June 25, 2021 Acad, Gov/Utilities Clinical Research/Diagn. Microscopy PR/Corporate

Roche’s Actemra/RoActemra receives U.S. FDA Emergency Use Authorization for the treatment of COVID-19 in hospitalised adults and children

The authorisation enables emergency use of Actemra/RoActemra for the treatment of COVID-19 in hospitalised adult and paediatric patients Basel, 25 June 2021 – Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that the U.S. Food and Drug Administration (FDA) has issued an Emergency Use Authorization (EUA) for intravenous Actemra/RoActemra® (tocilizumab) for the treatment of COVID-19... Read more

June 24, 2021 Acad, Gov/Utilities Microscopy

FDA accepts application for Roche’s Port Delivery System with ranibizumab (PDS) for treatment of neovascular or “wet” age-related macular degeneration (nAMD)

If approved, PDS would be the first and only eye implant with continuous drug delivery that offers people living with nAMD an alternative to frequent eye injections A pivotal study showed PDS extends time between treatments up to six months for more than 98% of patients and provides vision outcomes equivalent to monthly ranibizumab injections... Read more

June 15, 2021 Uncategorized

Roche data at EAN 2021 showcase significant impact of therapies across diverse neuroscience portfolio

Data for EVRYSDI reinforce safety profile and efficacy in a broad spinal muscular atrophy (SMA) population, following recent EU approval Data for ENSPRYNG in neuromyelitis optica spectrum disorder (NMOSD) build on safety profile and efficacy following recent CHMP opinion, including in adults with concomitant autoimmune diseases (CAIDs) OCREVUS data continue to show consistent benefit on... Read more

June 11, 2021 PAI Top-10

Roche announces data at EHA2021 reinforcing efficacy of Venclexta/Venclyxto combinations in chronic lymphocytic leukaemia and acute myeloid leukaemia

Four-year follow-up analysis from the phase III CLL14 study showed progression-free survival rate of 74.0% in previously untreated patients with chronic lymphocytic leukaemia (CLL) three years after completion of a one-year fixed-duration treatment with Venclexta/Venclyxto plus Gazyva/Gazyvaro1 New phase III MURANO study data suggested certain genetic risk factors may help tailor treatments for patients with... Read more

June 11, 2021 Product Launch

New Roche data for Evrysdi show improved motor function in pre-symptomatic babies after one year and confirm safety profile in previously treated people with spinal muscular atrophy (SMA)

Data from JEWELFISH, the first trial in a diverse population aged 1 to 60 years with SMA who received prior treatment, showed a consistent safety profile and >2-fold increase in SMN protein levels Pre-symptomatic babies with SMA treated with Evrysdi for at least one year were able to sit, stand and walk in preliminary data... Read more

June 4, 2021 PAI Top-10

Roche presents latest advances with immunotherapies in non-Hodgkin lymphoma

Data for investigational CD20xCD3 bispecific antibodies and new combination regimens with Polivy showed enhanced clinical benefits for people with non-Hodgkin lymphoma in early studies Basel, 4 June 2021 ‒ Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that new data on its investigational CD20xCD3 T-cell engaging bispecific antibodies, mosunetuzumab and glofitamab, and its first-in-class anti-CD79b... Read more

May 25, 2021 PAI Top-10 Product Launch

European Commission approves Venclyxto-based combinations for adults with newly diagnosed acute myeloid leukaemia who are ineligible for intensive chemotherapy

With hypomethylating agents significantly improved complete response rates in certain adults with newly diagnosed acute myeloid leukaemia In the VIALE-A study, Venclyxto plus azacitidine significantly improved overall survival in patients ineligible for intensive chemotherapy, a patient population who typically have a five-year overall survival rate of less than 10%1 Study data reinforces the potential of... Read more

May 20, 2021 Bio/Pharma/CRO

Pivotal Phase III data at ASCO show Roche’s Tecentriq helps certain people with early lung cancer live significantly longer without their disease returning

Tecentriq improved disease-free survival by more than one-third in people with PD-L1-positive resectable early-stage lung cancer, compared with best supportive care First and only cancer immunotherapy to show positive Phase III results in the adjuvant lung cancer setting New adjuvant treatment options are urgently needed in early lung cancer to help the approximately 50% of... Read more

May 11, 2021 Clinical Research/Diagn. PAI Top-10 Product Launch

Roche to present data from one of the most comprehensive oncology portfolios at the 2021 ASCO Annual Meeting showcasing advancements for people living with cancer

Data from the first positive phase III study of a cancer immunotherapy in early, resected lung cancer Studies in personalised healthcare exploring tumour agnostic treatments that demonstrate the impact of coupling biomarker testing with targeted therapies to develop individualised treatment plans New data, and drug combination strategies for the treatment of lymphoma from the largest... Read more