Simcere Zaiming Inks ~$1.53B Licensing Deal with Roche for SIM0660

Shots: Simcere Zaiming has entered into an exclusive global licensing agreement with Roche for the development & commercialization of SIM0660, a potential treatment of B-cell-mediated diseases As per the deal, Roche will acquire exclusive global rights to develop, manufacture, & commercialize SIM0660 in exchange for ~$1.53B in total, incl. $75M in upfront, as well as…

ByRidhi RastogiSeptember 2, 2026

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Roche Reports FDA Approval of HER2 Companion Diagnostics for Gastroesophageal Cancer

Shots: The US FDA has granted approval to expand the use of Pathway HER2 (4B5) & Ventana HER2 Dual ISH tests to identify HER2+ metastatic gastroesophageal adenocarcinoma (GEA), incl. gastric, GEJ & esophageal adenocarcinoma The companion diagnostics can help identify pts who may be eligible for HER2-targeted treatment with two Ziihera (zanidatamab-hrii) regimens for 1L…

ByRidhi RastogiAugust 27, 2026

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Roche’ Elecsys pTau217 Test Receives the US FDA Clearance to Rule in or Rule Out Alzheimer’s-Related Amyloid Pathology

Shots: The US FDA has granted clearance to Elecsys pTau217 to measure the phosphorylated Tau (pTau) 217 protein to help rule in or rule out Alzheimer’s-related amyloid pathology in people (≥55yrs.) with signs or complaints of cognitive decline In adults aged 55+ with cognitive decline associated with Alzheimer’s disease, Elecsys pTau217 showed high agreement with…

ByRidhi RastogiAugust 24, 2026

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Roche Reports CHMP Positive Opinion for Susvimo to Treat nAMD

Shots: The CHMP has recommended Susvimo (100mg/mL) for the treatment of neovascular age-related macular degeneration (nAMD) The opinion was based on the 3 studies, P-III (Archway), P-II (LADDER) & open-label LTE study (Portal), where Archway showed Susvimo (refilled in Q6M) maintained vision improvements equivalent to Lucentis (QM, IVT), with Portal showing maintenance of vision up…

ByRidhi RastogiJuly 27, 2026

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Roche Receives the US FDA Priority Review for Gazyva to Treat Primary Membranous Nephropathy

Shots: The US FDA has granted Priority Review to the sBLA of Gazyva/Gazyvaro (obinutuzumab) in pMN, based on the P-III (MAJESTY) study assessing Gazyva vs tacrolimus in adults (n=142), with a decision expected by Nov 2026 Trial met its 1EP, with 36.9% adults achieving CR at 2yrs. vs 5.7%, plus showed superiority across key 2EPs…

ByRidhi RastogiJuly 15, 2026

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Roche Receives CE Mark for Rapid Elecsys IGRA TB Test to Detect Latent Tuberculosis

Shots: Roche has received a CE Mark for its Elecsys IGRA TB test, a blood-based assay for detecting tuberculosis infection (latent TB) in routine laboratory settings Test delivers results in <24hrs., with IGRA assay completed in 19min., & automates result calculation, interpretation, & reporting on Roche immunoassay platforms while integrating with third-party liquid handlers to…

ByRidhi RastogiJuly 9, 2026

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Roche Reports P-III (Krascendo 1) Trial Results on Divarasib for KRAS G12C-Mutant NSCLC

Shots: Roche has reported the global P-III (Krascendo 1) trial assessing divarasib monotx. (QD) vs sotorasib (QD) or adagrasib (BID) in 338 pts with previously treated KRAS G12C-mutant advanced or metastatic NSCLC The trial met its 1 & key 2EPs, with divarasib achieving improvements in both PFS & OS; data to be submitted to health…

ByRidhi RastogiJuly 2, 2026

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Roche’s Enspryng Receives the US FDA Priority Review for At-Home SC Treatment of Thyroid Eye Disease

Shots: The US FDA has accepted sBLA & granted priority review to Roche's Enspryng (satralizumab; SC) for the treatment of thyroid eye disease (TED), with a decision expected by Oct 15, 2026 sBLA was supported by P-III (SatraGO-1 & SatraGO-2) trials assessing Enspryng vs PBO in total of 258 adults with active, mod. to sev.…

ByRidhi RastogiJune 30, 2026

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Nurix Therapeutics Inks ~$3B Deal with Roche to Advance Bexobrutideg

Shots: Nurix has entered a global collaboration with Roche to develop & commercialize bexobrutideg (PO), a BTK targeted protein degrader, which is under P-II/III trial for chronic lymphocytic leukemia Nurix will receive $700M upfront & ~$2.3B in milestones. Development costs will be shared (40% Nurix & 60% Roche), with both co-commercializing the drug & equally…

ByRidhi RastogiJune 8, 2026

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Roche’ Elecsys pTau217 Test Receives the European CE Mark Approval to Rule in or Rule Out Alzheimer’s-Related Amyloid Pathology

Shots: Roche has received CE Mark for Elecsys pTau217 to measure the phosphorylated Tau (pTau) 217 protein to help rule in or rule out Alzheimer’s-related amyloid pathology CE Mark was backed by retrospective real-world studies in early-stage Alzheimer’s pts, incl. Subjective Cognitive Decline, Mild Cognitive Impairment, & Mild Dementia, where individuals experience memory changes but…

ByRidhi RastogiMay 12, 2026

Simcere Zaiming Inks ~$1.53B Licensing Deal with Roche for SIM0660

Roche Reports FDA Approval of HER2 Companion Diagnostics for Gastroesophageal Cancer

Roche’ Elecsys pTau217 Test Receives the US FDA Clearance to Rule in or Rule Out Alzheimer’s-Related Amyloid Pathology

Roche Reports CHMP Positive Opinion for Susvimo to Treat nAMD

Roche Receives the US FDA Priority Review for Gazyva to Treat Primary Membranous Nephropathy

Roche Receives CE Mark for Rapid Elecsys IGRA TB Test to Detect Latent Tuberculosis

Roche Reports P-III (Krascendo 1) Trial Results on Divarasib for KRAS G12C-Mutant NSCLC

Roche’s Enspryng Receives the US FDA Priority Review for At-Home SC Treatment of Thyroid Eye Disease

Nurix Therapeutics Inks ~$3B Deal with Roche to Advance Bexobrutideg

Roche’ Elecsys pTau217 Test Receives the European CE Mark Approval to Rule in or Rule Out Alzheimer’s-Related Amyloid Pathology

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