FDA accepts Roche ’s Biologics License Application for fixed-dose subcutaneous combination of Perjeta and Herceptin for HER2-positive breast cancer
Basel, 25 February 2020 – Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that the US Food and Drug Administration (FDA) has accepted the company’s Biologics License Application (BLA) for the fixed-dose combination (FDC) of Perjeta® (pertuzumab) and Herceptin® (trastuzumab) with hyaluronidase, administered by subc utaneous (SC) injection in combination with intravenous (IV) chemotherapy, for the treatment of eligible patients with HER2-positive breast cancer. The BLA for the FDC is based on results from the phase III FeDeriCa study, which demonstrated non-inferior levels of Perjeta in the blood (phar...
Source: Roche Investor Update - February 25, 2020 Category: Pharmaceuticals Source Type: news

Chugai Obtains Approval for Additional Indication of Rozlytrek for ROS1 Fusion-Positive Non-Small Cell Lung Cancer
Dear Investor, Please find attached a press release by Chugai:https://www.roche.com/200221_IR_Chugai_eRozlytrek_ROS1-NSCLC_Approval.pdf Do not hesitate to contact us for any further questions. With best regards, (Source: Roche Investor Update)
Source: Roche Investor Update - February 21, 2020 Category: Pharmaceuticals Source Type: news

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 advanc ed non-squamous and squamous non-small cell lung cancer (NSCLC) without EGFR or ALK mutations with high PD-L1 expression (TC3/IC3 wild-type [WT]), as determined by PD-L1 biomarker testing. The FDA is expected to make a decision on approval by June 19, 2020.“In the IMpower110 study, Tecen...
Source: Roche Investor Update - February 19, 2020 Category: Pharmaceuticals Source Type: news

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
Basel, 14 February 2020 – Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that China National Medical Products Administration (NMPA) has approved Tecentriq® (atezolizumab) in combination with chemotherapy (carboplatin and etoposide) for the first-line treatment of patients with extensive-stage small cell lung cancer (ES-SCLC).“Small cell lung cancer is an area of major unmet need in China and one that has seen limited advances until now,” said Levi Garraway, M.D., Ph.D., Chief Medical Officer and Head of Global Product Development. “This approval makes Tecentriq the first cancer immunotherapy...
Source: Roche Investor Update - February 14, 2020 Category: Pharmaceuticals Source Type: news

Reminder: Invitation to Roche ’s Virtual Early Drug Development gRED Event 2020
We are pleased to invite investors and analysts to participate in a live video webcast and conference call onTuesday, February 18, 2020, highlighting Roche ’s early drug development with a focus on Genentech Research and Early Development (gRED). (Source: Roche Investor Update)
Source: Roche Investor Update - February 11, 2020 Category: Pharmaceuticals Source Type: news

Roche provides topline results from investigator-led Phase II/III trial with gantenerumab in rare inherited form of Alzheimer ’s disease
Basel, 10 February 2020 - Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that the gantenerumab arm of the Phase II/III DIAN-TU-001 study did not meet its primary endpoint in people who have an early-onset, inherited form of Alzheimer ’s disease (AD). This form of AD, known as autosomal dominant AD (ADAD), accounts for less than 1% of all cases of the disease.1 The study, sponsored by Washington University School of Medicine in St. Louis, US, did not show a significant slowing of the rate of cognitive decline in people treated with investigational medicine gantenerumab as measured by the novel DIAN Multivariate Co...
Source: Roche Investor Update - February 10, 2020 Category: Pharmaceuticals Source Type: news

Roche to present new data on Tecentriq in combination with Avastin that shows improvement in overall survival for Chinese patients with the most common form of liver cancer
Basel, 7 February 2020 - Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that additional data will be presented from a cohort of Chinese patients in the Phase III IMbrave150 study that evaluated Tecentriq ® (atezolizumab) in combination with Avastin® (bevacizumab) as a treatment for people with unresectable hepatocellular carcinoma (HCC) who have not received prior systemic therapy. Data from 194 Chinese patients who took part in the IMbrave150 study were consistent with the global results, that showed a statistically significant and clinically meaningful improvement in overall survival (OS) and progression-free...
Source: Roche Investor Update - February 7, 2020 Category: Pharmaceuticals Source Type: news

