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Latest Biotechnology, Pharmaceutical and Healthcare News from Hoffmann-La Roche Ltd

05:37 EDT 30th March 2020 | BioPortfolio

Here are the most relevant search results for "Hoffmann-La Roche Ltd" found in our extensive news archives from over 250 global news sources.

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Showing News Articles 1–25 of 346 from Hoffmann-La Roche Ltd

Friday 27th March 2020

FDA accepts Roche’s New Drug Application for Xofluza (baloxavir marboxil) for the treatment of influenza in children

Basel, 27 March  2020 - Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that the US Food and Drug Administration (FDA) has accepted a New Drug Application (NDA) as well as two supplemental New Drug Applications (sNDA) for Xofluza® (baloxavir marboxil). The FDA accepted a NDA for a new formulation of Xofluza as one-dose granules for oral suspension (2 mg/mL), potentially offering a more conven...

Wednesday 25th March 2020

Invitation to Roche’s First Quarter Sales 2020 Audio Webcast and Conference Call

Roche will publish its Sales Results for the 1st Quarter of 2020 prior to the opening of the Swiss Stock Exchange on Wednesday, April 22nd, 2020 07:00 CEST / 06:00 BST / 01:00 AM EDT / 10:00 PM PDT (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 ...

Tuesday 24th March 2020

Roche response to COVID-19 pandemic

Basel, 24 March 2020 - Roche Group (SIX: RO, ROG; OTCQX: RHHBY), today provided an update on the various actions the company is taking to address the COVID-19 pandemic. Roche initiates global phase III study and collects data on Actemra’s potential utility in severe COVID-19 pneumonia patients On March 19, 2020, Roche confirmed initiation of a randomised, double-blind, placebo-controlled Phase...

Monday 23rd March 2020

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 untr...

Thursday 19th March 2020

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 Preparedn...

Tuesday 17th March 2020

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 de...

Monday 16th March 2020

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.

Saturday 14th March 2020

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. Howeve...

Friday 13th March 2020

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...

Thursday 12th March 2020

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...

Wednesday 11th March 2020

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 provid...

Wednesday 4th March 2020

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...

Tuesday 3rd March 2020

FDA grants Breakthrough Therapy Designation for Roche’s Esbriet (pirfenidone) in unclassifiable interstitial lung disease

Basel, 3 March 2020 - Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation (BTD) to Esbriet® (pirfenidone) for adults with unclassifiable interstitial lung disease (uILD). The designation was granted based on data from a Phase II trial, which studied the efficacy and safety of Esbriet in uILD[1]. The stud...

Tuesday 25th February 2020

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 subcutaneous (SC) injection in combination with intravenous (IV) chemotherapy, f...

Friday 21st February 2020

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,

Wednesday 19th February 2020

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 advanced non-squamous and squamous non-small cell lung cancer (NSCLC) without EGFR...

Friday 14th February 2020

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 Chin...

Tuesday 11th February 2020

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 on Tuesday, February 18, 2020, highlighting Roche’s early drug development with a focus on Genentech Research and Early Development (gRED).

Monday 10th February 2020

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 Washingt...

Friday 7th February 2020

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 fr...

Thursday 6th February 2020

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 peo...

Friday 31st January 2020

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 ...

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

 

Thursday 30th January 2020

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

Monday 27th January 2020

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).


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