July 14, 2020 M&A, Partnerships PAI Top-10 Product Launch

Roche collaborates with Blueprint Medicines to bring a new treatment to people with RET-altered cancers

Roche will obtain co-development and co-commercialisation rights for pralsetinib, an investigational, precision therapy in late-stage development for people with RET-altered non-small cell lung cancer, various types of thyroid cancer and other solid tumours. Blueprint Medicines and Roche will collaborate on the development of pralsetinib. Roche and Blueprint Medicines will co-commercialise pralsetinib in the US while... Read more

July 13, 2020 Bio/Pharma/CRO PAI Top-10 Product Launch

New data from phase IIIb study reinforces safety profile of Roche’s Hemlibra in people with haemophilia A

Basel, 13 July 2020 Second interim analysis of the STASEY study, including data from 193 patients, consistent with results from phase III HAVEN studies, with no new safety signals identified1,2,3 STASEY is the largest open-label study primarily assessing safety and tolerability of a medicine for haemophilia A with factor VIII inhibitors A separate analysis also... Read more

July 13, 2020 Bio/Pharma/CRO

Roche provides update on Phase III study of Tecentriq in women with advanced stage ovarian cancer

Basel, 13 July 2020 – Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that the Phase III IMagyn050 study showed that the addition of Tecentriq® (atezolizumab) to Avastin® (bevacizumab), paclitaxel and carboplatin did not meet its primary endpoint of progression-free survival (PFS) for the front-line treatment of women with newly diagnosed advanced stage ovarian cancer.... Read more

June 29, 2020 Acad, Gov/Utilities

FDA approves Roche’s Phesgo (fixed-dose combination of Perjeta and Herceptin for subcutaneous injection) for HER2-positive breast cancer

             Basel, 29 June 2020 – Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that the US Food and Drug Administration (FDA) has approved Phesgo™, a fixed-dose combination of Perjeta® (pertuzumab) and Herceptin® (trastuzumab) with hyaluronidase, administered by subcutaneous (SC; under the skin) injection in combination with intravenous (IV) chemotherapy, for the treatment of early and... Read more

June 29, 2020 PAI Top-10 Product Launch

Roche announces new data at the ISTH 2020 Congress, demonstrating ongoing commitment to advancing care for people with haemophilia A

Spark Therapeutics will present data from the initial dose cohorts of its phase I/II SPK-8011 gene therapy study, showing stable and durable factor VIII expression, substantial improvement in annualised bleed rate for more than two years, and an acceptable safety profile after more than two years of follow-up1 Roche will present second interim analysis results... Read more

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