Search Results for GSK

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Asia Regulatory Roundup: Australia, Singapore Expand Generic Drug Work-Sharing Trial (12 December 2017) By Nick Paul Taylor - Published 12 December 2017

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

Categories: News, Asia, Oceania, TGA, Compliance, Drugs, Government affairs

Tags: Asia Regulatory Roundup, ACSS, GSK, Novartis

European Regulatory Roundup: ex-GSK CEO to Chair UK Accelerated Access Collaborative (9 November 2017) By Nick Paul Taylor - Published 09 November 2017

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

Categories: News, Europe, EC, EMA, Drugs, Government affairs, Regulatory intelligence

Tags: GSK, accelerated access, DKMA, Celgene

Biopharma Firms Seek Clarity on FDA Draft Guidance on CMC Annual Reports By Zachary Brennan - Published 16 October 2017

Industry groups and biopharma companies are seeking additional clarity from the US Food and Drug Administration (FDA) regarding draft guidance released in August on chemistry, manufacturing and controls (CMC) postapproval changes to be documented in annual reports.

Categories: News, US, FDA, Biologics and biotechnology, Manufacturing, Regulatory intelligence, Regulatory strategy

Tags: CMC changes, BIO, Sanofi, Pfizer, GSK, AAM

Industry Supports FDA Proposal to Create New Office of Patient Affairs By Zachary Brennan - Published 13 June 2017

Industry groups BIO and TransCelerate, as well as companies GlaxoSmithKline and Shire, have offered their support for the creation of a new office at the US Food and Drug Administration (FDA) focused on patient affairs.

Categories: News, US, FDA, Biologics and biotechnology, Business and Leadership, Drugs, Project management, Regulatory intelligence, Regulatory strategy

Tags: BIO, GSK, TransCelerate, Shire, Office of Patient Affairs, FDA patient engagement

FDA Science Board Weighs Plan for 'Cures' Funds By Zachary Brennan - Published 09 May 2017

The US Food and Drug Administration’s (FDA) science board met Tuesday to discuss an agency plan to spend $500 million over nine fiscal years on a variety of topics stipulated by the passage of the 21st Century Cures Act.

Categories: News, US, FDA, Biologics and biotechnology, Drugs, Regulatory intelligence, Regulatory strategy

Tags: FDA science board, Celgene, GSK, Amgen, 21st Century Cures

Asia Regulatory Roundup: CFDA Releases Draft Guidance on Data Management (18 October 2016) By Nick Paul Taylor - Published 18 October 2016

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

Categories: News, Asia, CDSCO, CFDA, TGA, Drugs, Labeling, Quality

Tags: Asia Regulatory Roundup, GSK, Abbott, data management

FDA Warns GSK’s UK Site for Contamination in API Manufacturing By Zachary Brennan - Published 20 July 2016

The US Food and Drug Administration (FDA) on Wednesday released a warning letter for GlaxoSmithKline’s Worthing, UK-based active pharmaceutical ingredient (API) manufacturing site.

Categories: News, Europe, US, FDA, Active pharmaceutical ingredients, Manufacturing

Tags: GSK, penicillin, API manufacturing

Gavi Commits $27.5m to WHO Malaria Vaccine Candidate’s Pilot Program as More Funds Needed By Zachary Brennan - Published 23 June 2016

The public-private vaccine alliance known as Gavi on Thursday pledged $27.5 million to a pilot project that the World Health Organization is running to introduce a malaria vaccine candidate into sub-Saharan Africa.

Categories: News, Africa, WHO, Biologics and biotechnology, Government affairs, Project management, Regulatory intelligence, Submission and registration

Tags: Gavi, PATH, malaria vaccine, GSK, Gates Foundation

FDA: Explosions at Chinese Chemical Warehouse Contaminated Drugs By Zachary Brennan - Published 22 December 2015

The US Food and Drug Administration (FDA) on Tuesday alerted compounders and drug manufacturers that shipments from Tianjin, China may be at risk of chemical contamination following two massive explosions in August at a chemical warehouse there. 

