Tag Archives: Novartis

Novartis: positive topline results from the global MONALEESA-7 trial

MONALEESA-7 met primary endpoint of progression-free survival, demonstrating superior efficacy of Kisqali combination therapy vs. endocrine treatment alone in first-line treatment of premenopausal women with HR+/HER2- advanced breast cancer[1]  Kisqali is the first CDK4/6 inhibitor to be studied in a Phase … Read the full press release

Novartis announced results from the FUTURE 5 study on psoriatic arthritis (PsA)

Structural joint damage in psoriatic arthritis (PsA) patients taking Cosentyx® (secukinumab) was inhibited at 24 weeks versus placebo in all arms of the study[1] PsA can lead to reduced mobility and irreversible joint damage[2]     FUTURE 5 is the largest randomized controlled … Read the full press release

Novartis: ACZ885 led to 15% reduction in the risk of major adverse cardiovascular events (MACE) compared to placebo

Study showed a significant 15% reduction of major adverse cardiovascular events (MACE) in people with a prior heart attack and inflammatory atherosclerosis who were treated with 150mg of ACZ885, in addition to standard of care including lipid-lowering therapy Effect driven … Read the full press release

Novartis: ACZ885 reduced the rate of lung cancer incidence and mortality among study participants

Review of blinded, pre-planned oncology safety analyses revealed a 77% reduction in lung cancer mortality and 67% reduction in lung cancer cases in patients treated with 300mg of ACZ885 CANTOS is the first Phase III clinical trial to support a … Read the full press release

Novartis announces the appointment of Bertrand Bodson to the new role of Chief Digital Officer

New leader to drive the digital transformation Novartis has embarked upon BASEL, 28-Aug-2017 — /EuropaWire/ — Novartis announced today that Bertrand Bodson, Chief Digital and Marketing Officer for Sainsbury’s Argos, has been appointed to the new role of Chief Digital Officer, … Read the full press release

Novartis Reinforces Commitment to Sandoz With Major Investment in Business

Total investment of EUR 105 million in Prevalje site reinforces commitment to largest Sandoz business, Anti-Infectives, and single largest global product, broad-spectrum antibiotic amoxicillin-clavulanic acid. The investment will bring 150 new jobs, more than doubling the number of employees at … Read the full press release

Novartis collaborates with Ionis and Akcea to license two novel treatments to reduce cardiovascular risk in patients with high levels of lipoproteins

Novartis enters into an exclusive option agreement with Ionis and Akcea to license two investigational treatments expected to significantly reduce cardiovascular risk in patients living with elevated levels of lipoprotein Lp(a) or ApoCIII, which is a potent regulator of triglycerides … Read the full press release

Rwanda becomes the third country to sign a MoU with Novartis Access

Rwanda becomes third country to launch Novartis Access portfolio against chronic diseases with first deliveries planned in early 2017 Since September 2015, Novartis Access has delivered more than 100,000 monthly treatments to Kenya, Ethiopia and Lebanon* First-year learnings underline broader … Read the full press release

Eye care leader Alcon to launch the CyPass® Micro-Stent at AAO annual meeting in Chicago

Alcon to host first live training program on the use of the CyPass® Micro-Stent, a minimally invasive glaucoma surgical device to treat cataract patients with mild to moderate primary open-angle glaucoma Two-year safety and efficacy data from landmark COMPASS study … Read the full press release

New analyses confirm Novartis’ Ultibro® Breezhaler® more effective option for patients at risk of COPD flare-ups

Ultibro® Breezhaler® reduced rate of all COPD exacerbations across different patient sub-groups vs Seretide® in new analyses from FLAME study Analyses show that Ultibro Breezhaler lowered patients’ need for rescue medication and had improved benefit-risk profile compared to Seretide, with … Read the full press release

Novartis third annual Meet Novartis Management event in Basel: Leading positions in oncology, eye care and biosimilars

Outlines actions underway to accelerate launch of Entresto®, including further expansion of US primary care field force, and reinforce strong uptake of Cosentyx® Highlights leading pipeline of second generation immuno-oncology assets Confirms Sandoz on track for 10 biosimilar filings by … Read the full press release

Novartis: European Commission (EC) approved Revolade® for treatment of pediatric chronic immune thrombocytopenic purpura (ITP) patients

EU approval of Revolade expands treatment options for pediatric patients aged 1 year and above with chronic ITP who have not responded to other therapies Two formulations approved: once-daily tablet and oral suspension formulation designed for younger children who may … Read the full press release

Helena Bragd bliver administrerende direktør for Becton Dickinson i Norden

OXFORD, 17-12-2015 — /EuropaWire/ — Helena Bragd tillsätts som vd för Becton, Dickinson and Companys (BD) affärsenhet BD Nordics. Helena har över 20 års erfarenhet som chef inom farmaceutisk och medicinteknisk verksamhet hos välkända aktörer inom branschen, bland annat ResMed, … Read the full press release

