FDA approves Roche ’s Tecentriq in combination with Avastin for people with the most common form of liver cancer
Basel, 2 June 2020 – Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that the US Food and Drug Administration (FDA) has approved Tecentriq® (atezolizumab) in combination with Avastin® (bevacizumab) for the treatment of people with unresectable or metastatic hepatocellular carcinoma (HCC) who have not received p rior systemic therapy.“We’re excited that today’s approval of Tecentriq in combination with Avastin for unresectable or metastatic hepatocellular carcinoma brings a cancer immunotherapy option to people with this aggressive form of liver cancer,” said Levi Garraway, M.D., Ph....
Source: Roche Media News - June 2, 2020 Category: Pharmaceuticals Source Type: news

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 EuropeBasel, 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 a positive opinion under conditional marketing authorisation for Rozlytrek® (entrectinib) for the treatment of adult and paediatric patients 12 years of age and older with solid tumours expressing a neurotrop...
Source: Roche Media News - May 29, 2020 Category: Pharmaceuticals Source Type: news

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 already demonstrated across three phase III clinical trials. Full findings were presented at the ASCO2 0 Virtual Scientific Programme, on 29 May 2020.“These data further support Alecensa as the standard of care for people with metastatic AL...
Source: Roche Media News - May 29, 2020 Category: Pharmaceuticals Source Type: news

Roche ’s OCREVUS (ocrelizumab) shorter 2-hour infusion time approved in Europe
             Basel, 28 May 2020 - Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced European Medicines Agency (EMA) approval of a new, shorter two-hour OCREVUS ® (ocrelizumab) infusion time, dosed twice yearly, for relapsing or primary progressive multiple sclerosis (MS). The approval is based on a positive opinion from the EMA’s Committee for Medicinal Products for Human Use (CHMP).“The approval of a shorter, two-hour infusion time for OCREVUS in Europe, dosed twice yearly, will further improve the treatment experience for patients while als...
Source: Roche Media News - May 28, 2020 Category: Pharmaceuticals Source Type: news

Roche initiates phase III clinical trial of Actemra/RoActemra plus remdesivir in hospitalised patients with severe COVID-19 pneumonia
Basel, 28 May 2020 - Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced the initiation of a global phase III, randomised, double-blind, multicentre study (REMDACTA) to evaluate the safety and efficacy of Actemra/RoActemra plus the investigational antiviral remdesivir, versus placebo plus remdesivir in hospitalised patients with severe COVID-19 pneumonia, in collaboration with Gilead Sciences, Inc.   (Source: Roche Media News)
Source: Roche Media News - May 28, 2020 Category: Pharmaceuticals Source Type: news

Roche ’s Port Delivery System with ranibizumab shows positive phase III results in neovascular age-related macular degeneration
Basel, 27 May 2020 - Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced positive topline results from the phase III Archway study, evaluating Port Delivery System with ranibizumab (PDS) in people living with neovascular or “wet” age-related macular degeneration (nAMD). PDS is a permanent refillable eye implant, approximately the size of a grain of rice, which continuously delivers a customised formulation of ranibizumab over a period of months. The Archway trial met its primary endpoint, demonstrating that patient s with PDS who received refills every six months achieved visual acuity outcomes equivalent to tho...
Source: Roche Media News - May 27, 2020 Category: Pharmaceuticals Source Type: news

Roche acquires Stratos Genomics to further develop DNA based sequencing for diagnostic use
Basel, 22 May 2020 - Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that it has acquired Stratos Genomics, an early-stage sequencing technology company to advance the development of Roche ’s nanopore sequencer. The acquisition provides Roche access to Stratos Genomics unique chemistry, Sequencing by Expansion (SBX™). The Roche nanopore sequencer, once developed, will utilise a novel approach that combines electronic and biological components to sequence DNA for fast, flexible and cost-effective clinical diagnostic testing.“Roche is dedicated to creating innovative diagnostics for the most challenging ...
Source: Roche Media News - May 22, 2020 Category: Pharmaceuticals Source Type: news

New longer-term data reinforce safety of Roche ’s satralizumab in adults and adolescents with neuromyelitis optica spectrum disorder
Basel, 22 May 2020 - Roche (SIX: RO, ROG; OTCQX: RHHBY) will present new pooled pivotal satralizumab safety results for the treatment of neuromyelitis optica spectrum disorder (NMOSD), a rare, debilitating central nervous system disorder. These data are being presented at the 6th Annual Meeting of the European Academy of Neurology (EAN) and show satralizumab was well-tolerated in a broad patient population – including adolescents, for whom there is no approved medicine. Satralizumab is an investigational humanised monoclonal antibody that targets the interleukin-6 (IL-6) receptor, believed to play a key role in the i...
Source: Roche Media News - May 22, 2020 Category: Pharmaceuticals Source Type: news

