European Commission approves label expansion of Roche ’s Hemlibra to include people with moderate haemophilia A in the EU
Hemlibra, already approved for severe haemophilia A in the EU, will now also provide an effective and convenient prophylactic treatment option for people with moderate haemophilia AModerate haemophilia A can have a significant impact on the lives of people affected, with only 15% living a bleed-free life1The approval is based on the HAVEN 6 results, whereHemlibra demonstrated effective bleed control and a favourable safety profile in people with moderate haemophilia A without inhibitors2Basel, 01 February 2023 - Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that the European Commission approved the expansion of the He...
Source: Roche Investor Update - February 1, 2023 Category: Pharmaceuticals Source Type: news

Reminder: Invitation to Roche ’s Full Year Results 2022 Presentation
  Roche will publish its Full Year Results for 2022 prior to the opening of the Swiss Stock Exchange on Thursday, 2 February 2023. 07:00 CET / 06:00 GMT / 01:00 AM EST / 10:00 PM PST (evening before)Release will be e-mailed and posted on the Roche IR website>click herePresentation slides will be posted on the Roche IR website>click here The webinar will start with presentations by senior management,followed by a Q&A session.Presenters:Severin Schwan, CEO Roche GroupThomas Schinecker, CEO Roche Pharmaceuticals ad interimMatt Sause, CEO Roche DiagnosticsAlan Hippe, Chief Financial and IT Officer We would lik...
Source: Roche Investor Update - January 26, 2023 Category: Pharmaceuticals Source Type: news

Invitation: Roche Virtual Event – Key ophthalmology data presented at the Angiogenesis 2023 Meeting
   We are pleased to invite investors and analysts to participate in our virtual event onMonday, 13February 2023, highlighting Roche data presented at the virtual Angiogenesis, Exudation, and Degeneration 2023 Meeting, from 10th to 11th February. 16:30 – 18:00 CET / 15:30– 17:00 GMT10:30 – 12:00pm EST / 7:30 –9:00 am PST  The webinar will start with a presentation, followed by a Q&A session (live access to the speakers). The slides will be available for download at 15:30 CET on the day of the event.>click here Access to virtual event (pre-registration required)Please pre-register for our webinarhere*. ...
Source: Roche Investor Update - January 23, 2023 Category: Pharmaceuticals Source Type: news

[Ad hoc announcement pursuant to Art. 53 LR] Roche ’s Tecentriq plus Avastin is the first treatment combination to reduce the risk of cancer returning in people with certain types of early-stage liver cancer in a Phase III trial
Pivotal Phase III IMbrave050 study investigatingTecentriq plusAvastin in people with early-stage hepatocellular carcinoma (HCC) at high risk of recurrence following surgery met primary endpoint of recurrence-free survivalNew adjuvant treatments are urgently needed as an estimated 70-80% of people with early-stage HCC experience disease recurrence following surgery1Data will be discussed with health authorities globally, including the US Food and Drug Administration and the European Medicines Agency to inform the next regulatory steps, and presented at an upcoming medical meetingBasel, 19 January 2023 - Roche (SIX: RO, ROG;...
Source: Roche Investor Update - January 19, 2023 Category: Pharmaceuticals Source Type: news

Save The Date: Roche Virtual Event – Key ophthalmology data presented at the Angiogenesis 2023 Meeting
  We are pleased to invite investors and analysts to participate in our virtual event onMonday, 13February 2023, highlighting Roche data presented at the virtual Angiogenesis, Exudation, and Degeneration 2023 Meeting, from 10th to 11th February. 16:30 – 18:00 CET / 15:30– 17:00 GMT10:30 – 12:00pm EST / 7:30 –9:00 am PST An invitation with the detailed programme and registration link will follow soon.  Best regards, Bruno EschliHead of Investor Relations  Loren KalmHead of Investor Relations, North AmericaRoche Investor Relations Dr. BrunoEschliPhone: +41 61 68-75284e-mail:bruno.eschli@roche.com Dr. Sabin...
Source: Roche Investor Update - January 13, 2023 Category: Pharmaceuticals Source Type: news

