# "Science Wire" gibt letzten Meldungen von Forschungsinstitutionen und F&E Unternehmen.



Novartis announces extension to FDA review period for multiple myeloma investigational compound LBH589
Basel , November 25, 2014 - Novartis announced today that the US Food and Drug Administration (FDA) has extended their priority review period by up to three months for the new drug application (ND
Novartis drug Signifor approved in EU, marking an advance for patients with inadequately controlled acromegaly
Acromegaly is a rare pituitary disorder, which requires normalization of hormonal levels to help prevent the serious consequences of the disease , , , Approval based on two large phase III
Medizin/Pharmakologie - Biowissenschaften
Novartis Cosentyx(TM) receives positive CHMP opinion for first-line treatment of moderate-to-severe psoriasis patients
Cosentyx (secukinumab, formerly AIN457) is recommended as first-line systemic therapy for the treatment of moderate-to-severe plaque psoriasis in adult patients in Europe In Phase III stud
Medizin/Pharmakologie - Umweltwissenschaften/Nachhaltige Entwicklung
Novartis Foundation symposium showcases sustainable healthcare interventions
Event illustrates how strong partnerships and innovative service delivery models can result in improved patient outcomes in lowand middle-income countries Selected interventions demonstrate success in moving past the pilot phase towards validation and scale, including a telemedicine project that aims to improve healthcare access in rural areas of Ghana The Novartis Foundation strategic approach to philanthropy includes partnerships,
Nine new analyses show Novartis’ LCZ696 could change course of heart failure for patients[1],[2]
New data from PARADIGM-HF shows LCZ696 cut incidence of sudden deaths, emergency room visits, hospitalizations, worsening symptoms and need for more intense treatment in HFrEF patients versus enalapril Patients' and doctors' assessments of disease severity were also significantly better with LCZ696 than enalapril Effects on certain heart biomarkers indicate that compared to enalapril, LCZ696 reduced cardiac stress and damage
Novartis reports landmark Phase III results for AIN457 (secukinumab) showing rapid and significant efficacy in psoriatic arthritis patients
Secukinumab demonstrated significant and sustained efficacy versus placebo in improving signs and symptoms of active psoriatic arthritis (PsA) in two pivotal studies - FUTURE 1 and FUTURE 2 are the first Phase III studies of a selective IL-17A inhibitor in PsA, a painful, debilitating condition causing inflammation of joints and skin , In FUTURE 1 more than 80% of secukinumab-treated patients experienced no progression of joi
Medizin/Pharmakologie - Biowissenschaften
Novartis presents ground-breaking Phase III results showing AIN457 (secukinumab) significant efficacy in ankylosing spondylitis patients
More than 60% of secukinumab 150 mg patients achieved significant improvements in AS symptoms, seen as early as Week 1 and sustained through one year of treatment , Secukinumab is the first selective IL-17A inhibitor to significantly improve signs and symptoms of ankylosing spondylitis (AS) versus placebo in Phase III studies , Up to 40% of AS patients have inadequate or no response to standard of care anti-TNF (tumor-necrosis-facto
Medizin/Pharmakologie - Betriebswissenschaft/VWL
Novartis and Malaria No More help fulfill malaria treatment goal in Zambia by raising funds for three million treatments through Power of One
Power of One campaign, supported by exclusive treatment sponsor Novartis, raises funds for three million treatments for children with malaria Novartis associates rallied behind Power of One
Medizin/Pharmakologie - Physik/Materialwissenschaft
Novartis to reveal landmark Phase III data for AIN457 (secukinumab) in psoriatic arthritis and ankylosing spondylitis at ACR 2014
Detailed results of four pivotal Phase III studies of secukinumab in psoriatic arthritis (PsA) and ankylosing spondylitis (AS) to be presented for the first time at ACR 2014 Secukinumab is the first selective interleukin-17A (IL-17A) inhibitor with Phase III data to demonstrate efficacy and improve symptoms in patients with PsA and AS Data will include study results from FUTURE 1 and FUTURE 2 in PsA and MEASURE 1 and MEASURE 2 in AS;
Novartis announces outcome of FDA advisory committee meeting for multiple myeloma investigational compound LBH589
Committee votes against recommending LBH589 plus bortezomib and dexamethasone for patients with previously treated multiple myeloma LBH589 has the potential to be an important treatment optio
