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Fexinidazole - First All-Oral Treatment for Sleeping Sickness Approved
The European Medicines Agency's Committee for Medicinal Products for Human Use has adopted a positive opinion of fexinidazole, the first all-oral treatment that has been shown to be efficacious for both stages of sleeping sickness.
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Pharmacology
Results 1 - 50 of 93.
FDA grants priority review to Roche’s polatuzumab vedotin in previously treated aggressive lymphoma
Diffuse large B-cell lymphoma is an aggressive type of blood cancer that typically becomes harder to treat each time it returns Polatuzumab vedotin has shown significant potential to improve outcomes
Diffuse large B-cell lymphoma is an aggressive type of blood cancer that typically becomes harder to treat each time it returns Polatuzumab vedotin has shown significant potential to improve outcomes
FDA grants Priority Review to Roche’s personalised medicine entrectinib
Roche today announced that the US Food and Drug Administration (FDA) has accepted the company's New Drug Applications (NDAs) and granted Priority Review for entrectinib for the treatment of adult and
Roche today announced that the US Food and Drug Administration (FDA) has accepted the company's New Drug Applications (NDAs) and granted Priority Review for entrectinib for the treatment of adult and
Novartis receives FDA approval for Egaten for the treatment of fascioliasis, a neglected tropical disease
Egaten is the only drug approved in the US for the treatment of people with fascioliasis and is currently the only treatment recommended by the WHO Fascioliasis, commonly known as liver fluke infes
Egaten is the only drug approved in the US for the treatment of people with fascioliasis and is currently the only treatment recommended by the WHO Fascioliasis, commonly known as liver fluke infes
Roche submits supplemental biologics license application to the US FDA for Kadcyla for adjuvant treatment of people with HER2-positive early breast cancer with residual disease after neoadjuvant treatment
Roche's application is being reviewed under the US FDA's Real-Time Oncology Review and Assessment Aid pilot programmes Kadcyla was granted Breakthrough Therapy Designation for this application Ro
Roche's application is being reviewed under the US FDA's Real-Time Oncology Review and Assessment Aid pilot programmes Kadcyla was granted Breakthrough Therapy Designation for this application Ro
CHMP recommends EU approval of Roche’s Tecentriq in combination with Avastin and chemotherapy as an initial treatment for lung cancer
Recommendation based on the Phase III IMpower150 study which showed that Tecentriq (atezolizumab) in combination with Avastin (bevacizumab) and chemotherapy (paclitaxel and carboplatin) helped people
Recommendation based on the Phase III IMpower150 study which showed that Tecentriq (atezolizumab) in combination with Avastin (bevacizumab) and chemotherapy (paclitaxel and carboplatin) helped people
CHMP recommends EU approval of Roche’s Hemlibra for people with severe haemophilia A without factor VIII inhibitors
First medicine to significantly reduce treated bleeds compared to prior factor VIII prophylaxis in a prospective intra-patient comparison First new class of medicine in nearly 20 years for people wit
First medicine to significantly reduce treated bleeds compared to prior factor VIII prophylaxis in a prospective intra-patient comparison First new class of medicine in nearly 20 years for people wit
Roche to discontinue Phase III CREAD 1 and 2 clinical studies of crenezumab in early Alzheimer’s disease (AD) - other company programmes in AD continue
At three years, 88.3% of people treated with Kadcyla in the adjuvant HER2-positive early breast cancer setting did not have their breast cancer return compared to 77.0% treated with Her
At three years, 88.3% of people treated with Kadcyla in the adjuvant HER2-positive early breast cancer setting did not have their breast cancer return compared to 77.0% treated with Her
FDA accepts Roche’s supplemental biologics license application for Tecentriq plus chemotherapy (Abraxane and carboplatin) for the initial treatment of metastatic non-squamous non-small cell lung cancer
Roche today announced that the US Food and Drug Administration (FDA) has accepted the company's supplemental Biologics License Application (sBLA) for Tecentriq (atezolizumab) in combination with Abra
Roche today announced that the US Food and Drug Administration (FDA) has accepted the company's supplemental Biologics License Application (sBLA) for Tecentriq (atezolizumab) in combination with Abra
