Search Results for Roche

Showing 1 – 25  of 34

Greek Health Minister Takes Issue With Roche's Withdrawal of Cancer Medicine Due to Mandatory Discount By Zachary Brennan - Published 31 October 2017

Drug prices are not just a US problem. Greece's minister of health on Tuesday expressed dismay over Roche's decision to withdraw a cancer medicine because of a new mandatory discount imposed by the country.

Categories: News, Europe, Drugs, Reimbursement

Tags: Greece, Roche, Cotellic

Asia Regulatory Roundup: Roche Cancer Drug First to Win TGA Priority Review Status (29 August 2017) By Nick Paul Taylor - Published 29 August 2017

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

Categories: News, Asia, CDSCO, CFDA, Biologics and biotechnology, Drugs, Government affairs

Tags: Asia Regulatory Roundup, Roche, DCGI

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

Asia Regulatory Roundup: India’s NPPA Withdraws List of Pricing Rule Violators (30 May 2017) By Nick Paul Taylor - Published 30 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, In vitro diagnostics, Regulatory intelligence, Regulatory strategy

Tags: Asia Regulatory Roundup, NPPA, Roche, Kazakhstan

New Indication for Roche’s Actemra Means First FDA-Approved Drug to Treat Giant Cell Arteritis By Zachary Brennan - Published 22 May 2017

The US Food and Drug Administration (FDA) on Monday expanded the approved use of Roche’s Actemra (tocilizumab) to treat adults with giant cell arteritis, making it the first FDA-approved therapy for this condition.

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

Tags: Actemra, Roche, giant cell arteritis, monoclonal antibodies

BD, Roche Weigh FDA’s Proposed Exemptions for Class II Devices By Zachary Brennan - Published 15 May 2017

Beckton, Dickinson and Co. (BD) and Roche Diagnostics are seeking clarifications and changes to the US Food and Drug Administration’s (FDA) proposed list of Class II medical devices to be exempted from premarket notification.

Categories: News, US, CDRH, Business and Leadership, Medical Devices, Regulatory intelligence, Regulatory strategy

Tags: Roche Diagnostics, BD, Class II exemptions, 21st Century Cures Act

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

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

UK’s MHRA Allows Early Access to Roche Bladder Cancer Treatment By Zachary Brennan - Published 23 January 2017

The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) on Monday said it will allow Roche’s atezolizumab to be used as part of an early access program for locally advanced or metastatic urothelial carcinoma.

Categories: News, Europe, MHRA, Biologics and biotechnology, Drugs, Government affairs, Regulatory intelligence, Regulatory strategy

Tags: Roche, bladder cancer, EAMS

Industry Weighs in on FDA Draft Guidance on Infectious Disease NGS-Based Diagnostics By Zachary Brennan - Published 27 September 2016

Diagnostic companies Illumina, Roche, AstraZeneca and others are offering a peek inside how they view next-generation sequencing (NGS) diagnostic devices, with the release of 20 comments on recent US Food and Drug Administration (FDA) draft guidance.

Categories: News, US, FDA, In vitro diagnostics, Regulatory intelligence, Regulatory strategy

Tags: Illumina, Roche, AstraZeneca, next-gen sequencing, infectious disease diagnostics

UK’s MHRA Cautions Diabetics on Roche’s Leaky Insulin Cartridges By Zachary Brennan - Published 16 August 2016

The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) on Tuesday said that patients with diabetes using Roche’s Accu-Chek Insight insulin pump should be careful when inserting pre-filled insulin cartridges as Roche has reported an increasing number of instances when patients experienced leaking insulin cartridges.

Categories: News, Europe, MHRA, Crisis management, Drugs, Government affairs, Medical Devices, Postmarket surveillance, Quality

Tags: Roche, insulin pumps, leaking insulin pumps, patients with diabetes, MHRA alerts

FDA Approves First Generic Version of Roche’s Blockbuster Flu Treatment By Zachary Brennan - Published 04 August 2016

The US Food and Drug Administration (FDA) on Thursday announced that it has approved the first generic version of Roche’s Tamiflu (oseltamivir phosphate), a widely used medication for the treatment of the flu (influenza A and B) in patients two weeks of age and older.

Categories: News, US, FDA, Generic drugs, Submission and registration

Tags: Tamiflu, Roche, Natco, ANDA approvals

European Regulatory Roundup: Roche Awaits Outcome of Pharmacovigilance Infringement Procedure (7 July 2016) By Nick Paul Taylor - Published 07 July 2016

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

Categories: News, Europe, EC, EMA, MHRA, Biologics and biotechnology, Drugs, Government affairs, Medical Devices, Research and development

Tags: European Regulatory Roundup, Roche

FDA Authorizes Use of Investigational Diagnostic to Screen Blood Donors for Zika By Michael Mezher - Published 30 March 2016

The US Food and Drug Administration (FDA) on Wednesday said it will permit the use of an investigational blood test to screen donated blood for the Zika virus.

Categories: News, FDA, Blood, In vitro diagnostics

Tags: Zika virus, Roche Diagnostics

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

French Regulator and Roche Trade Blows Over Off-Label Avastin Use By Michael Mezher - Published 25 June 2015

On Monday, Swiss drugmaker Roche announced its opposition to the use of its cancer drug Avastin to treat wet age-related macular degeneration (AMD) in France. The move is aimed squarely at France's drug regulator, who temporarily recommended the drug for AMD as a cost saving maneuver in April 2015.

Categories: News, Europe, Biologics and biotechnology, Labeling, Submission and registration

Tags: France, ANSM, Roche, Avastin, Lucentis, Wet AMD

UK's NICE Rejects Roche's Breast Cancer Drug Kadcyla, Citing Major Cost Concerns By Louise Zornoza, RegLink News - Published 08 August 2014

The UK’s National Institute for Health and Care Excellence (NICE) has issued final draft guidance confirming its earlier rejection of Roche’s breast cancer drug treatment Kadcyla for National Health Service (NHS) coverage.

Categories: News, Europe, NICE, Reimbursement

Tags: NICE, Final Draft Guidance, Roche, Kadcyla, Breast Cancer, Cost

EMA Investigation into Roche Adverse Event Reporting Failures Finds No New Risks By Alexander Gaffney, RF News Editor - Published 19 November 2013

Categories: EMA

Tags: Roche, EU

NICE Rejects Roche's Breast Cancer Drug Perjeta on Cost Considerations By Louise Zornoza, RegLink - Published 07 August 2013

Categories: NICE

Tags: Perjeta, Roche, UK, EU

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

UK's NICE Finds Roche's Avastin Not Cost-Effective for Ovarian Cancer By Louise Zornoza, RegLink - Published 18 December 2012

Categories: Regulatory Update, EMA, NICE, Reimbursement

Tags: Ovarian Cancer, HTA, Roche, Payor, Oncology, CER, UK

Researchers Launch Campaign Calling for Clinical Data Transparency By Alexander Gaffney, RF News Editor - Published 30 October 2012

Tags: Godlee, Goldacre, Researchers, Roche, BMJ, Latest News

EMA Launches EU-Wide Investigation into Roche for Alleged Pharmacovigilance Deficiencies By Alexander Gaffney, RF News Editor - Published 23 October 2012

Categories: EMA

Tags: ADR, Adverse Event Reporting, Roche, Reporting, ADE, Latest News, safety, pharmacovigilance, risk

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