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Policy & Regulation - Regulation
EVENTS
17 March 2010
Berlin, Germany
17 March 2010
Berlin, Germany
22 March 2010
London, UK
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DIRECTORY Scrip Directory 2009
Plavix gets US "boxed warning" about poor metabolisers
15 March 2010
Bristol-Myers Squibb and Sanofi-Aventis have added a "boxed warning" to the US label for the blockbuster blood thinner Plavix (clopidogrel), in order to warn about the diminished effectiveness of the drug in patients with a certain variant of the ...
Pfizer faces disappointment with anticancers after more Phase III failures
12 March 2010
Pfizer is facing more disappointment with the development of some of its most advanced anticancers after Sutent (sunitinib) failed two more Phase III trials in advanced breast cancer - ending development for the drug in the disease - and figitumumab ...
US FDA advisory committees back randomised trials for LABA safety
12 March 2010
The US FDA was established in 1931, but only three years ago did it get the power to order drug makers to conduct safety studies of products that have already been approved and put into general use. Just how difficult it is going to be to use that ...
Avastin fails only Phase III trial in advanced prostate cancer
12 March 2010
Roche 's Avastin (bevacizumab), the world's best-selling cancer drug, has failed to prolong overall survival in its only Phase III trial in advanced prostate cancer, CALGB 90401, which was sponsored by the US National Cancer Institute (NCI). Roche ...
Europe to give €12 million for influenza antiviral projects
12 March 2010
The European Commission will provide €12 million in funding for two new research projects which will develop novel influenza treatments, including against both (A) H1N1 pandemic influenza and (A) H5N1 avian flu. Speaking at an EU influenza meeting ...
 
Market Insight: Big pharma hit by Greece's fiscal crisis
09 March 2010
Hospitals' failure to pay pharmaceutical companies and newly announced price cuts are just some of the challenges facing the sector in Greece, Elizabeth Sukkar, Scrip's world editor, discovers. ...
Market Insight - Pharma sector in Turkey to shrink 25% under tough conditions
02 March 2010
The pharmaceutical industry has long eyed Turkey as one of its key emerging markets, but recent government action, which could see medicine access delayed by years, is giving it a wake-up call, ...
Market Insight - Power of observation propels comparative effectiveness research into the mainstream
02 March 2010
US agencies are making inroads in the use of comparative effectiveness research to support more robust decision-making. Observational studies are an emerging force in this area and promise to ...
 
Face to Face with Sandoz's "growth guy" Jeff George
04 March 2010
Jeff George took over as head of Sandoz, Novartis's generics business, in late 2008. With a big push in emerging markets, a leadership position in biosimilars and an expanded focus on injectables, he ...
Interview: European Medicines Agency gets serious about its global strategy
29 January 2010
Developing relationships with medicine regulators in China and India is just one of the challenges facing Emer Cooke, the international face of the European Medicines Agency (EMA), Scrip's Elizabeth ...
Face to face: Ex-Novartis manager takes two-step approach to women's health at Lumavita
12 January 2010
Many pharmaceutical and biotech companies devote themselves to the discovery and development of novel drugs for unmet medical needs. However, with R&D costs and regulatory hurdles multiplying, and ...
 
Private investment round-up: January 2010
16 February 2010
Private investments began 2010 in a much more positive fashion than at the start of 2009, but were still down on the strong finish to last year, a Scrip analysis has found. A total of 15 companies raised $286.7 million, 17% lower than December. ...
European Medicines Agency and logos: snakes, DNA and the pestle and mortar
22 December 2009
Logos are said to be an important part of an organisation's branding. Really good logos contribute to an organisation's visibility, credibility and memorability, so say branding experts. The logo of the most famous of the medicines regulators, the ...
GSK's malaria vaccine sails towards uncharted territory
05 November 2009
GlaxoSmithKline will enter unknown regulatory waters when it eventually comes to seek approval of its paediatric malaria vaccine, RTS,S, the most advanced in development for this disease. The parasite kills more than 800,000 people every year, the ...
 
Recent advances in the discovery of non-peptidic direct renin inhibitors as antihypertensives: new patent applications in years 2000 – 2008
01 June 2008
Background: The renin-angiotensin-aldosterone system (RAAS) is essential for the regulation of blood pressure and may play a critical role in the pathogenesis of cardiovascular diseases. A strong rationale suggests a more efficient control of RAAS ...
Incidence and management of cutaneous toxicities associated with cetuximab
01 March 2007
Cetuximab is a human/mouse chimeric monoclonal antibody that binds to the EGF receptor, competitively inhibiting ligand binding, and inducing receptor dimerization and downregulation. Cetuximab has been active in multiple tumors, including ...
The use of electrocardiograms in clinical trials: a public discussion of the proposed ICH E14 regulatory guidance
01 July 2005
This meeting, jointly sponsored by the FDA, Drug Information Association and Heart Rhythm Society, examined crucial issues on nonclinical and clinical evaluation of the potential of new drugs to prolong the QT interval of an electrocardiogram (ECG). ...
 
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