Search Results for Genentech

Showing 1 – 11

Genentech Files Complaint Over Amgen’s Development of Avastin Biosimilar By Zachary Brennan - Published 20 February 2017

Roche’s Genentech filed a complaint in Delaware District Court last week charging that Amgen, which is developing a biosimilar version of Genentech’s blockbuster cancer treatment Avastin (bevacizumab), has obstructed its ability to determine whether the manufacture and/or sale of Amgen’s biosimilar would infringe Genentech’s patents.

Categories: News, US, FDA, Biologics and biotechnology, Compliance, Regulatory intelligence, Submission and registration

Tags: Genentech, Roche, Avastin, Amgen, biosimilars

Illumina, Genentech and BIO Weigh in on FDA Draft Guidance on Companion Diagnostics By Zachary Brennan - Published 18 October 2016

The six public comments on the US Food and Drug Administration’s (FDA) draft guidance on companion diagnostics were mostly positive, with Genentech calling the draft “crucial for the advancement of personalized medicine,” while Illumina said it was “worth the wait,” though all commenters expressed interest in more clarity from FDA.

Categories: News, US, FDA, Biologics and biotechnology, Clinical, Combination products, Compliance, Drugs, Government affairs, In vitro diagnostics, Medical Devices, Regulatory intelligence, Regulatory strategy

Tags: companion diagnostics, IVDs, personalized medicine, Illumina, Genentech, AstraZeneca, BIO

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’s CDSCO Warns Against Using Roche’s Avastin as Eye Treatment By Zachary Brennan - Published 21 January 2016

India’s Central Drugs Standards Control Organization (CDSCO) issued an alert Thursday notifying state and local authorities that Roche’s blockbuster drug Avastin has not been approved to treat any ophthalmology conditions and can lead to vision loss.

Categories: News, India, CDSCO, Biologics and biotechnology, Drugs, Government affairs, Postmarket surveillance

Tags: Avastin, Roche, Novartis, Lucentis, Genentech, CDSCO

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

New Breast Cancer Treatment Approved by FDA is Fourth in Last Six Years By Alexander Gaffney, RF News Editor - Published 22 February 2013

Categories: FDA, CDER

Tags: Priority Review, Roche, Genentech

FDA Untitled Letter Chides Genentech Promo for Inadequate Substantiation of Claims By Alexander Gaffney, RF News Editor - Published 15 October 2012

Categories: FDA

Tags: Tarceva, Untitled Letter, Genentech, Latest News, marketing, advertising

Report: Comments on Draft Biosimilar Guidelines Mostly Trend Negative By Alexander Gaffney - Published 16 April 2012

Categories: FDA

Tags: Novo Nordisk, Comments, Genentech, Latest News, BPCI, testing, biosimilar, draft guidance, guidance, Biosimilars

New Batch of Counterfeit Cancer Drug Avastin Found in US By Alexander Gaffney - Published 04 April 2012

Categories: FDA

Tags: Fake, Counterfeit, Roche, Genentech, Avastin, Supply Chain, Latest News, cancer

Agency Releases Rationale Behind Withdrawal of Avastin's Breast Cancer Indication By Alexander Gaffney - Published 27 February 2012

Categories: FDA

Tags: Text, HER2, Breast Cancer, Roche, Genentech, Avastin, Latest News, Hamburg, decision

Counterfeit Avastin Found in US, Warns FDA By Alexander Gaffney - Published 15 February 2012

Categories: FDA

Tags: Counterfeit, Roche, Genentech, Avastin, Latest News, letters