Roche announces the European Commission approval of Xofluza for the treatment and prevention of influenza in children aged one year and above
Xofluza is now approved in the EU for the treatment of uncomplicated influenza and for post-exposure prophylaxis of influenza in children aged one year and above, and in adolescents and adultsXofluza is the first influenza antiviral with a new mechanism of action in almost 20 years, stopping viral replication faster thanoseltamivirSingle-doseXofluza helps reduce the societal burden of influenza by helping patients recover quickly and by preventing infection in individuals following contact with someone with the virusBasel, 12 January 2023 - Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that the European Commission (EC...
Source: Roche Investor Update - January 12, 2023 Category: Pharmaceuticals Source Type: news

FDA grants priority review to Roche ’s bispecific antibody glofitamab for people with relapsed or refractory large B-cell lymphoma
If approved,glofitamab would be the first fixed-duration CD20xCD3 T-cell engaging bispecific antibody approved to treat the most aggressive type of non-Hodgkin lymphomaResults from the pivotal phase I/II NP30179 study showedglofitamab induced durable response rates in people with heavily pre-treated large B-cell lymphoma, with 40% achieving a complete responseGlofitamab is part of Roche ’s industry-leading portfolio of T-cell engaging bispecific antibodies, which also includes the newly FDA-approved first-in-classLunsumio to treat follicular lymphomaBasel, 6 January 2023 - Roche (SIX: RO, ROG; OTCQX: RHHBY) today announc...
Source: Roche Investor Update - January 6, 2023 Category: Pharmaceuticals Source Type: news

FDA approves Roche ’s Lunsumio, a first-in-class bispecific antibody, to treat people with relapsed or refractory follicular lymphoma
The objective response rate is the combination of complete response (CR) rate (a disappearance of all signs and symptoms of cancer) and partial response rate (a decrease in the amount of cancer in the body). The median duration of response among those who responded was almost two years (22.8 months [95% CI: 10-not reached]). A CR was achieved in 60% of patients (54/90 [95% CI: 49-70]). Among 218 patients with haematologic malignancies who received Lunsumio at the recommended dose, the most common adverse event (AE) was cytokine release syndrome (CRS; 39%), which can be severe and life-threatening. The median duration of CR...
Source: Roche Investor Update - December 23, 2022 Category: Pharmaceuticals Source Type: news

Invitation to Roche ’s Full Year Results 2022 Presentation
   Roche will publish its Full Year Results for 2022 prior to the opening of the Swiss Stock Exchange onThursday, 2 February 2023. 07:00 CET / 06:00 GMT / 01:00 AM EST / 10:00 PM PST (evening before)Release will be e-mailed and posted on the Roche IR website>click herePresentation slides will be posted on the Roche IR website>click here 14:00 – 16:00 CET / 13:00 – 15:00 GMT08:00 – 10:00 AM EST / 05:00 - 07:00 AM PST  The webinar will start with presentations by senior management,followed by a Q&A session.Presenters:Severin Schwan, CEO Roche GroupThomas Schinecker, CEO Roche Pharmaceuticals ad inter...
Source: Roche Investor Update - December 21, 2022 Category: Pharmaceuticals Source Type: news

CHMP recommends expansion of EU label for Hemlibra to include people with moderate haemophilia A
Thepositive CHMP opinion is based on the results of the HAVEN 6 study, which demonstrated effective bleed control and afavourable safety profile ofHemlibra in people with moderatehaemophilia A without inhibitors1Given that many people with moderatehaemophilia A may not receive prophylaxis, they may endure a worsened clinical burden with only 15% living a bleed-free life2If approved,Hemlibra, already approved for severehaemophilia A in the EU, will offer an effective and convenient prophylactic treatment option with afavourable safety profile for people with moderatehaemophilia ABasel, 16 December 2022 - Roche (SIX: RO, ROG...
Source: Roche Investor Update - December 16, 2022 Category: Pharmaceuticals Source Type: news

