Industry News

- Read more about Janssen's Stelara receive European approval to treat adult patients with Crohn’s disease
Janssen-Cilag International NV (Janssen) announced that the European Commission (EC) has approved the use of Stelara (ustekinumab) for the treatment of adult patients with moderately to severely active Crohn’s disease who have had an inadequate response with, lost response to, or were intolerant to either conventional therapy or a tumour necrosis factor alpha (TNFa) antagonist or have medical contraindications to such therapies.
- Read more about Cellnovo files for 510(k) approval with the FDA for its diabetes management system
Cellnovo Group announces that it has filed for 510(k) approval with the US Food and Drug Administration (FDA) for marketing clearance of the Company's diabetes management system.
- Read more about Janssen’s New Phase 3 Data Show efficacy of SIMPONI ARIA® in Patients with Active Ankylosing Spondylitis
Janssen Research & Development, LLC (Janssen) announced new findings from a pivotal Phase 3 study showing the efficacy and safety profile of the intravenously administered anti-tumor necrosis factor (TNF)-alpha therapy SIMPONI ARIA® (golimumab) in the treatment of active ankylosing spondylitis (AS).
- Read more about Pfizer present Results from Phase 3 OPAL study for Investigating XELJANZ® for psoriatic arthritis
Pfizer Inc. announced that new results from the Phase 3 Oral Psoriatic Arthritis TriaL (OPAL) studies, Broaden and Beyond, will be presented at the 2016 ACR/ARHP Annual Meeting (November 11-16, Washington, DC). OPAL Broaden and OPAL Beyond evaluated the efficacy and safety of XELJANZ® (tofacitinib citrate) in adult patients with active psoriatic arthritis (PsA) who had an inadequate response (IR) to conventional synthetic disease-modifying antirheumatic drugs (csDMARDs) or to tumor necrosis factor inhibitors (TNFis), respectively. Detailed results from OPAL Broaden will be presented during a plenary session [#2983] for the first time at ACR/ARHP.
- Read more about Novartis' Entresto® new data shows long-term benefits on heart failure readmissions and total cardiovascular deaths
Novartis announced today results of a new analysis demonstrating that Entresto® (sacubitril/valsartan) tablets reduced the risk of all events - first and repeat heart failure (HF) hospitalizations as well as cardiovascular (CV) deaths that followed HF hospitalization - compared to enalapril among heart failure patients with reduced ejection fraction (HFrEF). The findings are from a post-hoc analysis of PARADIGM-HF, the largest clinical trial ever conducted in HF, and are being presented at the American Heart Association (AHA) Scientific Sessions 2016 in New Orleans.
- Read more about FDA grant Priority Review to Novartis drug PKC412 (midostaurin)
Novartis announced that the US Food and Drug Administration (FDA) granted Priority Review to the PKC412 (midostaurin) new drug application (NDA) for the treatment of acute myeloid leukemia (AML) in newly-diagnosed adults with an FMS-like tyrosine kinase-3 (FLT3) mutation, as well as for the treatment of advanced systemic mastocytosis (SM). The premarket approval application (PMA) for the PKC412 (midostaurin) FLT3 companion diagnostic, developed in collaboration with Invivoscribe Technologies, Inc. (IVS)* has also been accepted for review by the FDA. Outside the US, the marketing authorization application for PKC412 (midostaurin) in these indications has already been accepted by the European Medicines Agency (EMA).
- Read more about Dynavax Receives CRL from U.S. FDA for BLA for HEPLISAV-B
Dynavax Technologies Corporation announced that it has received a Complete Response Letter (CRL) from the U.S. Food and Drug Administration (FDA) regarding its Biologics License Application (BLA) for HEPLISAV-B™ [Hepatitis B Vaccine, Recombinant (Adjuvanted)] for immunization of adults 18 years and older against hepatitis B infection. The FDA issues CRLs to communicate that the Agency has completed a review cycle of an application and to request additional information for review and approval. Dynavax expects a Class 2 designation for a resubmission of the BLA, which would result in a target review period of six months.
- Read more about Novartis ranked third in 2016 Access to Medicine Index
Novartis ranked third in the 2016 Access to Medicine Index (up from 4th place in 2014), in recognition of its efforts to improve worldwide access to healthcare. The Index measures the performance of the top-20 pharmaceutical companies to improve access to medicines and healthcare in developing countries, and is conducted every other year. It covers seven categories, including access-to-medicine management, capacity building, pricing, manufacturing and distribution.

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- Read more about Novartis new data showing Cosentyx deliver long-lasting efficacy in psoriatic arthritis over 3 years in patient-reported pain
Novartis announced new data showing Cosentyx® (secukinumab) delivers sustained improvements in the signs and symptoms of psoriatic arthritis (PsA) over three years - including patient-reported pain. These findings were presented at the 2016 Annual Meeting of the American College of Rheumatology (ACR) in Washington DC, United States, at which Novartis presented 28 abstracts in total.
- Read more about Inovio Pharma Zika vaccine protects animals from infection, brain damage and death
Inovio Pharmaceuticals, Inc. announced that Inovio and its collaborators have published results in Nature Partner Journals (npj) Vaccines demonstrating that its Zika DNA vaccine (GLS-5700) protected animals from infection, brain damage and death. In this study 100% of GLS-5700 vaccinated animals were protected from Zika infection after exposure to the virus. In addition, vaccinated mice were protected from degeneration in the cerebral cortex and hippocampal areas of the brain while unvaccinated mice showed significant degeneration of the brain after Zika infection.