Apnimed Reports Topline P-III (LunAIRo) Trial Data of AD109 for Obstructive Sleep Apnea (OSA)

Shots: The P-III (LunAIRo) trial assessed AD109 (aroxybutynin 2.5mg/atomoxetine 75mg; n=329) vs PBO (n=331) for 12mos. in 660 adults with mild to sev. OSA across all weight classes, who are intolerant of or refuse CPAP therapy Trial met its 1EP with a 46.8% vs 6.8% decrease in AHI at 26wks., which remained significant through Wk.…

ByRidhi RastogiJuly 24, 2025

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Servier Reports the CHMP’s Positive Opinion Voranigo (Vorasidenib) to Treat Grade 2 IDH-Mutant Glioma

Shots: The CHMP has recommended to Voranigo for treating patients (age: ≥12yrs.; wt≥ 40kg) with Gr2 astrocytoma or oligodendroglioma with a susceptible IDH1/2 mutation post-surgery but do not currently require radiotherapy or CT; anticipated EC decision in all 30 EEA states The CHMP opinion is based on the global P-III (INDIGO) trial (N=331), which included…

ByDipanshu DixitJuly 24, 2025

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AstraZeneca Reports P-III (PREVAIL) Trial Data of Gefurulimab for Generalised Myasthenia Gravis (gMG)

Shots: AstraZeneca has reported P-III (PREVAIL) trial assessing gefurulimab vs PBO in 260 gMG adults for 26wks. across North America, EU, & APAC region; eligible pts could then enter an ongoing OLE study Trial met its 1EP & all 2EPs, showing significant improvement in MG-ADL total score from baseline at 26wks. in adults with AChR…

ByRidhi RastogiJuly 24, 2025

NEWS

GSK Receives Health Canada’s Approval for Blenrep (Belantamab Mafodotin) Regimens to Treat R/R Multiple Myeloma

Shots: Health Canada has approved Blenrep + BorDex & PomDex in MM pts with ≥1 prior therapy Approval was based on P-III (DREAMM-7 & DREAMM-8) trials assessing Blenrep + BorDex vs Darzalex + BorDex in 494 pts & Blenrep + PomDex (BPd) vs Velcade + PomDex in 302 pts, respectively DREAMM-7 showed improved PFS (1EP; mPFS: 36.6 vs 13.4mos.),…

ByDipanshu DixitJuly 24, 2025

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Johnson & Johnson’s Darzalex Secures the EC’s Approval for High-Risk Smouldering Multiple Myeloma

Shots: The EC has approved Darzalex SC (daratumumab) for the treatment of adults with high‑risk smouldering multiple myeloma (SMM) Approval was based on the P-III (AQUILA) study data assessing Darzalex SC monotx. vs active monitoring in high-risk SMM pts (n=390) At a mFU of 65.2mos., trial showed improved PFS, with 63.1% vs 40.8% pts alive…

ByRidhi RastogiJuly 24, 2025

NEWS

Johnson & Johnson’s Imbruvica Receives the EC’s Approval for Previously Untreated Mantle Cell Lymphoma (MCL)

Shots: The EC has approved a label extension for Imbruvica (ibrutinib) + R-CHOP alternating with R-DHAP (without ibrutinib), followed by ibrutinib monotx., for the treatment of previously untreated MCL pts ineligible for ASCT Approval was based on ongoing P-III (TRIANGLE) trial in 870 EU pts, assessing ibrutinib + chemoimmunotherapy (CIT) ± ASCT & 2yr. ibrutinib…

ByRidhi RastogiJuly 23, 2025

NEWS

Roche’s Itovebi Regimen Secures the EC’s Approval for PIK3CA-mutated Breast Cancer

Shots: The EC has approved Itovebi + Ibrance & fulvestrant as a 1L therapy for adults with PIK3CA-mutated, ER+/HER2- locally advanced or metastatic breast cancer recurring on or within 12mos. of adj. endocrine therapy, based on the P-III (INAVO120) trial Trial (n=325) assessed the regimen vs PBO + Ibrance & fulvestrant, which showed improved PFS…

ByRidhi RastogiJuly 23, 2025

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Merck’s Keytruda Regimen Receives Health Canada’s Approval for FIGO 2014 Stage III-IVA Cervical Cancer

Shots: Health Canada has approved Keytruda + chemoradiotherapy (CRT) for the treatment of adults with FIGO 2014 Stage III-IVA cervical cancer Approval was based on P-III (KEYNOTE-A18/ ENGOT-cx11/GOG-3047) trial assessing Keytruda (200mg, IV, Q3W × 5 cycles) + CRT followed by Keytruda (400mg, IV, Q6W × 15 cycles) vs PBO + CRT in 1060 pts with…

ByRidhi RastogiJuly 22, 2025

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Johnson & Johnson Submits NDA to the US FDA for Icotrokinra to Treat Plaque Psoriasis (PsO)

Shots: The US FDA has received NDA of icotrokinra for the treatment of pts (≥12yrs.) with mod. to sev. plaque PsO NDA was backed by P-III (ICONIC-TOTAL, ICONIC LEAD, ICONIC-ADVANCE 1 & 2) trials, where ICONIC-LEAD (vs PBO) met its co-1EPs of IGA 0/1 & PASI 90 at Wk. 16, plus showed higher rates of clear or almost clear…

ByRidhi RastogiJuly 22, 2025

NEWS

Sun Pharma Reports Topline Data from P-III (INSPIRE-1 & INSPIRE-2) Trials of Ilumya (Tildrakizumab) for Active Psoriatic Arthritis

Shots: Sun Pharma has reported topline data from P-III (INSPIRE-1 & INSPIRE-2) trials assessing Ilumya (100mg) in pts with active psoriatic arthritis (PsA) INSPIRE-1 & INSPIRE-2 trials to evaluate Ilumya (Q12W) vs PBO in ~800 active PsA pts over 52wks., where INSPIRE-1 enrolled pts with prior anti-TNF exposure & INSPIRE-2 enrolled anti-TNF naïve pts Both…

ByRidhi RastogiJuly 21, 2025

Apnimed Reports Topline P-III (LunAIRo) Trial Data of AD109 for Obstructive Sleep Apnea (OSA)

Servier Reports the CHMP’s Positive Opinion Voranigo (Vorasidenib) to Treat Grade 2 IDH-Mutant Glioma

AstraZeneca Reports P-III (PREVAIL) Trial Data of Gefurulimab for Generalised Myasthenia Gravis (gMG)

GSK Receives Health Canada’s Approval for Blenrep (Belantamab Mafodotin) Regimens to Treat R/R Multiple Myeloma

Johnson & Johnson’s Darzalex Secures the EC’s Approval for High-Risk Smouldering Multiple Myeloma

Johnson & Johnson’s Imbruvica Receives the EC’s Approval for Previously Untreated Mantle Cell Lymphoma (MCL)

Roche’s Itovebi Regimen Secures the EC’s Approval for PIK3CA-mutated Breast Cancer

Merck’s Keytruda Regimen Receives Health Canada’s Approval for FIGO 2014 Stage III-IVA Cervical Cancer

Johnson & Johnson Submits NDA to the US FDA for Icotrokinra to Treat Plaque Psoriasis (PsO)

Sun Pharma Reports Topline Data from P-III (INSPIRE-1 & INSPIRE-2) Trials of Ilumya (Tildrakizumab) for Active Psoriatic Arthritis

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