Tag Archives: Roche

Roche study combining Esbriet and nintedanib treatment: majority of the patients tolerated the combination treatment

New study combining Esbriet (pirfenidone) and nintedanib showing similar safety profile for the combination treatment to that expected for each treatment alone A second, retrospective, post-hoc, analysis suggests that treatment with Esbriet may be associated with a reduction of multiple … Read the full press release

Roche phase III BRIM8 study: 46% reduction in recurrence risk was observed in stage IIC-IIIB melanoma patients

BASEL, 14-Sep-2017 — /EuropaWire/ — Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced data for the phase III BRIM8 study, which was designed to investigate the efficacy and safety of Zelboraf® (vemurafenib) in the adjuvant (after surgery) treatment of people with … Read the full press release

Haemophilia A: data from Roche’s HAVEN 1 published in The New England Journal of Medicine (NEJM)

Positive phase III results for Roche’s emicizumab in haemophilia A published in The New England Journal of Medicine HAVEN 1 showed emicizumab reduced bleed rate by 87% compared with on-demand bypassing agents All 12 secondary endpoints in HAVEN 1 were … Read the full press release

Roche’s Lucentis is the first and only FDA-approved medicine to treat diabetic retinopathy

First and only medicine approved to treat all forms of diabetic retinopathy Granted Priority Review Designation by the FDA based on analysis of results from a National Institutes of Health (NIH)-funded collaborative group study BASEL, 24-Apr-2017 — /EuropaWire/ — Roche (SIX: … Read the full press release

FDA Approves Roche’s TECENTRIQ as initial treatment for certain advanced bladder cancer patients

First and only cancer immunotherapy approved in advanced bladder cancer as initial treatment for those unable to receive cisplatin chemotherapy BASEL, 24-Apr-2017 — /EuropaWire/ — Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that the US Food and Drug Administration (FDA) … Read the full press release

New Data on Roche’s OCREVUS To be Presented at AAN

Data presentations will include platform sessions and posters across relapsing multiple sclerosis and primary progressive multiple sclerosis BASEL, 24-Apr-2017 — /EuropaWire/ — Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that new data on OCREVUS™ (ocrelizumab) in people with relapsing … Read the full press release

Roche to present 60 abstracts featuring nine of its approved or investigational medicines at the 58th American Society of Hematology (ASH) in San Diego

New results from the phase III GALLIUM study which compared Gazyva/Gazyvaro (obinutuzumab) plus chemotherapy to Rituxan/ MabThera (rituximab) plus chemotherapy in previously untreated follicular lymphoma will be presented in the Plenary Scientific Session New results for Venclexta/Venclyxto(venetoclax) and investigational medicine … Read the full press release

Roche to present new data from Actemra®/RoActemra® and Rituxan®/MabThera® at the 2016 ACR/ARHP in Washington, D.C.

15 oral presentations from 17 abstracts across six autoimmune conditions First presentation of Actemra/RoActemra data from GiACTA – the largest ever clinical trial in people with giant cell arteritis (GCA), a condition for which there has been no approved therapy … Read the full press release

Roche’s Marketing Authorisation Application and Biologics License Application for OCREVUS accepted by EMA and FDA

OCREVUS is the first investigational medicine seeking marketing authorisation for both relapsing and primary progressive multiple sclerosis (MS) FDA grants Priority Review Designation for OCREVUS Biologics License Application (BLA) BASEL, 29-Jun-2016 — /EuropaWire/ — Roche (SIX: RO, ROG; OTCQX: RHHBY) announced … Read the full press release

European Medicines Agency accepted Sandoz’s Marketing Authorization Application for biosimilar to Roche’s EU-licensed MabThera®

Sandoz advances biosimilar portfolio with sixth major biosimilar file acceptance in less than one year Sandoz is seeking approval for all indications included in the reference product’s label Sandoz’ submission includes data from multiple clinical trials with over 800 patients … Read the full press release

Roche to present 19 approved and investigational medicines at American Society of Clinical Oncology (ASCO) Annual Meeting, 3rd – 7th June in Chicago

19 Roche medicines are included in more than 200 abstracts during ASCO 2016 New results for cancer immunotherapy atezolizumab in bladder cancer and other cancer types Early results for atezolizumab in combination with targeted medicines and the investigational cancer immunotherapy … Read the full press release

EU Committee for Medicinal Products for Human Use (CHMP) recommends EU approval of Roche’s Gazyvaro for people with previously treated follicular lymphoma

In the pivotal study, treatment with Gazyvaro plus bendamustine chemotherapy reduced the risk of disease worsening or death by 52 percent compared to bendamustine alone BASEL, 04-May-2016 — /EuropaWire/ — Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that the EU … Read the full press release

FDA approval for Roche’s cobas® HBV and cobas® HCV viral load tests

cobas 6800/8800 Systems offer fastest time to results and highest throughput of any molecular platform, helping to improve disease management and patient care BASEL, 19-10-2015 — /EuropaWire/ — Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that it has received … Read the full press release

Roche welcomed 100 European university students from 34 countries studying science and art to the Salzburg Festival

BASEL, 12-8-2015 — /EuropaWire/ — Today (11 August 2015), Roche welcomed 100 European university students from 34 countries studying science and art to the Salzburg Festival, the world’s largest and most prestigious festival of music and drama. The annual Roche … Read the full press release

Roche’s Perjeta recommended for approval in EU as pre-surgery breast cancer treatment

The Perjeta regimen is the first neoadjuvant (pre-surgery) breast cancer treatment recommended for approval in the EU based on the benefit in achieving pathological complete response (pCR) BASEL, 29-6-2015 — /EuropaWire/ — Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced … Read the full press release

