Top Pharma News - IgeaHub

Top Pharma News | May – June 2017

AstraZeneca’s Imfinzi (durvalumab) receives US FDA accelerated approval for previously treated patients with advanced bladder cancer 01 May 2017 AstraZeneca and its global biologics research and development arm, MedImmune, have announced that the US Food and Drug Administration (FDA) has granted accelerated approval to Imfinzi (durvalumab). Imfinzi is indicated for the treatment of patients with locally advanced or metastatic … Continue reading Top Pharma News | May – June 2017

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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

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

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

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FDA Approved Keytruda of Merck for Hodgkin lymphoma

March 14, 2017 Merck has received another FDA approval for Keytruda, and this time for classical Hodgkin lymphoma, marking the PD-1 blocker’s first green-light for use in liquid tumors. Regulators handed out the approval for patients who had already failed at least three therapies. The approval was a first for Merck, but it comes 9 months … Continue reading FDA Approved Keytruda of Merck for Hodgkin lymphoma

FDA lifts its hold on vadastuximab talirine after Seattle Genetics adds new safeguards

March 6, 2017 The FDA has given Seattle Genetics the green light to continue the trials for its armed antibody dubbed SGN-CD33A (vadastuximab talirine) used for the treatment of acute myeloid leukemia. The biotech says it is implementing additional risk mitigation measures in all vadastuximab talirine studies, including “revised eligibility criteria and stopping rules for veno-occlusive disease.” … Continue reading FDA lifts its hold on vadastuximab talirine after Seattle Genetics adds new safeguards

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Novartis gets FDA Approval for LEE011 for frontline use against breast cancer

March 13, 2017 Novartis has gained the FDA approval for LEE011, its CDK 4/6 drug now approved as a frontline therapy for postmenopausal women with hormone-receptor positive, human epidermal growth factor receptor-2 negative advanced or metastatic breast cancer in combination with any aromatase inhibitor. Also known as ribociclib, the drug hits the market as Kisqali with … Continue reading Novartis gets FDA Approval for LEE011 for frontline use against breast cancer

U.S. FDA and EMA Accepts Three Marketing Applications for Ertugliflozin-Containing Medicines for Adults with Type 2 Diabetes, Announced by Merck and Pfizer

March 6, 2017 Merck and Pfizer Inc. have announced that the U.S. Food and Drug Administration (FDA) has accepted for review three New Drug Applications (NDAs) for medicines containing ertugliflozin, an investigational SGLT2 inhibitor in development for helping to improve glycemic control in adults with type 2 diabetes: one for monotherapy, one for the fixed-dose … Continue reading U.S. FDA and EMA Accepts Three Marketing Applications for Ertugliflozin-Containing Medicines for Adults with Type 2 Diabetes, Announced by Merck and Pfizer

FDA Accepts the Biologics License Application for Avelumab for the Treatment of Metastatic Urothelial Carcinoma

February 28, 2017 EMD Serono, the biopharmaceutical business of Merck KGaA, Darmstadt, Germany, and Pfizer Inc. have announced that the US Food and Drug Administration (FDA) has accepted the Biologics License Application (BLA) for avelumab for Priority Review as a treatment for patients with locally advanced or metastatic urothelial carcinoma (mUC) with disease progression on … Continue reading FDA Accepts the Biologics License Application for Avelumab for the Treatment of Metastatic Urothelial Carcinoma