Industry News

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.

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).

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.

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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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.

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.

Silicon Valley medical device innovator CapsoVision, Inc. is pleased to announce that they have received U.S. Food and Drug Administration (FDA) 510(k) clearance for the CapsoCam® Plus small bowel capsule endoscope system.

Bristol-Myers Squibb Company  announced that the U.S. Food and Drug Administration (FDA) has approved Opdivo (nivolumab) injection, for intravenous use, for the treatment of patients with recurrent or metastatic squamous cell carcinoma of the head and neck (SCCHN) with disease progression on or after platinum-based therapy. Opdivo is the first and only Immuno-Oncology treatment proven in a Phase 3 trial to significantly extend overall survival (OS) for these patients. In oncology clinical trials, OS is considered the gold standard primary endpoint to evaluate the outcome of any therapy.

Gilead Sciences, Inc. announced that the US Food and Drug Administration (FDA) has approved Vemlidy (tenofovir alafenamide, TAF) 25mg, a once-daily treatment for adults with chronic hepatitis B virus (HBV) infection with compensated liver disease.

Roche announced positive results from the phase III GiACTA study, which evaluated Actemra®/RoActemra® (tocilizumab) in people with giant cell arteritis (GCA). GiACTA met its primary and key secondary endpoint, demonstrating that Actemra/RoActemra – initially in combination with a six month steroid (glucocorticoid) taper – enabled significantly more patients to achieve sustained disease remission while also significantly reducing steroid exposure compared with steroids alone.¹ Data results will be presented in an oral session on Sunday, 13 November at the 2016 American College of Rheumatology (ACR) and Association for Rheumatology Health Professionals (ARHP) Annual Meeting.