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GlobalData

Pharma

Shanghai Junshi renal cell carcinoma drug toripalimab to get first-mover advantage in China PD-1 market, says GlobalData

Shanghai Junshi Biosciences supplemental new drug application (sNDA) for toripalimab, the company’s anti-PD-1 monoclonal antibody, in combination with axitinib for the first-line treatment of patients with unresectable or metastatic renal cell carcinoma (RCC), has been accepted by the National Medical Products Administration (NMPA). Following the approval, the drug is expected to get a first-mover advantage […]
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NASH market holds enormous untapped potential, says GlobalData

The prevalence of nonalcoholic steatohepatitis (NASH), a more advanced stage of nonalcoholic fatty liver disease (NAFLD), continues to increase. Following the receipt of a complete response letter (CRL) from the FDA for its farnesoid X receptor (FXR) agonist, obeticholic acid (OCA), in NASH, Intercept Pharmaceuticals has joined the list of companies who have failed to […]
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Zurzuvae provides breakthrough for postpartum depression but misses out on larger MDD patient population, says GlobalData

Following the news that the FDA granted approval for Sage Therapeutics and Biogen’s novel antidepressant Zurzuvae (zuranolone) for the treatment of postpartum depression (PPD) but rejected the drug for the treatment of major depressive disorder (MDD), issuing a complete response letter (CRL); Philippa Salter, Senior Neurology Analyst at GlobalData, offers her view: “Zurzuvae is a […]
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Zynlonta’s clinical failure will increase opportunities for competing ADCs in DLBCL, says GlobalData

ADC Therapeutics recently announced plans to discontinue the Phase II LOTIS-9 trial investigating the combination of Zynlonta and rituximab in unfit or frail previously untreated diffuse large B-cell lymphoma (DLBCL) patients following reports of excessive respiratory-related treatment-emergent adverse events. The company disclosed that it will cease its investigation of the Zynlonta-rituximab regimen in this patient […]
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Janssen’s JNJ-2113 holds potential to become leading treatment for psoriasis, says GlobalData

Janssen Pharmaceuticals recently announced its latest clinical trial results of JNJ-2113, the novel, first-in-class oral interleukin 23 receptor (IL-23R) antagonist peptide in adult patients with moderate-to-severe plaque psoriasis (PsO). Representing an innovative oral therapy that specifically targets and binds with high affinity to the IL-23R, JNJ-2113 is set to become a leading treatment for this […]
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AI appreciation in clinical practice comes with hands-on experience and understanding of technology, says GlobalData

As artificial intelligence (AI) increasingly finds its way into healthcare, physicians recognize the true value of its advantages in clinical practice more prominently after successful implementation and regular usage in their day-to-day work, according to a survey by  GlobalData, a leading data and analytics company. A GlobalData survey*, “AI in Clinical Practice – Physician Perspective […]
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Positive FDA meeting could allow Iovance gain accelerated approval for TIL therapy, says GlobalData

On July 10, Iovance Biotherapeutics announced they received positive feedback from the FDA on the design of their Phase II IOV-LUN-202 study evaluating tumor-infiltrating lymphocyte (TIL) therapy LN-145 in patients with advanced non-small cell lung cancer (NSCLC). Following their Pre-Phase III meeting with the agency, the therapy may be acceptable for accelerated approval, says GlobalData, […]
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Almost half of healthcare industry professionals endorse AI in clinical practice, reveals GlobalData survey

Artificial intelligence (AI) is increasingly becoming embedded in the provision of healthcare. Against this backdrop, 49% of healthcare industry professionals with prior AI experience showed strong endorsement for its use in clinical practice and administrative tasks, according to a survey* by GlobalData, a leading data and analytics company. GlobalData’s latest Thematic Intelligence report, “AI in […]
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India’s rising profile in clinical trials sparks urgency to raise public awareness, says GlobalData

India is emerging as a key destination for clinical trials due to its large, diverse population and liberalized regulatory landscape. Despite the increase in the number of clinical trials initiated by either domestic or multinational pharmaceutical companies in recent years, awareness about the trials is low. Addressing the issue through strategic approaches is a pressing […]
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M&A activity of pharma CMOs will continue despite challenging borrowing environment, says GlobalData

The mergers and acquisitions (M&A) activity of well-capitalized pharmaceutical contract manufacturing organizations (CMOs) is set to continue over the coming years despite a challenging borrowing environment due to rising inflation and interest rates, according to GlobalData, a leading data and analytics company. GlobalData’s latest report, ‘M&A in the Contract Manufacturing Industry: Implications and Outlook – […]
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Phase III trial results could strengthen Ocrevus’s position in multiple sclerosis market, says GlobalData

Genentech recently announced positive results from its phase III trial, OCARINA II (NCT05232825), investigating the efficacy of Ocrevus (ocrelizumab) as a subcutaneous injection, administered twice yearly for ten minutes, in patients diagnosed with relapsing multiple sclerosis (RMS) and primary progressive multiple sclerosis (PPMS). Roche announced the trial met all of the primary and secondary endpoints, […]
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Lilly donanemab flaunts strong clinical profile in data read-out, ready to compete with Leqembi if approved, says GlobalData

Following the news that Eli Lilly published full results from its TRAILBLAZER-ALZ 2 (NCT04437511) study of anti-amyloid-beta (Aβ) monoclonal antibody (mAb), donanemab, in Alzheimer’s disease (AD); Rose Joachim, Director of Neurology at GlobalData, a leading data and analytics company, offers her view: “On the heels of the US FDA’s approval of Eisai and Biogen’s Leqembi […]
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