August 3, 2021 Acad, Gov/Utilities

US FDA grants Priority Review to Roche’s Tecentriq as adjuvant treatment for certain people with early non-small cell lung cancer

Basel, 3 August 2021 – Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that the US Food and Drug Administration (FDA) has accepted the company’s supplemental Biologics License Application (sBLA) and granted Priority Review for Tecentriq® (atezolizumab) as adjuvant treatment following surgery and platinum-based chemotherapy for people with non-small cell lung cancer (NSCLC) whose tumours... Read more

July 29, 2021 Acad, Gov/Utilities

FDA accepts application for Roche’s faricimab for the treatment of neovascular age-related macular degeneration (nAMD) and diabetic macular edema (DME)

Across four phase III studies, approximately half of patients receiving faricimab could extend treatment time to every four months – the first time this level of durability has been achieved in phase III nAMD and DME studies If approved, faricimab would be the first and only medicine designed to target two distinct pathways that drive... Read more

July 29, 2021 Licensing, IP, and Legal Product Launch

Data for Roche’s Evrysdi® (risdiplam) published in New England Journal of Medicine shows significant improvement in survival and motor milestones in babies with Type 1 spinal muscular atrophy (SMA)

FIREFISH Part 2 study showed treatment with Evrysdi helped babies stay free of permanent ventilation, sit without support and improve across a range of motor milestones Evrysdi has proven efficacy in adults, children and babies two months and older with over 4,000 patients treated to date SMA is the leading genetic cause of death in... Read more

July 21, 2021 Acad, Gov/Utilities Other Lab Products/Services PAI Top-10

FDA grants Breakthrough Therapy Designation for Venclexta in combination with azacitidine for the treatment of patients with myelodysplastic syndromes

Every year in the US, approximately 10,000 people are diagnosed with myelodysplastic syndromes (MDS), and there remains a high unmet need for new treatment options1 The designation is based on interim results from the phase Ib M15-531 study investigating Venclexta/Venclyxto plus azacitidine in people with previously untreated higher-risk MDS This is the 11th Breakthrough Therapy... Read more

July 20, 2021 Uncategorized

Japan becomes first country to approve Ronapreve (casirivimab and imdevimab) for the treatment of mild to moderate COVID-19

Full approval is based on a global phase III trial which found casirivimab and imdevimab reduced hospitalisation or death by 70% in high-risk non-hospitalised patients Basel, 20 July 2021 – Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that Japan’s Ministry of Health, Labour and Welfare (MHLW) has approved Ronapreve™(casirivimab and imdevimab), for the treatment... Read more

July 19, 2021 PAI Top-10 Product Launch

New data for Roche’s Hemlibra reinforce safety profile in people with haemophilia A

Final analysis from the phase IIIb STASEY study, including data from 193 people with haemophilia A, further support the benefit/risk profile of Hemlibra, with no new safety signals identified1 STASEY is one of the largest open-label studies primarily assessing safety and tolerability of a medicine for people with haemophilia A with factor VIII inhibitors Hemlibra... Read more

July 9, 2021 Clinical Research/Diagn. PAI Top-10

WHO guidelines now include Roche’s diagnostic tests in expanded effort to eliminate tuberculosis by providing patients greater access to timely diagnosis

Tuberculosis is a disease of poverty, and economic distress with 1.4 million deaths annually1 and the growing challenge of drug resistance is adding to the global health crisis WHO guidelines support the expansion of tuberculosis diagnostics in resource-limited countries, enabling patients to receive timely diagnosis leading to proper treatment, which benefits their recovery and slows... Read more

July 2, 2021 PAI Top-10 Product Launch

Roche to present new data at the ISTH 2021 Congress highlighting long-standing commitment to advancing haemophilia A standard of care

Roche will present the final analysis from the phase IIIb STASEY study, reinforcing the safety and efficacy profile of Hemlibra in a broad range of people with haemophilia A with factor VIII inhibitors1 Spark Therapeutics will share updated data from the ongoing phase I/II clinical trial of investigational gene therapy SPK-8011, demonstrating that hepatocyte expression... Read more

June 28, 2021 Uncategorized

Roche’s ENSPRYNG approved by European Commission as first and only at-home subcutaneous treatment for neuromyelitis optica spectrum disorder (NMOSD)

ENSPRYNG is the first and only treatment approved for both adults and adolescents in the EU with AQP4-IgG seropositive NMOSD ENSPRYNG can be used as a monotherapy or in combination with immunosuppressive therapy to reduce relapses and prevent permanent disability In Phase III studies, ENSPRYNG significantly reduced the number and severity of relapses in people... Read more