Pharmacology - Aug 16
FDA approves Roche’s RozlytrekTM (entrectinib) for people with ROS1- positive, metastatic non- small cell lung cancer and NTRK gene fusion- positive solid tumours
FDA approves Roche’s RozlytrekTM (entrectinib) for people with ROS1- positive, metastatic non- small cell lung cancer and NTRK gene fusion- positive solid tumours
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Treating muscular disease - Santhera and Biozentrum join forces
Santhera Pharmaceuticals and the University of Basel's Biozentrum announce their collaboration to advance gene therapy research for the treatment of congenital muscular dystrophy.
Pharmacology - Health - 16.05.2019
Health - Pharmacology - 16.05.2019
Pharmacology
Results 1 - 50 of 1237.
FDA approves Roche’s RozlytrekTM (entrectinib) for people with ROS1-positive, metastatic non-small cell lung cancer and NTRK gene fusion-positive solid tumours
First FDA-approved treatment designed to target both ROS1 and NTRK that also shows response in cancer that has spread to the brain Roche's first FDA-approved tumour-agnostic medicine Roche today announced that the US Food and Drug Administration (FDA) has approved Rozlytrek?
First FDA-approved treatment designed to target both ROS1 and NTRK that also shows response in cancer that has spread to the brain Roche's first FDA-approved tumour-agnostic medicine Roche today announced that the US Food and Drug Administration (FDA) has approved Rozlytrek?
Novartis stands behind Zolgensma (onasemnogene abeparvovec-xioi) for the treatment of children less than 2 years of age with spinal muscular atrophy
Basel, August 6, 2019 - Today the FDA released a statement addressing data integrity issues with the Biologics License Application (BLA) for Zolgensma (onasemnogene abeparvovec-xioi). First and foremost, we are fully confident in the safety, quality and efficacy of Zolgensma. The FDA supports the continued marketing and use of Zolgensma for patients with spinal muscular atrophy (SMA) less than 2 years of age.
Basel, August 6, 2019 - Today the FDA released a statement addressing data integrity issues with the Biologics License Application (BLA) for Zolgensma (onasemnogene abeparvovec-xioi). First and foremost, we are fully confident in the safety, quality and efficacy of Zolgensma. The FDA supports the continued marketing and use of Zolgensma for patients with spinal muscular atrophy (SMA) less than 2 years of age.
Roche’s Tecentriq plus platinum-based chemotherapy reduced the risk of disease worsening or death in people with previously untreated advanced bladder cancer
IMvigor130 is the first positive Phase III study of a cancer immunotherapy combination in previously untreated advanced bladder cancer Data will be shared with health authorities globally, including
IMvigor130 is the first positive Phase III study of a cancer immunotherapy combination in previously untreated advanced bladder cancer Data will be shared with health authorities globally, including
Roche and Spark Therapeutics, Inc. announce extension of tender offer for shares of Spark Therapeutics, Inc
Roche and Spark Therapeutics, Inc.
Roche and Spark Therapeutics, Inc.
Novartis receives positive CHMP opinion for Lucentis treatment
Lucentis (ranibizumab), if approved in the EU for this indication, will be the first and only pharmacological therapy for ROP in these vulnerable infants Positive opinion is based on the landmark Pha
Lucentis (ranibizumab), if approved in the EU for this indication, will be the first and only pharmacological therapy for ROP in these vulnerable infants Positive opinion is based on the landmark Pha
CHMP recommends EU approval of Roche’s Tecentriq in combination with chemotherapy
Decision based on results from first Phase III study to show a cancer immunotherapy-based combination significantly improved overall survival (OS) and progression-free survival (PFS) in over 20 years
Decision based on results from first Phase III study to show a cancer immunotherapy-based combination significantly improved overall survival (OS) and progression-free survival (PFS) in over 20 years
FDA accepts file and accelerates review of Novartis sickle cell disease medicine crizanlizumab (SEG101)
FDA grants crizanlizumab Priority Review based on Phase II data showing prevention of vaso-occlusive crises (VOCs) in patients with sickle cell disease, shortening FDA review to six months from stand
FDA grants crizanlizumab Priority Review based on Phase II data showing prevention of vaso-occlusive crises (VOCs) in patients with sickle cell disease, shortening FDA review to six months from stand
Roche presents a broad range of data for Hemlibra demonstrating continued benefits for people with haemophilia A at the ISTH 2019 Congress
New analyses from phase III HAVEN studies support Hemlibra's sustained efficacy, safety and quality of life benefit in people with haemophilia A, with and without factor VIII inhibitors First data of