Roche presents new data demonstrating the potential benefit of glofitamab and Lunsumio as fixed-duration, off-the-shelf treatment options for lymphoma
Data showcase the potential ofglofitamab andLunsumio to address diverse patient needsData presented at ASH 2022 andsimultaneouslypublished in theNew England Journal of Medicine showed thatglofitamab, given as a fixed course, induced early and durable responses in people with heavily pre-treated large B-cell lymphoma1,227-month follow-up data showedLunsumio continued to induce high and durable responses in people with relapsed or refractory follicular lymphoma, with 60% experiencing a complete response3Basel, 12 December 2022 - Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that updated clinical data for its CD20xCD3 T-...
Source: Roche Investor Update - December 12, 2022 Category: Pharmaceuticals Source Type: news

Roche presents new and updated data for Polivy in previously untreated diffuse large B-cell lymphoma at ASH 2022
Updated data from the phase III POLARIX study continue to demonstrate a statistically significant reduction in the risk of disease worsening or death for people with previously untreated diffuse large B-cell lymphoma (DLBCL)1Patients receivingPolivy plus R-CHP for DLBCL reported similar health-related quality of life outcomes, during and after fixed-duration treatment, to those receiving the current standard-of-care, withsuperiorprogression-free survival2Basel, 12 December 2022 - Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that new and updated data for its first-in-class anti-CD79b antibody-drug conjugate Polivy ® ...
Source: Roche Investor Update - December 12, 2022 Category: Pharmaceuticals Source Type: news

[Ad hoc announcement pursuant to Art. 53 LR] Roche: Changes in the Board of Directors and the Corporate Executive Committee
Board of DirectorsBasel, 12 December 2022 - Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that at its December meeting, the Board of Directors of Roche Holding Ltd has approved to propose the following changes at the Annual General Meeting on 14 March 2023:As previously announced in July 2022, Christoph Franz has decided not to seek re-election as Chairman. The Board of Directors will propose Severin Schwan as the new Chairman at the Annual General Meeting in 2023, and has appointed Thomas Schinecker as the new Roche Group CEO effective 14 March 2023.The Board of Directors will proposeMark Schneider, CEO of Nestle S.A...
Source: Roche Investor Update - December 12, 2022 Category: Pharmaceuticals Source Type: news

Interim data from phase III study presented at ASH 2022 show Hemlibra achieved meaningful bleed control in infants from birth
The HAVEN 7 studywas designed to further confirm the benefit of preventative treatment (prophylaxis) withHemlibra from birth in previously untreated or minimally treated infants with severehaemophilia A without inhibitorsIn the study, 77.8% of participants had no bleeding episodes that required treatment1In addition, real-world efficacy and safety data from the EUHASS database and ATHN 7 study were also presented2,3Basel, 11 December 2022 – Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced interim results from the phase III HAVEN 7 study. The study shows Hemlibra® (emicizumab) achieved meaningful bleed control with a ...
Source: Roche Investor Update - December 11, 2022 Category: Pharmaceuticals Source Type: news

Roche ’s subcutaneous crovalimab given every four weeks achieves disease control in people with PNH, a life-threatening blood condition
The phase III COMMODORE 3 study ofcrovalimab met primary endpoints of transfusion avoidance andhaemolysis control in people with paroxysmal nocturnal hemoglobinuria (PNH)1COMMODORE 3 is the first China-specific study in PNH. Current treatment options are extremely limited in China, resulting in significant levels of disease-related morbidity and mortality for people living with PNH2Based on these datacrovalimab has received Breakthrough Therapy Designation and is under Priority Review for approval in ChinaBasel, 11 December 2022 - Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced positive new data from the phase III COMMO...
Source: Roche Investor Update - December 11, 2022 Category: Pharmaceuticals Source Type: news