FDA approves Roche ’s Tecentriq as a first-line monotherapy for certain people with metastatic non-small cell lung cancer
Basel, 19 May 2020 – Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that the US Food and Drug Administration (FDA) has approved Tecentriq® (atezolizumab) as a first-line (initial) treatment for adults with metastatic non-small cell lung cancer (NSCLC) whose tumours have high PD-L1 expression (PD-L1 stained ≥ 50% of tumour cells [TC ≥ 50%] or PD-L1 stained tumour-infiltrating [IC] covering ≥ 10% of the tumour area [IC ≥ 10%]), as determined by an FDA-approved test, with no EGFR or ALK genomic tumour aberrations.“We are pleased to offer people with certain types of lung cancer a new chemothera...
Source: Roche Media News - May 19, 2020 Category: Pharmaceuticals Source Type: news

Roche launches new blood gas digital solution designed to improve patient care
Basel, 15 May 2020 - Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced the CE mark availability of Roche v-TAC, a new digital diagnostic solution that allows clinicians to obtain results for arterial blood gas values from patients with respiratory or metabolic abnormalities via a simpler, less invasive venous puncture through the use of a digital algorithm. Blood gas analysis is typically used in hospital point of care (POC) settings, where quick and accurate results are needed. This includes emergency rooms, intensive care units and operating rooms. The analysis provides clinicians with information about a patient &rsquo...
Source: Roche Media News - May 15, 2020 Category: Pharmaceuticals Source Type: news

Roche to present first clinical data on novel anti-TIGIT cancer immunotherapy tiragolumab at ASCO
Basel, 14 May 2020 – Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced positive results from the Phase II CITYSCAPE trial, the first randomised study evaluating the efficacy and safety of tiragolumab plus Tecentriq® (atezolizumab) compared with Tecentriq alone as an initial (first-line) treatment for people with P D-L1-positive metastatic non-small cell lung cancer (NSCLC). Tiragolumab is a novel cancer immunotherapy designed to bind to TIGIT, an immune checkpoint protein expressed on immune cells. Both TIGIT and PD-L1 play an important role in immune suppression, and blocking both pathways could enhance anti -t...
Source: Roche Media News - May 14, 2020 Category: Pharmaceuticals Source Type: news

A formative figure in the company's history: Roche Honorary Chairman Fritz Gerber dies at the age of 91
Basel, 11 Mai 2020 - On May 10th 2020 Dr. h.c. Fritz Gerber died in his 92nd year. For more than two decades, he had shaped Roche's development into a leading global healthcare company in an exceptionally successful dual role as Group CEO (1978-1998) and Chairman of the Board (1978-2001). He remained closely associated with Roche throughout his life as Honorary Chairman. Starting at the end of the 1970s, Fritz Gerber led the company from a difficult situation to new success. Under his leadership, Roche's Group structures were fundamentally renewed and decentralized – ranging from focusing on the core businesses to mo...
Source: Roche Media News - May 11, 2020 Category: Pharmaceuticals Source Type: news

Changes to the Roche Enlarged Corporate Executive Committee
Roche today announced that Michael Varney (1958) Ph.D., and Head of Genentech Research and Early Development (gRED) since 2015, will retire from the company at the end of July. (Source: Roche Media News)
Source: Roche Media News - May 11, 2020 Category: Pharmaceuticals Source Type: news

New data at the ASCO20 Virtual Scientific Program reflects Roche ’s commitment to accelerating progress in cancer care
Basel, 7 May 2020 - Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that new data from clinical trials of 19 approved and investigational medicines across 21 cancer types, will be presented at the ASCO20 Virtual Scientific Program organised by the American Society of Clinical Oncology (ASCO), which will be held 29-31 May, 2020. A total of 120 abstracts that include a Roche medicine will be presented at this year's meeting." At ASCO, we will present new data from many investigational and approved medicines across our broad oncology portfolio, " said Levi Garraway, M.D., Ph.D., Roche's Chief Medical Officer and ...
Source: Roche Media News - May 7, 2020 Category: Pharmaceuticals Source Type: news

