Basel, 07 March 2019 Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that it has commenced a cash tender offer for all of the outstanding shares of common stock of Spark Therapeutics, Inc. (NASDAQ: ONCE) at a price of US$ 114.50 per share. The tender offer is being made pursuant to the previously announced merger... Read more
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
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
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
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