March 8, 2019 Uncategorized

European Commission approves Roche’s Tecentriq in combination with Avastin and chemotherapy for the initial treatment of people with a specific type of metastatic lung cancer

Basel, 08 March 2019 European Commission approves Roche’s Tecentriq in combination with Avastin and chemotherapy for the initial treatment of people with a specific type of metastatic lung cancer Approval based on significant survival benefit of Tecentriq in combination with Avastin, paclitaxel and carboplatin (chemotherapy) in people with metastatic non-squamous non-small cell lung cancer (NSCLC)... Read more

March 7, 2019 Acad, Gov/Utilities Product Launch

Roche submits supplemental new drug application to FDA for Venclexta plus Gazyva for previously untreated chronic lymphocytic leukaemia with co-existing medical conditions

Basel, 07 March 2019 Roche submits supplemental new drug application to FDA for Venclexta plus Gazyva for previously untreated chronic lymphocytic leukaemia with co-existing medical conditions Application is being reviewed under FDA’s Real-Time Oncology Review pilot programme Combination was granted Breakthrough Therapy Designation, the fifth for Venclexta Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced... Read more

February 28, 2019 Acad, Gov/Utilities

FDA approves Herceptin Hylecta for subcutaneous injection in certain HER2-positive breast cancers

Basel, 28 February 2019 FDA approves Herceptin Hylecta for subcutaneous injection in certain HER2-positive breast cancers Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that the US Food and Drug Administration (FDA) has approved Herceptin Hylecta™ (trastuzumab and hyaluronidase-oysk) for subcutaneous (under the skin) injection for the treatment of certain people with HER2-positive early breast... Read more

February 25, 2019 Clinical Research/Diagn. M&A, Partnerships

Roche enters into definitive merger agreement to acquire Spark Therapeutics

Basel, 25 February 2019 Roche enters into definitive merger agreement to acquire Spark Therapeutics Roche to acquire Spark Therapeutics for US$ 114.50 per share Spark Therapeutics is a leader in discovering, developing and delivering gene therapies with one commercial asset and four programmes currently in clinical trials Transaction expected to close in Q2, 2019 Roche... Read more

February 19, 2019 Acad, Gov/Utilities

FDA grants Priority Review to Roche’s personalised medicine entrectinib

Basel, 19 February 2019 FDA grants Priority Review to Roche’s personalised medicine entrectinib Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that the US Food and Drug Administration (FDA) has accepted the company’s New Drug Applications (NDAs) and granted Priority Review for entrectinib for the treatment of adult and paediatric patients with neurotrophic tropomyosin receptor... Read more

February 19, 2019 Acad, Gov/Utilities

FDA grants priority review to Roche’s polatuzumab vedotin in previously treated aggressive lymphoma

Basel, 19 February 2019 FDA grants priority review to Roche’s polatuzumab vedotin in previously treated aggressive lymphoma Diffuse large B-cell lymphoma is an aggressive type of blood cancer that typically becomes harder to treat each time it returns Polatuzumab vedotin has shown significant potential to improve outcomes in people living with this disease Roche (SIX:... Read more

February 6, 2019 Clinical Research/Diagn.

Roche joins the World Federation of Hemophilia Humanitarian Aid Program

Basel, 06 February 2019 Roche joins the World Federation of Hemophilia Humanitarian Aid Program Hemlibra donation will provide prophylactic treatment to as many as 1,000 people with haemophilia A over five years in countries where there is little or no access to haemophilia treatment Donation will substantially increase the number of people receiving prophylactic treatment... Read more

February 5, 2019 Acad, Gov/Utilities

Roche submits supplemental biologics license application to the US FDA for Kadcyla for adjuvant treatment of people with HER2-positive early breast cancer with residual disease after neoadjuvant treatment

Basel, 05 February 2019 Roche submits supplemental biologics license application to the US FDA for Kadcyla for adjuvant treatment of people with HER2-positive early breast cancer with residual disease after neoadjuvant treatment Roche’s application is being reviewed under the US FDA’s Real-Time Oncology Review and Assessment Aid pilot programmes Kadcyla was granted Breakthrough Therapy Designation... Read more