Helena Bragd joins Becton Dickinson to lead newly empowered Nordic business

OXFORD, 17-12-2015 — /EuropaWire/ — Helena Bragd has joined global medical technology leader Becton, Dickinson and Company (BD) as General Manager for the Nordic region. Helena brings more than 20 years of pharmaceutical- and med-tech leadership experience to the role, … Read the full press release

Novartis: study confirms Ultibro Breezhaler is an effective steroid-free option in reducing COPD exacerbations

Ultibro® Breezhaler® met primary endpoint and demonstrated superiority to Seretide® in reducing COPD exacerbations during 52 weeks of treatment First large-scale study to confirm Ultibro Breezhaler is an effective steroid-free option that both reduces exacerbations and improves lung function in … Read the full press release

Novartis: updated data from study shows significant overall survival benefit for patients with aggressive form of melanoma when treated with Tafinlar® + Mekinist®

Phase III data showed median overall survival of 25.6 months in patients with BRAF+ V600E/K metastatic melanoma who received Tafinlar + Mekinist Tafinlar + Mekinist combination also demonstrated significant improvement in health-related quality of life vs vemurafenib monotherapy in this … Read the full press release

Novartis: study shows Afinitor® reduced the risk of progression in patients with advanced nonfunctional gastrointestinal and lung NET

In pivotal study, everolimus reduced risk of disease progression by 52%; showed 11.0-month median progression-free survival vs 3.9 months for placebo[1] Advanced, progressive, nonfunctional neuroendocrine tumors of GI or lung origin are rare forms of cancer with poor prognoses and … Read the full press release

Novartis to acquire all remaining rights to Ofatumumab from GlaxoSmithKline plc (GSK)

Novartis strengthens multiple sclerosis focus with the addition of Ofatumumab to leading MS portfolio which includes Gilenya and investigational treatments BAF312 and CJM112 Ofatumumab is a fully human monoclonal antibody for relapsing remitting multiple sclerosis (RRMS) which targets CD20 and … Read the full press release

Novartis confirms benefits of first-line Tasigna treatment seen in earlier trials in newly-diagnosed patients with chronic myeloid leukemia (CML)

Patients on Tasigna achieved rapid and high rates of molecular response with a very low rate of progression to advanced disease ENEST1st data confirm the favorable benefit/risk profile of Tasigna in newly-diagnosed CML patients seen in the pivotal ENESTnd study … Read the full press release

20th EHA Congress in Vienna: Novartis data shows increased PFS benefit of Farydak® in new subgroup of patients with previously treated multiple myeloma

Panobinostat combination more than doubled median PFS benefit by 7.8 months in patients who received >=2 prior lines of therapy, including bortezomib and IMiD[1] Multiple myeloma is an incurable cancer of the plasma cells, a type of white blood cell … Read the full press release

Novartis: Arzerra significantly improves median progression-free survival when added to fludarabine + cyclophosphamide after initial treatment stopped working in patients with relapsed chronic lymphocytic leukemia

Arzerra significantly improved PFS when added to fludarabine + cyclophosphamide (median 28.9 mos vs 18.8 mos) after initial treatment stopped working Patients receiving Arzerra plus existing CLL treatments also had a higher overall response rate (84% vs 68%) compared to … Read the full press release

Novartis: Xolair helps patients with Chronic Spontaneous Urticaria (CSU) achieve significant improvements in quality of life measures

New analysis from pivotal Phase III studies show Xolair® (omalizumab) significantly improved quality of life scores for Chronic Spontaneous Urticaria (CSU) patients compared to placebo[1],[2] Additional data at WCD show the consistent negative health impact and economic burden of CSU, … Read the full press release

Novartis: US FDA approved Promacta for the treatment of children six years and older with chronic immune thrombocytopenia (ITP)

Promacta® (eltrombopag) significantly increased and sustained platelet counts in two studies, including the largest Phase III clinical trial in this patient population Characterized by a low platelet count[1], ITP can affect up to 5 in 100,000 children each year[2] and … Read the full press release

Novartis: Cosentyx shows superior efficacy compared to placebo in patients with psoriasis of the palms, soles and nails, all difficult-to-treat locations of plaque psoriasis

Cosentyx (secukinumab) met the primary endpoints of superiority compared to placebo in patients with difficult-to-treat psoriasis of the nails, palms and soles[1],[2] One third of patients with moderate-to-severe palmoplantar psoriasis achieved clear or almost clear skin on their palms and … Read the full press release

Novartis: Phase III study of Afinitor® shows significant extension of progression-free survival in advanced gastrointestinal or lung neuroendocrine tumors

Study in patients with advanced nonfunctional neuroendocrine tumors (NET) of gastrointestinal (GI) or lung origin met primary endpoint[1] Full results will be submitted for presentation at a major medical meeting; worldwide regulatory filings are planned for 2015 Afinitor is already … Read the full press release

