Shots: Galderma’s Nemluvio (nemolizumab) was recently approved by the US FDA for the treatment of adults with prurigo nodularis, following positive Phase III results from the OLYMPIA study. Today at PharmaShots, we have Baldo Scassellati Sforzolini, Global Head of Research & Development at Galderma, to discuss the study’s design and the potential of Nemluvio in…
Shots: Atopic dermatitis remains one of the most common inflammatory skin diseases, affecting more than 230M people across the globe. Characterized by frequent itching and recurrent skin lesions, atopic dermatitis is a chronic condition Recently the Lancet published data from Galderma’s P-III trial, ARCADIA 1 and ARCADIA 2, demonstrating the potential of nemolizumab to improve skin…
Galderma Reports the US FDA’s Approval of Nemluvio (Nemolizumab) for Treating Prurigo Nodularis (PN)
Shots: The approval of Nemluvio (SC pre-filled pen) was based on P-III (OLYMPIA 1 & 2) studies assessing its safety & efficacy vs PBO in PN patients (n= >500) Studies met their 1 & 2EPs, showing at least a 4-point reduced itch intensity in 56% & 49% vs 16% (both PBO groups); skin nodules clearance…
The second quarter of 2022 highlights major acquisitions in the pharma and biotech industry along with multiple approvals. Meanwhile, AstraZeneca’s Farxiga (dapagliflozin) meet its primary endpoints for heart failure with a preserved ejection fractionStarting with the latest acquisitions, Pfizer acquire Biohaven for ~$11.6B, GSK acquire Affinivax for ~$3.3B. The second quarter of the year…
The US FDA has approved 6 NDAs in Apr 2022, leading to treatments for patients and advances in the healthcare industry. The CDER and CBER approved 26 novel products in 2022In Apr 2022, the major highlights drugs were Vivjoa for Recurrent Vulvovaginal Candidiasis, Cuvrior for Stable Wilson’s Disease, Igalmi for Acute Treatment of Agitation…
The US FDA's Center for Drug Evaluation and Research (CDER) and Center for Biologics Evaluation and Research (CBER) have approved 35 new products so far in 2019. In 2018 FDA approved 59 novel products including 42 New Chemical Entities and 17 Biologics while breaking its last year's record of approvals. However, there is a significant…

