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Regulation & Policy
New product approvals by the EMEA
Friday 26 September 2008
The European Medicines Agency has given positive opinions for three new medicinal products, thereby paving the way for the European Commission to issue marketing authorisations. The products are:
Location
United Kingdom
European Commission probe of pharma industry draws to a close
Wednesday 24 September 2008
One of the European Commission’s biggest ever antitrust probes – an investigation into competition in the pharmaceutical industry – is drawing to a close.
Location
United Kingdom
New members of the UK Human Fertilisation and Embryology Authority
Wednesday 17 September 2008
The UK’s Human Fertilisation and Embryology Authority, which regulates in vitro fertilisation treatment and embryo research, has appointed six new members.
Location
United Kingdom
Pfizer withdraws licensing applications for dalbavancin
Wednesday 10 September 2008
Pfizer Inc. has withdrawn its licensing applications in the US and Europe for the skin treatment, dalbavancin, in order to conduct a second Phase 3 trial. The withdrawals were announced on 9 September 2008.
Location
United States
EMEA issues new guidelines on designing trials for dementia
Sunday 7 September 2008
The European Medicines Agency has issued new guidelines on how companies should design trials for Alzheimer’s disease, dementias, and for Parkinson’s disease.
Location
United Kingdom
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EMEA is investigating two cases of adverse events linked to Tysabri
Friday 15 August 2008
The European Medicines Agency (EMEA) is investigating two reports of a rare brain infection in patients who have been treated with the multiple-sclerosis drug, Tysabri (natalizumab).
Location
United Kingdom
EMEA issues two positive and one negative opinion on new products
Monday 28 July 2008
The main scientific committee of the European Medicines Agency (EMEA) is recommending that two new medicines for use in surgical settings be granted marketing authorisations in Europe. But it has rejected an application for a new therapy to treat an inherited disorder known as Friedreich’s Ataxia. In a third decision, it reversed an earlier negative opinion for an orphan drug for adults with acute myeloid leukaemia.
Location
United Kingdom
News Link:
Use of norfloxacin-containing medicines to be restricted
Thursday 24 July 2008
The European Medicines Agency has recommended restrictions on the oral use of medicines containing norfloxacin for the treatment of urinary infections.
Location
United Kingdom
Power to the FDA
Monday 21 July 2008
There is at least one forum every year where biopharmaceutical executives can pose questions directly to the management of the US Food and Drug Administration’s Center for Drug Evaluation and Research. This is the ‘CDER Town Meeting’ at the annual meeting of the Drug Information Association (DIA).
Location
United States
Roche Pharma suspended from UK industry association
Monday 14 July 2008
The UK unit of the Swiss multinational, Roche, has been suspended from the Association of the British Pharmaceutical Industry (ABPI) for six months for breaches of the association’s code of practice, the ABPI announced on 14 July 2008.
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
Thursday June 6 2013
Charles DeCarli joins advisory board at DiaGenic
Thursday June 6 2013