Keyword: Complete Response Letter
Vanda Pharmaceuticals received a Complete Response Letter from the FDA taking issue with a small study testing Hetlioz in jet lag disorder.
Eli Lilly and Incyte were expecting an approval this weekend from the FDA for their blockbuster-in-waiting arthritis candidate baricitinib, but today announced that the agency wants more trial data, adding significant delays and costs.
GlaxoSmithKline has one of the lowest R&D budgets in percentage of revenue terms of its peers; although its research budget was slightly up on 2015, this is still markedly down from the around £4 billion it was spending in 2012-13.
Cempra has pulled a filing for approval of its antibiotic candidate solithromycin in the European Union.
Buried deep down in Novartis’ Q2 results out this morning was a previously unknown rejection by the FDA for a copycat version of Amgen’s blockbuster drug Neulasta (pegfilgrastim).