Roche ’s risdiplam showed significant improvement in motor function in people aged 2-25 with type 2 or 3 spinal muscular atrophy
Basel, 6 February 2020 - Roche (SIX: RO, ROG; OTCQX: RHHBY) today presented 1-year data from the pivotal Part 2 of SUNFISH, a global placebo-controlled study evaluating risdiplam in people aged 2-25 years with Type 2 or 3 spinal muscular atrophy (SMA). The study showed that change from baseline in the primary endpoint of the Motor Function Measure scale (MFM-32)[1]was significantly greater in people treated with risdiplam, compared to placebo (1.55 point mean difference; p=0.0156). The Revised Upper Limb Module (RULM),[2] a key secondary endpoint, also showed an improvement (1.59 point difference; p=0.0028). Safety for ris...
Source: Roche Investor Update - February 6, 2020 Category: Pharmaceuticals Source Type: news

Roche announces CHMP recommendation for EU approval of Venclyxto plus Gazyvaro for people with untreated chronic lymphocytic leukaemia
Basel, 31 January 2020 - Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that the European Medicines Agency ’s Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion for Venclyxto® (venetoclax) in combination with Gazyvaro® (obinutuzumab) for the treatment of adults with previously untreated chronic lymphocytic leukaemia (CLL).“Despite advances in treating chronic lymphocytic leukaemia, many patients cannot tolerate the side effects of chemotherapy-containing regimens,” said Levi Garraway, M.D., Ph.D., Roche’s Chief Medical Officer and Head of Global Product ...
Source: Roche Investor Update - January 31, 2020 Category: Pharmaceuticals Source Type: news

Reminder: Invitation to Roche ’s live audio webcast on efficacy and safety of risdiplam in patients with type 2/3 spinal muscular atrophy presented at SMA Europe 2020
  (Source: Roche Investor Update)
Source: Roche Investor Update - January 31, 2020 Category: Pharmaceuticals Source Type: news

Roche reports very strong results in 2019
Group sales increase 9% at constant exchange rates and 8% in Swiss francs, driven by new products, more than compensating for impact of competition from biosimilars (Source: Roche Investor Update)
Source: Roche Investor Update - January 30, 2020 Category: Pharmaceuticals Source Type: news

Invitation to Roche ’s Virtual Early Drug Development gRED Event 2020
We are pleased to invite investors and analysts to participate in a live video webcast and conference call on Tuesday, February 18, 2020, highlighting Roche ’s early drug development with a focus on Genentech Research and Early Development (gRED). (Source: Roche Investor Update)
Source: Roche Investor Update - January 27, 2020 Category: Pharmaceuticals Source Type: news

Roche submits supplemental Biologics License Application to the FDA for Tecentriq in combination with Avastin for the most common form of liver cancer
      ·Application is being reviewed under FDA ’s Real-Time Oncology Review pilot programmeBasel, 27 January 2020 – 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 unresectab le hepatocellular carcinoma (HCC) who have not received prior systemic therapy. The FDA is reviewing the application under the Real-Time Oncology Review pilot programme, wh...
Source: Roche Investor Update - January 27, 2020 Category: Pharmaceuticals Source Type: news

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-invasiv e urothelial cancer (MIUC). Safety for Tecentriq appeared consistent with the known safety profile of the medicine, and no new safety signals were identified.“Reducing the risk that muscle-invasive urothelial cancer will recur after surgery is ve...
Source: Roche Investor Update - January 24, 2020 Category: Pharmaceuticals Source Type: news

Reminder: Invitation to Roche ’s Full Year Results 2019 Presentation
Roche will publish its Full Year Results for 2019 prior to the opening of the Swiss Stock Exchange on  Thursday, 30 January 2020.7:00 CET / 6:00 GMT / 1:00 AM EST / 10:00 PM PST (evening before) Release will be e-mailed and posted on the Roche IR website>  click here. Presentation slides will be posted on the Roche IR website>  click here. We would like to  invite all interested parties to participate or dial in to the event outlined below.Thursday, 30 January 2020, London  The Full Year Presentation will be held at the   London Stock Exchange, 10 Paternoster Square, London EC4M 7LS...
Source: Roche Investor Update - January 23, 2020 Category: Pharmaceuticals Source Type: news

