Gilead Reports Topline P-III (ASCENT-03) Trial Data of Trodelvy for Triple-Negative Breast Cancer (TNBC)

Shots:Gilead has reported topline P-III (ASCENT-03) trial data (n=~540) assessing Trodelvy vs CT in 1L pts with locally advanced, inoperable, or metastatic TNBC without PD-L1 expression or PD-L1+ pts who are previously treated with a PD-L1 inhibitorTrial met its 1EP of improved PFS in treatment-naïve mTNBC pts ineligible for PD-1/PD-L1 inhibitors; OS (2EP) data…

ByRidhi Rastogi4 days ago

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GSK Receives the CHMP’s Positive Opinion for Blenrep (Belantamab Mafodotin) Regimens to Treat R/R Multiple Myeloma

SShots:CHMP recommended Blenrep + BorDex & PomDex in MM pts with ≥1 prior therapy; EC decision expected in Q3’25. Review ongoing in the US (PDUFA: Jul 23, 2025), Canada, China (PR for DREAMM-7), & Switzerland (PR for DREAMM-8)Opinion was based on P-III (DREAMM-7 & DREAMM-8) trials assessing Blenrep + BorDex vs Darzalex + BorDex in 494…

ByRidhi Rastogi4 days ago

News

The US FDA Approves Arcutis Biotherapeutics’ Zoryve Topical Foam for Plaque Psoriasis

Shots:FDA has approved sNDA of Zoryve (0.3% roflumilast) for pts (≥12yrs.) with plaque PsO of scalp & body based on P-III (ARRECTOR) & P-II (Trial 204) trials assessing it vs vehicle in 736 pts for 8wks.ARRECTOR met its co-1EPs, with 66.4% vs 27.8% pts achieving Scalp-IGA success & 45.5% vs 20.1% pts attaining…

ByRidhi RastogiMay 23, 2025

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Roche Reports the US FDA’s Approval of Susvimo to Treat Diabetic Retinopathy

Shots:The US FDA has approved Susvimo (port delivery platform with Lucentis) for the treatment of diabetic retinopathy (DR)Approval was based on 1 yr. P-III (Pavilion) trial data assessing Susvimo (100mg/mL, refilled Q9M) vs monthly clinical observation in 173 pts with non-proliferative DR without center-involved DME, where subjects in Susvimo arm received 2 loading…

ByRidhi RastogiMay 23, 2025

News

GSK Reports the US FDA’s Approval of Nucala (Mepolizumab) for Chronic Obstructive Pulmonary Disease (COPD)

Shots:The US FDA has approved Nucala as an add-on treatment for inadequately controlled COPD & eosinophilic phenotype based on the P-III (MATINEE & METREX) trial; EMA & NMPA’s submissions are under reviewMATINEE assessed Nucala (n=403; 100mg, SC, Q4W) vs PBO (n=401) in COPD pts (n=804) with type 2 inflammation while METREX evaluated it…

ByRidhi RastogiMay 23, 2025

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AstraZeneca’s Tagrisso (Osimertinib) Secures Health Canada’s Conditional Approval to Treat Unresectable EGFR-Mutated NSCLC

Shots:Health Canada has granted conditional approval to Tagrisso for the treatment of pts with locally advanced, inoperable NSCLC with EGFR exon 19 deletions or exon 21 (L858R) substitution mutations, whose disease progressed on or following Pt-based CRTApproval was based on P-III (LAURA) study assessing Tagrisso (80mg, QD, PO) vs PBO among adults (n=216)…

ByRidhi RastogiMay 22, 2025

News

Pfizer Enters a ~$6.05B Exclusive Licensing Agreement with 3SBio for SSGJ-707

Shots:3SBio & its subsidiaries will grant Pfizer exclusive license to develop, manufacture & market SSGJ-707 worldwide, excl. China, with an option to obtain marketing rights in ChinaAs per the deal, 3SBio will receive $1.25B upfront & ~$4.8B in development, regulatory & commercial milestones, plus double-digit tiered royalties on SSGJ-707 sales; closing is expected…

ByRidhi RastogiMay 20, 2025

News

Ionis Reveals Topline P-III (ESSENCE) Trial Data of Olezarsen for Moderate Hypertriglyceridemia

Shots:Ionis has reported topline P-III (ESSENCE) trial data assessing olezarsen (50mg: 276 pts or 80mg: 832 pts, SC, Q4W for 12mos.) vs PBO (n= 369) in 1,478 adults with mod. hypertriglyceridemia (fasting TG ≥150mg/dL to <500mg/dL) with or at risk of ASCVDTrial met its 1EP with significant PBO-adjusted TG reductions of 61% (80mg)…

ByRidhi RastogiMay 19, 2025

News

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

Shots:Apnimed has reported topline P-III (SynAIRgy) trial data assessing AD109 (aroxybutynin 2.5mg/atomoxetine 75mg) vs PBO for 6mos. in 646 adults with mild to sev. OSA across all weight classes who are intolerant of or refuse CPAP therapyTrial met its 1EP with a mean change in AHI at 26wks. & showed improvements across exploratory…

ByRidhi RastogiMay 19, 2025

News

BioMarin Pharmaceutical to Acquire Inozyme Pharma for ~$270M, Strengthening its Enzyme Therapies Portfolio

Shots:BioMarin has entered into a definitive agreement to acquire Inozyme, strengthening its enzyme therapies portfolio with the addition of INZ-701, an enzyme replacement therapyAs per the deal, Inozyme’s shareholders will receive $4.00 per share in an all-cash transaction for a total consideration of ~$270M; closing is expected in Q3’25INZ-701 (SC) is being evaluated…

ByRidhi RastogiMay 19, 2025

Gilead Reports Topline P-III (ASCENT-03) Trial Data of Trodelvy for Triple-Negative Breast Cancer (TNBC)

GSK Receives the CHMP’s Positive Opinion for Blenrep (Belantamab Mafodotin) Regimens to Treat R/R Multiple Myeloma

The US FDA Approves Arcutis Biotherapeutics’ Zoryve Topical Foam for Plaque Psoriasis

Roche Reports the US FDA’s Approval of Susvimo to Treat Diabetic Retinopathy

GSK Reports the US FDA’s Approval of Nucala (Mepolizumab) for Chronic Obstructive Pulmonary Disease (COPD)

AstraZeneca’s Tagrisso (Osimertinib) Secures Health Canada’s Conditional Approval to Treat Unresectable EGFR-Mutated NSCLC

Pfizer Enters a ~$6.05B Exclusive Licensing Agreement with 3SBio for SSGJ-707

Ionis Reveals Topline P-III (ESSENCE) Trial Data of Olezarsen for Moderate Hypertriglyceridemia

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

BioMarin Pharmaceutical to Acquire Inozyme Pharma for ~$270M, Strengthening its Enzyme Therapies Portfolio

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