Roche’s improved CARDIAC point-of-care Troponin T test now available for countries accepting the CE Mark

The Roche test enables healthcare professionals to identify patients with a suspected heart attack in the pre-hospital setting, helping ensure correct diagnosis and immediate, appropriate intervention. BASEL, 29-6-2015 — /EuropaWire/ — Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that … Read the full press release

Roche: New data in rheumatoid arthritis and other severe autoimmune conditions will be presented at European League Against Rheumatism Annual Congress (EULAR 2015) in Rome, 10-13 June 2015

40 data presentations across 7 autoimmune conditions, including new results from RoACTEMRA in early RA and systemic sclerosis (SSc) – a potentially fatal disease with limited treatment options¹ BASEL, 29-5-2015 — /EuropaWire/ — Roche (SIX: RO, ROG; OTCQX: RHHBY) today … Read the full press release

Roche received second Breakthrough Therapy Designation from FDA for its investigational cancer immunotherapy MPDL3280A (anti-PDL1)

Second FDA Breakthrough Therapy Designation for MPDL3280A following bladder cancer in 2014 BASEL, 3-2-2015 — /EuropaWire/ — Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that it has received a second Breakthrough Therapy Designation from the United States Food and … Read the full press release

Roche commences cash tender offer for up to 15,604,288 outstanding shares of common stock of Foundation Medicine, Inc. at a price of $50.00 per share

BASEL, 3-2-2015 — /EuropaWire/ — Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that it has commenced a cash tender offer for up to 15,604,288 outstanding shares of common stock of Foundation Medicine, Inc. (NASDAQ: FMI) at a price of … Read the full press release

Roche to acquire up to 56.3% interest in Foundation Medicine, Inc. on a fully diluted basis through a tender and acquisition of newly issued shares

BASEL, 12-1-2015 — /EuropaWire/ — Collaboration leverages both companies’ strengths to advance the progress of personalized treatments for patients with cancer Roche to acquire a majority interest in Foundation Medicine (FMI) of up to 56.3% on a fully diluted basis … Read the full press release

Roche acquired molecular diagnostics testing service provider Ariosa Diagnostics, Inc. based in San Jose, Calif.

BASEL, 3-12-2014 — /EuropaWire/ — Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced the acquisition of Ariosa Diagnostics, Inc. (Ariosa), a privately-held company based in San Jose, California, USA. Ariosa is a molecular diagnostics testing service provider that provides a … Read the full press release

Roche announced EU approved Avastin (bevacizumab) as treatment for women with recurrent ovarian cancer resistant to platinum-containing chemotherapy

First new treatment option for women in Europe in more than 15 years for most difficult to treat form of ovarian cancer BASEL, 13-8-2014 — /EuropaWire/ — Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that the European Commission (EU) approved the … Read the full press release

Roche announced the Japanese Ministry of Health, Labour and Welfare approved alectinib for the treatment of people with specific form of advanced lung cancer

Data showed that over 90 percent of Japanese people in the study responded to treatment with alectinib BASEL, 11-7-2014 — /EuropaWire/ — Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that the Japanese Ministry of Health, Labour and Welfare (MHLW) has approved … Read the full press release

Roche acquires California-based Genia Technologies

Basel, 04-6-2014 — /EuropaWire/ — Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today the acquisition of Genia Technologies, Inc. (Genia), a privately held company, based in Mountain View, California, USA. Genia is developing a single-molecule, semiconductor based, DNA sequencing platform using nanopore … Read the full press release

Roche’s cobas HPV Test for first-line primary screening test for cervical cancer gets FDA approval

Expanded indication makes cobas HPV Test the only test approved in U.S. that can be used instead of Pap in first-line primary screening in women 25 and older Basel, 29-4-2014 — /EuropaWire/ — Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that … Read the full press release

Roche subcutaneous formulation of RoACTEMRA received European Commission approval for moderate to severe rheumatoid arthritis treatment

First anti IL-6 receptor biologic now available for subcutaneous and intravenous administration for both monotherapy and combination therapy Basel, 29-4-2014 — /EuropaWire/ — Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that the subcutaneous formulation of RoACTEMRA (tocilizumab) has received approval from … Read the full press release

Roche to invest CHF 800 million to increase production capabilities for its biologic medicines

Investment to help meet rising demand for licensed biologics and expected pipeline growth Basel, Switzerland, 16-10-2013 — /EuropaWire/ — Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced plans to invest 800 million Swiss francs within its global manufacturing network to increase production … Read the full press release

Roche’s new medicine Erivedge received conditional EU approval for treatment of people with disfiguring and potentially life-threatening form of skin cancer

Erivedge is a new medicine that helps people with a disfiguring and potentially life-threatening form of skin cancer 19-7-2013 — /europawire.eu/ — Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that the European Commission has granted conditional approval to Erivedge (vismodegib) … Read the full press release

Roche launches Elecsys ProGRP test that distinguishes the two main types of lung cancer

New test expands cancer diagnostics portfolio and strengthens Roche Diagnostics’ comprehensive tumour marker menu 19-7-2013 — /europawire.eu/ — Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced the global launch (except US) of Elecsys ProGRP, a test that distinguishes between the two … Read the full press release

Roche launched two new highly sensitive therapeutic drug monitoring tests for the immunosuppressant medicines tacrolimus and cyclosporine

Tests support long-term routine management of organ transplant recipients and enhanced workflow in medical labs 19-7-2013 — /europawire.eu/ —  Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced the global launch (except US) of two new highly sensitive therapeutic drug monitoring … Read the full press release