Novartis announced positive results from two pivotal Phase III clinical trial programs for QVA149 and NVA237 in patients with COPD

QVA149 improved lung function, breathlessness and health-related quality of life in moderate-to-severe COPD patients, according to EXPEDITION trial results[1]-[7] GEM 1 & 2 studies showed NVA237 provided significant and clinically meaningful improvements in lung function in moderate-to-severe COPD patients[8],[9] In … Read the full press release

Novartis announces new Gilenya® analyses to be presented at the 67th American Academy of Neurology Annual Meeting in Washington, DC, April 18-25, 2015

New analysis will confirm high efficacy of Gilenya® in achieving ‘no evidence of disease activity’ (NEDA4) in previously-treated highly-active RMS patients Separate analyses will show adding brain shrinkage to an existing assessment tool enhances ability to predict disability progression in … Read the full press release

Novartis: EU approval for Jakavi® for the treatment of adult patients with polycythemia vera who are resistant to or intolerant of hydroxyurea

Jakavi® (ruxolitinib) approved by the European Commission for adult patients with polycythemia vera (PV) resistant to or intolerant of hydroxyurea PV is a rare blood cancer associated with an overproduction of blood cells that can lead to serious cardiovascular complications … Read the full press release

Novartis: FDA grants priority review designation to investigational medicine for the treatment of heart failure

Decision could speed access to LCZ696 for HFrEF patients in the US, reducing total review time from 12 to 8 months Filing is based on results from the landmark PARADIGM-HF study[1] Nearly six million people live with heart failure in … Read the full press release

Novartis: FDA granted accelerated approval of Bexsero® for active immunization to prevent invasive meningococcal disease caused by meningitis B

With today’s approval, Bexsero is now licensed in 37 countries; since first approval in Europe, over 1 million doses have been distributed worldwide Bexsero’s two-dose regimen offers a flexible dosing schedule, with the first and second doses administered at least … Read the full press release

Novartis: CHMP of the European Medicines Agency adopted a positive opinion for Jakavi® (ruxolitinib) for the treatment of adult patients with polycythemia vera

Polycythemia vera (PV) is associated with overproduction of blood cells that can cause serious cardiovascular complications, such as stroke and heart attack[1] Clinical data show Jakavi® (ruxolitinib) significantly improved hematocrit levels and reduced spleen size, key measures of disease control[2] … Read the full press release

Novartis’s Signifor® LAR to treat patients with life-threatening hormonal disorder acromegaly receives FDA approval

Acromegaly is an endocrine disorder caused by elevated growth hormone (GH) and insulin-like growth factor-1 (IGF-1) levels[1] Signifor LAR, a next-generation somatostatin analog, provides a new option for patients with acromegaly with inadequately controlled disease[2] Signifor LAR FDA approval is … Read the full press release

Novartis’ Signifor® (pasireotide) intramuscular injection to treat adult patients with acromegaly approved by the European Commission

Acromegaly is a rare pituitary disorder, which requires normalization of hormonal levels to help prevent the serious consequences of the disease[1],[2],[3],[4] Approval based on two large phase III trials showing superior efficacy of new formulation of Signifor over current SSAs … Read the full press release

Novartis to divest its influenza vaccines business to CSL Limited (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-influenza segments of Novartis Vaccines to GlaxoSmithKline Basel, Switzerland, 28-10-2014 — /EuropaWire/ — Novartis today … Read the full press release

Novartis’ two pivotal Phase III studies of AIN457 (secukinumab) in psoriatic arthritis (PsA) met primary and key secondary endpoints

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 … Read the full press release

Novartis published clinical trial results about novel and potent antimalarial drug candidate KAE609 (cipargamin)

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 … Read the full press release

Novartis signed licensing agreement with Ophthotech Corporation to market Fovista® outside the United States

Novartis acquires exclusive ex-US rights to Fovista from Ophthotech; upfront payment of USD 200 million plus potential future recruitment and other milestone payments; additionally Ophthotech to receive royalties on ex-US Fovista sales Fovista is the most advanced anti-PDGF technology in … Read the full press release

Rare Disease Day: Novartis hosts 2nd international conference dedicated to the research of rare and orphan diseases

Company is pleased to host second international conference dedicated to the research of rare and orphan diseases Novartis is engaging in public dialogue to help raise greater awareness of rare diseases and support for patients Company celebrates more than 50 … Read the full press release

Novartis to extend its leadership in clinical trial data transparency

Novartis announces that researchers can now request access to patient level data on newly approved innovative medicines in the United States and EU in 2014 through the Idea Point portal, and is committed to enhancing Clinical Study Report summaries for … Read the full press release

Vaccination: Novartis to provide meningococcal serogroup B (MenB) vaccine Bexsero® to University of California Santa Barbara

FDA granted special use of Bexsero for nearly 20,000 UCSB students and staff in response to outbreak; the vaccine is licensed in Europe, Australia and Canada Novartis is pursuing a US license that would allow immediate public health response to … Read the full press release