Drug Delivery

GMP for Atrix

GMP for Atrix

Drug delivery company Atrix Laboratories confirmed this week that
the German regulatory authority, Bundesinstitut fur Arzneimittel
und Medizinprodukte (BfArM), had recently completed a successful
inspection of Atrix's manufacturing...

FDA planning GMP revamp

FDA planning GMP revamp

The US Food and Drug Administration is gearing up for the first
major overhaul of its current Good Manufacturing Practice
guidelines in 25 years, according to the agency's Commissioner Mark
McClellan. The move is just one strand...

EU: Investment in R&D slipping

EU: Investment in R&D slipping

European scientists continue to be strong in areas such as medical
research and chemistry and Europe may produce the highest number of
science graduates but it is lagging behind in biotechnology, still
employs fewer researchers, accounts...

Green light for Pfizer

Green light for Pfizer

The European Commission has given Pfizer the all clear to acquire
Pharmacia corporation - paving the way for the creation of the
largest pharmaceutical company in the world.

Steps forward for US cGMP

Steps forward for US cGMP

The US Food and Drug Administration announced this week that it has
accomplished the initial objectives outlined in its ongoing
initiative to modernise the agency's regulation of pharmaceutical
manufacturing and product quality.

Shire goes to court

Shire goes to court

UK Shire Pharmaceuticals group said this week that its US
subsidiary Shire Laboratories has filed a lawsuit in the US
District Court against Barr Laboratories for the infringement of
the US patent No. 6,322,819 ( '819 Patent')