Roche ’s Risdiplam meets primary endpoint in pivotal FIREFISH trial in infants with type 1 spinal muscular atrophy
             Basel, 23 January 2020 - Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced positive topline results from the pivotal Part 2 of the FIREFISH study, evaluating risdiplam in infants aged 1-7 months with Type 1 spinal muscular atrophy (SMA). The primary outcome measure of the study was the proportion of infants sitting without support for at least five seconds at 12-months of treatment, assessed by the Gross Motor Scale of the Bayley Scales of Infant and Toddler Development Third Edition (BSID-III). Safety for risdiplam in the FIREFISH study was con...
Source: Roche Investor Update - January 23, 2020 Category: Pharmaceuticals Source Type: news

European Commission approves Roche ’s Polivy for people with previously treated aggressive lymphoma
  (Source: Roche Investor Update)
Source: Roche Investor Update - January 21, 2020 Category: Pharmaceuticals Source Type: news

European Commission approves Roche ’s Polivy for people with previously treated aggressive lymphoma
Roche today announced that the European Commission has granted conditional marketing authorisation for Polivy ® (polatuzumab vedotin), in combination with bendamustine plus MabThera® (rituximab) (BR), for the treatment of adult patients with relapsed or refractory (R/R) diffuse large B-cell lymphoma (DLBCL) who are not candidates for a haematopoietic stem cell transplant. (Source: Roche Investor Update)
Source: Roche Investor Update - January 21, 2020 Category: Pharmaceuticals Source Type: news

Invitation to Roche ’s live audio webcast on efficacy and safety of risdiplam in patients with type 2/3 spinal muscular atrophy presented at SMA Europe 2020
  (Source: Roche Investor Update)
Source: Roche Investor Update - January 17, 2020 Category: Pharmaceuticals Source Type: news

Roche and Illumina partner to broaden patient access to genomic testing
             Basel, 13 January 2020 - Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that it has entered into a 15-year, non-exclusive partnership with Illumina to broaden the adoption of distributable next-generation sequencing (NGS) based testing in oncology. As the understanding of the genomic drivers of cancer evolves, NGS has the potential to transform cancer risk prediction, detection, diagnosis, treatment and monitoring. This agreement brings together complementary capabilities of each company to broaden global adoption of NGS in cancer care. As pa...
Source: Roche Investor Update - January 13, 2020 Category: Pharmaceuticals Source Type: news

Reminder: Invitation to Roche ’s Full Year Results 2019 Presentation
Roche will publish its Full Year Results for 2019 prior to the opening of the Swiss Stock Exchange on  Thursday, 30 January 2020.7:00 CET / 6:00 GMT / 1:00 AM EST / 10:00 PM PST (evening before) Release will be e-mailed and posted on the Roche IR website>  click here. Presentation slides will be posted on the Roche IR website>  click here. We would like to  invite all interested parties to participate or dial in to the event outlined below.Thursday, 30 January 2020, London  The Full Year Presentation will be held at the   London Stock Exchange, 10 Paternoster Square, London EC4M 7LS...
Source: Roche Investor Update - January 10, 2020 Category: Pharmaceuticals Source Type: news

F1CDx approved in Japan as a CDx of ROS1+NSCLC for Rozlytrek
Dear Investor, Please find attached a press release by Chugai:https://www.roche.com/200102_IR_Chugai_Approval_ROS1_CDx_en.pdf Do not hesitate to contact us for any further questions. With best regards, (Source: Roche Investor Update)
Source: Roche Investor Update - January 2, 2020 Category: Pharmaceuticals Source Type: news