Novartis investigational therapy crizanlizumab (SEG101) receives FDA Breakthrough Therapy designation for the prevention of vaso-occlusive crises in sickle cell disease
Crizanlizumab is a monthly infusion under development to prevent pain crises (also called vaso-occlusive crises, or VOCs) in patients with sickle cell disease Sickle cell VOCs, which are triggered
Crizanlizumab is a monthly infusion under development to prevent pain crises (also called vaso-occlusive crises, or VOCs) in patients with sickle cell disease Sickle cell VOCs, which are triggered
Sandoz and Pear Therapeutics Announce US Launch of reSET-OTM to Help Treat Opioid Use Disorder
ReSET-O(TM)* is the first US FDA-cleared prescription digital therapeutic for patients with Opioid Use Disorder Cleared by the FDA in December, reSET-O is available immediately As part of a broader f
ReSET-O(TM)* is the first US FDA-cleared prescription digital therapeutic for patients with Opioid Use Disorder Cleared by the FDA in December, reSET-O is available immediately As part of a broader f
Novartis receives European Commission (EC) approval for expanded indication for Kisqali (ribociclib)
Basel, December 21, 2018 - Novartis today announced that the European Commission (EC) approved an expanded indication for Kisqali (ribociclib), the CDK4/6 inhibitor with the largest body of first-li
Basel, December 21, 2018 - Novartis today announced that the European Commission (EC) approved an expanded indication for Kisqali (ribociclib), the CDK4/6 inhibitor with the largest body of first-li
Novartis announces offer to acquire CellforCure to expand manufacturing capacity for innovative cell and gene therapies
Proposed acquisition builds on existing agreement with CellforCure for contract manufacturing of Novartis leading CAR-T cell therapy Kymriah (tisagenlecleucel) and recent successful completion of tec
Proposed acquisition builds on existing agreement with CellforCure for contract manufacturing of Novartis leading CAR-T cell therapy Kymriah (tisagenlecleucel) and recent successful completion of tec
PRIME designation granted by European Medicines Agency for Roche’s risdiplam for treatment of spinal muscular atrophy (SMA)
PRIME designation granted by European Medicines Agency for Roche's risdiplam for treatment of spinal muscular atrophy (SMA) Risdiplam has the potential to be the first oral medicine for the treatment
PRIME designation granted by European Medicines Agency for Roche's risdiplam for treatment of spinal muscular atrophy (SMA) Risdiplam has the potential to be the first oral medicine for the treatment
Novartis receives European Commission approval for self-administration of Xolair across all indications
The EC approval underscores the long-term safety and efficacy of Xolair demonstrated in clinical studies and by 13 years of real-world use in Europe Xolair (omalizumab) prefilled syringe (PFS) is t
The EC approval underscores the long-term safety and efficacy of Xolair demonstrated in clinical studies and by 13 years of real-world use in Europe Xolair (omalizumab) prefilled syringe (PFS) is t
Sandoz Inc. and Pear Therapeutics Obtain FDA Clearance for reSET-O(TM) to Treat Opioid Use Disorder
ReSET-O TM is the first FDA-cleared Prescription Digital Therapeutic (PDT) for patients with Opioid Use Disorder Pear Therapeutics is leading the development of a new therapeutic class with two FDA-a
ReSET-O TM is the first FDA-cleared Prescription Digital Therapeutic (PDT) for patients with Opioid Use Disorder Pear Therapeutics is leading the development of a new therapeutic class with two FDA-a
Novartis data demonstrates consistent efficacy and tolerability of Kisqali combination therapy in HR+/HER2- advanced breast cancer in patients with difficult-to-treat visceral disease
Subgroup analyses of three pivotal Phase III MONALEESA trials showed Kisqali plus endocrine therapy extended PFS in all patients with and without visceral involvement compared to endocrine therapy
Subgroup analyses of three pivotal Phase III MONALEESA trials showed Kisqali plus endocrine therapy extended PFS in all patients with and without visceral involvement compared to endocrine therapy
FDA approves Roche’s Tecentriq in combination with Avastin and chemotherapy for the initial treatment of people with a specific type of metastatic lung cancer
Approval based on survival benefit of Tecentriq in combination with Avastin, paclitaxel and carboplatin (chemotherapy) in people with metastatic non-squamous non-small cell lung cancer (NSCLC) with n
Approval based on survival benefit of Tecentriq in combination with Avastin, paclitaxel and carboplatin (chemotherapy) in people with metastatic non-squamous non-small cell lung cancer (NSCLC) with n
