukodystrophy (cALD). Leriglitazone is a promising treatment that can […]
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Allecra’s EXBLIFEP approval to treat cUTIs provides valuable new weapon to tackle ESBL mediated AMR, says GlobalData

The FDA has approved Allecra Therapeutics’ novel antibiotic combination, EXBLIFEP (cefepime/enmetazobactam), to treat complicated urinary tract infections (cUTIs), including acute pyelonephritis (AP), in patients ≥ 18 years of age caused by the following gram-negative bacteria: Escherichia coli, Klebsiella pneumoniae, Pseudomonas aeruginosa, Proteus mirabilis, and Enterobacter cloacae complex. Designed as a “carbapenem-sparing” treatment for multi-drug resistant […]
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FDA denial could delay launch of Minerva’s schizophrenia treatment roluperidone by at least two years, says GlobalData

Following the news that the FDA denied approval for Minerva Neurosciences for its roluperidone for the treatment of negative symptoms in patients with schizophrenia; Christie Wong, Neurology Analyst at GlobalData, a leading data and analytics company, offers her view: “The FDA has issued a Complete Response Letter (CRL) for Minerva Neurosciences’ roluperidone. It follows a […]
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Voluntary pause of epetraborole Phase III enrollment setback for NTM late-stage pipeline, says GlobalData

AN2 Therapeutics recently announced a decision to voluntarily pause enrollment of the Phase III portion of the Phase II/III trial, EBO-301, in light of potentially lower than expected efficacy data obtained from the Phase II trial. EBO-301 (NCT05327803) is a pivotal trial evaluating the orally administered antibiotic epetraborole in patients with treatment-refractory Mycobacterium avium complex […]
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Takeda oncology pipeline remains robust despite shift in focus from CAR-T to allogeneic cell therapies, says GlobalData

Takeda has decided to discontinue the development programs of its four oncology assets—Phase III asset modakafusp alfa (TAK-573) and three Phase I chimeric antigen receptor (CAR-T)  assets: TAK-102, TAK-103 and TAK-940—as part of a plan to align its focus on advancing allogeneic cell therapies. Despite these adjustments, the Japan-based pharma major’s oncology pipeline remains robust, […]
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ViiV Healthcare and GSK’s Cabenuva could reduce poor treatment adherence in HIV, says GlobalData

Following the release of positive results for Phase III trial of ViiV Healthcare and GSK’s long-acting injectable antiretroviral treatment (ART) Cabenuva (cabotegravir + rilpivirine); Barbora Salcman, Infectious Disease Analyst at GlobalData, offers her view: “Cabenuva was approved by the FDA in January 2021, as a once monthly or once every other month complete HIV treatment […]
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Daiichi Sankyo poised to add another ADC blockbuster with datopotamab deruxtecan for non-squamous NSCLC, says GlobalData

Following the news that the FDA has accepted the BLA submission for datopotamab deruxtecan in non-squamous NSCLC patients; Israel Stern, MSc,  Oncology & Hematology Analyst at GlobalData, a leading data and analytics company, offers his view: “As sales for Daiichi Sankyo’s and AstraZeneca’s HER2+-targeting antibody-drug conjugate (ADC) Enhertu (trastuzumab deruxtecan) continue to skyrocket, the companies […]
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India pharma giants and global big pharma join forces for NMEs commercialization in India, says GlobalData

The pharmaceutical landscape has undergone a significant shift towards collaboration and partnership between global big pharma and Indian pharmaceutical firms in recent years to drive innovation and expand market reach. This strategic alliance brings together the strengths and resources of both parties to accelerate commercialization. The focus is on introducing new molecular entities (NMEs) into […]
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Iovance’s Amtagvi to gain major share in melanoma treatment with first-to-market advantage, says GlobalData

Iovance Biotherapeutics’ Amtagvi has been introduced as the first FDA-approved T-cell immunotherapy for a solid tumor, employing a polyclonal tumor infiltrating lymphocyte (TIL) cell therapy. The personalized one-time cellular therapy is indicated for the treatment of adult patients with unresectable or metastatic melanoma who have previously received standard of care front-line PD-1 therapy and targeted […]
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International Gaucher Alliance reveals five-year plan to empower patients worldwide, says GlobalData

The International Gaucher Alliance (IGA) marks its 30th anniversary with a five-year strategic plan to advocate for Gaucher patients globally. The plan underscores a commitment to advocacy and collaboration, aiming to drive tangible advancements in patient access, research, and community empowerment, according to GlobalData, a leading data and analytics company. Gaucher disease, which is caused […]
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Alirocumab can address unmet needs in pediatric familial hypercholesterolemia, says GlobalData

Heterozygous familial hypercholesterolemia (HeFH) is an autosomal dominant disorder characterized by elevated levels of low-density lipoprotein cholesterol (LDL-C), leading to an increased risk of cardiovascular disease. Praluent (alirocumab) is a monoclonal antibody against proprotein convertase subtilisin kexin type 9 (PCSK9), an enzyme that promotes degradation of the low-density lipoprotein (LDL) receptor, which is responsible for […]
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Vivjoa to strengthen Jiagsu Hengrui infectious diseases portfolio in China, says GlobalData

Mycovia Pharmaceuticals Inc has recently announced that Jiangsu Hengrui Medicine Co Ltd has commercially launched Vivjoa* (oteseconazole) in China, making available an innovative oral azole antifungal treatment for recurrent vulvovaginal candidiasis (RVVC). This is expected to boost Jiangsu Hengrui’s infectious diseases portfolio in China and presents a promising treatment option amidst significant prevalence rates, says […]
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