Igeahub.com - Top Pharma News - Luca Dezzani

Pharma 2016: One Year in Review

Lots of new things happened in the pharmaceutical industry in 2016. At igeahub.com, our mission is to make the pharmaceutical world simple and clear to everyone. We want our readers to have a privileged view on the key player in the healthcare system, and we do our best to keep things simple but highly accurate. The … Continue reading Pharma 2016: One Year in Review

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Igeahub.com - Top Pharma News - Luca Dezzani

Top Pharma News – November 2016

New Research Details Published by Merck Scientists About the Early Development of Verubecestat November 2, 2016 Merck has announced the publication of research conducted by Merck scientists on the discovery and development of verubecestat. It is an investigational small molecule inhibitor of the enzyme beta-site amyloid precursor protein cleaving enzyme 1 (BACE1), which is used … Continue reading Top Pharma News – November 2016

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Janssen Submits Application Seeking Approval of Anti-Interleukin-23 Monoclonal Antibody Guselkumab to EMA for Treating Moderate-to-Severe Plaque Psoriasis

November 25 2016 Janssen-Cilag International NV has announced about the submission of a Marketing Authorization Application to the European Medicines Agency (EMA) that seeks approval of guselkumab for treating adults with moderate to severe plaque psoriasis. Guselkumab is a human monoclonal antibody targeting the protein interleukin (IL)-23, which plays an important role in developing immune-mediated … Continue reading Janssen Submits Application Seeking Approval of Anti-Interleukin-23 Monoclonal Antibody Guselkumab to EMA for Treating Moderate-to-Severe Plaque Psoriasis

Biosimilars

Biosimilar Products and Its Commercial Potential

The increasing demand for medicines and other biologic products paved the way to the development of methods that can speed up its production in order to meet the needs of its consumers. One of which is the utilization of biosimilar product, which is defined by the U.S. Food and Drug Administration (FDA) as ‘a biological … Continue reading Biosimilar Products and Its Commercial Potential

Igeahub.com - Top Pharma News - Luca Dezzani

Pharma Oncology | Top News – Fall 2016

AbbVie and Bristol-Myers Squibb Collaborate to Evaluate the Combination of Rova-T plus Opdivo and Opdivo + Yervoy Regimen July 25, 2016 AbbVie and Bristol-Myers Squibb Company have announced a clinical trial collaboration for evaluating the safety, efficacy, and tolerability of investigational biomarker-specific antibody drug conjugate Rova-T (rovalpituuzumab tesirine) of AbbVie in combination with Opdivo (nivolumab) and Opdivo + Yervoy (ipilimumab) regimen … Continue reading Pharma Oncology | Top News – Fall 2016

Igeahub.com - Top Pharma News - Luca Dezzani

Top Pharma News – September and October, 2016

  Bristol-Myers Squibb’s ORENCIA® (abatacept) is Approved by European Commission for the Treatment of Adult Patients with Rheumatoid Arthritis September 6, 2016 Bristol-Myers Squibb Company has announced that the European Commission has approved ORENCIA ® (abatacept) intravenous (IV) infusion and subcutaneous (SC) injection, combined with methotrexate (MTX), for treating highly active and progressive disease in adult patients with rheumatoid … Continue reading Top Pharma News – September and October, 2016

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U.S. FDA Approves Vermox™ Chewable (Mebendazole) for Treating both Children and Adults with Whipworm and Roundworm Infections

Oct 19, 2016 Janssen Pharmaceuticals, Inc. has announced that the Food and Drug Administration (FDA) of U.S. has approved VERMOXTM  CHEWABLE (mebendazole chewable 500mg tablets) for treating patients, both adults and children, with gastrointestinal infections caused by Trichuris trichiura (whipworm) and Ascaris lumbricoides (roundworm). Around the world, this new tablet formulation can provide alternative treatment for millions of children … Continue reading U.S. FDA Approves Vermox™ Chewable (Mebendazole) for Treating both Children and Adults with Whipworm and Roundworm Infections

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Treatment outcome data from The Prostate Cancer Registry presented for the first time at the ESMO Congress 2016

Oct 10, 2016 Janssen-Cilag International NV has presented the first reported primary treatment outcome data from The Prostate Cancer Registry at the 2016 European Society for Medical Oncology (ESMO) Congress in Copenhagen, Denmark. The Prostate Cancer Registry is the first and largest prospective study of men with metastatic castration-resistant prostate cancer (mCRPC) in Europe. The preliminary data … Continue reading Treatment outcome data from The Prostate Cancer Registry presented for the first time at the ESMO Congress 2016

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Janssen Submits Marketing Authorisation Application to European Medicines Agency for Darunavir-Based Single Tablet Regimen for the Treatment of HIV-1

Sep 12, 2016 Janssen-Cilag International NV (Janssen) has announced that it has submitted a Marketing Authorisation Application to the European Medicines Agency (EMA), which seeks approval for a new once-daily darunavir-based single tablet regimen (STR). This tablet would be the first protease inhibitor (PI)-based STR option (D/C/F/TAF FDC) if approved, indicated as a complete regimen … Continue reading Janssen Submits Marketing Authorisation Application to European Medicines Agency for Darunavir-Based Single Tablet Regimen for the Treatment of HIV-1

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Janssen submits application to European Union seeking approval of sirukumab for rheumatoid arthritis

Sep 12, 2016 Janssen-Cilag International NV (Janssen) has announced the submission of a Marketing Authorisation Application (MAA) to the European Medicines Agency (EMA) seeking approval of sirukumab for treating adult patients with moderately to severely active rheumatoid arthritis (RA). Approximately 6.2 million Europeans are affected by RA, which is a chronic, systemic inflammatory condition. Sirukumab … Continue reading Janssen submits application to European Union seeking approval of sirukumab for rheumatoid arthritis