Roche announces FDA approval of Gavreto (pralsetinib) for people with advanced or metastatic RET-mutant and RET fusion-positive thyroid cancers
Basel, 2 December 2020 - Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that the U.S. Food and Drug Administration (FDA) has approved Gavreto ™ (pralsetinib) for the treatment of adult and paediatric patients 12 years of age and older with advanced or metastatic rearranged during transfection (RET)-mutant medullary thyroid cancer (MTC) who require systemic therapy, or with advanced or metastatic RET fusion-positive thyroid cancer who re quire systemic therapy and who are radioactive iodine-refractory (if radioactive iodine is appropriate). These indications were approved under the FDA’s accelerated approval program...
Source: Roche Media News - December 2, 2020 Category: Pharmaceuticals Source Type: news

Roche receives FDA Emergency Use Authorization for new test to measure the level of SARS-CoV-2 antibodies
Basel, 2 December 2020 - Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that its Elecsys ® Anti-SARS-CoV-2 S antibody test has received Emergency Use Authorization (EUA) from the U.S. Food and Drug Administration (FDA). The serology (blood) test can be used to measure the level of antibodies in people who have been exposed to the SARS-CoV-2 virus. The EUA in the United States follows t he launch of the Elecsys® Anti-SARS-CoV-2 S antibody test for markets accepting the CE Mark announced on 18 September. (Source: Roche Media News)
Source: Roche Media News - December 2, 2020 Category: Pharmaceuticals Source Type: news

FDA approves Xolair ® (omalizumab) for adults with nasal polyps
             Basel, 01 December 2020 - Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that the U.S. Food and Drug Administration (FDA) has approved the company ’s supplemental Biologics License Application (sBLA) for Xolair® (omalizumab) for the add-on maintenance treatment of nasal polyps in adult patients 18 years of age and older with inadequate response to nasal corticosteroids.1 Nasal polyps can lead to a loss of smell and nasal congestion, and frequently co-occur with other respiratory conditions, such as allergies and asthma. With this approval, Xolair is now the first biologic for the treatment ...
Source: Roche Media News - December 1, 2020 Category: Pharmaceuticals Source Type: news

Roche announces FDA approval of Xofluza for the prevention of influenza following contact with an infected person
             Basel, 24 November 2020 - Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that the U.S. Food and Drug Administration (FDA) has approved a supplemental New Drug Application (sNDA) for Xofluza ® (baloxavir marboxil) as a treatment to prevent influenza in people 12 years of age and older following contact with someone with influenza (known as post-exposure prophylaxis). Xofluza is the first single-dose influenza medicine approved for post-exposure prophylaxis.“With today’s approval, Xofluza is now available as the first single-dose, post-exposure preventive treatment for influenza,” said Le...
Source: Roche Media News - November 24, 2020 Category: Pharmaceuticals Source Type: news

Roche ranked the most sustainable healthcare company in the Dow Jones Sustainability Indices for the eleventh time
             Basel, 16 November 2020 - For the eleventh time, Roche (SIX: RO, ROG; OTCQX: RHHBY) has been recognised as the most sustainable company in the Pharmaceuticals index of the Dow Jones Sustainability Indices (DJSI). This is based on an in-depth analysis of economic, social and environmental performance. The DJSI family of indices serves as a benchmark for investors who integrate sustainability considerations into their portfolios. Roche has maintained its leadership through its sustainability strategy which is fully embedded in the company ’s business and culture.“We are proud of being recognised...
Source: Roche Media News - November 16, 2020 Category: Pharmaceuticals Source Type: news

CHMP recommends EU approval of Roche ’s Xofluza® (baloxavir marboxil) for the treatment of influenza
Basel, 13 November 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 recommended the approval of Xofluza® (baloxavir marboxil) for the treatment of uncomplicated influenza in patients aged 12 years and above. I n addition, Xofluza has been recommended for approval as a preventive treatment (post-exposure prophylaxis) of influenza in individuals aged 12 years and above. The CHMP recommendation is based on the results of the phase III CAPSTONE-1, CAPSTONE-2 and BLOCKSTONE studies.1,2,3 A final decision regarding ...
Source: Roche Media News - November 13, 2020 Category: Pharmaceuticals Source Type: news

CHMP recommends EU approval of Roche ’s Phesgo (fixed-dose combination of Perjeta and Herceptin for subcutaneous injection) for HER2-positive breast cancer
Basel, 13 November 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 recommended the approval of Phesgo®, a fixed-dose combination of Perjeta® (pertuzumab) and Herceptin® (trastuzumab) with hyaluronidase, adm inistered by subcutaneous (SC; under the skin) injection in combination with intravenous (IV) chemotherapy, for the treatment of early and metastatic HER2-positive breast cancer. Based on this recommendation, a final decision regarding the approval of Phesgo is expected from the European Commission in th...
Source: Roche Media News - November 13, 2020 Category: Pharmaceuticals Source Type: news

