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Research and Development

Showing 15 posts of 9573 posts found.

Regulators must catch up with medical science, says FDA

November 2, 2010 Research and Development, Sales and Marketing Advancing Regulatory Science, Critical Path Initiative’, Dr Margaret Hamburg, FDA, regulatory affairs

The head of the FDA has declared a need for ‘regulatory science’ to catch up with the advances in medical …
News

‘Therapeutic clusters’ collaboration launched

November 2, 2010 Research and Development ABPI, BIA, Immunology Initiative, Medical Research Council, Office for Strategic Co-ordination of Health and Research, Therapeutic Capability Clusters’, UCB, therapeutic clusters

Two initiatives linking the pharma industry and government-funded research and academia are to go ahead, with the aim of reviving …
News

6 tips for regulatory compliance in logistics

November 2, 2010 Manufacturing and Production, Research and Development Biocair, GMP, International Council for Harmonisation, pharma logistics, regulatory compliance

Regulation! Regulation! Regulation! Never has our business been more highly regulated than it is today. Seemingly, rules change every day. …
Feature

Relief as life sciences spared in UK cutbacks

November 1, 2010 Research and Development ABPI, Comprehensive Spending Review, Diamond Synchrotron, UK Centre for Medical Research Innovation, UKCMRI, government, science funding

UK government funding for life sciences R&D has been spared from the deep cuts some had feared. Many in the …
News

Pfizer to seek US approval for crizotinib next year

November 1, 2010 Research and Development, Sales and Marketing FDA submission, NSCLC, Pfizer, crizotinib, lung cancer, non-small cell lung cancer

Pfizer will submit its lung cancer candidate crizotinib to the FDA for US approval in the first half of next …
News

GSK signs rare diseases deal with Amicus

November 1, 2010 Research and Development, Sales and Marketing Amicus Therapeutics, Fabrazyme, Fabry disease, GSK, GlaxoSmithKline, pharmacological chaperones

GlaxoSmithKline is partnering with US biopharmaceutical company Amicus Therapeutics to develop and commercialise its late-stage Fabry disease drug Amigal. GSK …
News

Intercell appoints Staph Leavenworth Bakali

October 27, 2010 Research and Development Intercell, Staph Leavenworth Bakali, appointment, research and development

Austrian biotech company Intercell has appointed Staph Leavenworth Bakali as chief business officer. He will have key responsibilities for the …
Appointment

Contract research news in brief

October 27, 2010 Research and Development Almac, Kinaxo, MediData Solutions, Quintiles, Ricerca Biosciences, Southern Research Institute, Venn Life Sciences, biofocus, contract research

Our latest crop of contract research news includes updates from Quintiles, Venn Life Sciences, Medidata Solutions, Southern Research Institute, Ricerca …
News

Health outcomes – does anything else matter?

October 27, 2010 Research and Development Les Rose, evidence-based medicine, healthcare outcomes, randomised controlled trials

So the mould of British politics has been broken, and we now have a government with probably a broader range …
Feature

Pharma engages HTA bodies in early-stage drug discussions

October 27, 2010 Research and Development, Sales and Marketing Andrew Witty, AstraZeneca, EMA, European Medicines Agency, GlaxoSmithKline, Johnson & Johnson, health technology assessment, hta

Three pharma companies are taking part in a new pilot to harmonise European standards in health technology assessment (HTA). AstraZeneca, …
News

Sanofi moves teriflunomide into phase III MS trials

October 26, 2010 Research and Development MS, Sanofi, Sanofi-Aventis, TERACLES, multiple sclerosis, relapsing multiple sclerosis, teriflunomide

Sanofi-Aventis is to begin the first phase III study of an oral drug as an add-on to standard therapy in …
News

Conducting clinical trials in China

October 26, 2010 Research and Development China, Jim Wei, Medpace, clinical trials, clinical trials in Chaia, regulatory affairs

As industry pressure to conduct successful global clinical trials on time and on budget continue, tapping emerging global markets will …
Feature

Two thirds of pharma companies face ‘strategic crisis’

October 25, 2010 Research and Development, Sales and Marketing Novartis, Pfizer, Roland Berger, generics, pharma research, pharma sales

The pharma industry is moving away from traditional in-house innovation and toward a more diversified business model, but will encounter …
News

Lilly suspends late-stage trials of diabetes drug Protege

October 22, 2010 Research and Development, Sales and Marketing MacroGenics, Protege, diabetes, lilly, type I diabetes

Eli Lilly and its partner MacroGenics have suspended phase III trials of their investigational type I diabetes drug Protege after …
News

European medicines legislation and pharmacovigilance

October 20, 2010 Research and Development NDA, pharmacovigilance, regulatory affairs

During the past decade, changes in European medicines legislation and guidelines have increased the scope and regulatory scrutiny of pharmacovigilance …
Feature
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