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European regulators begin Tysabri review
October 26, 2009Sales 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 …
FDA revises cancer vaccine guidance
October 12, 2009Sales 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There are concerns that draft guidance from the US Food and Drug Administration, which will recommend that cancer vaccine trials …
European pharma companies raided
October 7, 2009Sales 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 …
Cervarix not to blame for UK post-vaccination death
October 5, 2009Sales 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 …
FDA streamlines GMP for combination products
October 2, 2009Manufacturing 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 …
Europe warns pharma about further competition probes
October 1, 2009Sales 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 …
Safety First
September 22, 2009Research 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 …
FDA warns Bayer over German API facility
September 17, 2009Manufacturing 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 …
FDA finalises transgenic animals guide
January 23, 2009Research 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. …
PMCPA cautions on the way new prices are promoted
January 7, 2009Sales and Marketing par, reg
UK pharma companies have been warned not to mislead doctors about new lower prices of medicines. Code of Practice regulator …
MedImmune’s respiratory treatment faces US approval delay
December 3, 2008Sales 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 …
Commission to reveal anti-competitive probe findings
November 27, 2008Sales and Marketing EU, reg
The European pharmaceutical industry could shortly face a major inquiry into its practices, with the European Commission ready to reveal …
Pharma input vital to UK research vision
November 21, 2008Research and Development reg
Initiatives to make the UK a world class location for medical research needs significant pharma input to be a success, …
Avandia hit by further restrictions
January 25, 2008Sales and Marketing reg, safety
GlaxoSmithKline has strengthened the safety warnings on its diabetes drug Avandia following recommendations from European regulators. The drug was hit …
