August 16, 2019 Acad, Gov/Utilities

FDA approves Roche’s RozlytrekTM (entrectinib) for people with ROS1-positive, metastatic non-small cell lung cancer and NTRK gene fusion-positive solid tumours

Basel, 16 August 2019 FDA approves Roche’s RozlytrekTM (entrectinib) for people with ROS1-positive, metastatic non-small cell lung cancer and NTRK gene fusion-positive solid tumours First FDA-approved treatment designed to target both ROS1 and NTRK that also shows response in cancer that has spread to the brain Roche’s first FDA-approved tumour-agnostic medicine Roche (SIX: RO, ROG;... Read more

August 5, 2019 Uncategorized

Roche’s Tecentriq plus platinum-based chemotherapy reduced the risk of disease worsening or death in people with previously untreated advanced bladder cancer

Basel, 05 August 2019 Roche’s Tecentriq plus platinum-based chemotherapy reduced the risk of disease worsening or death in people with previously untreated advanced bladder cancer IMvigor130 is the first positive Phase III study of a cancer immunotherapy combination in previously untreated advanced bladder cancer Data will be shared with health authorities globally, including the U.S.... Read more

July 31, 2019 Atomic Spectroscopy Clinical Research/Diagn.

Roche and Spark Therapeutics, Inc. announce extension of tender offer for shares of Spark Therapeutics, Inc.

Basel, 31 July 2019 Roche and Spark Therapeutics, Inc. announce extension of tender offer for shares of Spark Therapeutics, Inc. Roche (SIX: RO, ROG; OTCQX: RHHBY) and Spark Therapeutics, Inc. (NASDAQ: ONCE) (“Spark”) today announced that Roche has extended the offering period of its previously announced tender offer to purchase all of the outstanding shares... Read more

July 26, 2019 PR/Corporate Product Launch

Roche receives CHMP positive opinion for new Tecentriq-based combination therapy as an initial treatment for most common form of advanced lung cancer

Basel, 26 July 2019 Roche receives CHMP positive opinion for new Tecentriq-based combination therapy as an initial treatment for most common form of advanced lung cancer Decision based on data showing that the Tecentriq plus chemotherapy combination demonstrated a significant overall survival (OS) and progression-free survival (PFS) benefit in the first-line treatment of people with... Read more

July 26, 2019 Uncategorized

CHMP recommends EU approval of Roche’s Tecentriq in combination with chemotherapy as an initial treatment of adults with extensive-stage small cell lung cancer

Basel, 26 July 2019 CHMP recommends EU approval of Roche’s Tecentriq in combination with chemotherapy as an initial treatment of adults with extensive-stage small cell lung cancer Decision based on results from first Phase III study to show a cancer immunotherapy-based combination significantly improved overall survival (OS) and progression-free survival (PFS) in over 20 years... Read more

July 22, 2019 Clinical Research/Diagn.

Roche expands the Global Access Program beyond HIV to also include diagnostic tests for Tuberculosis, Hepatitis, and Human Papillomavirus

Basel, 22 July 2019 Roche expands the Global Access Program beyond HIV to also include diagnostic tests for Tuberculosis, Hepatitis, and Human Papillomavirus Access to innovative diagnostic solutions will contribute to the World Health Organization’s infectious disease elimination goals Improving access to reliable diagnostics for disease management in countries with the highest burden Early detection... Read more

July 9, 2019 PR/Corporate

Roche presents a broad range of data for Hemlibra demonstrating continued benefits for people with haemophilia A at the ISTH 2019 Congress

Basel, 09 July 2019 Roche presents a broad range of data for Hemlibra demonstrating continued benefits for people with haemophilia A at the ISTH 2019 Congress New analyses from phase III HAVEN studies support Hemlibra’s sustained efficacy, safety and quality of life benefit in people with haemophilia A, with and without factor VIII inhibitors First... Read more

June 28, 2019 Licensing, IP, and Legal

CHMP recommends EU approval of Roche’s Tecentriq in combination with Abraxane as an initial treatment for people with PD-L1-positive, metastatic triple-negative breast cancer

Basel, 28 June 2019 CHMP recommends EU approval of Roche’s Tecentriq in combination with Abraxane as an initial treatment for people with PD-L1-positive, metastatic triple-negative breast cancer Recommendation based on the results of IMpassion130 study in triple-negative breast cancer, an aggressive type of breast cancer with high unmet medical need First positive Phase III cancer... Read more

June 18, 2019 Uncategorized

Japan becomes the first country to approve Roche’s personalised medicine Rozlytrek

Basel, 18 June 2019 Japan becomes the first country to approve Roche’s personalised medicine Rozlytrek First tumour-agnostic medicine approved in Japan for adult and paediatric patients with NTRK fusion-positive advanced recurrent solid tumours Approval supported by the data mainly from the pivotal Phase II STARTRK-2 study showing that Rozlytrek shrank tumours in more than half... Read more

June 11, 2019 Acad, Gov/Utilities

FDA grants Roche’s Polivy accelerated approval for people with previously treated aggressive lymphoma

Basel, 11 June 2019 FDA grants Roche’s Polivy accelerated approval for people with previously treated aggressive lymphoma New targeted medicine shown to improve clinical outcomes in people with relapsed or refractory diffuse large B-cell lymphoma compared to a commonly used regimen First-in-class antibody-drug conjugate that specifically targets CD79b, a protein expressed in the majority of... Read more