January 5, 2021 Acad, Gov/Utilities

Roche’s novel anti-TIGIT tiragolumab granted FDA Breakthrough Therapy Designation in combination with Tecentriq for PD-L1-high non-small cell lung cancer

Basel, 5 January 2021 – Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that tiragolumab, a novel cancer immunotherapy designed to bind to TIGIT, has been granted Breakthrough Therapy Designation (BTD) by the US Food and Drug Administration (FDA), in combination with Tecentriq® (atezolizumab) for the first-line treatment of people with metastatic non-small cell lung... Read more

December 23, 2020 Uncategorized

European Commission approves Roche’s Phesgo (fixed-dose combination of Perjeta and Herceptin for subcutaneous injection) for people with HER2-positive breast cancer

Subcutaneous administration is preferred by patients, physicians and healthcare providers, and is associated with a reduction in healthcare costs1,2,3 Treatment with Phesgo is over 90% faster, administered under the skin in just minutes compared to hours with intravenous (IV) infusion of Perjeta plus Herceptin4,5,6 Approval is based on results from the pivotal phase III FeDeriCa... Read more

December 21, 2020 Acad, Gov/Utilities Bio/Pharma/CRO

Roche’s faricimab meets primary endpoint and shows strong durability across two global phase III studies for diabetic macular edema, a leading cause of blindness

Faricimab given every eight weeks and at personalised dosing intervals of up to 16 weeks demonstrated non-inferior visual acuity gains compared to aflibercept given every eight weeks in both studies More than half of participants in the faricimab personalised dosing arms had extended time between treatments to 16 weeks at year one – the first... Read more

December 15, 2020 Product Launch

Roche launches cobas PIK3CA Mutation Test for patients with advanced or metastatic breast cancer in countries accepting the CE mark

This genetic test identifies mutations in the PIK3CA gene that can cause cells to grow uncontrollably, which may lead to cancer PIK3CA is the most commonly mutated gene in advanced or metastatic breast cancer, with nearly 40 percent of patients harbouring a mutation in this gene1 The cobas PIK3CA Mutation Test is a PCR-based test... Read more

December 14, 2020 Acad, Gov/Utilities Licensing, IP, and Legal

FDA approves Roche’s OCREVUS® (ocrelizumab) shorter 2-hour infusion for relapsing and primary progressive multiple sclerosis

Basel, 14 December 2020 – Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that the U.S. Food and Drug Administration (FDA) has approved a shorter two-hour infusion time for OCREVUS® (ocrelizumab), dosed twice-yearly for those living with relapsing or primary progressive multiple sclerosis (MS) who have not experienced any prior serious infusion reactions (IRs). The... Read more

December 10, 2020 Bio/Pharma/CRO Clinical Research/Diagn.

Roche presents exploratory data from the Phase III IMvigor010 study in early bladder cancer at the ESMO Immuno-Oncology Virtual Congress 2020

People with muscle-invasive urothelial cancer (MIUC) who had detectable circulating tumour DNA (ctDNA) were more likely to benefit from treatment with adjuvant (after surgery) Tecentriq monotherapy, compared with those without ctDNA The goal of current treatment in people with MIUC is to provide early intervention to reduce the risk of the disease recurring or spreading... Read more

December 9, 2020 M&A, Partnerships

Roche partners with Moderna to include SARS-CoV-2 antibody test in ongoing COVID-19 vaccine trials

Moderna’s vaccine triggers an antibody response to the SARS-CoV-2 spike protein The Elecsys Anti-SARS-CoV-2 S test can quantitatively measure the level of antibodies against SARS-CoV-2 in vaccine trial participants and could help to establish correlation to protection from COVID-19 Emergency Use Authorisation by the US FDA for the Elecsys Ab test was granted on 25... Read more

December 7, 2020 PAI Top-10 Product Launch

New data presented at ASH 2020 reinforces the benefit/risk profile of fixed-duration Polivy plus bendamustine and MabThera/Rituxan in patients with relapsed or refractory diffuse large B-cell lymphoma

Basel, 07 December 2020 – Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced longer-term data from the pivotal phase Ib/II GO29365 study, including data from a single-arm extension cohort of 106 additional patients, which show the benefit of Polivy® (polatuzumab vedotin) plus bendamustine and MabThera®/Rituxan® (rituximab) (BR) in people with relapsed or refractory (R/R) diffuse... Read more