New analyses from phase III HAVEN studies support Hemlibra's sustained efficacy, safety and quality of life benefit in people with haemophilia A, with and without factor VIII inhibitors First data of
CHMP recommends EU approval of Tecentriq for people with breast cancer
Recommendation based on the results of IMpassion130 study in triple-negative breast cancer, an aggressive type of breast cancer with high unmet medical need First positive Phase III cancer immunother
Recommendation based on the results of IMpassion130 study in triple-negative breast cancer, an aggressive type of breast cancer with high unmet medical need First positive Phase III cancer immunother
Japan becomes the first country to approve Roche’s personalised medicine Rozlytrek
First tumour-agnostic medicine approved in Japan for adult and paediatric patients with NTRK fusion-positive advanced recurrent solid tumours Approval supported by the data mainly from the pivotal Ph
First tumour-agnostic medicine approved in Japan for adult and paediatric patients with NTRK fusion-positive advanced recurrent solid tumours Approval supported by the data mainly from the pivotal Ph
New analysis of Novartis data confirms that Cosentyx demonstrates durable comprehensive treatment across psoriatic disease
For the first time efficacy and safety data from dedicated phase III trials are analyzed together in one abstract, backing Cosentyx as comprehensive treatment across multiple manifestations of psoria
For the first time efficacy and safety data from dedicated phase III trials are analyzed together in one abstract, backing Cosentyx as comprehensive treatment across multiple manifestations of psoria
New Sandoz biosimilar adalimumab data confirms switching from reference biologic has no impact on safety or efficacy
Data show switching to Hyrimoz (biosimilar adalimumab) from the reference medicine provides sustained efficacy with no new safety concerns in patients with moderate-to-severe rheumatoid arthritis A
Data show switching to Hyrimoz (biosimilar adalimumab) from the reference medicine provides sustained efficacy with no new safety concerns in patients with moderate-to-severe rheumatoid arthritis A
Novartis continues to innovate in CML with long-term treatment-free remission results following Tasigna use and promising combination data with investigational compound asciminib (ABL001)
Results from two Phase II trials, ENESTfreedom and ENESTop, support and extend previous findings of long-term durability of molecular response after stopping Tasigna, reducing time on drug for many C
Results from two Phase II trials, ENESTfreedom and ENESTop, support and extend previous findings of long-term durability of molecular response after stopping Tasigna, reducing time on drug for many C
Novartis Cosentyx first to show efficacy in all key manifestations of psoriatic arthritis
First-of-its-kind data shows efficacy and safety of a biologic in the management of axial manifestations of psoriatic arthritis (PsA), which affect up to an estimated 35 million people worldwide 66
First-of-its-kind data shows efficacy and safety of a biologic in the management of axial manifestations of psoriatic arthritis (PsA), which affect up to an estimated 35 million people worldwide 66
Cosentyx provides long-lasting inhibition of radiographic progression in psoriatic arthritis, new Novartis data show
Almost 90% of patients had no radiographic progression of psoriatic arthritis (PsA) at 2 years with Cosentyx (secukinumab) 300mg Data at 2 years demonstrate over 50% of adults with active PsA achie
Almost 90% of patients had no radiographic progression of psoriatic arthritis (PsA) at 2 years with Cosentyx (secukinumab) 300mg Data at 2 years demonstrate over 50% of adults with active PsA achie
FDA grants Roche’s Polivy accelerated approval for people with previously treated aggressive lymphoma
New targeted medicine shown to improve clinical outcomes in people with relapsed or refractory diffuse large B-cell lymphoma compared to a commonly used regimen First-in-class antibody-drug conjugate that specifically targets CD79b, a protein expressed in the majority of B-cells Ninth indication with Breakthrough Therapy Designation in Roche's haematology portfolio to receive FDA approval Roche today announced that the US Food and Drug Administration (FDA) has granted accelerated approval to Polivy?
New targeted medicine shown to improve clinical outcomes in people with relapsed or refractory diffuse large B-cell lymphoma compared to a commonly used regimen First-in-class antibody-drug conjugate that specifically targets CD79b, a protein expressed in the majority of B-cells Ninth indication with Breakthrough Therapy Designation in Roche's haematology portfolio to receive FDA approval Roche today announced that the US Food and Drug Administration (FDA) has granted accelerated approval to Polivy?