Betriebswissenschaft/VWL - Medizin/Pharmakologie
Novartis delivered solid sales growth with strong margin expansion and major innovation in the third quarter
Net sales up 4% (+5% cc) in Q3, with operating margin increase across Q3 and 9M Net sales of USD 14.7 billion grew 4% (+5% cc ) in Q3 Strong operating income growth in Q3 of 14% (+18% cc) Core
Medizin/Pharmakologie - Betriebswissenschaft/VWL
Novartis announces divestiture of influenza vaccines business to CSL for USD 275 million
CSL to acquire Novartis influenza vaccines business, including development pipeline, for USD 275 million Announcement follows a transaction announced on April 22, 2014 to divest the non-influen
Medizin/Pharmakologie - Biowissenschaften
Novartis AIN457 (secukinumab) meets primary endpoint in two Phase III studies in ankylosing spondylitis, a debilitating joint condition of the spine
Secukinumab is the first selective IL-17A inhibitor to meet primary endpoint in two pivotal Phase III studies showing improvement in active ankylosing spondylitis (AS) patients' symptoms versus placebo AS is a painful, progressively debilitating condition associated with inflammation of the spine, causing irreversible consequences that significantly reduce patients' mobility and quality of life , Up to 40% of patients have an
Medizin/Pharmakologie - Biowissenschaften
Novartis announces FDA Advisory Committee unanimously recommends approval of AIN457 (secukinumab) for patients with moderate-to-severe plaque psoriasis
Biologics License Application (BLA) for secukinumab, a "first-in-class" IL-17A inhibitor, is currently under FDA review with an anticipated action date in early 2015 FDA Advisory Committee recommendation based on efficacy and safety outcomes of 10 Phase II/III clinical studies of secukinumab in moderate-to-severe plaque psoriasis Affecting 7.5 million Americans, psoriasis may negatively impact daily life and is associated with increas
Medizin/Pharmakologie - Biowissenschaften
Novartis announces CTL019 data published in NEJM demonstrating efficacy in certain patients with acute lymphoblastic leukemia (ALL)
Preliminary study results show 27 of 30 pediatric and adult patients with relapsed/refractory (r/r) ALL (90%) experienced complete remissions with personalized cell therapy, CTL019 Largest published cohort to date for CTL019, which served as the basis for recent Breakthrough Therapy designation from the FDA Sustained remissions of up to two years in r/r ALL patients with six-month event-free survival of 67% and overall survival of 7
Novartis data at EADV show consistent efficacy of AIN457 (secukinumab) in clearing skin of psoriasis patients
New analyses of Phase III data show consistent efficacy in clearing psoriasis skin with AIN457 (secukinumab) regardless of how bad patients' disease is at start of treatment Significant positive responses to secukinumab seen in patients with severe psoriasis at start of treatment Significant positive relationship between achieving clear to almost clear skin and psoriasis patients' health-related quality of life, as shown by add
Medizin/Pharmakologie - Betriebswissenschaft/VWL
New data on the global economic impact and burden of preventable blindness and vision impairment highlighted for World Sight Day
Annual economic impact equals more than 350,000 healthy life years lost and over €20 billion EUR as a result of blindness for 14 countries studied Screening for diabetic retinopathy, catarac
Medizin/Pharmakologie - Betriebswissenschaft/VWL
Changes to the Novartis Executive Committee after expected completion of portfolio transactions
Three members of the Executive Committee of Novartis to leave company, following completion of portfolio transactions expected to close in first half 2015 Basel, October 8, 2014 - Novartis
Novartis announces clinical collaboration to evaluate Bristol-Myers Squibb’s novel immunotherapy in combination treatments for NSCLC
Phase I/II studies will evaluate Zykadia(TM), INC280 and EGF816 in combination with Bristol-Myers Squibb's investigational immunotherapy Opdivo Combination studies will evaluate compounds
Medizin/Pharmakologie - Biowissenschaften
Novartis showcases dermatology leadership on International Urticaria Day announcing new data to be presented at EADV 2014
New data for the IL-17A inhibitor AIN457 (secukinumab) in psoriasis and Xolair in Chronic Spontaneous Urticaria (CSU) at EADV to highlight benefit to patients' quality of life Data continue to reinforce the landmark Phase III results of secukinumab in psoriasis and Xolair in CSU that showed consistent, fast efficacy and acceptable safety - Important head-to-head trial of secukinumab versus Stelara (CLEAR), powered to eval
