Search Results for Herceptin

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FDA Approves Eighth Biosimilar, First for Cancer Drug Herceptin By Zachary Brennan - Published 01 December 2017

The US Food and Drug Administration (FDA) on Friday approved the first biosimilar to Roche’s breast and stomach cancer drug Herceptin (trastuzumab). Mylan and Biocon’s biosimilar is called Ogivri (trastuzumab-dkst) and follows a back and forth of delays with regulators over manufacturing issues at a plant in India.

Categories: News, Canada, Europe, US, FDA, Biologics and biotechnology

Tags: Herceptin, biosimilar, FDA approval

FDA Panel Unanimously Backs Avastin and Herceptin Biosimilars By Michael Mezher - Published 13 July 2017

The US Food and Drug Administration's (FDA) Oncologic Drugs Advisory Committee (ODAC) on Thursday unanimously backed the approval of biosimilar versions of two of Roche's top selling cancer drugs, Avastin (bevacizumab) and Herceptin (trastuzumab).

Categories: News, US, FDA, Biologics and biotechnology, Submission and registration

Tags: Avastin, Herceptin, Biosimilars, ADP 215, MYL-1401O

NICE, Roche Reach Deal on Breast Cancer Drug By Michael Mezher - Published 15 June 2017

Patients in the UK could soon get access to Roche's targeted breast cancer drug Kadcyla (trastuzumab emtansine) through the National Health Service (NHS) as early as next month, the National Institute for Health and Care Excellence (NICE) said on Thursday.

Categories: News, Europe, NICE, Biologics and biotechnology, Reimbursement

Tags: NICE, Roche, Kadcyla, Herceptin, Trastuzumab

WHO to Begin Cancer Biosimilar Prequalification Pilot This Fall By Michael Mezher - Published 04 May 2017

The World Health Organization (WHO) on Thursday announced it will invite biosimilar makers to participate in a pilot program to prequalify biosimilars of two top selling biologics this September in an effort bring lower cost versions of the products to low- and middle-income countries.

Categories: News, WHO, Biologics and biotechnology, Submission and registration

Tags: Biosimilars, Prequalification, Rituxan, Herceptin, Rituximab, Trastuzumab

Asia Regulatory Roundup: Indian Watchdog Probes Allegations Roche Tried to Influence Regulators (2 May 2017) By Nick Paul Taylor - Published 02 May 2017

Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia.

Categories: News, Asia, CDSCO, CFDA, TGA, Biologics and biotechnology, Drugs, Government affairs, Medical Devices, Regulatory intelligence, Regulatory strategy

Tags: Medtronic, Abbott, Roche, Herceptin, biosimilars

European Regulatory Roundup: EMA Begins Review of First Herceptin Biosimilar (1 September 2016) By Nick Paul Taylor - Published 01 September 2016

Welcome to our European Regulatory Roundup, our weekly overview of the top EU regulatory news.

Categories: News, Europe, EC, EMA, MHRA, NICE, Biologics and biotechnology, Drugs, Manufacturing, Medical Devices, Regulatory intelligence, Regulatory strategy

Tags: EUnetHTA, 3D modeling of heart disease, Genentech, Herceptin

India Releases New Biosimilars Guidance By Zachary Brennan - Published 28 March 2016

India’s Central Drugs Standard Control Organization (CDSCO) on Saturday released new guidance for biosimilar developers as new biosimilars come to market there before other regions, and as India's regulators look to develop more specific guidance on postmarketing studies.

Categories: News, India, Korea, CDSCO, Biologics and biotechnology, Clinical, Government affairs, Manufacturing, Postmarket surveillance

Tags: biosimilars, biosimilar guidance, CDSCO guidance, India biosimilars, Herceptin

EU Regulators Warn of Counterfeit Copies of Cancer Drug Herceptin By Alexander Gaffney, RAC - Published 16 April 2014

Categories: EMA

Tags: FMD, Theft, Herceptin, Counterfeit, Latest News, Falsified Medicines Directive, EU

Non-Proprietary Name Confusion Leads to Safety Warning for New Breast Cancer Drug By Alexander Gaffney, RF News Editor - Published 06 May 2013

Categories: US, FDA

Tags: Herceptin, MedWatch

India Moves to Grant Three More Compulsory Licenses for Cancer Medications Based on Cost Published 03 May 2013

Categories: India

Tags: Compulsory License, BMS, Herceptin, Roche, Genentech, Patent

UK: NICE Says No to Two Breast Cancer Drugs By Louise Zornoza, RegLink - Published 28 June 2012

Categories: Regulatory Update, NICE

Tags: GlaxoSmithkline, Herceptin, lapatinib, trastuzumab, Tyverb, Breast Cancer, Roche, UK

FDA Approves New Breast Cancer Drug Despite Manufacturing Concerns By Alexander Gaffney - Published 11 June 2012

Categories: FDA, CDER

Tags: Perjeta, Herceptin, Breast Cancer, Woodcock, Pazdur, Latest News

UK: Two Breast Cancer Drugs not Recommended by NICE in Latest Draft Guidance By Louise Zornoza, RegLink - Published 27 April 2012

Categories: Regulatory Update, EMA, NICE

Tags: GlaxoSmithkline, Herceptin, lapatinib, trastuzumab, Tyverb, Cost Effectiveness, MBC, HER2, Breast Cancer, GSK, Roche, cost, UK, cancer