Capitol Hill Briefs
This article was originally published in The Gray Sheet
Two House bills that seem simple on the surface – one on protecting “good Samaritans” from liability when they use automatic external defibrillators on cardiac arrest victims; one targeting public educational programs for cell-free DNA prenatal screening – sparked debate at a Dec. 9 Energy and Commerce Committee hearing. Also: legislators are attempting to insert device tax repeal provisions into must-pass 2016 agency funding and tax-extender bills.
You may also be interested in...
CMS Deputy Administrator for Innovation and Quality Patrick Conway and FDA Device Center Director Jeffrey Shuren told a House subcommittee that legislators’ efforts to replace FDA’s proposed laboratory-developed test framework would lead to duplicative, time-consuming, expensive regulation, and could only result in ineffective and delayed diagnostics that might harm patients.
Public Company Edition: Lixte’s small uplisting was the only biopharma initial public offering in the US during Thanksgiving week, but IPOs are ramping up again. Also, LifeSci launched its second SPAC and in follow-on offerings Reata brought in $281m and Intellia grossed $175m.
Orladeyo is the first oral prophylactic approved in the US for hereditary angioedema, with Japan and EU approvals expected to follow. Pricing of $485,000 a year undercuts segment leader.