Medizin/Pharmakologie - Biowissenschaften
Patients lived average of 18 months without cancer progressing when taking Novartis’ Zykadia(TM) as their first ALK inhibitor for ALK+ NSCLC
Longest median progression-free survival (PFS) ever reported in this ALK+ non-small cell lung cancer patient population, most who received prior chemotherapy Zykadia (ceritinib) achieved ov
Medizin/Pharmakologie - Biowissenschaften
Novartis drug Afinitor is first treatment for advanced pancreatic NET to provide overall survival of more than 3.5 years in Phase III trial
Afinitor led to an unprecedented median overall survival of 44 months, which represents a clinically meaningful while not statistically significant improvement Pancreatic NET (pNET) affects ab
Novartis drug Signifor LAR recommended by CHMP for EU approval to treat patients with rare hormonal disorder acromegaly
Acromegaly is an endocrine disorder caused by elevated growth hormone (GH) and insulin-like growth factor-1 (IGF-1) levels Signifor LAR (pasireotide) represents a potential new option for acro
Novartis AIN457 (secukinumab) is the first ever IL-17A inhibitor to meet primary endpoint in two Phase III studies in psoriatic arthritis
Secukinumab met primary and key secondary endpoints in two pivotal Phase III studies showing superiority to placebo in patients with adult onset psoriatic arthritis (PsA) PsA is a debilitating, long-lasting condition that causes inflammation of joints and skin and affects up to 30% of people with psoriasis globally , Many people with PsA do not respond to current standard of care, with approximately 45% of people dissatisf
Novartis data in The Lancet Oncology show LBH589 offers 4-month increase in median PFS for patients with multiple myeloma
Results show statistically significant and clinically relevant increase in median progression-free survival with LBH589 plus bortezomib and dexamethasone LBH589, a first-in-class treatment for patients with relapsed/refractory multiple myeloma if approved, helps extend benefit of standard-of-care therapy First Phase III study to demonstrate superiority of a three-drug over two-drug combination in this patient population Multip
Medizin/Pharmakologie - Biowissenschaften
Novartis presents oncology research advances with new data on Zykadia(TM), Afinitor and key pipeline compounds at ESMO 2014
Latest Zykadia data in patients with ALK+ non-small cell lung cancer, including updated brain metastases analysis from pivotal trial Final overall survival data from Phase III trial of Afini
Medizin/Pharmakologie - Betriebswissenschaft/VWL
Novartis demonstrates leadership in ophthalmology with new products and over 40 abstracts at EURETINA
Retrospective analysis of US claims data suggests risk of endophthalmitis is 65% higher in patients treated with aflibercept than those treated with Lucentis Presentations discuss safety o
Medizin/Pharmakologie - Biowissenschaften
New data confirm high efficacy of Gilenya
A key treatment goal for patients with MS is 'no evidence of disease activity' (NEDA), currently defined as no relapses, MRI lesions and disability progression Including MS-related brain shrinkage (brain volume loss) as a fourth key measure captures underlying damage that begins early in MS and is associated with loss of function The likelihood of achieving NEDA across four key measures was more than four-times greater in patients treat
Biowissenschaften - Medizin/Pharmakologie
Gilenya data confirm reducing brain shrinkage matters
Brain shrinkage is associated with a loss of physical and cognitive function and occurs at a faster rate in people with MS than those without the disease New data showed patients who had the highest rates of brain shrinkage (brain volume loss) at two years had a higher risk of disability progression at four years Separate analyses showed that patients continuously treated with Gilenya for six years had sustained low rates of brain shri
Novartis data at ERS 2014 show once-daily Ultibro Breezhaler is superior in reducing COPD flare ups compared to Seretide *
Once-daily Ultibro Breezhaler reduced exacerbations (flare ups) by 31% compared to twice-daily Seretide Accuhaler * in moderate-to-severe COPD patients LANTERN study further confirmed superiority of Ultibro Breezhaler in improving lung function compared to Seretide in moderate-to-severe COPD patients First presentation of LANTERN trial at European Respiratory Society International Congress involving over 700 COPD
Medizin/Pharmakologie - Biowissenschaften
