Legislation

Full EU ban on animal testing for cosmetics deadline reached

European Commissioner in charge of Health & Consumer Policy, Tonio BorgAs of the 11th of March 2013, cosmetics tested on animals cannot be marketed any more in the EU.

A Communication adopted by the Commission on the 11th March 2013 confirmed the Commission's commitment to respect the deadline set by Council and Parliament in 2003 and outlined how it intends to further support research and innovation in this area while promoting animal welfare world-wide.

Zetes launches serialisation capability at Propak

Serialisation is the first and crucial step in the product identification and traceability processWhile complete product identification and traceability is a relatively modern concept within supply chain control and management, it has become a strategic consideration for companies that wish to meet food and pharmaceutical safety, legislative or economic imperatives.

Fake Avastin reignites ‘track-and-trace’ debate, but the clock is ticking

AvastinThe US Food and Drug Administration (FDA) announced in February that counterfeit vials of Roche/Genentech’s cancer drug Avastin were sold to a number of medical practices across the country. While the exact sources of the phony drug remain a mystery, authorities traced the fake batch through several distributors throughout Canada, the UK, Denmark and Switzerland to only end up with an unlicensed supplier in the Middle East as the possible culprit.  When tested, the phony batch did not contain any bevacizumab, the active ingredient in Avastin, which was substituted with salt and starch. Along with fake batch numbers, the drug packaging was also counterfeit, bearing Roche’s name and French labelling, contrasted to the authentic Avastin packaging which imprints Genentech’s name and has English labelling.

The world’s first (official) biosimilar antibody goes to… Rheumatoid Arthritis

 

Rheumatoid arthritis

The end of July 2012 proved exciting for the world of biosimilar manufacturers. However, for the regulatory officials worldwide it meant more uncertainty and unknowns about proper, global biosimilar guidelines. On 23 July, South Korean biosimilar manufacturer Celltrion announced the approval of Remsima (CT-P13), a biosimilar antibody, by the Korean Food and Drug Administration. Remsima is a biosimilar version of Johnson & Johnson’s Remicade (infliximab) which was one of the first monoclonal antibody TNF inhibitors approved for the treatment of Rheumatoid Arthritis (RA). Remsima is approved for several indications and will be marketed in Asia and South America by the end of the year.

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