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Showing 15 posts of 21 posts found.

European regulators begin Tysabri review

October 26, 2009
Sales and Marketing EU, Tysabri, reg

European regulators have begun a risk-benefit review of Biogen Idec’s multiple sclerosis drug Tysabri, which has been linked to 23 …

News

FDA revises cancer vaccine guidance

October 12, 2009
Sales and Marketing Cancer, US, reg, vacccine

There are concerns that draft guidance from the US Food and Drug Administration, which will recommend that cancer vaccine trials …

News

European pharma companies raided

October 7, 2009
Sales and Marketing EU, reg

Several pharma companies have been raided as part of ongoing European Commission investigations into competitiveness issues. Sanofi-Aventis, Novartis and generic …

News

Cervarix not to blame for UK post-vaccination death

October 5, 2009
Sales and Marketing Cervarix, NHS, reg, vaccines

The death of a 14-year-old girl who died shortly after having received a cervical cancer vaccine was caused by an …

News

FDA streamlines GMP for combination products

October 2, 2009
Manufacturing and Production FDA, US, reg

The US Food and Drug Administration has said it will draw up new rules on Good Manufacturing Practices (GMP) for …

News

Europe warns pharma about further competition probes

October 1, 2009
Sales and Marketing EU, antitrust investigation, reg

The European Commission has warned the industry a new round of antitrust probes will be coming soon, just as the …

News

Safety First

September 22, 2009
Research and Development, Sales and Marketing EU, US, reg, safety

A series of high-profile drug withdrawals in recent years has brought safety concerns to the fore, prompting more rigorous monitoring …

Feature

FDA warns Bayer over German API facility

September 17, 2009
Manufacturing and Production Bayer, FDA, reg

The US regulator has sent a warning letter to Bayer indicating it found "significant deviations from US current good manufacturing …

News

FDA finalises transgenic animals guide

January 23, 2009
Research and Development, Sales and Marketing FDA, US, reg

The route map for companies wishing to sell medicines made in genetically-engineered animals has been drawn up by the FDA. …

News

PMCPA cautions on the way new prices are promoted

January 7, 2009
Sales and Marketing par, reg

UK pharma companies have been warned not to mislead doctors about new lower prices of medicines. Code of Practice regulator …

News

MedImmune’s respiratory treatment faces US approval delay

December 3, 2008
Sales and Marketing US, reg, resp

One of MedImmune's key products has hit a delay in the US, after regulators demanded further data. The FDA asked …

News

Commission to reveal anti-competitive probe findings

November 27, 2008
Sales and Marketing EU, reg

The European pharmaceutical industry could shortly face a major inquiry into its practices, with the European Commission ready to reveal …

News

Pharma input vital to UK research vision

November 21, 2008
Research and Development reg

Initiatives to make the UK a world class location for medical research needs significant pharma input to be a success, …

News

GSK abandons malaria drugs

March 4, 2008
Sales and Marketing reg, safety

News

Avandia hit by further restrictions

January 25, 2008
Sales and Marketing reg, safety

GlaxoSmithKline has strengthened the safety warnings on its diabetes drug Avandia following recommendations from European regulators. The drug was hit …

News
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