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Regulation & Policy
Experts says size matters in defining nanomedicine
Thursday 2 September 2010
In the realm of nanotechnology, size matters. But exactly what is meant by ‘nanoscale’ and ‘nanomedicine’ is still open for discussion. This was one of the themes to emerge from the first day of a two-day workshop on nanotechnology which is being hosted by the European Medicines Agency in London.
Location
United Kingdom
See map: Google Maps
FDA rejects motavizumab again
Tuesday 31 August 2010
The US Food and Drug Administration has issued its second ‘complete response letter’ to the AstraZeneca unit, MedImmune, rejecting its application to market motavizumab, a new monoclonal antibody for respiratory syncytial virus disease.
Location
United Kingdom
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FDA approves Novartis blood pressure drug
Friday 27 August 2010
The US Food and Drug Administration has approved a new treatment for high blood pressure from Novartis which combines the renin inhibitor, aliskiren, with the calcium channel blocker, amlodipine, in a single pill.
Location
United States
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FDA grants priority review to belimumab
Friday 20 August 2010
The US Food and Drug Administration has granted priority review status to belimumab, a potential treatment for systemic lupus erythematosus, according to the drug’s co-developers, GlaxoSmithKline Plc and Human Genome Sciences Inc.
Location
United States
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Regulatory review of gene therapy on schedule
Wednesday 18 August 2010
The European regulatory review of a ground-breaking gene therapy for the treatment of a protein deficiency linked to pancreatitis is on schedule with a decision expected by mid-2011, according to the developer, Amsterdam Molecular Therapeutics (AMT).
Location
Netherlands
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NicOx to seek post-review discussions with FDA
Friday 30 July 2010
NicOx SA will be seeking a meeting with the Food and Drug Administration to discuss the agency’s refusal to approve its lead product, naproxcinod, for marketing, the company’s chief executive, Michele Garufi, told analysts in a conference call on 30 July.
Location
France
Cladribine to get priority review at the FDA
Wednesday 28 July 2010
Merck Serono said that its new small molecule drug for relapsing-remitting multiple sclerosis, which is an oral formulation of cladribine, has been granted priority review by the FDA, which means a decision can be expected in about six months.
Location
Switzerland
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Sativex approved by the Spanish regulator
Wednesday 28 July 2010
A cannabis medicine developed by GW Pharmaceuticals Plc for the treatment of spasticity due to multiple sclerosis has been approved by the Spanish regulator. This follows its approval in June, 2010, by the UK regulator, the MHRA.
Location
United Kingdom
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EMA gives positive opinion to BI hypertension drug
Tuesday 27 July 2010
The European Medicines Agency’s main scientific committee has recommended that Boehringer Ingelheim’s new combination pill for hypertension, Twynsta, be approved for marketing.
Location
United Kingdom
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EMA to complete rosiglitazone review by September
Thursday 22 July 2010
The European Medicines Agency said it expects to complete its review of the safety of rosiglitazone-containing medicines, including Avandia, by September 2010. The review is looking at the risk of cardiovascular problems with the drugs.
Location
United Kingdom
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Recent Appointments
Colin Stewart appointed CEO at Amarin
Friday August 20 2010
Karl Keegan nominated as CFO of Pharming
Friday August 20 2010
Axel Müller becomes CEO at SkyePharma
Thursday August 19 2010
Colin Bond appointed CFO at Evotec
Thursday August 12 2010
Orexo appoints Robin Wright as finance director
Tuesday August 10 2010