science wire

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 revealing the reduction in cardio

Roche announced that the European Commission (EU) approved the use of Avastin in combination with chemotherapy as a treatment for women with recurrent ovarian cancer that is resistant to platinum-containing chemotherapy.

Viral diseases like Ebola aren't regarded as commercially interesting; therefore research usually gets stuck in the preclinical phase. But there may be a vaccine available in about one year from now. The Basel-based biotech company Okairos (GSK acquired the company in 2013) has an Ebola vaccine in the preclinical phase.

Basel, 06 August 2014 EU approves Roche's Avastin for platinum-resistant recurrent ovarian cancer First new treatment option for women in Europe in more than 15 years for most difficult to treat form of ovarian cancer Roche announced today that the European Commission (EU) approved the use of Avastin (bevacizumab) in combination with paclitaxel, topotecan, or pegylated liposomal doxorubicin chemotherapy as a treatment for women with recurrent ovarian cancer that is resistant to platinum-containing chemotherapy.

Incyte Corporation announced a clinical trial agreement with Genentech, a subsidiary of Roche, to evaluate the safety, tolerability and preliminary efficacy of Incyte's oral indoleamine dioxygenase-1

Roche and AmorChem announced a collaboration to discover novel small molecule disease-modifying therapy for the treatment of myotonic muscular dystrophy 1 (known as Steinert's disease).

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 treatment and buil

AstraZeneca has announced a partnership with Roche to develop a plasma-based companion diagnostic test to support the development of AZD9291, a clinical stage compound to treat patients with non-small-cell lung cancer (NSCLC) who are resistant to initial treatment.

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 and adolesce

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 therapie

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).

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

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 evolve technolog

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 a crit

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 dissatisfied with curr

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).

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 University of

Genentech, a member of the Roche Group, has entered into a definitive agreement to acquire Seragon Pharmaceuticals, which was spun out of Aragon Pharmaceuticals in August 2013 when the latter was bought by Johnson & Johnson for as much as $1 billion.

Roche has entered a partnership with Inception Sciences (a drug discovery incubator backed by Versant Ventures) to create Inception 5, a new company dedicated to the research and development of novel small molecule remyelinating therapies for patients with multiple sclerosis, an autoimmune-mediated disease of the central nervous system.

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 treating ch

BIND Therapeutics announced that it has entered into a research agreement with Roche to discover novel nanomedicines. The revolutionary clinical-stage nanomedicine platform company develops targeted and programmable therapeutics called Accurins. Accurins are polymeric nanoparticles that incorporate a therapeutic payload and are designed to have prolonged circulation within the bloodstream, enable targeting of the diseased tissue or cells, and provide for the controlled and timely release of the therapeutic payload.

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, complement

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 aggressive disease th

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 antibioticand prese

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 Research s

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 patients had a 5

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 meta

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 available to this population B

Roche acquires Genia Technologies to strengthen next generation sequencing pipeline Roche announced today the acquisition of Genia Technologies, Inc.

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 o

7-Day Challenge integrates wearable technology and social media to track daily activities of people with MS, allowing valuable personal insights to enable change Novartis is collaborating with Tictra

Simbrinza reduced intraocular pressure in two Phase III studies by 23%-34%, 25%-37% respectively, providing strong efficacy, sustained control throughout the day Only beta blocker-free, fixed-dose co

CHMP confirms negative opinion following re-examination of RLX030 - further evidence is required Novartis aims to resubmit for approval with data from ongoing second Phase 3 study (RELAX-AHF-2) Basel, May 23, 2014 - Novartis announced today that the Committee for Medicinal Products for Human Use (CHMP) has adopted a negative opinion for the use of RLX030 (serelaxin) in the treatment of acute heart failure (AHF) indicating that further evidence is required for a license to be granted in the EU.

Pivotal data in ALK+ NSCLC for Zykadia(TM); recently approved by US FDA, marking fastest oncology approval under Breakthrough Therapy designation First presentation of pivotal data from Phase III tri

QUANTIFY study met primary endpoint demonstrating non-inferiority of Ultibro Breezhaler vs tiotropium 18 mcg plus formoterol 12 mcg in improving health-related quality of life outcomes , QUANTIFY stu

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 rece

Agency states further evidence of the efficacy of RLX030 is required for US approval Second phase III study RELAX-AHF-2 progressing well - Novartis intends to resubmit NDA with additional data when available Basel, May 16, 2014 - Novartis announced today that the US Food and Drug Administration (FDA) has issued a Complete Response Letter (CRL) regarding the Biologics License Application (BLA) for RLX030 (serelaxin) for the treatment of acute heart failure (AHF), stating that further evidence on the efficacy of RLX030 is required for a US license to be granted.

Litigation settlement upholds validity of US patents covering polymorphic forms of Gleevec and permits Sun Pharma subsidiary to launch a generic version on February 1, 2016 Patents are vital to the a

LUMINOUS, the largest ongoing trial in medical retina, presented 1-year results on the effectiveness and safety profile of Lucentis in patients with wet AMD COMRADE-B study indicates BRVO patients treated with Lucentis had significantly higher vision gains at month 6 compared with dexamethasone New real-world data demonstrates significant differences in rates of endophthalmitis with aflibercept and Lucentis Basel, May 9, 2014 - Novartis reports

Acromegaly, an endocrine disorder resulting from elevated growth hormone (GH) and insulin-like growth factor-1 (IGF-1) levels, is associated with high mortality[1,2] Phase III data show patients on p

Ultibro Breezhaler demonstrated superiority in lung function compared to Seretide Accuhaler * in chronic obstructive pulmonary disease ( COPD) patients with or without exacerbations in the previous year Primary and key secondary objectives met in pivotal Phase III LANTERN study Positive results to be part of the regulatory submission for Ultibro Breezhaler in China later this year Basel, April 30, 2014 - Novartis today announced positive first r

MS patients have accelerated brain volume loss (up to 3-5 times faster than people without MS), which is associated with physical & cognitive loss of function Data at AAN showed significantly more Gilenya-treated patients (vs.

Zykadia (ceritinib) demonstrated an overall response rate of 54.6% in patients with ALK+ metastatic NSCLC who have no other treatment option Median duration of response to Zykadia was 7&period