June 29, 2020 Uncategorized

Roche’s ENSPRYNG®️ (satralizumab) approved in Japan for adults and children with neuromyelitis optica spectrum disorder

ENSPRYNG is Japan’s first and only approved therapy for both adults and children with neuromyelitis optica spectrum disorder (NMOSD) ENSPRYNG is the first and only approved therapy targeting the interleukin-6 (IL-6) receptor given subcutaneously every four weeks Approval is supported by data demonstrating ENSPRYNG’s robust efficacy, which was well-tolerated with a consistent safety profile, in... Read more

June 26, 2020 PAI Top-10

Roche improves speed and accuracy of non-small cell lung cancer diagnosis with launch of automated digital pathology algorithm

uPath PD-L1 (SP263) image analysis uses automated pre-computing and one-click scoring to enable quicker and accurate detection and measurement of tumour cell staining positivity Roche advances personalised healthcare with development of image analysis algorithms using artificial intelligence Faster, more accurate diagnoses are critical with non-small cell lung cancer, which accounts for about 85 percent of... Read more

June 19, 2020 Licensing, IP, and Legal

Roche’s IPATential150 study evaluating ipatasertib in combination with abiraterone and prednisone/prednisolone met one of its co-primary endpoints

      ·Phase III IPATential150 study evaluating ipatasertib in combination with abiraterone and prednisone/prednisolone compared to current standard-of-care (abiraterone and prednisone/prednisolone alone) plus placebo met its co-primary endpoint of radiographic progression free survival (rPFS) in patients with PTEN loss tumours Basel, 19 June 2020 – Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that the phase III... Read more

June 18, 2020 Licensing, IP, and Legal

Roche’s Tecentriq in combination with chemotherapy (including Abraxane) meets primary endpoint of improved pathological complete response, regardless of PD-L1 status, as initial treatment for people with early triple-negative breast cancer

IMpassion031 data will be discussed with health authorities globally, including the US Food and Drug Administration and the European Medicines Agency Tecentriq is the only approved cancer immunotherapy for the treatment of metastatic triple-negative breast cancer, a very aggressive and difficult-to-treat form of breast cancer Basel, 18 June 2020 – Roche (SIX: RO, ROG; OTCQX:... Read more

June 13, 2020 Bio/Pharma/CRO PAI Top-10

Positive phase III results for Venclexta/Venclyxto combination in acute myeloid leukaemia presented at EHA 2020

Basel, 13 June 2020 – Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced positive results from the phase III VIALE-A study, evaluating Venclexta®/Venclyxto® (venetoclax) in combination with azacitidine in people with previously untreated acute myeloid leukaemia (AML) who were ineligible for intensive induction chemotherapy. VIALE-A results were featured in the 25th European Hematology Association Virtual... Read more

June 12, 2020 Licensing, IP, and Legal Product Launch

Roche announces 2-year risdiplam data from SUNFISH and new data from JEWELFISH in infants, children and adults with spinal muscular atrophy (SMA)

Basel, 12 June 2020 – Roche (SIX: RO, ROG; OTCQX: RHHBY) today presented two-year data from Part 1 of its pivotal SUNFISH trial in people aged 2-25 years with Type 2 or 3 spinal muscular atrophy (SMA) at the virtual Cure SMA Annual Conference, 8-12 June, 2020. The results of an exploratory efficacy analysis show... Read more

June 4, 2020 Acad, Gov/Utilities PR/Corporate

Roche’s Elecsys IL-6 test receives FDA Emergency Use Authorisation to help in identifying patients at high risk of severe inflammatory response

FDA EUA1 now makes IL-6 testing accessible to patients in the United States to assist in identifying severe inflammatory response in patients with confirmed COVID-19 and is also available in markets accepting the CE-mark2 Interleukin 6 (IL-6) is an early indicator for acute inflammation to aid in the management of critically ill patients This test... Read more

June 2, 2020 Acad, Gov/Utilities

FDA approves Roche’s Tecentriq in combination with Avastin for people with the most common form of liver cancer

Tecentriq in combination with Avastin is the first and only cancer immunotherapy regimen approved for the treatment of unresectable or metastatic hepatocellular carcinoma Tecentriq combination improved overall survival and progression-free survival compared to the previous standard of care Application approved under FDA’s Project Orbis initiative and Real-Time Oncology Review pilot programme Basel, 2 June 2020... Read more

May 29, 2020 Uncategorized

CHMP recommends EU approval of Roche’s Rozlytrek for people with NTRK fusion-positive solid tumours and for people with ROS1-positive, advanced non-small cell lung cancer

      ·Rozlytrek has shown durable responses across multiple tumour types, including cancer that has spread to the brain, and could become Roche’s first tumour-agnostic therapy in Europe Basel, 29 May 2020 – Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has adopted... Read more

May 29, 2020 Uncategorized

Updated data demonstrate Roche’s Alecensa increases overall survival rate for people with ALK-positive non-small cell lung cancer

Basel, 29 May 2020 – Roche (SIX: RO, ROG; OTCQX: RHHBY) today presented updated data from the pivotal phase III ALEX study, showing an increased five-year survival rate with Alecensa® (alectinib), compared with crizotinib, in people living with anaplastic lymphoma kinase (ALK)-positive non-small cell lung cancer (NSCLC). These data confirm the longer-term efficacy of Alecensa... Read more