Gilenya data at ACTRIMS-ECTRIMS to show Novartis is redefining MS treatment goals for patients
'No evidence of disease activity' (NEDA), the ultimate treatment goal in MS, is currently assessed by measuring relapses, MRI lesions and disability progression New Gilenya data will highlight importance of brain shrinkage as NEDA fourth key measure, giving physicians more complete assessment of MS disease in patients Separate analyses will confirm the clinical relevance of brain shrinkage based on its association with future long-ter
Medizin/Pharmakologie - Betriebswissenschaft/VWL
Novartis to unveil new data from three key clinical trials at European Respiratory Society International Congress 2014
First presentation of LANTERN study to confirm superior efficacy of once-daily Ultibro Breezhaler versus Seretide Accuhaler * in COPD patients QUANTIFY study to show superiority of Ultibro Breezhaler in lung function and shortness of breath versus tiotropium plus formoterol New data from GLISTEN study will provide important evidence for the benefits of once-daily Seebri Breezhaler
Medizin/Pharmakologie - Physik/Materialwissenschaft
Novartis’ LCZ696 cut cardiovascular deaths by 20%
Study showed significantly more HF-REF patients on LCZ696 regimen were alive, had fewer hospitalizations than those given enalapril regimen On all-cause mortality, LCZ696 doubled the effect that enalapril, an ACE-inhibitor, previously showed vs placebo when added to current best treatment for HF-REF , 26 million people across US and Europe live with heart failure , facing high risk of death and poor quality of life , Basel, Augus
Medizin/Pharmakologie - Biowissenschaften
Novartis experts and future scientific leaders meet at International BioCamp 2014 to consider ’The Race Against Time’
Global experts present potential solutions to support healthy aging from Novartis businesses and R&D organization The 11th annual event brings 60 top university students from 25 countries and t
Medizin/Pharmakologie - Betriebswissenschaft/VWL
Novartis provides drug candidate compounds to TB Alliance
Exclusive worldwide license from Novartis includes a novel class of drugs that is active against drug sensitive and multi-resistant strains of tuberculosis Basel, August 20, 2014 - Novartis has signed an exclusive worldwide licensing agreement with the Global Alliance for TB Drug Development (TB Alliance) for compounds to fight tuberculosis (TB) that have been discovered at the Novartis Institutes for Tropical Diseases (NITD).
Novartis to showcase heart failure leadership at ESC Congress 2014 with results on new first of its type medicine LCZ696
LCZ696 significantly reduced cardiovascular deaths in head to head study against enalapril, in addition to current best treatment, in patients with HF-REF PARADIGM-HF is the largest heart failure study ever conducted - stopped early in March 2014 due to compelling efficacy , LCZ696 recently granted FDA Fast Track status - rolling submission expected to be complete by end of year Basel, August 11, 2014 - New data reveali
Medizin/Pharmakologie - Betriebswissenschaft/VWL
KAE609 shows promise as next generation treatment for malaria
KAE609 is the first antimalarial drug candidate with a novel mechanism of action to achieve positive clinical proof-of-concept in over 20 years KAE609 was tested in adult patients with uncomplicated malaria and showed a median parasite clearance time of 12 hours, including in patients with resistant infections For more than a decade, Novartis has been a leader in the fight against malaria, setting the current gold standard for tre
Medizin/Pharmakologie - Biowissenschaften
Novartis vaccine Bexsero sees high uptake in first large-scale public vaccination program to help protect against devastating meningitis B
Program in Québec's Saguenay-Lac-Saint-Jean region is the first public campaign globally to offer Bexsero to all from 2 months to 20 years of age More than 45,000 infants, young children an
Medizin/Pharmakologie - Verwaltung/Regierung
Alcon’s Simbrinza approved in the EU to treat patients living with glaucoma, a chronic sight-threatening eye disease
Simbrinza provides a convenient option to reduce treatment burden versus concomitant administration of single drugs Simbrinza is the only beta blocker-free formulation combining two approved th
Biowissenschaften - Medizin/Pharmakologie
FDA accepts Sandoz application for biosimilar filgrastim
Sandoz is the first company to announce it has filed for approval of a biologic under the biosimilars pathway created in the Biologics Price Competition and Innovation Act of 2009 (BPCIA).