Roche ’s COVID-19 antibody test receives FDA Emergency Use Authorization and is available in markets accepting the CE mark
Basel, 03 May 2020 - Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that the U.S. Food and Drug Administration (FDA) has issued an Emergency Use Authorization (EUA)1 for its new Elecsys ® Anti-SARS-CoV-2 antibody test. The test is designed to help determine if a patient has been exposed to the SARS-CoV-2 virus and if the patient has developed antibodies against SARS-CoV-2. Roche has already started shipping the new antibody test to leading laboratories globally and will ramp up pr oduction capacity to high double-digit millions per month to serve healthcare systems in countries accepting the CE mark2 as well as the...
Source: Roche Media News - May 3, 2020 Category: Pharmaceuticals Source Type: news

New 6-year data for Roche ’s OCREVUS (ocrelizumab) show earlier treatment initiation nearly halves risk of needing walking aid in relapsing multiple sclerosis
             Basel, 28 April 2020 - Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced new analyses of Phase III OPERA I and OPERA II studies, as well as the open-label extensions, showing that OCREVUS ® (ocrelizumab) treatment reduced the risk of disease and disability progression in RMS and PPMS. These new analyses add additional evidence to the benefit-risk profile of OCREVUS, including the impact of MS on people’s daily lives. The data were selected for the 72nd American Academy of Neurolog y (AAN) Annual Meeting and will be made available onlin...
Source: Roche Media News - April 28, 2020 Category: Pharmaceuticals Source Type: news

Roche ’s risdiplam shows significant improvement in survival and motor milestones in infants with Type 1 spinal muscular atrophy (SMA)
Basel, 28 April 2020 - Roche (SIX: RO, ROG; OTCQX: RHHBY) today presented 1-year data from FIREFISH Part 2, a pivotal global study evaluating risdiplam in infants aged 1 – 7 months old with symptomatic Type 1 spinal muscular atrophy (SMA). The study met its primary endpoint with 29% of infants (12/41; p
Source: Roche Media News - April 28, 2020 Category: Pharmaceuticals Source Type: news

First quarter with 2% growth in Swiss francs, 7% at constant exchange rates
Group sales increase 2% in Swiss francs and 7% at constant exchange rates, driven by new products, more than compensating for impact of competition from biosimilars Pharmaceuticals Division sales up 7%, led by Tecentriq, Hemlibra, Ocrevus and Perjeta Diagnostics Division sales grow 5%, with molecular testing as main contributor (Source: Roche Media News)
Source: Roche Media News - April 22, 2020 Category: Pharmaceuticals Source Type: news

Roche receives FDA approval for cobas HPV test for use on the cobas 6800/8800 Systems to identify women at risk for cervical cancer
             Basel, 21 April 2020 - Roche (SIX: RO, ROG; OTCQX:RHHBY) today announced US Food and Drug Administration (FDA) approval for the cobas ® HPV test for use on the fully automated, high-throughput cobas® 6800/8800 Systems. The cobas® HPV test identifies women at risk for cervical cancer by detecting the presence of high-risk human papillomavirus (HPV) DNA in cervical samples. Persistent high-risk HPV infections can develop into pre cancerous lesions and, if left untreated, these lesions can progress to cervical cancer.“The approval ...
Source: Roche Media News - April 21, 2020 Category: Pharmaceuticals Source Type: news

US FDA and EMA accept applications for Roche ’s OCREVUS (ocrelizumab) shorter 2-hour infusion time
             Basel, 20 April 2020 - Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that the U.S. Food and Drug Administration (FDA) has accepted the company ’s supplemental Biologics License Application (sBLA) and the European Medicines Agency (EMA) has validated the application for a two-hour OCREVUS® (ocrelizumab) infusion time, dosed twice yearly for relapsing or primary progressive multiple sclerosis (MS).“With more than 150,000 people treated with OCREVUS, the twice-yearly dosing schedule has benefited many MS patients and their physi...
Source: Roche Media News - April 20, 2020 Category: Pharmaceuticals Source Type: news

Roche develops new serology test to detect COVID-19 antibodies
Basel, 17 April 2020 - Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced the development and upcoming launch of its Elecsys ® Anti-SARS-CoV-2 serology test to detect antibodies in people who have been exposed to the Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) that causes the COVID-19 disease. Antibody testing is central to help identify people who have been infected by the virus, especially those who may have been infected but did not display symptoms. ³ Additionally, the test can support priority screening of high risk groups, such as healthcare workers, food supply workers who might already hav...
Source: Roche Media News - April 17, 2020 Category: Pharmaceuticals Source Type: news

Roche provides regulatory update on risdiplam for the treatment of spinal muscular atrophy (SMA)
Basel, 07 April 2020 - Roche (SIX: RO, ROG; OTCQX: RHHBY), today announced that the U.S. Food and Drug Administration (FDA) has extended the Prescription Drug User Fee Act (PDUFA) date for its review of the New Drug Application (NDA) of risdiplam with a decision expected by August 24, 2020. The extension is a result of the recent submission of additional data by Roche, including data from the pivotal SUNFISH Part 2 study, in close collaboration with the FDA. These data were recently presented at the 2nd International Scientific and Clinical Congress on Spinal Muscular Atrophy. In November 2019, the FDA granted Priority Rev...
Source: Roche Media News - April 7, 2020 Category: Pharmaceuticals Source Type: news