Advanced Accelerator Applications Receives Positive CHMP Opinion for LysaKare
Advanced Accelerator Applications Receives Positive CHMP Opinion for LysaKare for Reduction of Kidney Exposure to Radiation During Peptide Receptor Radionuclide Therapy with Lutetium ( 177 Lu) Oxodot
Advanced Accelerator Applications Receives Positive CHMP Opinion for LysaKare for Reduction of Kidney Exposure to Radiation During Peptide Receptor Radionuclide Therapy with Lutetium ( 177 Lu) Oxodot
Long-term survival benefit shown for metastatic melanoma patients treated with Novartis Tafinlar + Mekinist
Five-year Tafinlar + Mekinist survival data presented at the 2019 American Society of Clinical Oncology (ASCO) Annual Meeting and published simultaneously in The New England Journal of Medicine Results are from the largest dataset and longest follow-up of more than 500 patients with BRAF-mutated metastatic melanoma, a genetic mutation common for this aggressive skin cancer Additional Novartis melanoma research presented at ASCO includes effi
Five-year Tafinlar + Mekinist survival data presented at the 2019 American Society of Clinical Oncology (ASCO) Annual Meeting and published simultaneously in The New England Journal of Medicine Results are from the largest dataset and longest follow-up of more than 500 patients with BRAF-mutated metastatic melanoma, a genetic mutation common for this aggressive skin cancer Additional Novartis melanoma research presented at ASCO includes effi
Pivotal phase III CLL14 results for Venclexta/Venclyxto in combination with Gazyva/Gazyvaro for chronic lymphocytic leukaemia presented at ASCO 2019 and published in the New England Journal of Medicine
Venclexta/Venclyxto plus Gazyva/Gazyvaro showed improvements across multiple efficacy measures compared to Gazyva/Gazyvaro plus chlorambucil, including progression-free survival and deep remissions a
Venclexta/Venclyxto plus Gazyva/Gazyvaro showed improvements across multiple efficacy measures compared to Gazyva/Gazyvaro plus chlorambucil, including progression-free survival and deep remissions a
Roche presents data from across its breast cancer portfolio at the 2019 American Society of Clinical Oncology (ASCO) Annual Meeting
Roche data from 17 breast cancer abstracts presented at this year's meeting An overall survival improvement was observed with Tecentriq and nab-paclitaxel in PD-L1-positive metastatic triple-negative
Roche data from 17 breast cancer abstracts presented at this year's meeting An overall survival improvement was observed with Tecentriq and nab-paclitaxel in PD-L1-positive metastatic triple-negative
Xolair (omalizumab) significantly reduced nasal polyps and congestion symptoms in adults with chronic rhinosinusitis with nasal polyps in two phase III studies
In the phase III POLYP 1 and POLYP 2 studies, omalizumab met both co-primary endpoints and key secondary endpoints in adults with chronic rhinosinusitis with nasal polyps (CRSwNP) with inadequate res
In the phase III POLYP 1 and POLYP 2 studies, omalizumab met both co-primary endpoints and key secondary endpoints in adults with chronic rhinosinusitis with nasal polyps (CRSwNP) with inadequate res
Novartis Shows Growing Strength in Lung Cancer Innovation with New Capmatinib Investigational Data and Novel Canakinumab Clinical Trials
Primary analysis of investigational capmatinib (INC280) in the GEOMETRY mono-1 study demonstrates promising efficacy in patients with locally advanced or metastatic non-small cell lung cancer (NSCLC)
Primary analysis of investigational capmatinib (INC280) in the GEOMETRY mono-1 study demonstrates promising efficacy in patients with locally advanced or metastatic non-small cell lung cancer (NSCLC)
Roche’s Tecentriq in combination with Avastin and chemotherapy for the initial treatment of people with a specific type of metastatic lung cancer shows positive data in those with liver metastases
Data will be presented at the American Society of Clinical Oncology (ASCO) annual meeting on 2 June 2019 Roche today announced positive additional results of a prespecified exploratory analysis from
Data will be presented at the American Society of Clinical Oncology (ASCO) annual meeting on 2 June 2019 Roche today announced positive additional results of a prespecified exploratory analysis from
Novartis Kisqali significantly extends life in women with HR+/HER2- advanced breast cancer in MONALEESA-7 trial
Kisqali is the only CDK4/6 inhibitor to show superior overall survival in advanced breast cancer (HR=0.712; p=0.00973) After a median of 42 months follow-up, the survival rate was 70&pe
Kisqali is the only CDK4/6 inhibitor to show superior overall survival in advanced breast cancer (HR=0.712; p=0.00973) After a median of 42 months follow-up, the survival rate was 70&pe
