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Regulation & Policy
Dapagliflozin recommended for approval in Europe
Friday 20 April 2012
Dapagliflozin, a treatment for Type 2 diabetes that has been co-developed by AstraZeneca Plc and Bristol-Myers Squibb Company, has been recommended for approval in Europe. In January, the same drug was turned down by the FDA.
Location
United Kingdom
CHMP gives Flutiform a positive opinion
Friday 20 April 2012
SkyePharma Plc’s asthma treatment, Flutiform, has been given a positive opinion by the European Medicines Agency’s Committee for Medicinal Products for Human Use. This brings the drug one step closer to a marketing authorisation in Europe.
Location
United Kingdom
CHMP chairman resigns
Wednesday 4 April 2012
Eric Abadie, the chair of the European Medicines Agency’s Committee for Medicinal Products for Human Use, has resigned and the agency’s executive director, Guido Rasi, has accepted the resignation with immediate effect, the EMA said.
Location
United Kingdom
European regulators agree on disclosure policy
Wednesday 28 March 2012
Drug regulators in the European Union have reached an agreement on what kinds of data submitted to them from companies can be made public, effectively making the pharmaceutical sector more responsive to public demands for information.
Location
United Kingdom
Alkermes withdraws EMA application
Tuesday 13 March 2012
Alkermes Pharma Ireland Ltd has withdrawn its marketing authorisation application from the European Medicines Agency for the drug, megestrol, which was intended to be used to treat unexplained weight loss in patients with AIDS and cancer.
Location
United Kingdom
AstraZeneca sues FDA over generic
Tuesday 13 March 2012
AstraZeneca Plc has filed a lawsuit against the US Food and Drug Administration seeking to overturn the agency’s decision to deny the company’s petition to withhold approval of generic versions of its antipsychotic, Seroquel (quetiapine).
Location
United Kingdom
FDA approves allogeneic cell therapy
Saturday 10 March 2012
The US Food and Drug Administration has approved an allogeneic cell therapy- the first of its kind – to treat vascular wounds caused by surgery to treat mucogingival conditions in adults. The product, Gintuit, was developed by Organogenesis Inc of Massachusetts, US.
Location
United States
FDA revises label for statins
Thursday 1 March 2012
The US Food and Drug Administration has revised the safety labels for statins, the cholesterol-lowering drugs, to include a warning about an increased risk of raised blood sugar levels and the development of Type 2 diabetes.
Location
United States
EMA to make more drug data public
Thursday 23 February 2012
From 1 March, the European Medicines Agency will begin publishing information on new drug applications that it receives from companies. The measure is part of an ongoing policy to make the European regulatory procedures more transparent.
Location
United Kingdom
CHMP recommends Nimenrix and Pixuvri
Saturday 18 February 2012
A meningococcal vaccine and a new treatment for non-Hodgkin’s B-cell lymphoma were among four new medicines to receive positive opinions from the European Medicines Agency’s Committee for Medicinal Products for Human Use on 17 February.
Location
United Kingdom
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Recent Appointments
Steffen Thirstrup joins NDA Group
Monday June 10 2013
Tarquin Bennett-Coles joins Odgers Berndtson
Monday June 10 2013
Sandy Eisen becomes non-executive director at Phosphate Therapeutics
Thursday June 6 2013
Eric-Paul Paques to chair Grünenthal
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Charles DeCarli joins advisory board at DiaGenic
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