Roche response to COVID-19 pandemic
(Source: Roche Media News)
Source: Roche Media News - March 24, 2020 Category: Pharmaceuticals Source Type: news

Roche announces Venclexta/Venclyxto combination improved overall survival in people with previously untreated acute myeloid leukaemia
Basel, 23 March 2020 - Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that the phase III VIALE-A study met its dual primary endpoints of overall survival and composite complete remission rate (CR + CRi). Venclexta ®/Venclyxto® (venetoclax) in combination with azacitidine, a hypomethylating agent, showed a statistically significant improvement in overall survival in people with previously untreated acute myeloid leukaemia (AML) who were ineligible for intensive induction chemotherapy, compared to azacitidine alone. Safety for Venclexta/Venclyxto plus azacitidine appeared consistent with the known safety profile ...
Source: Roche Media News - March 23, 2020 Category: Pharmaceuticals Source Type: news

Roche initiates Phase III clinical trial of Actemra/RoActemra in hospitalised patients with severe COVID-19 pneumonia
Basel, 19 March 2020- Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced   we are working with the Food& Drug Administration (FDA) to initiate a randomised, double-blind, placebo-controlled Phase III clinical trial in collaboration with the Biomedical Advanced Research and Development Authority (BARDA), a part of the US Health and Human Services Office of the Assistant Secretary for Preparedness and Response (ASPR), to evaluate the safety and efficacy of Actemra ®/RoActemra® (tocilizumab) plus standard of care in hospitalised adult patients with severe COVID-19 pneumonia compared to placebo plus standard o...
Source: Roche Media News - March 19, 2020 Category: Pharmaceuticals Source Type: news

Roche Annual General Meeting 2020
Basel, 17 March 2020 – Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that its shareholders approved all proposals of the Board of Directors at its ordinary Annual General Meeting (AGM). On the basis of COVID-19 Ordinance 2 of the Swiss Federal Council, no shareholders were admitted to attend the General Meeting in person. Roche had already recommended on March 10 that shareholders should delegate their votes to the independent proxy. The independent proxy represented 85.47 % of the total 160,000,000 shares. The Management Report, the Financial Statements and the Consolidated Financial Statements for 2019 were ap...
Source: Roche Media News - March 17, 2020 Category: Pharmaceuticals Source Type: news

Roche Annual General Meeting 2020: Voting will take place by independent proxy. Participation on site is neither possible nor permitted by Federal Council ordinance
Basel, 16 March 2020 - Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that due to the declaration of the extraordinary situation by the Federal Council to combat the corona virus, voting at tomorrow's Ordinary General Meeting will be done by the independent proxies. Roche is thus complying with Ordinance 2 on Measures to Combat the Corona Virus (COVID-19) (COVID-19- 2) as amended on 16 March. Shareholders on site cannot be granted access to the meeting room. They may submit their votes to the independent proxy on site. Urgent questions can be submitted in writing to Investor Relations athttps://www.roche.com/de/investo...
Source: Roche Media News - March 16, 2020 Category: Pharmaceuticals Source Type: news

Roche Annual General Meeting 2020 to take place under special conditions set by the authorities - electronic voting strongly recommended
Basel, 14 March 2020 - Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that, even under the new federal guidelines on the COVID-19 situation (coronavirus), the Annual General Meeting will continue to take place on 17 March in accordance with an exemption provided for by the cantonal authorities Basel-Stadt. Roche will comply with all federal and cantonal health protection requirements. However, Roche continues to strongly advise all shareholders against physical attendance at the Annual General Meeting, particularly people whose age or pre-existing condition may make them more susceptible, as part of preventive healthca...
Source: Roche Media News - March 14, 2020 Category: Pharmaceuticals Source Type: news

Roche ’s cobas SARS-CoV-2 Test to detect novel coronavirus receives FDA Emergency Use Authorization and is available in markets accepting the CE mark
             Basel, 13 March 2020 - Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that the U.S. Food and Drug Administration (FDA) has issued an Emergency Use Authorization (EUA) for the cobas ® SARS-CoV-2 Test. It is intended for the qualitative detection of SARS-CoV-2, the virus that causes COVID-19 disease, in nasopharyngeal and oropharyngeal swab samples from patients who meet COVID-19 clinical and/or epidemiological criteria for testing. Hospitals and reference laboratories can run the test on Roche’s fully automated cobas® 6800 and co...
Source: Roche Media News - March 13, 2020 Category: Pharmaceuticals Source Type: news