Roche enters licensing agreement with Sarepta Therapeutics to improve the lives of patients living with Duchenne muscular dystrophy
Basel, 23 December 2019 - Roche (SIX: RO, ROG; OTCQX: RHHBY) and Sarepta Therapeutics, Inc. (NASDAQ:SRPT), today announced the signing of a licensing agreement providing Roche exclusive commercial rights to SRP-9001 (AAVrh74.MHCK7.micro-dystrophin),   Sarepta’s investigational gene therapy for Duchenne muscular dystrophy (DMD), outside the United States. Under the terms of the agreement, Sarepta will receive an upfront payment of $750million in cash and $400million in equity. In addition, Sarepta is eligible to receive regulatory and sales m ilestones, and royalties on net sales. Roche and Sarepta will equally s...
Source: Roche Investor Update - December 23, 2019 Category: Pharmaceuticals Source Type: news

Invitation to Roche ’s Full Year Results 2019 Presentation
Roche will publish its Full Year Results for 2019 prior to the opening of the Swiss Stock Exchange on  Thursday, 30 January 2020.7:00 CET / 6:00 GMT / 1:00 AM EST / 10:00 PM PST (evening before) Release will be e-mailed and posted on the Roche IR website>  click here. Presentation slides will be posted on the Roche IR website>  click here. We would like to  invite all interested parties to participate or dial in to the event outlined below.Thursday, 30 January 2020, London  The Full Year Presentation will be held at the   London Stock Exchange, 10 Paternoster Square, London EC4M 7LS...
Source: Roche Investor Update - December 20, 2019 Category: Pharmaceuticals Source Type: news

European Commission approves Roche ’s Kadcyla for the adjuvant treatment of people with HER2-positive early breast cancer with residual invasive disease after neoadjuvant treatment
Basel, 19 December 2019 - Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that the European Commission has approved Kadcyla ® (trastuzumab emtansine) for the adjuvant (after surgery) treatment of adult patients with HER2-positive early breast cancer (eBC) who have residual invasive disease in the breast and/or lymph nodes after neoadjuvant (before surgery) taxane-based and HER2-targeted therapy.“Optimal treatment is vital for every patient with early-stage breast cancer, a setting where cures are possible,” said Levi Garraway, M.D., Ph.D., Roche’s Chief Medical Officer and Head of Global Product De...
Source: Roche Investor Update - December 19, 2019 Category: Pharmaceuticals Source Type: news

Roche concludes acquisition of Spark Therapeutics, Inc. to strengthen presence in gene therapy
Spark will continue its operations in Philadelphia as an independent company within the Roche Group             Basel, 17 December 2019 - Roche (SIX: RO, ROG; OTCQX: RHHBY) and Spark Therapeutics, Inc. (NASDAQ: ONCE) ( “Spark”) today announced the completion of the acquisition following the receipt of regulatory approval from all government authorities required by the merger agreement. Commenting on this important step forward, Severin Schwan, CEO of Roche, said, “We are excited about this important milestone because we believe that together...
Source: Roche Investor Update - December 17, 2019 Category: Pharmaceuticals Source Type: news

Roche purchases shares in tender offer for Spark Therapeutics, Inc.
Roche intends to complete Spark acquisition today (Source: Roche Investor Update)
Source: Roche Investor Update - December 17, 2019 Category: Pharmaceuticals Source Type: news

Roche and Spark Therapeutics, Inc. announce closing of investigation and unconditional clearance by the FTC and expiration of Hart-Scott-Rodino waiting period for acquisition of Spark Therapeutics, Inc.
All antitrust approvals required to close the transaction received. (Source: Roche Investor Update)
Source: Roche Investor Update - December 16, 2019 Category: Pharmaceuticals Source Type: news

Roche and Spark Therapeutics, Inc. announce unconditional clearance by UK Competition and Markets Authority
             Basel, 16 December 2019 - Roche (SIX: RO, ROG; OTCQX: RHHBY) and Spark Therapeutics, Inc. (NASDAQ: ONCE) ( “Spark”) today announced that the UK Competition and Markets Authority has unconditionally cleared Roche’s pending acquisition of Spark pursuant to its previously announced tender offer to purchase all of the outstanding shares of common stock (the “Shares”) of Spark for USD 114.50 per Sha re, net to the seller thereof in cash, without interest and subject to any withholding taxes required by applicable law and upon the terms and subjec...
Source: Roche Investor Update - December 16, 2019 Category: Pharmaceuticals Source Type: news

