GSK Reports the US FDA’s Application Acceptance of Arexvy to Prevent Respiratory Syncytial Virus (RSV) Disease

Shots: The US FDA has accepted application of Arexvy RSV vaccine for adults aged 18-49yrs. at increased risk, expanding its use beyond those aged ≥50yrs.; FDA decision is anticipated H1’26. GSK is also seeking expanded RSV vaccine indications in other regions, incl. the EEA & Japan Submission was based on P-IIIb trial (n=1458) assessing immune response & safety…

ByRidhi RastogiJuly 14, 2025

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LEO Pharma Reports Interim P-IIIb (ADHAND) Trial Data on Adbry for Atopic Dermatitis

Shots: LEO Pharma has reported 16wk. interim data from P-IIIb (ADHAND) trial assessing Adbry monotx. (tralokinumab; 300mg, Q2W) vs PBO for 16wks. in adults with mod. to sev. atopic dermatitis on hands eligible for systemic therapy, followed by a 16wk. open-label phase, where all pts received Adbry Trial met its 1EP, with higher proportion of…

ByRidhi RastogiJuly 10, 2025

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GSK Reports the MHLW’s sNDA Acceptance of Arexvy to Prevent Respiratory Syncytial Virus (RSV) Disease

Shots: Japan’s MHLW has accepted sNDA of Arexvy RSV vaccine for adults aged 18-49yrs. at increased risk, expanding its use beyond those aged ≥50yrs. Submission was based on P-IIIb trial (n=1458) assessing non-inferiority & safety of Arexvy RSV vaccine in individuals (18-49yrs.; n=426) compared to adults (≥60yrs.; n=429); an additional cohort (18-49yrs.; n=603) was followed for…

ByRidhi RastogiJune 20, 2025

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Novartis to Highlight P-IIIb Trial Data of Fabhalta for Paroxysmal Nocturnal Hemoglobinuria (PNH) at EHA 2025

Shots: Novartis has reported P-IIIb (APPULSE-PNH) trial data assessing Fabhalta (iptacopan; 200mg, BID, PO) for 24wks. in 52 PNH adults with Hb levels ≥10g/dL who switched from anti-C5 therapies (eculizumab or ravulizumab) Trial showed a 2.01 g/dL mean Hb increase, with 92.7% pts achieving ≥12g/dL & no transfusions over 24wks. It also depicted improved fatigue…

ByRidhi RastogiJune 12, 2025

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Johnson & Johnson Presents P-IIIb (APEX) Trial Findings of Tremfya for Active Psoriatic Arthritis at EULAR 2025

Shots: The P-IIIb (APEX) trial assessed Tremfya (Q4W or Q8W) vs PBO for 24wks. in biologic-naïve PsA pts with inadequate response to SoCs, followed by a 24wk. active treatment period then a 12wk. safety follow-up; pts could enter a 2yr. extension phase prior to the final safety follow-up Trial showed reduced joint damage progression per…

ByRidhi RastogiJune 12, 2025

NEWS

Johnson & Johnson Reports P-IIIb (APEX) Trial Findings of Tremfya for Active Psoriatic Arthritis

Shots: J&J has reported P-IIIb (APEX) trial data assessing Tremfya vs PBO in biologic-naïve PsA pts with inadequate response to standard therapies for 24wks., followed by a 12wk. safety follow-up; eligible pts could enter a 2yr. extension phase prior to the final safety follow-up Trial met its 1EP of improved ACR20 response, showing reduced signs…

ByRidhi RastogiApril 7, 2025

GSK Reports the US FDA’s Application Acceptance of Arexvy to Prevent Respiratory Syncytial Virus (RSV) Disease

LEO Pharma Reports Interim P-IIIb (ADHAND) Trial Data on Adbry for Atopic Dermatitis

GSK Reports the MHLW’s sNDA Acceptance of Arexvy to Prevent Respiratory Syncytial Virus (RSV) Disease

Novartis to Highlight P-IIIb Trial Data of Fabhalta for Paroxysmal Nocturnal Hemoglobinuria (PNH) at EHA 2025

Johnson & Johnson Presents P-IIIb (APEX) Trial Findings of Tremfya for Active Psoriatic Arthritis at EULAR 2025

Johnson & Johnson Reports P-IIIb (APEX) Trial Findings of Tremfya for Active Psoriatic Arthritis

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