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GlobalData

Pharma

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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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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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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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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Otsuka’s new formulations to offset Abilify Maintena dual patent expiry impact, says GlobalData

Otsuka Pharmaceutical is poised for a strategic transition as it approaches the loss of market exclusivity of Abilify Maintena (Aripiprazole) in Europe and the US in October 2024. This significant development signals a forthcoming shift in the drug’s sales trajectory, highlighting Otsuka’s readiness to embrace changes with new formulations for continued growth in mental health […]
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AI may automate diagnosis of lupus nephritis, says GlobalData

Systemic lupus erythematosus (SLE) is a chronic autoimmune that can affect multiple major organ systems in the body. One of its most severe manifestations is renal (kidney) involvement, known as lupus nephritis (LN). Although LN can be detected via blood or urine tests, a kidney biopsy is considered the most precise diagnostic approach. However, there […]
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FDA awarded record number of review designations to CRISPR drugs in 2023, reveals GlobalData

In late 2023, Vertex Pharmaceuticals and CRISPR Therapeutics made history by gaining the first FDA approval for a CRISPR-based drug, exagamglogene autotemcel (Casgevy) for the treatment of sickle cell disease with vaso-occlusive crisis. This historic achievement coincided with a record number of 14 review designations awarded by the FDA to CRISPR-based therapies in 2023, according […]
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