Public Citizen Strikes Out In Call For Opioid Approval Moratorium After Recent Win
Petition was consumer advocacy group's first request for halt to approval of an entire drug class; Public Citizen has gotten full and partial approval of other recent petitions.
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Levorphanol Write-Down Dents Zydus in Q2 But Saroglitazar Expectations Build
As returns from levorphanol fall on the back of increased competition, Zydus Cadila writes down investment by $37.5m causing Q2 profits to slump 74%. Post successful Phase II trials in the US for NASH and NAFLD indications, its hopes are now pinned on saroglitazar magnesium.
New Opioids: Industry Stakeholders Support US FDA's Desire For Active Comparator Data
Although only a few companies commented on the FDA's draft guidance on the benefit/risk assessment of new opioids, they cut against conventional wisdom by supporting the agency's desire to see active comparator data.
New Opioids May Need Comparative Effectiveness Data For Approval
Draft guidance says US FDA will consider product's benefit-risk balance relative to approved analgesics; it is particularly interested in comparative efficacy and safety data.