Roche Reports Positive P-II Results of Dual GLP-1/GIP Agonist CT-388 in Obesity

Shots: Roche reported positive topline results from the P-II (CT388-103) study evaluating CT-388, an investigational dual GLP-1/GIP receptor agonist, for the treatment of obesity Once-weekly CT-388 (SC) achieved a statistically significant PBO-adjusted weight loss of 22.5% (p<0.001; efficacy estimand) at 48 wks. at the highest dose (24 mg), with no weight-loss plateau observed; 54% of…

ByPrince GiriJanuary 28, 2026

NEWS

Roche Signs an Exclusive Licensing Deal with MediLink Therapeutics for YL201

Shots: MediLink has entered into an additional collaboration & exclusive licensing agreement with Roche for the development & commercialization of YL201 (B7H3 ADC) across numerous solid tumor types Under the deal, Roche will obtain an exclusive license to develop, manufacture, & commercialize YL201 worldwide, excl. Mainland China, Hong Kong SAR, & Macau SAR In return,…

ByRidhi RastogiJanuary 9, 2026

NEWS

Roche Receives the US FDA Approval of Lunsumio VELO for Subcutaneous Use in R/R Follicular Lymphoma

Shots: The US FDA has approved Roche’s Lunsumio VELO (mosunetuzumab) as an SC formulation for the treatment of adults with r/r follicular lymphoma (FL) after ≥2L of systemic therapy, under accelerated approval Approval was based on the P-I/II (GO29781) study in third-line or later FL pts, where Lunsumio VELO demonstrated an ORR of 75% and…

ByPrince GiriDecember 23, 2025

NEWS

STADA & Bio-Thera Receive the CHMP Positive Opinion for Gotenfia (Biosimilar, Simponi)

Shots: The CHMP has recommended STADA & Bio-Thera’s Gotenfia (BAT2506; 50mg/0.5mL & 100mg/mL PFS), a biosimilar version of Simponi (golimumab), for EC approval valid in all 30 EEA states Opinion was based on extensive analytical characterization & biosimilarity of BAT2506 in comparison to US & EU Simponi from P-I trial in healthy subjects, plus P-III…

ByRidhi RastogiDecember 12, 2025

NEWS

Roche Reports P-III (lidERA Breast Cancer) Trial Data on Giredestrant for Early Breast Cancer

Shots: Roche has reported P-III (lidERA Breast Cancer) trial assessing giredestrant (QD) vs SoC endocrine therapy in pts (n=~4,100) with medium or high-risk stage I-III ER+, HER2- breast cancer At the interim analysis, trial met its 1EP of improved invasive disease-free survival (iDFS) by 30%, with 92.4% vs 89.6% pts alive & invasive disease free…

ByRidhi RastogiDecember 11, 2025

NEWS

Roche’s Point-of-Care PCR Test Gains FDA’s 510(k) Clearance with CLIA Waiver and European CE Mark to Diagnose Bordetella infections

Shots: Roche has received 510(k) clearance with CLIA waiver & CE-IVDR certification for its point-of-care test to diagnose whooping cough (pertussis) & other Bordetella infections The PCR test on the cobas liat system delivers results in 15min. in GP clinics & emergency rooms, allowing real-time diagnosis during consultation & supporting immediate antibiotic decisions to help…

ByRidhi RastogiDecember 2, 2025

TOP 20

Top 20 Prescription Drugs of 2025

Shots: In 2025, the global Prescription Drugs market is projected to generate an impressive $1.13T, with steady annual growth of 3.94% expected through 2030, ultimately reaching $1.37T. Leading the pack is Keytruda, securing the first position with $29.48B, closely followed by Ozempic at $28.18B, and Eliquis, which recorded $20.69B in global sales. Fourth position is…

ByPrince GiriNovember 20, 2025

NEWS

Genentech (Roche) Reports Interim P-III (lidERA Breast Cancer) Trial Data on Giredestrant for Early Breast Cancer

Shots: Genentech has reported P-III (lidERA Breast Cancer) trial assessing giredestrant (QD) vs SoC endocrine therapy in pts (n=~4,100) with medium or high-risk stage I-III ER+, HER2- breast cancer Trial met its 1EP of improved invasive disease-free survival & showed a favorable OS trend; OS data remains immature. Results to be presented in future meetings…

ByRidhi RastogiNovember 18, 2025

NEWS

EirGenix Enters ~$152M Licensing Deal with Sandoz to Commercialize EG1206A (Biosimilar, Perjeta)

Shots: EirGenix has partnered with Sandoz to commercialize EG1206A, a biosimilar to Roche’s Perjeta (Pertuzumab), globally excl. Taiwan, Mainland China, Macau, South Korea, Mongolia, Brunei, Cambodia, Indonesia, Laos, Myanmar, the Philippines, & Japan As per the deal, EirGenix will handle product development, manufacturing, & supply, receiving ~$152M in upfront & milestone payments, profit share post-launch…

ByRidhi RastogiNovember 12, 2025

NEWS

Geneseeq’s PanTRKare NTRK Gene Fusion Detection Kit Receives NMPA Approval as Companion Diagnostic

Shots: The Chinese NMPA has approved PanTRKare NTRK1/2/3 Gene Fusion Detection Kit as a companion diagnostic for Roche’s Rozlytrek (entrectinib) The kit was validated through a large-scale study across 33 tumor types & 2,400+ clinical samples, where it demonstrated high accuracy, sensitivity, & reproducibility, with detection of 200+ unique NTRK fusion variants Also, clinical bridging studies…

ByRidhi RastogiNovember 11, 2025

Roche Reports Positive P-II Results of Dual GLP-1/GIP Agonist CT-388 in Obesity

Roche Signs an Exclusive Licensing Deal with MediLink Therapeutics for YL201

Roche Receives the US FDA Approval of Lunsumio VELO for Subcutaneous Use in R/R Follicular Lymphoma

STADA & Bio-Thera Receive the CHMP Positive Opinion for Gotenfia (Biosimilar, Simponi)

Roche Reports P-III (lidERA Breast Cancer) Trial Data on Giredestrant for Early Breast Cancer

Roche’s Point-of-Care PCR Test Gains FDA’s 510(k) Clearance with CLIA Waiver and European CE Mark to Diagnose Bordetella infections

Top 20 Prescription Drugs of 2025

Genentech (Roche) Reports Interim P-III (lidERA Breast Cancer) Trial Data on Giredestrant for Early Breast Cancer

EirGenix Enters ~$152M Licensing Deal with Sandoz to Commercialize EG1206A (Biosimilar, Perjeta)

Geneseeq’s PanTRKare NTRK Gene Fusion Detection Kit Receives NMPA Approval as Companion Diagnostic

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