Search Results for GlaxoSmithKline

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Multiple Endpoints in Clinical Trials: Biopharma Companies Seek More From FDA Draft Guidance By Zachary Brennan - Published 16 March 2017

Biopharmaceutical heavyweights – from Novartis to GlaxoSmithKline to Regeneron – are seeking additional clarification from the US Food and Drug Administration (FDA) on draft guidance on multiple endpoints in clinical trials, according to comments posted to the docket on Thursday.

Categories: News, US, FDA, Biologics and biotechnology, Clinical, Drugs, Postmarket surveillance

Tags: GlaxoSmithKline, Regeneron, Novartis, Teva, BIO, Celgene, AstraZeneca, clinical trial endpoints

Brexit Rejig: UK Taps Three Leaders to Helm Office for Life Sciences By Zachary Brennan - Published 04 August 2016

The UK’s Office for Life Sciences, which will continue to be a joint unit across the Department of Health (DH) and the newly formed Department for Business, Energy, and Industrial Strategy (BEIS), on Thursday selected three new ministers to lead.

Categories: News, Europe, EMA, MHRA, NICE, Biologics and biotechnology, Drugs, Government affairs

Tags: Brexit, UK Office for Life Sciences, GlaxoSmithKline

EMA, MHRA, Janssen Warn of Increased Risk of Toe Amputation With Type 2 Diabetes Drug By Zachary Brennan - Published 11 May 2016

A two-fold higher incidence of lower limb amputation, primarily of the toe, has been seen in a clinical trial with canagliflozin, Janssen, the European Medicines Agency (EMA) and UK’s Medicines and Healthcare products Regulatory Agency (MHRA) said in a letter to health professionals.

Categories: News, Europe, EMA, MHRA, Active pharmaceutical ingredients, Biologics and biotechnology, Crisis management, Drugs, Labeling, Postmarket surveillance

Tags: Janssen, Johnson & Johnson, Pfizer, GlaxoSmithKline, canagliflozin, Celgene, Novartis

Industry Calls for More Guidance From FDA on New Clinical Trials Technology By Zachary Brennan - Published 11 May 2016

The initiation of a new era of mobile health technology has erupted into industry calling on the US Food and Drug Administration (FDA) to offer more guidance on how best to use new technology, like Fitbits and mobile apps, in clinical trials, and to find ways that don’t restrict the development of novel tech products.

Categories: News, US, FDA, Clinical, Government affairs, Medical Devices, Research and development

Tags: Fitbit, mHealth, Medidata, Pfizer, GlaxoSmithKline, mobile health technology

Updated: UK’s MHRA Calls Out GSK China Plant Over GMP Non-Compliance By Zachary Brennan - Published 23 October 2015

The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) on Friday released an inspection report that found a GlaxoSmithKline (GSK) manufacturing facility in Tianjin, China was non-compliant with Good Manufacturing Practices (GMPs).

Categories: Drugs, Manufacturing, Quality, Regulatory intelligence, Regulatory strategy

Tags: GlaxoSmithKline, China, drug manufacturing, China drug manufacturing

GSK Announces Grant Program to Support 'Electroceuticals,' Raising Regulatory Questions By Alexander Gaffney, RF News Editor - Published 11 April 2013

Tags: GlaxoSmithkline, GSK

In Shift, GSK to Publish Clinical Trials Data By Alexander Gaffney - Published 11 October 2012

Tags: Paxil, Avandia, GlaxoSmithkline, GSK, Public, Transparency, Latest News, clinical trials

Lung Disease Drug Testing Complete; Global Approval Sought Published 27 August 2012

The final stage of testing for a lung disease drug is finished, and GlaxoSmithKline (GSK) said it will seek global market approval, according to a Reuters report.

Tags: COPD, GlaxoSmithkline, Latest News, drug

GSK Settles Charges, Agrees to Record-Setting Fine By Alexander Gaffney - Published 03 July 2012

Categories: DOJ

Tags: CIA, GlaxoSmithkline, GSK, Settlement, Fine, OIG, Latest News, DHHS

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

New Combination Vaccine Approved by FDA By Alexander Gaffney - Published 15 June 2012

Categories: FDA, CBER

Tags: Midthun, GlaxoSmithkline, Vaccine, GSK, 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