CSL Reports P-IIIb Trial Data on Andembry for HAE

Shots: CSL has reported topline P-IIIb results evaluating Andembry (garadacimab-gxii) in children aged 2 to 11yrs. with hereditary angioedema (HAE) Pts aged 6–11 years received 100mg (QM, n=16), while those aged 2–5yrs. received 100mg (Q2M, n=6). Andembry showed a favorable safety profile & treatment response, with most pts remaining attack-free over 12mos. Full results will be…

ByRidhi Rastogi1 day ago

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ViiV Healthcare Reports P-IIIb (VOGUE) Trial Data on Dovato for Treatment-Naïve Adults with HIV

Shots: ViiV has reported P-IIIb (VOGUE) study data assessing Dovato (DTG/3TC; n=254) vs Biktarvy (BIC/FTC/TAF; n=255) in 509 treatment-naïve adults living with HIV-1, where treatment was initiated before the availability of baseline resistance testing results At baseline, 47% pts had HIV-1 RNA ≥100,000 copies/mL, 16% had ≥500,000 copies/mL, & 16% had CD4+ counts <200 cells/mm³. At Wk.…

ByRidhi Rastogi2 days ago

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GSK Reports EMA Submission Acceptance to Update Bexsero Label

Shots: The EMA has accepted a submission to update Bexsero’s label to incl. a single-dose booster for individuals (≥10yrs.) who were previously vaccinated with Bexsero Submission was backed by a P-IIIb study showing that a single Bexsero booster dose effectively enhanced immune responses in individuals (10–20yrs.) who completed primary vaccination series during infancy; full data…

ByRidhi RastogiJuly 20, 2026

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Otsuka Reports P-IIIb Trial Data on Centanafadine in ADHD and Comorbid Anxiety

Shots: Otsuka has reported topline P-IIIb trial results evaluating centanafadine XR (280mg, QD) vs PBO in 315 adults (18-65yrs.) with attention-deficit/hyperactivity disorder (ADHD) & comorbid generalized anxiety disorder and/or social anxiety disorder The trial met its 1EP, with AISRS total score improvement at Wk. 8 (-18.5 vs -12.6), evident from Wk. 1 & sustained throughout the…

ByRidhi RastogiJune 25, 2026

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GSK Receives MHLW Approval for Arexvy to Prevent Respiratory Syncytial Virus (RSV) Disease

Shots: The Japanese MHLW has approved GSK's Arexvy RSV vaccine for adults (18-49yrs.) at increased risk for RSV disease, expanding its use beyond those aged ≥50yrs. Approval was based on P-IIIb trial (n=1458) assessing Arexvy in individuals (18-49yrs.; n=426) compared to adults (≥60yrs.; n=429), which showed a non-inferior immune response in individuals (18-49yrs.) who are at increased…

ByRidhi RastogiMay 19, 2026

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GSK Receives the US FDA Approval of Arexvy to Prevent Respiratory Syncytial Virus (RSV) Disease

Shots: The US FDA has approved Arexvy RSV vaccine for adults (18-49yrs.) at increased risk for lower respiratory tract disease, expanding its use beyond those aged ≥50yrs. Approval was based on P-IIIb trial (n=1458) assessing immune response & 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…

ByRidhi RastogiMarch 13, 2026

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Eli Lilly Reports the P-IIIb (TOGETHER-PsO) Trial Data on Taltz + Zepbound for Adults with Psoriasis and Obesity or Overweight

Shots: Eli Lilly has reported P-IIIb (TOGETHER-PsO) trial data assessing Taltz (ixekizumab) + Zepbound (tirzepatide) vs Taltz alone in 274 adults with mod. to sev. plaque psoriasis & obesity/overweight with ≥1 additional weight-related comorbid condition At 36wks., the trial met its 1EP with 27.1% pts reaching PASI 100 & ≥10% weight loss compared to 5.8% pts. Trial…

ByRidhi RastogiFebruary 19, 2026

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Eli Lilly Reports P-IIIb (TOGETHER-PsA) Trial on Taltz + Zepbound for Psoriatic Arthritis and Obesity or Overweight

Shots: Eli Lilly has reported P-IIIb (TOGETHER-PsA) trial assessing concomitant Taltz (ixekizumab) & Zepbound (tirzepatide) vs Taltz alone in 271 adults with active PsA & obesity or overweight with ≥1 weight-related condition Trial met its 1EP, with 31.7% of pts achieving ACR50 & ≥10% weight loss at Wk. 36 vs 0.8%, & met a key…

ByRidhi RastogiJanuary 9, 2026

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Eli Lilly Reports Kisunla (Donanemab) Approval in the EU to Treat Early Symptomatic Alzheimer’s Disease

Shots: The EC has approved Kisunla to treat early symptomatic Alzheimer’s disease in adults with mild impairment or dementia & confirmed amyloid pathology who are ApoE4 heterozygotes or non-carriers Approval was based on P-III (TRAILBLAZER-ALZ 2) study (n=1736, ≥18mos.) & P-IIIb (TRAILBLAZER-ALZ 6) trial (n=843, 60-85yrs.) assessing Kisunla (QM) vs PBO in AD pts The TRAILBLAZER-ALZ 2 trial showed…

ByRidhi RastogiSeptember 26, 2025

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Takeda’s Vonvendi Receives the US FDA’s Approval for Adults and Children with Von Willebrand Disease

Shots: FDA has approved a label extension for Vonvendi to incl. routine prophylaxis for reducing bleeding in adults with Type 1 & 2 von Willebrand disease (VWD), & for on-demand & perioperative bleeding management in pediatric pts Approval was backed by extensive data, incl. a P-III trial in adults, a P-III trial in children, a P-IIIb continuation…

ByRidhi RastogiSeptember 8, 2025

CSL Reports P-IIIb Trial Data on Andembry for HAE

ViiV Healthcare Reports P-IIIb (VOGUE) Trial Data on Dovato for Treatment-Naïve Adults with HIV

GSK Reports EMA Submission Acceptance to Update Bexsero Label

Otsuka Reports P-IIIb Trial Data on Centanafadine in ADHD and Comorbid Anxiety

GSK Receives MHLW Approval for Arexvy to Prevent Respiratory Syncytial Virus (RSV) Disease

GSK Receives the US FDA Approval of Arexvy to Prevent Respiratory Syncytial Virus (RSV) Disease

Eli Lilly Reports the P-IIIb (TOGETHER-PsO) Trial Data on Taltz + Zepbound for Adults with Psoriasis and Obesity or Overweight

Eli Lilly Reports P-IIIb (TOGETHER-PsA) Trial on Taltz + Zepbound for Psoriatic Arthritis and Obesity or Overweight

Eli Lilly Reports Kisunla (Donanemab) Approval in the EU to Treat Early Symptomatic Alzheimer’s Disease

Takeda’s Vonvendi Receives the US FDA’s Approval for Adults and Children with Von Willebrand Disease

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