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Research & Development - Product Approvals
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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 ...
US FDA warns of meningitis risk with GSK's Lamictal
13 August 2010
The US FDA has issued a safety warning for GlaxoSmithKline's Lamictal (lamotrigine) over an increased risk of aseptic meningitis associated with its use. The agency is revising the warnings and precautions section of the drug's label and patient ...
GSK/Valeant's Potiga gets unanimous support from US FDA advisory panel
12 August 2010
The US FDA's peripheral and central nervous system drugs advisory committee on 11 August smoothed the way for approval of the anti-epileptic Potiga (ezogabine, previously known as retigabine), which is being developed under an agreement between ...
FDA approval of generic Lovenox sparks debate and lawsuit
27 July 2010
The US FDA approval of the first generic version of Sanofi-Aventis's Lovenox (enoxaparin sodium) to Novartis ' generics arm Sandoz, which uses technology from Momenta Pharmaceuticals , has caused a buzz because the agency has treated the application ...
 
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 ...
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 ...
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 ...
 
Archimedes – a fast mover in a niche sector
19 June 2009
Archimedes Pharma, inspired by the inventor of the screw pump, has been nurturing its own inventiveness as it sets about transforming the cancer pain market. Breakthrough cancer pain remains a ...
Face-to-face: The FDA, Amgen, and its blockbuster biologic, denosumab
15 June 2009
In escaping the sweltering heat of America's south, Scrip's US reporter Christopher Spillane meets Amgen's chief medical officer, Dr Sean Harper , who coolly explains how the firm plans to negotiate ...
New BTG propels itself for growth
20 January 2009
BTG , the UK's largest speciality pharmaceutical company, has bounced back from a recent dip in its share price, and has set its sights on becoming the next Shire . Earlier this month, BTG's stock ...
 
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 ...
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 ...
Commentary: Japanese concessions could pave the way to EU trade pact
07 May 2010
The high-level summit between Japan and the EU in Tokyo last week produced little in the way of substantive progress, at least according to a reading of the publicly released material from the ...
 
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