Roche’s Kadcyla cut the risk of disease recurring by half compared to Herceptin in people with HER2-positive early breast cancer with residual disease after neoadjuvant treatment
At three years, 88.3% of people treated with Kadcyla in the adjuvant HER2-positive early breast cancer setting did not have their breast cancer return compared to 77.0% treated with Her
At three years, 88.3% of people treated with Kadcyla in the adjuvant HER2-positive early breast cancer setting did not have their breast cancer return compared to 77.0% treated with Her
FDA grants priority review to Roche’s Tecentriq in combination with chemotherapy for the initial treatment of extensive-stage small cell lung cancer
Roche 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 (atezolizum
Roche 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 (atezolizum
Novartis advances ligelizumab (QGE031) in urticaria to Phase III on basis of strong Phase II head-to-head data
PEARL 1 and PEARL 2, the largest pivotal trials to date in chronic spontaneous urticaria (CSU), will enroll more than 2,000 CSU patients , Ligelizumab (QGE031), a monoclonal antibody, is being deve
PEARL 1 and PEARL 2, the largest pivotal trials to date in chronic spontaneous urticaria (CSU), will enroll more than 2,000 CSU patients , Ligelizumab (QGE031), a monoclonal antibody, is being deve
New Venclexta/Venclyxto data demonstrate deep responses in two of the most common types of leukaemia
New analyses from the phase III MURANO study in previously treated chronic lymphocytic leukaemia show continued benefit from fixed-duration regimen after a median follow-up of three years Updated res
New analyses from the phase III MURANO study in previously treated chronic lymphocytic leukaemia show continued benefit from fixed-duration regimen after a median follow-up of three years Updated res
Roche’s Hemlibra provided sustained bleed control in the largest pivotal study to date of children with haemophilia A with factor VIII inhibitors
Nearly 77% of children receiving Hemlibra once weekly experienced zero treated bleeds Hemlibra once weekly reduced treated bleeds by 99% compared to prior bypassing agents in a prospective intra-pati
Nearly 77% of children receiving Hemlibra once weekly experienced zero treated bleeds Hemlibra once weekly reduced treated bleeds by 99% compared to prior bypassing agents in a prospective intra-pati
Longer-term follow-up data demonstrate sustained benefit of polatuzumab vedotin-based treatment in relapsed or refractory diffuse large B-cell lymphoma
Polatuzumab vedotin in combination with MabThera/Rituxan (rituximab) plus bendamustine more than doubled overall survival, compared to MabThera/Rituxan plus bendamustine alone in the phase Ib/II GO29365 study Polatuzumab vedotin has the potential to provide a promising new treatment option at first relapse Results from the GO29365 study, the first and only randomised study to suggest a survival benefit for patients not eligible for a haematopoie
Polatuzumab vedotin in combination with MabThera/Rituxan (rituximab) plus bendamustine more than doubled overall survival, compared to MabThera/Rituxan plus bendamustine alone in the phase Ib/II GO29365 study Polatuzumab vedotin has the potential to provide a promising new treatment option at first relapse Results from the GO29365 study, the first and only randomised study to suggest a survival benefit for patients not eligible for a haematopoie
Novartis announces FDA filing acceptance and Priority Review of AVXS-101, a one-time treatment designed to address the genetic root cause of SMA Type 1
The AVXS-101, now known as ZOLGENSMA (onasemnogene abeparvovec-xxxx) , filing is supported by data from the START trial which demonstrated a dramatic increase in survival and transformative improvement in achievement of developmental milestones compared to the natural history of SMA Type 1 SMA Type 1 is a progressive neuromuscular disease and the leading cause of genetic mortality in infants globally ZOLGENSMA represents the first in a propr
The AVXS-101, now known as ZOLGENSMA (onasemnogene abeparvovec-xxxx) , filing is supported by data from the START trial which demonstrated a dramatic increase in survival and transformative improvement in achievement of developmental milestones compared to the natural history of SMA Type 1 SMA Type 1 is a progressive neuromuscular disease and the leading cause of genetic mortality in infants globally ZOLGENSMA represents the first in a propr
Real-world data show Novartis drug Revolade improves outcomes for ITP patients compared to other second-line therapies
Revolade (eltrombopag) showed lower rate of bleeding-related episodes and similar rate of thrombotic events vs.
