Pharma News

Clever Culture Systems AG (CCS), the Swiss based joint venture between Australian medical technology company LBT Innovations Limited (ASX: LBT) and Hettich AG (Switzerland) has received clearance of its 510(k) de novo submission to the US Food and Drug Administration (FDA) for APAS® as a Class II medical device.

Novartis announced data from the phase III COMBI-v study demonstrating an overall survival (OS) and a progression-free survival benefit for patients with BRAF V600 mutation-positive advanced melanoma when treated first-line with the combination of Tafinlar (dabrafenib) + Mekinist (trametinib) compared to vemurafenib monotherapy. The results of this study, which was conducted in 704 patients, are being presented at the European Society for Medical Oncology (ESMO) 2016 Congress in Copenhagen.

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Novartis announced updated results from a Phase II study (ASCEND-3), which demonstrated that anaplastic lymphoma kinase-positive (ALK+) non-small cell lung cancer (NSCLC) patients taking Zykadia® (ceritinib) as their first ALK inhibitor (post-chemotherapy) had a median progression-free survival (PFS) of 18.4 months [95% CI: 10.9-26.3; median follow-up time of 25.9 months, as measured by blinded independent review committee (BIRC).Results were presented during an oral session at the Annual European Society for Medical Oncology Congress (ESMO) in Copenhagen.

Nicox S.A. announced that it has received a Complete Response Letter (CRL) from the U.S. Food and Drug Administration (FDA) regarding the New Drug Application (NDA) for AC-170, its novel, proprietary, cetirizine eye drop formulation, for the treatment of ocular itching associated with allergic conjunctivitis.

Although individuals often consume natural products because of their potential health benefits, a new review indicates that it is not clear whether the benefits of plant-derived compounds that mimic estrogen outweigh the possible health risks. The findings are published in the British Journal of Pharmacology.

Zydus group has entered into an in-licensing agreement with Neovii, a Switzerland based global biopharmaceutical company to launch Grafalon, an immunosuppresant extensively used in solid organ transplants and stem cell transplant, in India. Neovii has been dedicated for over three decades to improve the outcomes in transplantation medicine, hemato-oncological and immune disorders.

Innovus Pharmaceuticals, Inc. (Innovus Pharma), an emerging commercial stage pharmaceutical company, has initiated a pre-clinical and clinical programme intended to evaluate the safety and efficacy of the combination of its supplement Vesele for promoting sexual health with sildenafil indicated for treating erectile dysfunction. Sildenafil in the US is sold under the name Viagra by Pfizer, Inc. (Pfizer).

Amgen announced that new data on Imlygic (talimogene laherparepvec) in combination with an immune checkpoint inhibitor and results from retrospective analyses on Vectibix (panitumumab) will be presented at the European Society for Medical Oncology (ESMO) 2016 Congress, October 7-11, 2016, in Copenhagen.