July 20, 2021 Uncategorized

Japan becomes first country to approve Ronapreve (casirivimab and imdevimab) for the treatment of mild to moderate COVID-19

Full approval is based on a global phase III trial which found casirivimab and imdevimab reduced hospitalisation or death by 70% in high-risk non-hospitalised patients Basel, 20 July 2021 – Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that Japan’s Ministry of Health, Labour and Welfare (MHLW) has approved Ronapreve™(casirivimab and imdevimab), for the treatment... Read more

July 19, 2021 PAI Top-10 Product Launch

New data for Roche’s Hemlibra reinforce safety profile in people with haemophilia A

Final analysis from the phase IIIb STASEY study, including data from 193 people with haemophilia A, further support the benefit/risk profile of Hemlibra, with no new safety signals identified1 STASEY is one of the largest open-label studies primarily assessing safety and tolerability of a medicine for people with haemophilia A with factor VIII inhibitors Hemlibra... Read more

July 9, 2021 Clinical Research/Diagn. PAI Top-10

WHO guidelines now include Roche’s diagnostic tests in expanded effort to eliminate tuberculosis by providing patients greater access to timely diagnosis

Tuberculosis is a disease of poverty, and economic distress with 1.4 million deaths annually1 and the growing challenge of drug resistance is adding to the global health crisis WHO guidelines support the expansion of tuberculosis diagnostics in resource-limited countries, enabling patients to receive timely diagnosis leading to proper treatment, which benefits their recovery and slows... Read more

July 2, 2021 PAI Top-10 Product Launch

Roche to present new data at the ISTH 2021 Congress highlighting long-standing commitment to advancing haemophilia A standard of care

Roche will present the final analysis from the phase IIIb STASEY study, reinforcing the safety and efficacy profile of Hemlibra in a broad range of people with haemophilia A with factor VIII inhibitors1 Spark Therapeutics will share updated data from the ongoing phase I/II clinical trial of investigational gene therapy SPK-8011, demonstrating that hepatocyte expression... Read more

June 28, 2021 Uncategorized

Roche’s ENSPRYNG approved by European Commission as first and only at-home subcutaneous treatment for neuromyelitis optica spectrum disorder (NMOSD)

ENSPRYNG is the first and only treatment approved for both adults and adolescents in the EU with AQP4-IgG seropositive NMOSD ENSPRYNG can be used as a monotherapy or in combination with immunosuppressive therapy to reduce relapses and prevent permanent disability In Phase III studies, ENSPRYNG significantly reduced the number and severity of relapses in people... Read more

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