Roche to present new data across 16 blood disorders at the American Society of Hematology 2020 Annual Meeting
Basel, 5 November 2020 - Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that new data for its approved and investigational medicines will be presented at the all-virtual 62nd American Society of Hematology (ASH) Annual Meeting and Exposition from 5 – 8 December 2020. Eleven Roche medicines will be featured in more than 80 abstracts, including 22 oral presentations. With studies spanning 16 blood disorders, including non-Hodgkin lymphoma (NHL), leukaemia, multiple myeloma (MM) and haemophilia A, these data highlight the strength and breadth o f Roche’s haematology portfolio and pipeline, and commitment to developing...
Source: Roche Media News - November 5, 2020 Category: Pharmaceuticals Source Type: news

European Commission approves Roche ’s Tecentriq in combination with Avastin for the treatment of people with the most common form of liver cancer
Basel, 2 November 2020 - Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that the European Commission has approved Tecentriq ® (atezolizumab) in combination with Avastin® (bevacizumab) for the treatment of adult patients with advanced or unresectable hepatocellular carcinoma (HCC) who have not received prior systemic therapy.“Tecentriq in combination with Avastin is the first treatment to be approved in over a decade that has improved overall survival for people with previously untreated advanced or unresectable hepatocellular carcinoma,” said Levi Garraway, M.D., Ph.D., Roche’s Chief Medical Officer and Head of...
Source: Roche Media News - November 2, 2020 Category: Pharmaceuticals Source Type: news

Roche ’s Tecentriq in combination with Avastin approved in China for people with the most common form of liver cancer
             Basel, 29 October 2020 – Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that the China National Medical Products Administration (NMPA) has approved Tecentriq® (atezolizumab) in combination with Avastin® (bevacizumab) for the treatment of people with unresectable hepatocellular carcinoma (HCC) who have not received prior systemic therapy.“Today’s approval of Tecentriq in combination with Avastin for unresectable hepatocellular carcinoma means that people in China now have a cancer immunotherapy option which is changing the treatment landscape for this aggressive disease”, said Levi Ga...
Source: Roche Media News - October 29, 2020 Category: Pharmaceuticals Source Type: news

Roche announces collaboration with Atea Pharmaceuticals to develop a potential oral treatment for COVID-19 patients
Basel, 22 October 2020 - Roche (SIX: RO, ROG; OTCQX: RHHBY) and Atea Pharmaceuticals, Inc. announced today that they are joining forces in the fight against COVID-19 to develop, manufacture and distribute AT-527, Atea ’s investigational oral direct-acting antiviral, to people around the globe. AT-527 acts by blocking the viral RNA polymerase enzyme needed for viral replication, and is currently being studied in a Phase 2 clinical trial for hospitalised patients with moderate COVID-19. A Phase 3 clinical trial, expected to start in Q1 2021, will explore the potential use in patients outside of the hospital setting. In add...
Source: Roche Media News - October 22, 2020 Category: Pharmaceuticals Source Type: news

Roche announces full FDA approval for Venclexta combinations for acute myeloid leukaemia
             Basel, 19 October 2020 - Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that the US Food and Drug Administration (FDA) has granted full approval of Venclexta® (venetoclax) in combination with azacitidine, or decitabine, or low-dose cytarabine (LDAC) for the treatment of newly diagnosed acute myeloid leukaemia (AML) in adults 75 years or older, or who have comorbidities that preclude use of intensive induction chemotherapy. Venclexta was previously granted provisional approval in this setting under the FDA ’s accelerated approval programme in November 2018. Today’s FDA approval converts Ve...
Source: Roche Media News - October 19, 2020 Category: Pharmaceuticals Source Type: news

First nine months of the year with 1% sales growth at constant exchange rates, significant impact of COVID-19 pandemic
Group sales increase 1% at constant exchange rates and decline 5% in Swiss francs as a result of continued appreciation of the Swiss franc against most currencies (Source: Roche Media News)
Source: Roche Media News - October 15, 2020 Category: Pharmaceuticals Source Type: news

Roche to launch laboratory SARS-CoV-2 antigen test to support high-volume testing of suspected COVID-19 patients
Roche announced today that it intends to launch a high-volume SARS-CoV-2 Antigen test as an aid in the diagnosis of Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) infection. (Source: Roche Media News)
Source: Roche Media News - October 13, 2020 Category: Pharmaceuticals Source Type: news

Roche presents new 2-year data for Evrysdi (risdiplam) in infants with Type 1 spinal muscular atrophy (SMA)
Basel, 28 September 2020 - Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced new 2-year data from Part 1 of the pivotal FIREFISH study of Evrysdi ™ (risdiplam) in infants aged 2-7 months with symptomatic Type 1 spinal muscular atrophy (SMA). The 2-year results in infants treated with the therapeutic dose of Evrysdi (17/21) showed that they continued to improve and achieve motor milestones. This exploratory analysis showed that an estimated 88% of infants were alive and required no permanent ventilation at two years. In addition, at two years, 59% (10/17 vs. 7/17 at 1-year) of infants were able to sit without support for...
Source: Roche Media News - September 28, 2020 Category: Pharmaceuticals Source Type: news