Categories: News, China, US, CFDA, FDA, Active pharmaceutical ingredients, Crisis management, Distribution, Drugs, Government affairs, Product withdrawl and retirement, Quality, Regulatory intelligence

Tags: FDA, Tianjin, CFDA, chemical explosion, GSK

Why EMA Recommends Medicines for Foreign Use: Article 58 Procedure By Michael Mezher - Published 24 July 2015

Today, the European Medicines Agency (EMA) recommended the world's first malaria vaccine. However, unlike most of the medicines EMA reviews, the agency's recommendation won't be forwarded to the European Commission for authorization.

Categories: Africa, Asia, Europe, Latin America and Caribbean, EMA, WHO, Biologics and biotechnology, Regulatory strategy

Tags: Mosquirix, GSK, Article 58, malaria

India Fines GSK, Sanofi for Alleged Anti-Competitive Practices By Michael Mezher - Published 09 June 2015

The Indian subsidiaries of two European drugmakers, GlaxoSmithKline (GSK) and Sanofi, have been fined for allegedly plotting to charge higher prices in a government tender for a meningitis vaccine, The Economic Times reports.

Categories: News, India, Biologics and biotechnology

Tags: Competition Commission of India, CCI, GSK, Sanofi, Meningitis vaccine

FDA Warning Letter Hits GSK for Contaminated API, Reproducibility Challenges By Alexander Gaffney, RAC - Published 01 April 2014

Categories: US, FDA

Tags: GSK, warning letter, Contamination, Latest News, cGMP

As GSK Recalls Weight Loss Drug After Tampering, A Focus on Limits of the DQSA By Alexander Gaffney, RAC - Published 28 March 2014

Categories: US, FDA

Tags: 503(b)(1), Prescription Drug, Alli, Drug Quality and Security Act, DQSA, OTC, GSK, Track and Trace, Latest News, pharmaceutical, drug

GSK Warns Some of its OTC Weight Loss Drug Has Been 'Tampered With' By Alexander Gaffney, RAC - Published 26 March 2014

Categories: US

Tags: Tampering, Alli, OTC, GSK, Counterfeit, Investigation, Adulteration, Latest News

GSK Bets Big on Bioelectronic Medicine as Regulatory Questions Loom on Horizon By Alexander Gaffney, RF News Editor - Published 08 August 2013

Tags: GSK, Biopharmaceutical

In Reversal, NICE Gives GSK’s Revolade Thumbs-up for Bleeding Disorder By Louise Zornoza, RegLink - Published 25 July 2013

Categories: NICE

Tags: GSK, UK, EU

NICE Opens Second Consultation on GSK's Belimumab for Lupus By Louise Zornoza, RegLink - Published 24 July 2013

Categories: NICE

Tags: GSK, UK, EU

GSK's Less Effective, Less Costly Bleeding Disorder Treatment Wins NICE Backing By Louise Zornoza, RegLink - Published 13 June 2013

Categories: NICE

Tags: GSK, UK

GSK's new COPD Therapy Wins FDA Approval By Alexander Gaffney, RF News Editor - Published 10 May 2013

Categories: US, FDA

Tags: GSK, approval, NDA

GSK Investigated for 'Pay-for-Delay' Agreements in UK By Alexander Gaffney, RF News Editor - Published 19 April 2013

Tags: Competition, GSK, Pay-For-Delay, Pay For Delay, UK

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

Tags: GlaxoSmithkline, GSK

PhRMA, BIO, GSK Call on FDA to Alter eCTD Draft Guidance By Alexander Gaffney, RF News Editor - Published 12 March 2013

Categories: FDA

Tags: BIO, GSK, PhRMA, eCTD

GSK to Publish Results of All Clinical Trials Conducted since Company's Founding By Alexander Gaffney, RF News Editor - Published 05 February 2013

Tags: AllTrials, Goldacre, Clinical Data, GSK, clinical trials

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

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