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Research & Development - Product Filings
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Extended review for Acetadote supplement hits Cumberland shares
25 August 2010
Shares in Cumberland Pharmaceuticals, which have languished since the company broke the deadlock in a recession-hit pharmaceutical sector by raising around $75 million net in an IPO last August, took a further battering yesterday after Cumberland ...
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 ...
FDA hands refusal to file letter to EpiCept for lead leukaemia product
25 August 2010
EpiCept has received a rare refusal to file letter from the US FDA for its NDA for its lead product, Ceplene (histamine dihydrochloride), which it was intending to be a maintenance treatment for patients with acute myeloid leukaemia (AML) in their ...
Optimer's fidaxomicin filing accepted in EU
26 August 2010
The EMA has accepted Optimer Pharmaceuticals' MAA for its narrow-spectrum antibiotic fidaxomicin for the treatment of Clostridium difficile infection (CDI) and for the prevention of recurrences of CDI. The company, which filed the application ...
No automatic approval of post-market changes to biologics in India
19 August 2010
The Indian drug regulatory agency, the Central Drugs Standard Control Organization, has done away with a provision that allowed manufacturers of biological drugs to obtain default clearance of post-approval changes to their products if the agency ...
 
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 ...
Rare diseases in the Middle East: prospects for CROs
28 July 2010
The treatment of rare diseases in Europe has been significantly enhanced by the EU's Orphan Drug Regulation and by raised levels of public awareness, thanks largely to the activities of interest ...
Scrip Asia 100 - Rich pickings from Indonesia?
29 June 2010
Indonesia is attracting increasing attention from the international pharmaceutical industry, helped by the emergence of a middle class estimated to number around 35 million and the prospect of a more ...
 
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, ...
Light Sciences Oncology - making light-activated drug therapy a commercial reality
12 March 2009
As Dr Keltner pulled out what looked like a computer mouse from his briefcase, I was surprised to hear him say it was in fact Litx, the company's innovative light-activated drug technology. It didn't ...
Japan's biosimilar guidelines edge forward
18 February 2009
Japan's regulator, the PMDA , expects to finalise a new guideline for the regulation of follow-on biologics this year, following the first draft put out for public comment last September. This ...
 
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 ...
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 ...
Commentary - EC final report: bark worse than bite?
23 July 2009
On July 8th, 2009, the European Commission reported on its 18-month inquiry into competition in the pharmaceuticals sector. Bill Batchelor of Baker & McKenzie 's Brussels antitrust practice ...
 
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