European Commission approves Venclyxto plus Gazyvaro for adults with previously untreated chronic lymphocytic leukaemia
Basel, 12 March 2020 - Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that the European Commission has approved Venclyxto ® (venetoclax) in combination with Gazyvaro® (obinutuzumab) for the treatment of adult patients with previously untreated chronic lymphocytic leukaemia (CLL).“Venclyxto plus Gazyvaro is the first fixed-duration, chemotherapy-free treatment option that has been shown to help patients with untreated chronic lymphocytic leukaemia live longer without their disease progressing,” said Levi Garraway, M.D., Ph.D., Roche’s Chief Medical Officer and Head of Global Product Development...
Source: Roche Media News - March 12, 2020 Category: Pharmaceuticals Source Type: news

Roche receives FDA approval for CINtec PLUS Cytology test to aid clinicians in improving cervical cancer prevention
Basel, 11 March 2020 — Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced US Food and Drug Administration (FDA) approval of CINtec®PLUS Cytology as the first biomarker-based triage test for women whose primary cervical cancer screening results are positive for the human papillomavirus (HPV) using the cobas ® 4800 HPV Test. This biomarker technology simplifies clinical decision making by providing easy to understand results so that clinicians and women are clear on next steps. The CINtecPLUS Cytology test identifies those women whose HPV infections are most likely to be associated with cervical pre-cancers. It...
Source: Roche Media News - March 11, 2020 Category: Pharmaceuticals Source Type: news

FDA grants Breakthrough Device Designation for Roche's Elecsys GALAD score to support earlier diagnosis of hepatocellular carcinoma
Basel, 4 March 2020 - Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Device Designation to the Elecsys ® GALAD score.* This algorithmic score combines gender and age with the biomarker results of the Elecsys AFP, AFP-L3 and PIVKA-II and is intended to aid diagnosis of early stage hepatocellular carcinoma (HCC). Dr. Amit Singal, Medical Director of the Liver Tumor Program   and Clinical Chief of Pathology at UT Southwestern Medical Center in Dallas, USA, stated, " HCC is the fourth leading cause of cancer-related death worldwide, wit...
Source: Roche Media News - March 4, 2020 Category: Pharmaceuticals Source Type: news

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 Media News - February 25, 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 Media News - 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 Media News - February 14, 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 Media News - February 10, 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, 06 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 risdi...
Source: Roche Media News - February 6, 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 Media News)
Source: Roche Media News - January 30, 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
Roche 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 unresectable hepatocellular carcinoma (HCC) who have not received prior systemic therapy. (Source: Roche Media News)
Source: Roche Media News - 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 very difficult, and we are disappointed that we w...
Source: Roche Media News - January 24, 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 Media News - January 23, 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 Media News)
Source: Roche Media News - January 21, 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 Media News - January 13, 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 Media News - December 23, 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, ...
Source: Roche Media News - 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 Media News - December 17, 2019 Category: Pharmaceuticals Source Type: news

Roche purchases shares in tender offer for Spark Therapeutics, Inc.
Basel, 17 December 2019 - Roche (SIX: RO, ROG; OTCQX: RHHBY) and Spark Therapeutics, Inc. (NASDAQ: ONCE) ( “Spark”) today announced that Roche’s wholly owned subsidiary 022019 Merger Subsidiary, Inc. has accepted for payment all shares validly tendered and not validly withdrawn pursuant to its tender offer for all outstanding shares of common stock of Spark, at a price of USD 114.50 per share in ca sh.  The tender offer expired at 5:00 p.m., New York City time, on 16 December 2019 and was not extended. Roche has been advised by Citibank, N.A., the depositary for the tender offer, that a total of appr...
Source: Roche Media News - 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
  (Source: Roche Media News)
Source: Roche Media News - December 16, 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.
Roche and Spark Therapeutics, Inc. (NASDAQ: ONCE) ( “Spark”) today announced that the Federal Trade Commission closed its investigation and granted unconditional clearance and termination of the waiting period under the Hart-Scott-Rodino Antitrust Improvements Act of 1976 (“HSR Act”) in connection with Roche’s pending acquisition of Spark p ursuant 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 Share, net to the seller thereof in cash, without interest and subject to any withholding taxes...
Source: Roche Media News - 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 subject to the conditions set forth in the Offer to Purchas...
Source: Roche Media News - December 16, 2019 Category: Pharmaceuticals Source Type: news