USA Annual numbers of new molecular entities (NMEs) and biologics license applications (BLAs) approved by the FDA’s Center for Drug Evaluation and Research (CDER). Approvals of products such as vaccines and gene therapies by the Center for Biologics Evaluation and Research (CBER) are not included in this drug count. Made with…
USA In 2019, the US FDA’s Center for Drug Evaluation and Research approved 42 novel drugs, down from 59 drugs approved in 2018. Novartis had four drugs approved, the highest number from any single pharma company. 16 of the 42, or 38 per cent, received orphan drug designation. This listing does…
USA The bestselling drugs of 2018 in the USD 485 billion US pharma market. The list features several major blockbusters benefiting from the delays in biosimilar approval in the US, as well as several small-molecule medications that stand to lose out to generic competition in the coming years. AbbVie’s Humira is…
Top 10 The Top 10 bestselling orphan drugs in the USA in 2017. Celgene’s Revlimid (generic name lenolidamide) leads the way with sales of USD 5.4 billion, followed by Roche’s Rituxan (rituximab) with USD 4.2 billion in sales and TEVA’s Copaxone (glatiramer acetate) with USD 3.1 billion. The most expensive drug in…
USA 80 orphan drugs (those drugs intended to treat diseases so rare that sponsors are reluctant to develop them under usual marketing conditions) were approved in the USA in 2017, a record year and more than double the 40 approved in 2016. Orphan drug spending grew from 5 to 10%…
USA 59 novel drugs were approved in the USA in 2018, representing a leap from the 46 approved in 2017 and 22 approved in 2016. 19 of the 59 drugs (32 percent) have been designated ‘first-in-class’ and 34 of the 59 drugs (58 percent) were approved to treat rare or “orphan”…
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