Pharma News

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.

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).

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.

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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Scientists from the National Institutes of Health have identified an antibody from an HIV-infected person that potently neutralized 98 percent of HIV isolates tested, including 16 of 20 strains resistant to other antibodies of the same class. The remarkable breadth and potency of this antibody, named N6, make it an attractive candidate for further development to potentially treat or prevent HIV infection, say the researchers.