Pharmaceuticals firm Shire has withdrawn its Biologics Licence Application for its enzyme replacement product REPLAGAL with the US Food and Drug Administration (FDA).
Recent interactions with the FDA have led the Shire to believe that the agency will require additional controlled trials for approval of the product. No concerns over the product's safety profile were raised by the FDA. Shire has concluded that the likely additional studies would cause a significant delay, and an approval of REPLAGAL for US patients would only be possible in the distant future.
More to follow ...
Subscribe to MoneyWeek
Subscribe to MoneyWeek today and get your first six magazine issues absolutely FREE
Sign up to Money Morning
Don't miss the latest investment and personal finances news, market analysis, plus money-saving tips with our free twice-daily newsletter
Don't miss the latest investment and personal finances news, market analysis, plus money-saving tips with our free twice-daily newsletter
jh
-
German chancellor Olaf Scholz's coalition collapses – what went wrong?EU Economy After Olaf Scholz fired a key minister, Germany's coalition has collapsed. But political turmoil in the country couldn’t have come at a worse time
-
BT cuts revenue forecast – what's next for the telecoms giant?BT has trimmed its sales forecast, but the overall outlook remains positive and big investors have bought in. Should you invest?
