Search Results for Celgene

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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

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

Multiple Endpoints in Clinical Trials: Biopharma Companies Seek More From FDA Draft Guidance By Zachary Brennan - Published 16 March 2017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GlaxoSmithKline to Regeneron – are seeking additional clarification from the US Food and Drug Administration (FDA) on draft guidance on multiple endpoints in clinical trials, according to comments posted to the docket on Thursday.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

Celgene, Takeda and Others Found in Breach of UK’s Pharma Code of Practice By Zachary Brennan - Published 14 March 2017

When is it OK for a pharmaceutical company to fail to quality check bags stored in a basement for three years before supplying them to pharmacies to use when dispensing the chemotherapy Navelbine (vinorelbine) to patients? Apparently never, according to Tuesday’s rundown of companies breaching the Association of British Pharmaceutical Industry’s (APBI) Code of Practice.

Categories: News, Europe, MHRA, Biologics and biotechnology, Compliance, Crisis management, Drugs, Ethics

Tags: Celgene, Takeda, Pierre Fabre, PMCPA, ABPI

Pharma Companies Take Issue With FDA Proposal to Overhaul Nonclinical Study Regulations By Zachary Brennan - Published 26 January 2017

A group of the world’s largest biopharmaceutical companies, including Pfizer, Novartis, Celgene, Bristol-Myers Squibb and more than 170 others have offered their critiques and are seeking further clarifications on the US Food and Drug Administration’s (FDA) proposed rule to amend the regulations for good laboratory practice (GLP) for nonclinical laboratory studies.

Categories: News, US, FDA, Biologics and biotechnology, Clinical, Drugs, Research and development

Tags: Pfizer, Novartis, Celgene, GLP for nonclinical lab studies, FDA proposed rules

FDA Tells Sanofi and Celgene to Stop Airing Misleading TV Advertisements By Zachary Brennan - Published 14 December 2016

The US Food and Drug Administration’s Office of Prescription Drug Promotion (OPDP) on Wednesday called on Sanofi-aventis and Celgene to stop broadcasting two of their direct-to-consumer television advertisements due to their misleading nature.

Categories: News, US, FDA, Advertising and Promotion, Biologics and biotechnology, Drugs

Tags: Celgene, Sanofi-aventis, Otezla, Toujeo, diabetes

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