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Policy & Regulation - Pharmacovigilance
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01 January 1970
London, UK
01 January 1970
San Diego, US
01 January 1970
Providence, Rhode Island, and San Francisco, California
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Relief for Dendreon on upcoming US Medicare coverage meeting on Provenge
02 September 2010
The US agency that runs Medicare – the Centers for Medicare and Medicaid Services (CMS) - has scheduled a 17 November advisory panel meeting to consider on-label and off-label use of Dendreon's prostate cancer treatment Provenge (sipuleucel-T). ...
US delay for GSK/Valeant's novel antiepileptic Potiga
01 September 2010
GlaxoSmithKline and Valeant Pharmaceuticals have hit a three-month delay in achieving US approval for their novel antiepileptic Potiga (ezogabine). The US FDA has pushed back the PDUFA goal date for the NDA until 30 November while it reviews a risk ...
Genzyme snubs offer from Sanofi-Aventis
31 August 2010
After months of speculation Sanofi-Aventis, the French pharma major, at the weekend unveiled an all-cash $69.00 a share bid for Genzyme, which values the US biotech at about $18.5 billion. Not surprisingly, the Genzyme board unanimously rejected the ...
P&G to co-promote Somaxon's Silenor in the US
27 August 2010
Somaxon Pharmaceuticals and Procter & Gamble Pharmaceuticals are to co-promote Somaxon's insomnia drug Silenor (low-dose doxepin) in the US. Somaxon's share price rose by 29% on the news, closing at $4.34 on Nasdaq on 25 August. Somaxon said it was ...
Pipeline progress at Oxford BioMedica as H1 losses reach £2.9 million
25 August 2010
Widening losses at Oxford BioMedica in the first half of 2010 were tempered by positive news on a number of the company's product development programmes. These included possibilities for accelerating clinical trials with ProSavin, the gene-based ...
 
2010 Scrip 100 - Mixed fortunes on the R&D front
23 August 2010
Continued problems with anti-obesity drugs, more measures designed to improve R&D efficiency, and the approval of first-in-class therapeutics such as Amgen's Prolia and Dendreon's Provenge: the first ...
Liver cancer becomes more preventable and treatable
12 August 2010
New drugs to treat viral hepatitis infection, coupled with renewed interest from companies in developing therapies to treat liver cancer following Nexavar's approval, have improved prospects for both ...
2010 Scrip 100 - Changes pharma can believe in?
23 August 2010
Ian Schofield picks some of the most significant developments in the health policy and regulation circles in the first half of 2010 and explains their likely impacts on pharma. Barack Obama signed ...
 
GW high on pipeline of cannabis extracts
23 August 2010
GW Pharma has enjoyed recent success with its cannabinoid extract product Sativex (nabiximols), which is now approved in the UK and Spain as an add-on therapy for spasticity in multiple sclerosis, ...
Face-to-Face: Trophos - The French firm that hooked Actelion
23 July 2010
Actelion this week acquired the option to buy private company Trophos, with the final decision dependent on the success of the French firm's lead product olesoxime, which is in Phase III development ...
Connexios: Harnessing the Indian cost advantage in network biology
01 June 2010
Imagine if a start-up company could afford to hire enough high-calibre scientists to spend years creating a detailed map of a broad and complex pathology like metabolic disease, incorporating large ...
 
Value-based pricing: Who should set drug prices in the UK?
11 August 2010
While the UK's NHS and pharma sector ponder who may end up negotiating drug prices in light of a new white paper, health economists Stuart Carroll, Neil Hawkins and David A Scott contemplate four options which keep NICE very much in the picture ...
GLP-1 receptor agonists vie for diabetes market share
13 July 2010
After enjoying almost five years of exclusivity, Lilly/Amylin's first-in-class antidiabetic GLP-1 receptor analogue Byetta (exenatide) has started to feel competition nipping at its heels. Asher Mullard investigates the future for this growing drug ...
AstraZeneca judgement changes the rules for dominant companies
07 July 2010
On 1 July 2010 the EU General Court handed down its judgement in the long-running saga of AstraZeneca's proton pump inhibitor anti-ulcer product Losec (omeprazole). Although dealing with events that happened almost two decades ago, the case – ...
 
Clinical immunotoxicity of therapeutic proteins
11 May 2009
Therapeutic proteins are proteins engineered in the laboratory for pharmaceutical use. Although they tend to offer a better safety margin than most synthetic small molecules because they are processed by the same pathways as natural proteins in the ...
Etravirine: the renaissance of non-nucleoside reverse transcriptase inhibitors
01 December 2008
Background: Etravirine is the first non-nucleoside reverse transcriptase inhibitor (NNRTI) to be active against human immunodeficiency virus with NNRTI mutations. Objective: To understand the unique features of etravirine and to evaluate its safety, ...
Polycystic ovary syndrome: treatment strategies and management
01 December 2008
Background: The polycystic ovary syndrome (PCOS) is possibly the most common endocrine disorder in premenopausal women, with prevalences in the 6 – 7% range reported worldwide. Although PCOS is primarily a disorder of androgen excess, affected women ...
 
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