Recovering from a complete response letter (CRL) in 2018, Trevena Inc. resubmitted its NDA for oliceridine, branded Olinvyk. On Aug. 7, the drug received agency approval for managing moderate to severe acute pain in adults when the pain is severe enough to require an I.V. opioid and for patients whose alternative treatments are inadequate. The FDA has now approved a total of 34 new molecular entities (NMEs) so far this year. That total is well ahead of the 18 NMEs that were approved at this time in 2019 even though the FDA suggested back in May that it might have trouble meeting PDUFA dates due to the resources it needed to devote to the COVID-19 pandemic.
As the money keeps rolling in, 2020 is certainly a year for the biopharma record books. With a total of $81.26 billion raised through Aug. 6, it is a standout year in every type of financing, hitting all kinds of record highs.
Out of 922 biopharma financings so far in 2020, nearly a quarter of them – 211 – were done by companies working on a COVID-19 therapeutic or vaccine. More strikingly, however, the $27.8 billion raised by those pandemic-focused firms represents about 40% of the $71.8 billion total collected through the end of July. That amount is the highest BioWorld has ever tracked.
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