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Latest From Sarah Karlin-Smith
Pink Sheet Podcast: Another Coronavirus Stimulus Bill, Remdesivir’s Brief Orphan Status, Teva Sues Over Copaxone Regulation
Pink Sheet editor and reporters discuss the effects of the latest coronavirus stimulus package on pharma, Gilead’s request for rescission of an orphan designation, and Teva’s suit over Copaxone regulation.
What's in – and what fell out of – the massive US stimulus package.
Early versions of US Congress's coronavirus relief bill contained a number of policies that would have benefited drug firms, but they didn't make it into the final bill. However, the $2 trillion package does provide pharmaceutical companies with relief from the threat of drug pricing reform until after the 2020 elections.
Senate and House versions of a pending coronavirus stimulus package take off the table a key legislative vehicle lawmakers planned to use to push for bipartisan drug pricing reform until at least after the 2020 elections, signaling a potential reprieve for the pharmaceutical industry.
Pivot from individual- to multi-patient protocols for expanded access may help generate data to inform regulatory filings and even payer determinations for Gilead’s potential COVID-19 treatment.
Issued as part of the new approach to releasing guidances during the pandemic, FDA said flexibility was needed for two reasons: anticipated higher levels of absenteeism among staff for both sponsors and the agency, and the necessity of prioritizing a focus on adverse events for products used to treat coronavirus.