Research and Development

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Submission of labels and leaflets in the UK

April 5, 2012 Business Services, Manufacturing and Production, Medical Communications, Research and Development, Sales and Marketing Labelling, Wainwright Associates

The MHRA has announced procedural changes concerning the requirement to submit full-colour mock-ups of labels and patient leaflets for medicinal …
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The brain drain

April 5, 2012 Business Services, Manufacturing and Production, Medical Communications, Research and Development, Sales and Marketing AstraZeneca, R&D, brain drain, research and development

Concerns about the growing number of companies disinvesting from neuroscience research have been growing in recent years, and the latest …

Eric Abadie resigns as chair of the CHMP

April 5, 2012 Business Services, Manufacturing and Production, Medical Communications, Research and Development, Sales and Marketing CHMP, Eric Abadie

Dr Eric Abadie has told the European Medicines Agency that he is resigning as chair of the Committee for Medicinal …

FDA grants priority review for Sanofi cancer drug

April 5, 2012 Research and Development, Sales and Marketing Erbitux, FDA, Regeneron, Sanofi, Zaltrap, colorectal cancer, prostate cancer

The FDA has granted Sanofi and partner Regeneron priority review for their colorectal cancer drug Zaltrap. Zaltrap (aflibercept) is seeking a …

AstraZeneca signs respiratory pact with Amgen

April 5, 2012 Research and Development Amgen, AstraZeneca, MedImmune, respiratory

AstraZeneca has bought its way into Amgen’s inflammation portfolio with a $50 million upfront payment to co-develop and commercialise five …

Orphan Medicinal Products in the EU- Free Webinar

April 4, 2012 Business Services, Manufacturing and Production, Medical Communications, Research and Development, Sales and Marketing

Orphan Medicinal Products in the EU: Eligibility, Orphan Designation and IncentivesThe structure of this webinar is:Introduction: Legislative Basis and Criteria …
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GSK’s diabetes drug misses goal

April 4, 2012 Research and Development, Sales and Marketing Bydureon, GSK, Victoza, albiglutide, diabetes

GlaxoSmithKline has insisted its new long-acting Type 2 diabetes drug albiglutide remains on course for filing following topline results from …

EMG appoints two new senior members

April 4, 2012 Business Services, Manufacturing and Production, Research and Development, Sales and Marketing EMG, Matthew Speers, Steve Turley, UCB

A new chair and vice-chair have been appointed to lead the European Medicines Group (EMG).   EMG is the voice of …

Glyn Edwards appointed as chief executive of Summit

April 4, 2012 Business Services, Manufacturing and Production, Research and Development, Sales and Marketing Glyn Edwards, summit

Summit, a UK drug discovery company, has appointed Glyn Edwards as its new chief executive. Edwards will take up the …

New Europe-wide approach for the classification of commercially confidential information and personal data in MAAs

April 3, 2012 Business Services, Manufacturing and Production, Medical Communications, Research and Development, Sales and Marketing

The Heads of Medicines Agencies(HMA) and the European Medicines Agency (EMA) have adopted a joint guidance document, providing a consistent …

Catalent Extends Development and Analytical Solutions Capabilities in Swindon, UK

April 3, 2012 Research and Development

Somerset, NJ – March 22, 2012 — Catalent Pharma Solutions today announces the completion of new Development and Analytical Solutions’ …
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Bayer cancer drug meets Phase III goal

April 3, 2012 Research and Development, Sales and Marketing Bayer, Cancer, Glivec, Novartis, phase III, regorafenib

Bayer’s stomach cancer pill regorafenib has significantly improved progression free survival in late-stage patients. Results from the Phase III trial …

Standardised equipment and centralised spirometry for optimal data quality

April 3, 2012 Research and Development

IntroductionWhen developing the treatments for asthma and COPD, pharmaceutical companies utilise pulmonary function testing (PFT) to determine each compound’s efficacy. …

Considerations with dual site production

April 3, 2012 Research and Development

There are generally two options available when looking to expand storage capacity – build to develop existing facilities or select …

Michael Cola resigns from Shire

April 3, 2012 Business Services, Manufacturing and Production, Research and Development, Sales and Marketing Michael Cola, Shire

Michael Cola has resigned as the president of Shire Specialty Pharmaceuticals after seven years at the firm.  “On behalf of …
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