NEWS

Roche’s Itovebi Regimen Secures the CHMP’s Positive Opinion for PIK3CA-mutated Breast Cancer

Shots: The CHMP has recommended Itovebi + Ibrance & fulvestrant as a 1L therapy for adults with PIK3CA-mutated, HR+/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, improved PFS (1EP) by…

May 26, 2025

mAbxience and Abiogen Pharma Enter into a Strategic Licensing Agreement for Biosimilar across Italy

Shots: mAbxience, majority-owned by Fresenius Kabi and partially by Insud Pharma, has partnered with Abiogen Pharma in a strategic licensing agreement to develop & commercialize a biosimilar in Italy As per the agreement, mAbxience will hold marketing authorization, while Abiogen Pharma handles commercialization and marketing in Italy This collaboration leverages mAbxience’s biosimilar development expertise and…

May 26, 2025

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 inhibitor Trial met its 1EP of improved PFS in treatment-naïve mTNBC pts ineligible for PD-1/PD-L1 inhibitors; OS (2EP) data…

May 26, 2025

The CHMP Adopts Positive Opinion for SpringWorks Therapeutics’ Mirdametinib to Treat NF1-PN

Shots: The CHMP has recommended conditional approval of mirdametinib for pts (≥2yrs.) with unresectable neurofibromatosis type 1 associated symptomatic plexiform neurofibromas (NF1-PN) based on P-IIb (ReNeu) trial; EC’s decision expected in Q3’25 The P-IIb (ReNeu) study assessed mirdametinib (2mg/m^2, BID) in 2 Arms (N=114: 56 pediatric & 58 adults) & met its 1EP of cORR…

May 26, 2025

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

S Shots: 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…

May 26, 2025

Gyre Therapeutics Releases P-III Trial Findings on Hydronidone for Chronic Hepatitis B-Associated Liver Fibrosis

Shots: Gyre Therapeutics has reported P-III trial data assessing Hydronidone (270mg, QD, PO) + entecavir (n=123) vs PBO + entecavir (n=124) in 248 Chinese pts with chronic hepatitis B-associated liver fibrosis for 52wks.; 1 untreated subject was excluded from analysis Trial met its 1EP, with 52.85% vs 29.84% achieving ≥1-stage fibrosis regression (Ishak score) & 2EP,…

May 23, 2025

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…

May 23, 2025

Petvivo Holdings Collaborates with PiezoBioMembrane to Develop Functional Biomaterials

Shots: PetVivo Holdings & its subsidiary PetVivo Animal Health has entered into a master services agreement with PiezoBioMembrane to develop biocompatible biomaterial that mimics mammalian extracellular matrix As per the deal, PetVivo & PiezoBio will co-develop a piezo-biomaterial combining ECM biomaterial & piezoelectric nanofibers to enable biologically activated healing, regeneration, & remodelling of damaged or…

May 23, 2025

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…

May 23, 2025

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 review MATINEE assessed Nucala (n=403; 100mg, SC, Q4W) vs PBO (n=401) in COPD pts (n=804) with type 2 inflammation while METREX evaluated it…

May 23, 2025

NEWS

Roche’s Itovebi Regimen Secures the CHMP’s Positive Opinion for PIK3CA-mutated Breast Cancer

mAbxience and Abiogen Pharma Enter into a Strategic Licensing Agreement for Biosimilar across Italy

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

The CHMP Adopts Positive Opinion for SpringWorks Therapeutics’ Mirdametinib to Treat NF1-PN

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

Gyre Therapeutics Releases P-III Trial Findings on Hydronidone for Chronic Hepatitis B-Associated Liver Fibrosis

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

Petvivo Holdings Collaborates with PiezoBioMembrane to Develop Functional Biomaterials

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)

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