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Research & Development - Product Delays
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Ark Therapeutics has withdrawn the EU filing of its brain cancer gene therapy candidate Cerepro (sitimagene ceradenovec), dropping a previous appeal over a negative opinion from the CHMP. It has at the same time initiated a full strategic review of ...
An advisory committee to Japan's ministry of health, labour and welfare has recommended for approval Takeda 's oral antidiabetic, alogliptin. The positive opinion moves the DPP-4 inhibitor closer to what is likely to be its first market, following ...
The EU's CHMP has refused to endorse the approval of Basilea Pharmaceutica 's intravenous broad-spectrum cephalosporin antibiotic Zeftera (ceftobiprole) for the treatment of complicated skin and skin structure infections. The decision has prompted ...
The US FDA has issued GlaxoSmithKline and XenoPort a complete response letter for their non-dopaminergic restless legs syndrome (RLS) therapy, Horizant (gabapentin enacarbil extended-release, previously known as Solzira). Horizant is ...
A US federal advisory panel has released six recommendations concerning gene patents. Most significantly, the panel advises that Congress exempt gene patents from infringement liability in certain areas, specifically by limiting the ability of ...
 
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. ...
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, ...
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 ...
 
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 ...
 
The US is a great place to do business. Being an almost free market, the profits are good, but so also are the temptations. So if you can't be bothered to put the money into a clinical trial to find ...
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 ...
Cancer treatment is undergoing a revolution, driven by ageing populations, advanced technologies and an increasingly informed society. Health economics considerations and top-up payments are gaining ...
 
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