February 19, 2020 Acad, Gov/Utilities

FDA grants priority review to Roche’s Tecentriq monotherapy as first-line treatment of certain people with advanced non-small cell lung cancer

Basel, 19 February 2020 – Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that the US Food and Drug Administration (FDA) has accepted the company’s supplemental Biologics License Application (sBLA) and granted Priority Review for Tecentriq® (atezolizumab) as a first-line (initial) monotherapy for people with advanced non-squamous and squamous non-small cell lung cancer (NSCLC) without... Read more

February 14, 2020 Uncategorized

China National Medical Products Administration grants approval of Roche’s Tecentriq in combination with chemotherapy as first-line treatment of people with extensive-stage small cell lung cancer

This marks the first approval for a Tecentriq-based therapy in China, less than a year after the US Food and Drug Administration (FDA) and European Medicines Agency (EMA) approvals in this indication Tecentriq with chemotherapy (carboplatin and etoposide) is the first and only cancer immunotherapy combination approved for the initial treatment of extensive-stage small cell... Read more

February 10, 2020 Bio/Pharma/CRO

Roche provides topline results from investigator-led Phase II/III trial with gantenerumab in rare inherited form of Alzheimer’s disease

Primary endpoint was not met in a study sponsored by Washington University; additional analyses are ongoing to understand the totality of the data Data from study in people with or at-risk for autosomal dominant Alzheimer’s disease will be presented at the AAT-AD/PD Focus meeting in April 2020 Results do not impact Roche’s two ongoing Phase... Read more

February 6, 2020 Licensing, IP, and Legal

Roche’s risdiplam showed significant improvement in motor function in people aged 2-25 with type 2 or 3 spinal muscular atrophy

First placebo-controlled trial to include adults with SMA demonstrates risdiplam improved or stabilised motor function  Medically meaningful and statistically significant results in primary and key secondary endpoints Pivotal SUNFISH Part 2 study population represents broad, real-world spectrum of people living with SMA Basel, 06 February 2020 – Roche (SIX: RO, ROG; OTCQX: RHHBY) today presented... Read more

January 30, 2020 Uncategorized

Roche reports very strong results in 2019

Basel, 30 January 2020 Group sales increase 9%1 at constant exchange rates and 8% in Swiss francs, driven by new products, more than compensating for impact of competition from biosimilars Pharmaceuticals Division sales up 11%, resulting from high demand for recently launched medicines, led by Ocrevus, Hemlibra, Tecentriq and Perjeta Diagnostics Division sales grow by... Read more

January 27, 2020 Acad, Gov/Utilities

Roche submits supplemental Biologics License Application to the FDA for Tecentriq in combination with Avastin for the most common form of liver cancer

Basel, 27 January 2020 Application is being reviewed under FDA’s Real-Time Oncology Review pilot programme Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced the completion of a supplemental Biologics License Application (sBLA) submission to the US Food and Drug Administration (FDA) for Tecentriq® (atezolizumab) in combination with Avastin® (bevacizumab), for the treatment of people with... Read more

January 24, 2020 Bio/Pharma/CRO

Roche provides an update on Phase III study of Tecentriq in people with muscle-invasive urothelial cancer

Basel, 24 January 2020 – Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that the Phase III IMvigor010 study evaluating Tecentriq® (atezolizumab) as an adjuvant (after surgery) monotherapy treatment did not meet its primary endpoint of disease-free survival (DFS) compared to observation in people with muscle-invasive urothelial cancer (MIUC). Safety for Tecentriq appeared consistent with... Read more

January 23, 2020 Licensing, IP, and Legal

Roche’s Risdiplam meets primary endpoint in pivotal FIREFISH trial in infants with type 1 spinal muscular atrophy

Risdiplam demonstrated statistically significant and medically meaningful motor milestone improvement in infants with Type 1 SMA No treatment related safety findings leading to withdrawal seen in any risdiplam trial to date Data will be shared with health authorities globally              Basel, 23 January 2020 – Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced positive topline results... Read more

January 21, 2020 PAI Top-10

European Commission approves Roche’s Polivy for people with previously treated aggressive lymphoma

Basel, 21 January 2020 Novel combination regimen includes first-in-class antibody-drug conjugate that specifically targets CD79b Targeted off-the-shelf treatment provides much-needed new option for people with relapsed or refractory diffuse large B-cell lymphoma Polivy approval is based on a phase Ib/II study, the first and only study showing improved response rates and overall survival in patients... Read more

January 15, 2020 Clinical Research/Diagn. Product Launch

Roche helps further reduce risk of severe illness for transplant patients by expanding the portfolio to include Adenovirus Test on the cobas 6800/8800 Systems

●  Immunocompromised transplant recipients are at risk of major complications when infected with adenovirus, a common and highly contagious virus ●  Healthcare professionals can use this new test to determine whether transplant patients are at risk of developing severe illness from adenovirus infection ●  The Adenovirus Test leverages the flexibility, automation, and reliability of the cobas omni Utility... Read more