Shots:Bio-Thera Solutions & SteinCares signed an agreement to commercialize a proposed dupilumab biosimilar for inflammatory diseases in Latin AmericaAs per the deal, Bio-Thera will handle product development and supply, while SteinCares manages registration and commercialization in Latin AmericaDupilumab (SC) is a fully human mAb that blocks IL-4 and IL-13 signalling pathways and…
Shots :Regeneron highlighted the data at RAD’25 from the P-IV (DISCOVER) study evaluating Dupixent in pts (N=120) with atopic dermatitis with skin of color that received Dupixent as monotx. Q2W based on weight after loading dose: 200mg for 30-60kg pts & 300mg for ≥60kg ptsDupixent achieved a ≥75% improvement in overall disease severity…
Shots:Japan’s MHLW has approved Dupixent to treat COPD in adults whose disease is inadequately controlled with existing therapyApproval was based on P-III (BOREAS) trial assessing Dupixent + SoC vs PBO in uncontrolled COPD adults with elevated blood eosinophils, which showed reduced exacerbations & improved lung function; data from BORUS & its replicate P-III (NOTUS)…
Shots: The CHMP’s positive opinion of Dupixent as an add-on maintenance therapy for uncontrolled COPD patients with type 2 inflammation was based on P-II (BOREAS & NOTUS) studies assessing its safety & efficacy for the same Studies met the 1EP depicting a 34% reduction in annualized moderate or severe acute COPD exacerbations, sustained lung function…
Shots:The EMA approved 4 New Chemical Entity (NCE) and 5 Biologic Drugs in March 2023, leading to treatments for patients and advances in the healthcare industryIn March 2023, the major highlights drugs were Reblozyl’s Approval for anemia in adult patients with non-transfusion-dependent beta thalassemia, Pombiliti for late-onset pompe diseasePharmaShots has compiled a…
Shots:In continuation of our previous series on the top-performing drug of the month, based on 2021 revenue, this month we have selected Dupixent and prepared a curated analysis report for our readersDupixent is an interleukin-4 receptor alpha antagonist used for the treatment of multiple indications including atopic dermatitis, asthma, eosinophilic esophagitis, etc.PharmaShots…