Roche announces positive Phase III study results for Tecentriq plus Cotellic and Zelboraf in people with previously untreated BRAF V600 mutation-positive advanced melanoma
             Basel, 13 December 2019 - Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced the Phase III IMspire150 study, in people with previously untreated BRAF V600 mutation-positive advanced melanoma, met its primary endpoint of progression-free survival (PFS). The study showed adding Tecentriq ® (atezolizumab) to Cotellic® (cobimetinib) and Zelboraf® (vemurafenib) helped to reduce the risk of disease worsening or death, compared to placebo plus Cotellic and Zelboraf. A significant and clinically meaningful improvement in PFS was demonstrated in the study. The safety ...
Source: Roche Investor Update - December 13, 2019 Category: Pharmaceuticals Source Type: news

Roche ’s fixed-dose subcutaneous combination of Perjeta and Herceptin comparable to intravenous formulations in people with HER2-positive breast cancer
Roche today announced new data from the phase III FeDeriCa study which showed the investigational fixed-dose combination (FDC) of Perjeta ® (pertuzumab) and Herceptin® (trastuzumab), administered by subcutaneous (SC) injection in combination with intravenous (IV) chemotherapy, demonstrated non-inferior levels of Perjeta in the blood (pharmacokinetics) and comparable efficacy and safety to standard IV infusions of Perjeta plus Hercep tin and chemotherapy in eligible people with HER2-positive early breast cancer (eBC). (Source: Roche Investor Update)
Source: Roche Investor Update - December 12, 2019 Category: Pharmaceuticals Source Type: news

APHINITY six-year results strengthen evidence of clinical benefit with Roche ’s Perjeta-based regimen
             Basel, 11 December 2019 - Roche (SIX: RO, ROG; OTCQX: RHHBY), the Breast International Group (BIG), Institut Jules Bordet Clinical Trials Support Unit (IJB-CTSU) and Frontier Science Foundation (FS) today announced data from a second interim overall survival (OS) analysis of the phase III APHINITY study, evaluating the combination of Perjeta® (pertuzumab), Herceptin® (trastuzumab) and chemotherapy (the Perjeta-based regimen) as an adjuvant (after surgery) treatment for patients with HER2-positive early breast cancer (eBC). This latest int...
Source: Roche Investor Update - December 11, 2019 Category: Pharmaceuticals Source Type: news

FDA accepts supplemental biologics license application for Xolair (omalizumab) for the treatment of nasal polyps
Roche announced today that the U.S. Food and Drug Administration (FDA) has accepted the company ’s supplemental Biologics License Application (sBLA) for Xolair® (omalizumab) for the treatment of nasal polyps in adult patients 18 years of age and older with inadequate response to intranasal corticosteroids. (Source: Roche Investor Update)
Source: Roche Investor Update - December 11, 2019 Category: Pharmaceuticals Source Type: news

Roche receives CE Mark for its Accu-Chek SugarView app
Roche today announced that it has obtained the CE Mark for its Accu-Chek SugarView app. (Source: Roche Investor Update)
Source: Roche Investor Update - December 10, 2019 Category: Pharmaceuticals Source Type: news

Reminder: Invitation to Roche ’s live audio webcast and conference call on key data presented at SABCS 2019
We are pleased to invite investors and analysts to participate in a live audio webcast and conference call on Monday, 16 December 2019, highlighting Roche data presented at the San Antonio Breast Cancer Symposium in San Antonio, Texas, from 10th - 14th December. (Source: Roche Investor Update)
Source: Roche Investor Update - December 9, 2019 Category: Pharmaceuticals Source Type: news