Betriebswissenschaft/VWL - Medizin/Pharmakologie
Novartis maintained strong innovation momentum in second quarter, while reconfirming full year outlook
Net sales grew 2% in Q2, with core operating leverage across Q2 and H1 Net sales of USD 14.6 billion grew 2% (+2% cc ) in Q2; USD 28.7 billion (+2%, +2% cc) in H1 Strong operating income growth i
Novartis to license Google "smart lens" technology
Innovative technology offers potential to transform eye care and further enhance Alcon's leadership in contact lenses and intraocular lenses Agreement is a first step for Novartis to evo
Medizin/Pharmakologie - Biowissenschaften
Novartis announces collaboration with Banner Alzheimer’s Institute on a pioneering prevention study for Alzheimer’s Disease
Two Novartis anti-amyloid investigational treatments will be studied in people with a genetic risk of developing Alzheimer's Disease (AD) The build-up of amyloid in the brain is believed to be
Medizin/Pharmakologie - Biowissenschaften
Novartis announces NEJM publication of two phase III studies demonstrating high efficacy of secukinumab (AIN457) in psoriasis patients
Results of two phase III psoriasis studies consistently show rapid, very high skin clearance, sustained efficacy and an acceptable safety profile with secukinumab More than 70% of secukinumab 300 mg patients experienced clear (PASI 100) or almost clear skin (PASI 90) during the first 16 weeks of treatment[ 1] If approved, secukinumab could address a high unmet need for new psoriasis treatments, as up to 50% of patients are dissat
Medizin/Pharmakologie - Betriebswissenschaft/VWL
Novartis releases 2013 Corporate Responsibility Performance Report using best-in-class reporting standard, increasing transparency
2013 Corporate Responsibility (CR) Performance Report builds on a long history of CR and reporting Report uses new Global Reporting Initiative G4 guidelines, one year ahead of required implem
Medizin/Pharmakologie - Philosophie
Novartis reinforces its leadership in research with new global guidelines for Investigator Initiated Trials (IITs)
Novartis committed to support ethical clinical research; new global guidelines emphasizing the principles of ethics, governance and transparency Clinical research conducted by qualified independent investigators is an important part of drug discovery and development and can help explore unmet medical needs New guidelines reinforce requirement that no commercial funding, involvement or influence are permitted in any aspect of IITs Basel, July 8, 2014 - Novartis released today new global guidelines for Investigator Initiated Trials (IITs).
Medizin/Pharmakologie - Biowissenschaften
Novartis personalized cell therapy CTL019 receives FDA Breakthrough Therapy designation
Designation supports the advancement of CTL019 to help address the unmet need of patients with relapsed/refractory acute lymphoblastic leukemia (r/r ALL) The filing was submitted by the Unive
Sandoz joins forces with United Nations to combat a leading cause of child mortality worldwide
Sandoz makes long-term commitment to support UN initiative on child mortality Commitment to UN Every Newborn Action Plan involves development and supply of recommended WHO formulation for treat
Medizin/Pharmakologie - Betriebswissenschaft/VWL
Novartis emphasizes new focused portfolio at its first Meet Novartis Management investor day
New Novartis focused on three leading businesses with innovation power and global scale Pharmaceuticals building business depth in Dermatology, Heart Failure, Respiratory and Cell Therapy, comple
Medizin/Pharmakologie - Biowissenschaften
Novartis submits application to the FDA for meningitis B vaccine candidate Bexsero
Submission follows receipt of Breakthrough Therapy designation in April 2014, highlighting unmet need for a licensed vaccine for serogroup B in the US Meningitis B is a rare but aggress
Medizin/Pharmakologie - Veranstaltung
Novartis Holly Springs facility becomes first US pandemic-ready site licensed by the FDA to produce cell-culture influenza vaccines
Cell-culture technology is a modern alternative to manufacture influenza vaccines without chicken eggs, with potential to rapidly respond to a pandemic Flucelvax , an FDA-approved antibiot
Medizin/Pharmakologie - Umweltwissenschaften/Nachhaltige Entwicklung
Novartis Foundation for Sustainable Development to work with Netherlands Leprosy Relief to help reduce leprosy transmission
Collaboration to provide evidence on the impact of preventatively treating high risk groups to reduce the transmission of leprosy in several countries across Asia, Africa and Latin America Rese
Pivotal Phase III data show polycythemia vera patients on Novartis drug Jakavi achieved significant improvement in disease control
77% of patients on Jakavi (ruxolitinib) vs 20% on best available therapy achieved hematocrit control or spleen reduction, key treatment goals in PV Nearly half of ruxolitinib-treated pati
Zykadia(TM) shrank tumors in the majority of patients with ALK+ NSCLC, regardless of prior ALK treatment
Ceritinib achieved overall response rate of 58.5%, with a median progression-free survival of 8.2 months Similar findings were observed in patients who started the study with brain metastase
Novartis data at ASCO show LBH589 significantly improved progression-free survival in patients with multiple myeloma
Results show adding LBH589 to bortezomib and dexamethasone significantly improved PFS by 37%, meeting Phase III study primary endpoint Median PFS increased by 4 months (12 months in LBH589 arm versus 8 months in placebo arm) ; effect of LBH589 observed across all patient subgroups Most people with multiple myeloma will relapse or become refractory; if approved, LBH589 will be first in its class of anticancer agents availab
Pivotal data for Novartis’ investigational compound LDE225 show marked tumor responses in advanced basal cell carcinoma
The study met the primary endpoint with objective response rates of 41.8% and 32.5% respectively in the 200 mg and 800 mg treatment arms , Basal cell carcinoma is the most common form of skin
Medizin/Pharmakologie - Betriebswissenschaft/VWL
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