Novartis’ phase III QUARTZ study of new investigational inhaled combination treatment QMF149 meets primary and key secondary endpoints in patients with inadequately controlled asthma
Low dose QMF149 (indacaterol acetate and mometasone furoate) demonstrated both statistically significant and clinically meaningful improvements in lung function and asthma control compared to inhaled
Low dose QMF149 (indacaterol acetate and mometasone furoate) demonstrated both statistically significant and clinically meaningful improvements in lung function and asthma control compared to inhaled
FDA approves Novartis Piqray - the first and only treatment specifically for patients with a PIK3CA mutation in HR+/HER2- advanced breast cancer
Piqray (alpelisib, formerly BYL719) plus fulvestrant nearly doubled median PFS (11.0 vs 5.7 months) in HR+/HER2- advanced breast cancer patients with a PIK3CA mutation compared to fulve
Piqray (alpelisib, formerly BYL719) plus fulvestrant nearly doubled median PFS (11.0 vs 5.7 months) in HR+/HER2- advanced breast cancer patients with a PIK3CA mutation compared to fulve
AveXis Announces Innovative Zolgensma Gene Therapy Access Programs for US Payers and Families
One-time treatment with Zolgensma (onasemnogene abeparvovec-xioi) is designed to replace lifetime of chronic therapy for all pediatric patients with SMA Annualized cost of Zolgensma is USD 425,000
One-time treatment with Zolgensma (onasemnogene abeparvovec-xioi) is designed to replace lifetime of chronic therapy for all pediatric patients with SMA Annualized cost of Zolgensma is USD 425,000
AveXis receives FDA approval for Zolgensma , the first and only gene therapy for pediatric patients with spinal muscular atrophy (SMA)
SMA is a rare genetic disease that leads to progressive muscle weakness, paralysis and, when left untreated in its most severe form, permanent ventilation or death for most patients by age 2 , Zolg
SMA is a rare genetic disease that leads to progressive muscle weakness, paralysis and, when left untreated in its most severe form, permanent ventilation or death for most patients by age 2 , Zolg
Novartis phase II data for new inhaled combination treatment (QVM149) demonstrates significant improvements over current standard-of-care inhaled treatment
New inhaled combination for asthma treatment (indacaterol acetate, glycopyrronium bromide and mometasone furoate - IND/GLY/MF) was superior to the standard of care (long-acting beta-agonist/inhaled c
New inhaled combination for asthma treatment (indacaterol acetate, glycopyrronium bromide and mometasone furoate - IND/GLY/MF) was superior to the standard of care (long-acting beta-agonist/inhaled c
Bern Center for Precision Medicine inaugurated
The Bern Center for Precision Medicine (BCPM) of the University of Bern and Inselspital, University hospital of Bern, were officially opened today in the presence of Director of Education Christine Häsler.
The Bern Center for Precision Medicine (BCPM) of the University of Bern and Inselspital, University hospital of Bern, were officially opened today in the presence of Director of Education Christine Häsler.
Santhera Pharmaceuticals and the University of Basel's Biozentrum announce their collaboration to advance gene therapy research for the treatment of congenital muscular dystrophy.
Novartis data at ASCO and EHA demonstrate novel approaches to reimagining medicine in cancer and serious blood disorders
Overall survival results from MONALEESA-7 with Kisqali (ribociclib)* plus endocrine therapy in premenopausal women with HR+/HER2- advanced breast cancer, to be presented at ASCO Primary results of
Overall survival results from MONALEESA-7 with Kisqali (ribociclib)* plus endocrine therapy in premenopausal women with HR+/HER2- advanced breast cancer, to be presented at ASCO Primary results of
Roche’s personalised medicine entrectinib shrank tumours harbouring NTRK, ROS1 or ALK gene fusions in children and adolescents
Phase I/II study of entrectinib, an investigational medicine, showed responses in all paediatric tumour types harbouring neurotrophic tyrosine receptor kinase (NTRK), ROS1 or anaplastic lymphoma kina
Phase I/II study of entrectinib, an investigational medicine, showed responses in all paediatric tumour types harbouring neurotrophic tyrosine receptor kinase (NTRK), ROS1 or anaplastic lymphoma kina
Pharmacology - Aug 16
FDA approves Roche’s RozlytrekTM (entrectinib) for people with ROS1- positive, metastatic non- small cell lung cancer and NTRK gene fusion- positive solid tumours
FDA approves Roche’s RozlytrekTM (entrectinib) for people with ROS1- positive, metastatic non- small cell lung cancer and NTRK gene fusion- positive solid tumours