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Policy & Regulation - Regulation
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Pfizer to bolster rare disease portfolio with FoldRx acquisition
02 September 2010
Pfizer has reiterated its commitment to developing an orphan and rare diseases franchise by acquiring the private US company FoldRx Pharmaceuticals. The two companies did not disclose the financial terms of the acquisition, though Pfizer will make ...
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). ...
More FDA warnings on GMP: Sun Pharma's NJ plant and Albany Molecular
01 September 2010
The US FDA has issued a warning letter to a wholly owned US unit of India's Sun Pharmaceutical Industries in Cranbury, New Jersey, over good manufacturing practice (GMP) deviations at the plant. FDA inspectors made a number of observations, which ...
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 ...
Ranbaxy opens second plant in South Africa
01 September 2010
Ranbaxy Laboratories has opened its second manufacturing facility in South Africa at Roodepoort, Johannesburg, at an investment of $30 million. It will manufacture a range of products including analgesics, cold, cough and flu preparations, ...
 
2010 Scrip 100 - Pharma muscles into emerging markets with M&A
23 August 2010
This year has seen many firms facing patent expiries on core revenue generators. The current climate is driving M&A strategies, particularly in emerging markets and often with a focus on branded ...
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 ...
 
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 ...
Interview: Croatia's state insurer changes its role to raise efficiency
19 July 2010
Croatia's HZZO main responsibilities include setting drug prices, selecting reimbursable products and reimbursement. The institute uses France, Italy and Slovenia as reference countries for setting ...
 
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 ...
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 – ...
Commentary: Russia reforms obligatory medical insurance, but will this help patients?
18 June 2010
Insurance companies and public organisations are concerned about the contents of the bill just as they were concerned about the quality of two other recent bills, on the circulation of medicines (scripnews.com, 19 March 2010) and changing the legal ...
 
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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