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Goodwin

CuraTeQ Biologics’ Trastuzumab biosimilar Receives Positive Opinion in Europe

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This week, CuraTeQ Biologics (a wholly owned step-down subsidiary of Aurobindo Pharma Limited) announced that its trastuzumab biosimilar, DAZUBLYS, has received a positive opinion from the European Medicines Agency Committee...more

Foley & Lardner LLP

Cancer Drugs: Antibody-Drug Conjugate Litigation

Foley & Lardner LLP on

Antibody-drug conjugates (ADCs) are typically composed of a monoclonal antibody attached to a cytotoxic drug via a chemical linker. The antibody is able to identify biomarkers on and attach to cancer cells, allowing targeted...more

Womble Bond Dickinson

FDA Approves the Gardasil 9 Human Papillomavirus (HPV) Vaccine for Prevention of Head and Neck Cancer

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After a decade or more of research suggesting that the HPV vaccine could be effective in protecting against certain types of head and neck cancer, the FDA has finally given approval for this application of Gardasil 9, the...more

Foley & Lardner LLP

The Era of Personalized Medicine Has Arrived - PMC’s Annual Progress and Outlook Report

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The Personalized Medicine Coalition (PMC) released its annual “Personalized Medicine At FDA: A Progress & Outlook Report” (Report) that monitors current successes and challenges in bringing personalized therapies to market....more

Wilson Sonsini Goodrich & Rosati

CMS Makes CAR T-Cell Cancer Therapy Available to Medicare Beneficiaries Nationwide

Wilson Sonsini Goodrich & Rosati on

Autologous chimeric antigen receptor (CAR) T-cells—which are “living drugs”—are promising, emerging therapeutics in immuno-oncology. One example of these “living drugs” is Kymriah (tisagenlecleucel). The drug, a CD-19...more

Goodwin

ASCO Issues Statement on Use of Biosimilars in Oncology

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The American Society of Clinical Oncology (ASCO) recently issued a statement on use of biosimilars in oncology. According to ASCO, “[a]s many biosimilars come to market in the next several years, their use in oncology will...more

Goodwin

Brazilian Society of Clinical Oncology Publishes Position Statement on Biosimilars in Oncology

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This month the Brazilian Society of Clinical Oncology (SBOC) published a position paper on approval and use issues concerning biosimilars in oncology. The paper, published in the Brazilian Journal of Medical and Biological...more

Goodwin

Samsung Bioepis Receives EU Marketing Authorization For Trastuzumab Biosimilar

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Samsung Bioepis announced today that the European Commission (EC) has granted marketing authorization for Ontruzant®, a biosimilar for Herceptin® (trastuzumab), across all 28 European Union member states and the European...more

Goodwin

Mylan and Biocon Present Trastuzumab Biosimilar Data at ASCO

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On June 3, Mylan N.V. and Biocon Ltd. presented phase 3 clinical data regarding their trastuzumab product (dubbed MYL-1401O), which is a proposed biosimilar to Genentech’s Herceptin, at the 2016 American Society of Clinical...more

Mintz - Health Care Viewpoints

CMS Takes Initial Steps to Address Medicare & Medicaid Coverage for Biosimilars

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On March 30, 2015, CMS released guidance addressing Medicare and Medicaid coverage for biosimilar drug products. The Medicare/Medicaid coverage guidance comes on the heels of the FDA’s landmark approval of a biosimilar...more

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