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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 74.
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
Roche to present new data from its industry-leading haematology portfolio at the American Society of Hematology 2018 Annual Meeting
Ten medicines featured in over 70 abstracts, including 25 oral presentations Additional data from three pivotal studies of Hemlibra in people with haemophilia A, with or without factor VIII inhibitor
Ten medicines featured in over 70 abstracts, including 25 oral presentations Additional data from three pivotal studies of Hemlibra in people with haemophilia A, with or without factor VIII inhibitor
Two-year data for Novartis brolucizumab reaffirm superiority versus aflibercept in reducing retinal fluid in patients with nAMD
Year two results consistent with previously announced key secondary endpoint data on retinal fluid (IRF and/or SRF) showing superior reductions versus aflibercept Superior reductions in central sub
Year two results consistent with previously announced key secondary endpoint data on retinal fluid (IRF and/or SRF) showing superior reductions versus aflibercept Superior reductions in central sub
Roche announces FDA approval of Xofluza (baloxavir marboxil) for influenza
Roche announces FDA approval of Xofluza (baloxavir marboxil) for influenza First and only single-dose oral medicine approved to treat the flu Xofluza significantly reduced the duration of flu symptom
Roche announces FDA approval of Xofluza (baloxavir marboxil) for influenza First and only single-dose oral medicine approved to treat the flu Xofluza significantly reduced the duration of flu symptom
Novartis announces Lancet publication of pioneering study in migraine prevention showing efficacy of Aimovig where other treatments have failed
The LIBERTY trial is the first study of a CGRP-targeted therapy in a patient population where multiple preventive treatments had previously failed Patients treated with Aimovig, reported significan
The LIBERTY trial is the first study of a CGRP-targeted therapy in a patient population where multiple preventive treatments had previously failed Patients treated with Aimovig, reported significan
Roche’s Tecentriq plus chemotherapy (carboplatin and Abraxane) as an initial treatment helped people with advanced non-squamous non-small cell lung cancer live significantly longer compared to chemotherapy alone
Roche's Tecentriq plus chemotherapy (carboplatin and Abraxane) as an initial treatment helped people with advanced non-squamous non-small cell lung cancer live significantly longer compared to chemot
Roche's Tecentriq plus chemotherapy (carboplatin and Abraxane) as an initial treatment helped people with advanced non-squamous non-small cell lung cancer live significantly longer compared to chemot
Novartis COMBI-AD study of Tafinlar + Mekinist continues to demonstrate relapse free survival benefit in patients with BRAF V600-mutant stage III melanoma
Extended follow up results confirm leading BRAF/MEK inhibitor combination Tafinlar + Mekinist continues to show relapse free survival benefit Cure rate modeling which estimates fraction of patients
Extended follow up results confirm leading BRAF/MEK inhibitor combination Tafinlar + Mekinist continues to show relapse free survival benefit Cure rate modeling which estimates fraction of patients
Roche’s investigational personalised medicine entrectinib shrank tumours in people with NTRK fusion-positive solid tumours
Entrectinib showed response irrespective of tumour type or spread to the central nervous system (CNS) Data will be submitted to global regulatory authorities, including the US Food and Drug Administr
Entrectinib showed response irrespective of tumour type or spread to the central nervous system (CNS) Data will be submitted to global regulatory authorities, including the US Food and Drug Administr
Roche’s Tecentriq in combination with Abraxane improves outcomes as an initial treatment for people with PD-L1-positive metastatic triple-negative breast cancer
Tecentriq combination first immunotherapy regimen to demonstrate positive Phase III results in breast cancer Tecentriq and nab -paclitaxel significantly reduced the risk of disease worsening or death in both the intention-to-treat and PD-L1-positive populations Clinically meaningful overall survival improvement in the PD-L1-positive population at this interim analysis Data are being presented at the European Society for Medical Oncology (ESMO) 2
Tecentriq combination first immunotherapy regimen to demonstrate positive Phase III results in breast cancer Tecentriq and nab -paclitaxel significantly reduced the risk of disease worsening or death in both the intention-to-treat and PD-L1-positive populations Clinically meaningful overall survival improvement in the PD-L1-positive population at this interim analysis Data are being presented at the European Society for Medical Oncology (ESMO) 2
Roche’s Kadcyla reduced the risk of disease recurring in people with HER2-positive early breast cancer with residual disease after neoadjuvant treatment
