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
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
Monday February 11, 2019 http://www.enzo.com/uploads/Roche_8-K_for_website.pdf Read more
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
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
Basel, 01 February 2019 CHMP recommends EU approval of Roche’s Hemlibra for people with severe haemophilia A without factor VIII inhibitors First medicine to significantly reduce treated bleeds compared to prior factor VIII prophylaxis in a prospective intra-patient comparison First new class of medicine in nearly 20 years for people with severe haemophilia A without... Read more
Basel, 30 January 2019 Roche to discontinue Phase III CREAD 1 and 2 clinical studies of crenezumab in early Alzheimer’s disease (AD) – other company programmes in AD continue The Alzheimer’s Prevention Initiative (API) study of crenezumab in familial Alzheimer’s disease continues Roche remains committed to ongoing clinical studies in Alzheimer’s disease, including GRADUATE Phase... Read more
Basel, 17 January 2019 FDA accepts Roche’s supplemental biologics license application for Tecentriq plus chemotherapy (Abraxane and carboplatin) for the initial treatment of metastatic non-squamous non-small cell lung cancer 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) for... Read more
DISTRIBUTION AGREEMENT ANNOUNCEMENT January 14, 2019 Merck and Roche Renew Global Distribution Agreement Global distribution agreement renewed under existing terms for additional five years Includes Biochemical Reagents and Kapa Biosystems portfolios, and select qPCR & Nucleic Acid Purification products Merck and Roche have agreed to renew their current distribution agreement for the Biochemical Reagents and... Read more
cobas pro integrated solutions enhances automated procedures to overcome key challenges in lab management This new Serum Work Area solution in the cobas family minimizes hands-on time and maximizes productivity through automated procedures This new innovation offers flexibility for future changing testing needs, enabling labs to further deliver quality patient care Basel, 9 Jan. 2019 Roche (SIX: RO,... Read more