Revolade (eltrombopag) showed lower rate of bleeding-related episodes and similar rate of thrombotic events vs.
Novartis announces longer-term analyses from pivotal Kymriah trials that showed durable responses are maintained in patients with advanced blood cancers
In the updated analysis from ELIANA, Kymriah demonstrated an 82% remission rate within 3 months in pediatric patients with r/r ALL; relapse-free survival was 62% at 24 months, with median duration of
In the updated analysis from ELIANA, Kymriah demonstrated an 82% remission rate within 3 months in pediatric patients with r/r ALL; relapse-free survival was 62% at 24 months, with median duration of
Novartis announces new crizanlizumab (SEG101) data analysis in sickle cell disease, and investment in SENTRY clinical program
New post-hoc analysis of SUSTAIN study, presented at ASH 2018, highlights results among patients who were treated per protocol compared with all randomized patients Crizanlizumab, a monthly infusion
New post-hoc analysis of SUSTAIN study, presented at ASH 2018, highlights results among patients who were treated per protocol compared with all randomized patients Crizanlizumab, a monthly infusion
Novartis announces EU approval of Gilenya for children and adolescents with MS, making it the first and only oral disease-modifying treatment for these patients in Europe
Approval based on landmark PARADIGMS study showing Gilenya (fingolimod) significantly reduced relapse rates by 82% vs interferon beta-1a; additionally, 85.7% of Gilenya patients were relapse-f
Approval based on landmark PARADIGMS study showing Gilenya (fingolimod) significantly reduced relapse rates by 82% vs interferon beta-1a; additionally, 85.7% of Gilenya patients were relapse-f
Novartis announces landmark EU approval for one-time gene therapy Luxturna to restore vision in people with rare inherited retinal disease
Luxturna* (voretigene neparvovec) is the first gene therapy to treat an inherited retinal disease, indicated for children and adults with vision loss caused by mutations in both copies of the RPE65 g
Luxturna* (voretigene neparvovec) is the first gene therapy to treat an inherited retinal disease, indicated for children and adults with vision loss caused by mutations in both copies of the RPE65 g
Sandoz and Pear Therapeutics announce launch of reSET for treatment of patients with Substance Use Disorder
ReSET is the first and only FDA-authorized prescription digital therapeutic for Substance Use Disorder (SUD) Adding reSET to outpatient therapy significantly improved abstinence in substances of abus
ReSET is the first and only FDA-authorized prescription digital therapeutic for Substance Use Disorder (SUD) Adding reSET to outpatient therapy significantly improved abstinence in substances of abus
The European Medicines Agency's Committee for Medicinal Products for Human Use has adopted a positive opinion of fexinidazole, the first all-oral treatment that has been shown to be efficacious for both stages of sleeping sickness.
FDA approves Novartis drug Promacta for first-line SAA and grants Breakthrough Therapy designation for additional new indication
Promacta receives FDA approval for first-line treatment of severe aplastic anemia (SAA) and Breakthrough Therapy designation for low platelet counts in people exposed to radiation Approval based on compelling benefit established through complete response rates among SAA patients when Promacta is added to standard immunosuppressive therapy relative to historic information on that therapy alone Promacta is the first new treatment in decades fo
Promacta receives FDA approval for first-line treatment of severe aplastic anemia (SAA) and Breakthrough Therapy designation for low platelet counts in people exposed to radiation Approval based on compelling benefit established through complete response rates among SAA patients when Promacta is added to standard immunosuppressive therapy relative to historic information on that therapy alone Promacta is the first new treatment in decades fo
Novartis receives positive CHMP opinion to expand Kisqali combination therapy to all women with HR+/HER2- locally advanced or metastatic breast cancer
Novartis receives positive CHMP opinion to expand Kisqali combination therapy to all women with HR+/HER2- locally advanced or metastatic breast cancer Kisqali is the CDK4/6 inhibitor with the largest body of first-line evidence demonstrating consistent, superior and sustained efficacy vs.