Roche and Spark Therapeutics, Inc. announce extension of tender offer for shares of Spark Therapeutics, Inc. to December 16, 2019
Roche and Spark Therapeutics, Inc. (NASDAQ: ONCE) ( “Spark”) today announced that Roche has extended the offering period of its previously announced tender offer to purchase all of the outstanding shares of common stock (the “Shares”) of Spark for USD 114.50 per Share, net to the seller thereof in cash, without interest and subject to any wit hholding taxes required by applicable law and upon the terms and subject to the conditions set forth in the Offer to Purchase dated March 7, 2019 (as it may be amended and supplemented from time to time, the “Offer”). (Source: Roche Investor Update)
Source: Roche Investor Update - December 9, 2019 Category: Pharmaceuticals Source Type: news

Changes in the Board of Directors and the Corporate Executive Committee of Roche
Roche announced today that at its December meeting the Board of Directors of Roche Holding Ltd has approved first proposals to the Annual General Meeting on 17 March 2020. (Source: Roche Investor Update)
Source: Roche Investor Update - December 9, 2019 Category: Pharmaceuticals Source Type: news

New data demonstrate the continued clinical benefit of fixed-duration, chemotherapy-free Venclexta/Venclyxto-based treatments in chronic lymphocytic leukaemia
Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced updated data from two pivotal phase III Venclexta ®/Venclyxto® (venetoclax) studies (MURANO and CLL14) that highlight Venclexta/Venclyxto combination treatments as chemotherapy-free, fixed-duration options that achieve minimal residual disease (MRD)-negativity, in people with chronic lymphocytic leukaemia (CLL). (Source: Roche Investor Update)
Source: Roche Investor Update - December 8, 2019 Category: Pharmaceuticals Source Type: news

Roche announces new data on novel CD20-CD3 bispecific cancer immunotherapies in people with difficult-to-treat lymphomas
Roche today announced new data on two investigational CD20-CD3 T-cell engaging bispecific antibodies, mosunetuzumab and CD20-TCB, in people with relapsed or refractory (R/R) B-cell non-Hodgkin lymphoma (NHL). (Source: Roche Investor Update)
Source: Roche Investor Update - December 7, 2019 Category: Pharmaceuticals Source Type: news

FDA approves Roche ’s Tecentriq plus chemotherapy (Abraxane and carboplatin) for the initial treatment of metastatic non-squamous non-small cell lung cancer
Roche today announced that the US Food and Drug Administration (FDA) approved Tecentriq ® (atezolizumab) in combination with chemotherapy (Abraxane® [paclitaxel protein-bound; nab-paclitaxel] and carboplatin) for the initial (first-line) treatment of adults with metastatic non-squamous non-small cell lung cancer (NSCLC) with no EGFR or ALK genomic tumour aberrations. (Source: Roche Investor Update)
Source: Roche Investor Update - December 4, 2019 Category: Pharmaceuticals Source Type: news

Reminder: Invitation to Roche ’s live audio webcast and conference call on key hematology data presented at ASH 2019
We are pleased to invite investors and analysts to participate in a live audio webcast and conference call on Tuesday, 10 December 2019, highlighting Roche data presented at the American Society of Hematology (ASH) 61st Annual meeting in Orlando, Florida, from 7-10th December. (Source: Roche Investor Update)
Source: Roche Investor Update - December 3, 2019 Category: Pharmaceuticals Source Type: news

Positive phase III results for Roche ’s satralizumab in neuromyelitis optica spectrum disorder published in the New England Journal of Medicine
Roche announced today that data from SAkuraSky, a pivotal phase III study of the investigational medicine satralizumab for the treatment of neuromyelitis optica spectrum disorder (NMOSD), were published in the 27 November 2019 online issue of the New England Journal of Medicine (NEJM). (Source: Roche Investor Update)
Source: Roche Investor Update - December 2, 2019 Category: Pharmaceuticals Source Type: news

FDA grants priority review to Roche ’s risdiplam for spinal muscular atrophy
Roche today announced that the U.S. Food and Drug Administration (FDA) has accepted the New Drug Application (NDA) and granted Priority Review for risdiplam, an investigational survival motor neuron-2 (SMN-2) splicing modifier for SMA. (Source: Roche Investor Update)
Source: Roche Investor Update - November 25, 2019 Category: Pharmaceuticals Source Type: news

