Tag Archives: Sandra Horning MD

Roche: US FDA granted Breakthrough Therapy Designation to Hemlibra® for people with haemophilia A without factor VIII inhibitors

Designation based on phase III HAVEN 3 study demonstrating Hemlibra prophylaxis significantly reduced bleeds compared to no prophylaxis First medicine to show superior efficacy compared to prior factor VIII prophylaxis in an intra-patient comparison BASEL, 19-Apr-2018 — /EuropaWire/ — Roche … Read the full press release

Roche study combining Esbriet and nintedanib treatment: majority of the patients tolerated the combination treatment

New study combining Esbriet (pirfenidone) and nintedanib showing similar safety profile for the combination treatment to that expected for each treatment alone A second, retrospective, post-hoc, analysis suggests that treatment with Esbriet may be associated with a reduction of multiple … Read the full press release

Roche phase III BRIM8 study: 46% reduction in recurrence risk was observed in stage IIC-IIIB melanoma patients

BASEL, 14-Sep-2017 — /EuropaWire/ — Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced data for the phase III BRIM8 study, which was designed to investigate the efficacy and safety of Zelboraf® (vemurafenib) in the adjuvant (after surgery) treatment of people with … Read the full press release

Haemophilia A: data from Roche’s HAVEN 1 published in The New England Journal of Medicine (NEJM)

Positive phase III results for Roche’s emicizumab in haemophilia A published in The New England Journal of Medicine HAVEN 1 showed emicizumab reduced bleed rate by 87% compared with on-demand bypassing agents All 12 secondary endpoints in HAVEN 1 were … Read the full press release

FDA Approves Roche’s TECENTRIQ as initial treatment for certain advanced bladder cancer patients

First and only cancer immunotherapy approved in advanced bladder cancer as initial treatment for those unable to receive cisplatin chemotherapy BASEL, 24-Apr-2017 — /EuropaWire/ — Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that the US Food and Drug Administration (FDA) … Read the full press release

Roche to present 60 abstracts featuring nine of its approved or investigational medicines at the 58th American Society of Hematology (ASH) in San Diego

New results from the phase III GALLIUM study which compared Gazyva/Gazyvaro (obinutuzumab) plus chemotherapy to Rituxan/ MabThera (rituximab) plus chemotherapy in previously untreated follicular lymphoma will be presented in the Plenary Scientific Session New results for Venclexta/Venclyxto(venetoclax) and investigational medicine … Read the full press release

Roche to present new data from Actemra®/RoActemra® and Rituxan®/MabThera® at the 2016 ACR/ARHP in Washington, D.C.

15 oral presentations from 17 abstracts across six autoimmune conditions First presentation of Actemra/RoActemra data from GiACTA – the largest ever clinical trial in people with giant cell arteritis (GCA), a condition for which there has been no approved therapy … Read the full press release

Roche announced the Japanese Ministry of Health, Labour and Welfare approved alectinib for the treatment of people with specific form of advanced lung cancer

Data showed that over 90 percent of Japanese people in the study responded to treatment with alectinib BASEL, 11-7-2014 — /EuropaWire/ — Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that the Japanese Ministry of Health, Labour and Welfare (MHLW) has approved … Read the full press release