Novartis receives positive CHMP opinion to expand Kisqali combination therapy to all women with HR+/HER2- locally advanced or metastatic breast cancer Kisqali is the CDK4/6 inhibitor with the largest body of first-line evidence demonstrating consistent, superior and sustained efficacy vs.
FDA grants priority review to Roche’s Tecentriq in combination with Abraxane for the initial treatment of people with PD-L1-positive, metastatic triple-negative breast cancer
Triple-negative breast cancer is an aggressive disease, with high unmet medical need If approved, this Tecentriq (atezolizumab) combination would be the first cancer immunotherapy regimen for the treatment of PD-L1-positive, metastatic triple-negative breast cancer Roche today announced the US Food and Drug Administration (FDA) has accepted the company's supplemental Biologics License Application (sBLA) and granted Priority Review for Tecentriq
Triple-negative breast cancer is an aggressive disease, with high unmet medical need If approved, this Tecentriq (atezolizumab) combination would be the first cancer immunotherapy regimen for the treatment of PD-L1-positive, metastatic triple-negative breast cancer Roche today announced the US Food and Drug Administration (FDA) has accepted the company's supplemental Biologics License Application (sBLA) and granted Priority Review for Tecentriq
New Novartis study supports Entresto as foundational HFrEF therapy and in-hospital initiation in appropriate stabilized heart failure patients
Entresto (sacubitril/valsartan) outperformed commonly used heart failure medicine enalapril in landmark study; delivered significantly greater and more rapid reductions in an established biomarker fo
Entresto (sacubitril/valsartan) outperformed commonly used heart failure medicine enalapril in landmark study; delivered significantly greater and more rapid reductions in an established biomarker fo
Federal authorities launch a campaign to promote appropriate use of antibiotics
Bern, 09.11.2018 - Maintaining the effectiveness of antibiotics for humans and animals, and combating resistance - these are the two main objectives of the national Strategy on Antibiot
Bern, 09.11.2018 - Maintaining the effectiveness of antibiotics for humans and animals, and combating resistance - these are the two main objectives of the national Strategy on Antibiot
Novartis R&D update highlights industry leading development pipeline including potential blockbusters and advanced therapy platforms
26 potential blockbusters in confirmatory development. 13 projects in clinical development across Cell, Gene & Radioligand therapies.
26 potential blockbusters in confirmatory development. 13 projects in clinical development across Cell, Gene & Radioligand therapies.
Novartis data at ASH and SABCS show strength of pipeline and portfolio in hematology and oncology
Additional analysis from pivotal Phase III SOLAR-1 clinical trial studying investigational alpha-specific PI3K inhibitor BYL719 (alpelisib) and fulvestrant in patients with PIK3CA-mutated HR+/HER2- a
Additional analysis from pivotal Phase III SOLAR-1 clinical trial studying investigational alpha-specific PI3K inhibitor BYL719 (alpelisib) and fulvestrant in patients with PIK3CA-mutated HR+/HER2- a
Roche announces EU approval of Venclyxto plus MabThera for people with previously treated chronic lymphocytic leukaemia
Approval is based on randomised phase III MURANO study showing that fixed duration of treatment with Venclyxto plus MabThera is well tolerated and reduced risk of disease progression or death by 83%
Approval is based on randomised phase III MURANO study showing that fixed duration of treatment with Venclyxto plus MabThera is well tolerated and reduced risk of disease progression or death by 83%
Phase III data showed that Venclexta/Venclyxto plus Gazyva/Gazyvaro reduced the risk of disease worsening or death in people with previously untreated chronic lymphocytic leukaemia with co-morbidities
The phase III CLL14 study compared Venclexta/Venclyxto in combination with Gazyva/Gazyvaro to standard-of-care Gazyva/Gazyvaro plus chlorambucil Data will be submitted to health authorities and prese
The phase III CLL14 study compared Venclexta/Venclyxto in combination with Gazyva/Gazyvaro to standard-of-care Gazyva/Gazyvaro plus chlorambucil Data will be submitted to health authorities and prese