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Amgen Submits Applications in the US and Europe for Expanding Current Indication For XGEVA (denosumab) to Include Patients with Multiple Myeloma

April 4, 2017 Amgen has announced the submission of a supplemental Biologics License Application (sBLA) to the U.S. Food and Drug Administration (FDA) and an application for a variation to the marketing authorization to the European Medicines Agency (EMA) for XGEVA® (denosumab). These submissions to regulatory authorities seek to expand the currently approved XGEVA indication for the prevention of skeletal-related events … Continue reading Amgen Submits Applications in the US and Europe for Expanding Current Indication For XGEVA (denosumab) to Include Patients with Multiple Myeloma

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Bristol-Myers Squibb Collaborates with Foundation Medicine to Identify Predictive Biomarkers Across Multiple Tumor Types and Immunotherapy Agents

March 30, 2017 Bristol-Myers Squibb Company and Foundation Medicine has announced a collaboration that leverages comprehensive genomic profiling and molecular information solutions of Foundation Medicine to identify predictive biomarkers like Tumor Mutational Burden (TMB) and Microsatellite Instability (MSI) in patients enrolled across clinical trials investigating cancer immunotherapies of Bristol-Myers Squibb. Biomarkers can be used to characterize a … Continue reading Bristol-Myers Squibb Collaborates with Foundation Medicine to Identify Predictive Biomarkers Across Multiple Tumor Types and Immunotherapy Agents

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EU approves Novartis drug combination Tafinlar + Mekinist for BRAF V600-positive advanced non-small cell lung cancer (NSCLC)

APR 03, 2017 Novartis has announced the European Commission has approved Tafinlar®(dabrafenib) in combination with Mekinist® (trametinib) for treating patients with BRAF V600-positive advanced or metastatic non-small cell lung cancer (NSCLC). This approval marks the first targeted treatment approved for the patient population, who previously had few treatment options, in all 28 member states of the … Continue reading EU approves Novartis drug combination Tafinlar + Mekinist for BRAF V600-positive advanced non-small cell lung cancer (NSCLC)

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Top Pharma News | March – April 2017

Bristol-Myers Squibb Planning Collaboration with GRAIL on Blood-Based Cancer Screening March 1, 2017 Bristol-Myers Squibb Company plans for a research collaboration with GRAIL Inc., a life sciences company whose mission is to detect cancer early when it potentially can be cured. GRAIL aims to develop highly sensitive blood tests that detect cancer in its early … Continue reading Top Pharma News | March – April 2017

FDA Approves Tesaro’s niraparib for ovarian cancer

March 27, 2017 The FDA has given approval to Tesaro for the use of its PARP drug niraparib, which will now be marketed as Zejula as a maintenance therapy for the treatment of recurrent ovarian cancer. Tesaro had argued that the efficacy data for niraparib qualified for an approval for use in patients who are either … Continue reading FDA Approves Tesaro’s niraparib for ovarian cancer

Addiction-Resistant Opioid of Nektar Reduces Chronic Back Pain

Mar 20, 2017 Nektar Therapeutics has reported results from the first late-stage clinical trial showing its experimental, addiction-resistant opioid NKTR-181 reduces pain significantly more than a placebo in patients with chronic back problems. NKTR-181 failed to beat placebo in a previous, randomized phase II pain study. Hence, this positive outcome of the phase III "SUMMIT-07" study comes as … Continue reading Addiction-Resistant Opioid of Nektar Reduces Chronic Back Pain

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Roche announces the launch of cobas HPV on the cobas 6800/8800 Systems for cervical cancer screening in markets

28 March 2017 Roche has announced the CE-IVD launch of cobas® HPV for use on the cobas® 6800/8800 Systems for cervical cancer screening. Human Papillomavirus (HPV) is a known cause of cervical cancer and is used to identify women at risk. This HPV DNA assay adds to the growing CE-IVD menu on the cobas 6800/8800 Systems, … Continue reading Roche announces the launch of cobas HPV on the cobas 6800/8800 Systems for cervical cancer screening in markets

FDA green-lights Newron’s Parkinson’s disease drug Xadago

After seven years of trial and error, the FDA has finally offered a green light for Newron’s Parkinson’s drug safinamide after following two radically different paths to get it on the market in Europe and the US. Previously, FDA refused to even accept their first application in 2014, faulting them for a series of mistakes … Continue reading FDA green-lights Newron’s Parkinson’s disease drug Xadago

FDA Approves the checkpoint contender avelumab from Merck KGaA and Pfizer

  March 23, 2017 The biopharma partners Merck KGaA and Pfizer came away with their first FDA approval of the checkpoint inhibitor avelumab. This made it the fourth drug in this category to make it to the market. The FDA approves this for Merkel cell carcinoma under an accelerated approval process. The drug is currently in … Continue reading FDA Approves the checkpoint contender avelumab from Merck KGaA and Pfizer

Investigational Ebola Vaccine Regimen Induced Durable Immune Response 1 Year After Vaccination in Phase 1 Study, Reported by Johnson & Johnson

March 14, 2017 Johnson & Johnson announced that final Phase 1 clinical trial data published in JAMA: The Journal of the American Medical Association show that the investigational “prime-boost” Ebola vaccine regimen of Janssen Pharmaceutical Companies induced a durable immune response in 100 percent of healthy volunteers one year following vaccination. The Oxford Vaccine Group at the University … Continue reading Investigational Ebola Vaccine Regimen Induced Durable Immune Response 1 Year After Vaccination in Phase 1 Study, Reported by Johnson & Johnson