Merck KGaA to Present P-III (MANEUVER) Trial Data of Pimicotinib for Tenosynovial Giant Cell Tumor at ASCO 2025

Shots:Part 1 of P-III (MANEUVER) trial assessed pimicotinib (n=63) vs PBO (n=31) for 24wks. in 94 TGCT pts who required systemic therapy & had no prior anti-CSF-1/CSF-1R treatment; trial also incl. an open-label Part 2 (data expected in mid-2025) & an OLE phase (Part 3)Trial met its 1EP of improved ORR (54.0% vs…

ByRidhi Rastogi9 hours ago

News

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

Shots:GRIN Therapeutics has granted Angelini Pharma exclusive rights to develop & market radiprodil worldwide, while GRIN will retain its rights in the US, Canada, & MexicoAs per the deal, GRIN will get $50M upfront & ~$520M in development, regulatory & sales milestones, with net sales-based tiered royalties & payments from future sublicenses outside…

ByRidhi Rastogi14 hours ago

News

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 regionsOpinion 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 Rastogi1 day ago

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 therapiesIn 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 Rastogi1 day ago

News

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 Rastogi1 day ago

News

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 ptsAt 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 Rastogi2 days ago

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) trialTrial (n=325) assessed the regimen vs PBO + Ibrance & fulvestrant, improved PFS (1EP) by…

ByRidhi Rastogi2 days ago

News

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 Rastogi3 days ago

News

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 Rastogi3 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

Merck KGaA to Present P-III (MANEUVER) Trial Data of Pimicotinib for Tenosynovial Giant Cell Tumor at ASCO 2025

GRIN Therapeutics Collaborates with Angelini Pharma to 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

Contact US

OUR INFORMATION

FOLLW US

FOLLW US

Sign Up to Our Newsletter