Phase III KATHERINE study shows Kadcyla significantly improved invasive disease-free survival compared to Herceptin in people with HER2-positive early breast cancer with residual disease after neoadjuvant treatment Data will be submitted to health authorities around the world, including the US Food and Drug Administration and European Medicines Agency Results will be presented at the 2018 San Antonio Breast Cancer Symposium in December Roche tod
Phase III KATHERINE study shows Kadcyla significantly improved invasive disease-free survival compared to Herceptin in people with HER2-positive early breast cancer with residual disease after neoadjuvant treatment Data will be submitted to health authorities around the world, including the US Food and Drug Administration and European Medicines Agency Results will be presented at the 2018 San Antonio Breast Cancer Symposium in December Roche tod
Positive phase III results for baloxavir marboxil in people at high risk of complications from influenza to be presented at IDWeek 2018
Baloxavir marboxil - a first-in-class, single-dose, investigational oral medicine - is the first potential influenza treatment in clinical trials to demonstrate a clinically meaningful benefit for people highly vulnerable to serious influenza complications CAPSTONE-2 showed that baloxavir marboxil significantly reduced time to improvement of influenza symptoms versus placebo Influenza, or ‘flu', results in millions of debilitating illnesse
Baloxavir marboxil - a first-in-class, single-dose, investigational oral medicine - is the first potential influenza treatment in clinical trials to demonstrate a clinically meaningful benefit for people highly vulnerable to serious influenza complications CAPSTONE-2 showed that baloxavir marboxil significantly reduced time to improvement of influenza symptoms versus placebo Influenza, or ‘flu', results in millions of debilitating illnesse
FDA approves Roche’s Hemlibra for haemophilia A without factor VIII inhibitors
First medicine to significantly reduce treated bleeds compared to prior factor VIII prophylaxis based on an intra-patient comparison Only medicine that can be self-administered subcutaneously once we
First medicine to significantly reduce treated bleeds compared to prior factor VIII prophylaxis based on an intra-patient comparison Only medicine that can be self-administered subcutaneously once we
Roche’s investigational medicine entrectinib showed a durable response of more than two years in people with a specific type of lung cancer
Entrectinib reduced tumours in people with ROS1-positive non-small cell lung cancer (NSCLC), including those whose disease had spread to the central nervous system (CNS) Data will be submitted to glo
Entrectinib reduced tumours in people with ROS1-positive non-small cell lung cancer (NSCLC), including those whose disease had spread to the central nervous system (CNS) Data will be submitted to glo
Roche’s NAVIFY decision support portfolio unlocks relevant content from clinical trial and medical publication databases
Roche launches an app ecosystem with the first two clinical decision support apps The apps query globally-renowned resources based on real-world data Patient-specific results lead to more personalise
Roche launches an app ecosystem with the first two clinical decision support apps The apps query globally-renowned resources based on real-world data Patient-specific results lead to more personalise
Roche to present new data from its extensive lung cancer programme at the 2018 World Conference on Lung Cancer (WCLC)
Roche to present new data from its extensive lung cancer programme at the 2018 World Conference on Lung Cancer (WCLC) New and updated pivotal data from the TECENTRIQ lung programme, including overall
Roche to present new data from its extensive lung cancer programme at the 2018 World Conference on Lung Cancer (WCLC) New and updated pivotal data from the TECENTRIQ lung programme, including overall
China National Drug Administration grants rapid approval of Roche’s Alecensa (alectinib) as a treatment for ALK-positive lung cancer
China National Drug Administration grants rapid approval of Roche's Alecensa (alectinib) as a treatment for ALK-positive lung cancer Approval follows priority review of Alecensa in China, just eight
China National Drug Administration grants rapid approval of Roche's Alecensa (alectinib) as a treatment for ALK-positive lung cancer Approval follows priority review of Alecensa in China, just eight
Roche to present new data demonstrating the breadth and depth of its Alzheimer’s programme at the upcoming Alzheimer’s Association International Conference
Roche to present new data demonstrating the breadth and depth of its Alzheimer's programme at the upcoming Alzheimer's Association International Conference Late-breaking Phase II exploratory analysis
Roche to present new data demonstrating the breadth and depth of its Alzheimer's programme at the upcoming Alzheimer's Association International Conference Late-breaking Phase II exploratory analysis