Roche presents pivotal data demonstrating Tecentriq in combination with Avastin improves overall survival in people with the most common form of liver cancer
Roche will today present positive results from the Phase III IMbrave150 study evaluating Tecentriq ® (atezolizumab) in combination with Avastin® (bevacizumab). The data show statistically significant and clinically meaningful improvements in overall survival (OS) and progression-free survival (PFS), compared with sorafenib, in people with unresectable hepatocellular carcinoma (HCC) who have not received prior systemic therapy. (Source: Roche Investor Update)
Source: Roche Investor Update - November 22, 2019 Category: Pharmaceuticals Source Type: news

Roche and Spark Therapeutics, Inc. announce extension of tender offer for shares of Spark Therapeutics, Inc.
Roche and Spark Therapeutics, Inc. (NASDAQ: ONCE) ( “Spark”) today announced that Roche has extended the offering period of its previously announced tender offer to purchase all of the outstanding shares of common stock (the “Shares”) of Spark for USD 114.50 per Share, net to the seller thereof in cash, without interest and subject to any wit hholding taxes required by applicable law and upon the terms and subject to the conditions set forth in the Offer to Purchase dated March 7, 2019 (as it may be amended and supplemented from time to time, the “Offer”). (Source: Roche Investor Update)
Source: Roche Investor Update - November 22, 2019 Category: Pharmaceuticals Source Type: news

Invitation to Roche ’s live audio webcast and conference call on key data presented at SABCS 2019
We are pleased to invite investors and analysts to participate in a live audio webcast and conference call on Monday, 16 December 2019, highlighting Roche data presented at the San Antonio Breast Cancer Symposium in San Antonio, Texas, from 10th - 14th December. (Source: Roche Investor Update)
Source: Roche Investor Update - November 21, 2019 Category: Pharmaceuticals Source Type: news

Roche to present new and updated data for seven approved and investigational medicines across multiple types of breast cancer at the 2019 San Antonio Breast Cancer Symposium
Roche today announced that results from a number of studies from across its growing breast cancer portfolio will be presented at the San Antonio Breast Cancer Symposium (SABCS), from 10-14 December 2019. (Source: Roche Investor Update)
Source: Roche Investor Update - November 18, 2019 Category: Pharmaceuticals Source Type: news

CHMP recommends EU approval of Roche ’s Kadcyla for the adjuvant treatment of people with HER2-positive early breast cancer with residual invasive disease after neoadjuvant treatment
Roche today announced that the European Medicines Agency ’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has recommended the approval of Kadcyla® (trastuzumab emtansine) for the adjuvant (after surgery) treatment of adult patients with HER2-positive early breast cancer (eBC) who have residual invasive disease, in the breast and/or lymph nodes, after neoadjuvant (before surgery) taxane-based and HER2-targeted therapy. (Source: Roche Investor Update)
Source: Roche Investor Update - November 15, 2019 Category: Pharmaceuticals Source Type: news

CHMP recommends conditional EU approval of Roche ’s Polivy for people with previously treated aggressive lymphoma
Roche today announced that the EU Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion for Polivy ® (polatuzumab vedotin) in combination with bendamustine plus MabThera® (rituximab) (BR) for the treatment of adults with relapsed or refractory (R/R) diffuse large B-cell lymphoma (DLBCL), who are not candidates for a haematopoietic stem cell transplant. (Source: Roche Investor Update)
Source: Roche Investor Update - November 15, 2019 Category: Pharmaceuticals Source Type: news

Invitation to Roche ’s live audio webcast and conference call on key hematology data presented at ASH 2019
We are pleased to invite investors and analysts to participate in a live audio webcast and conference call on Tuesday, 10 December 2019, highlighting Roche data presented at the American Society of Hematology (ASH) 61st Annual meeting in Orlando, Florida, from 7-10th December. (Source: Roche Investor Update)
Source: Roche Investor Update - November 13, 2019 Category: Pharmaceuticals Source Type: news