GRIN Therapeutics Collaborates with Angelini Pharma to Co-Develop and Commercialize Radiprodil for Neurological Disorders

Shots: GRIN has granted Angelini Pharma exclusive rights to commercialize radiprodil worldwide, while GRIN will retain its rights in the US, Canada, & Mexico as well as lead global development As per the deal, GRIN will get $50M upfront & ~$520M in development, regulatory & sales milestones, with net sales-based tiered royalties & payments from…

ByRidhi RastogiMay 28, 2025

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AstraZeneca Reports the CHMP’s Positive Opinion for Perioperative Imfinzi to Treat Muscle-Invasive Bladder Cancer (MIBC)

Shots: The CHMP has recommended Imfinzi as a perioperative treatment of MIBC; regulatory review is ongoing in Japan & other regions Opinion was based on the P-III (NIAGARA) trial (n=1063) MIBC pts randomized to either neoadj. Imfinzi + CT before cystectomy followed by adj. Imfinzi or neoadj. CT with no further treatment after surgery …

ByRidhi RastogiMay 27, 2025

NEWS

RemeGen’s Telitacicept Receives the NMPA’s Approval for Generalized Myasthenia Gravis (gMG)

Shots: The NMPA has approved telitacicept for the treatment of AChR antibody-positive gMG in combination with standard therapies In P-III trial for gMG, telitacicept demonstrated favorable efficacy vs PBO, with 98.1% vs 12% pts achieving ≥3-point MG-ADL reduction (-5.74 vs -0.91) as well as 87% vs 16% pts having ≥5-point QMG reduction (-8.66 vs -2.27) at…

ByRidhi RastogiMay 27, 2025

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GSK Reports Health Canada’s NDS Acceptance of Depemokimab for Asthma with Type 2 Inflammation and CRSwNP

Shots: Health Canada has accepted NDS of depemokimab as an adjunctive therapy for asthma pts (≥12yrs.) with type 2 inflammation marked by blood eosinophil count as well as inadequately controlled CRSwNP based on P-III (SWIFT & ANCHOR) trials, respectively SWIFT-1 (n=382) & SWIFT-2 (n=380) trials assessed depemokimab vs PBO + SoC, ICS & controller…

ByRidhi RastogiMay 27, 2025

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Genentech Reports P-III (STARGLO) Trial Data on Columvi for R/R Diffuse Large B-Cell Lymphoma (DLBCL)

Shots: Genentech has reported 2yr. P-III (STARGLO) trial data assessing Columvi + GemOx vs Rituxan + GemOx in previously treated ASCT-ineligible r/r DLBCL pts At 24.7mos. mFU, trial showed a 40% improvement in OS (mOS: not reached vs 13.5mos.), a 59% reduction in risk of progression or death, & CRs in 58.5% vs 25.3% pts;…

ByRidhi RastogiMay 26, 2025

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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…

ByRidhi RastogiMay 26, 2025

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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…

ByRidhi RastogiMay 26, 2025

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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…

ByRidhi RastogiMay 26, 2025

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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

NEWS

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

GRIN Therapeutics Collaborates with Angelini Pharma to Co-Develop and Commercialize Radiprodil for Neurological Disorders

AstraZeneca Reports the CHMP’s Positive Opinion for Perioperative Imfinzi to Treat Muscle-Invasive Bladder Cancer (MIBC)

RemeGen’s Telitacicept Receives the NMPA’s Approval for Generalized Myasthenia Gravis (gMG)

GSK Reports Health Canada’s NDS Acceptance of Depemokimab for Asthma with Type 2 Inflammation and CRSwNP

Genentech Reports P-III (STARGLO) Trial Data on Columvi for R/R Diffuse Large B-Cell Lymphoma (DLBCL)

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

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

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