The FDA released final guidance to help sponsors develop systemic drugs for HIV-1 pre-exposure prophylaxis (PrEP). The guidance provides nonclinical and clinical recommendations, with a focus on long-acting systemic drugs intended to prevent sexually acquired infections.
Following FDA approval of Novartis AG's VEGF-A inhibitor, Beovu, in wet age-related macular degeneration earlier this month, speculation immediately started on how much market share that new therapeutic will capture at the expense of Regeneron Pharmaceutical Inc.'s Eylea.
While the general markets are leaning toward positive territory following a quiet summer period, the enthusiasm for biopharma equities remains muted. One of the most closely monitored therapeutic areas is oncology. Earlier this year, public companies developing innovative medicines in that area had enjoyed strong support; however, investors now appear to be more selective in backing companies in that sector.
Abalos Therapeutics GmbH raised €12 million (US$13.2 million) in series A funding to advance a distinctive approach to harnessing viruses for immuno-oncology applications.
The Congressional Budget Office is estimating $345 billion could be saved in direct federal spending on Medicare Part D prescription drugs from 2023 through 2029 if H.R. 3, the Lower Drug Costs Now Act, was passed.
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