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Latest From Cardinal Health, Inc.

Aldeyra Therapeutics Eyes First Line Market As Phase II Dry Eye Candidate Impresses

The firm’s lead asset, reproxalap, one-upped Novartis’s Xiidra in a mid-stage ophthalmology study, signalling its first-line promise in a market ridden with compliance issues.

Clinical Trials Ophthalmic

US FDA Novel Approvals Grew To 60 In 2021; CDER Cleared 50 New Agents, Turned Down 18

Approval total is one of FDA’s highest, but the large number of complete response letters obscures the staggering total of almost 80 new molecular entities and novel biologics that the agency acted on over the year.

Approvals US FDA Performance Tracker

Opioid Jury Verdict May Change Settlement Equation For Sponsors

New York jury finds that Teva and distributor Anda violated state’s public nuisance law in their marketing and distribution of opioids. Such claims had been rejected by two previous courts and the verdict in this case shows the challenges companies face in ongoing litigation.

Advertising, Marketing & Sales Legal Issues

Aldeyra Looking At Paths To Approval In Dry Eye After Phase III Miss

Firm revises second Phase III trial for co-primary endpoints, possibly improving its chances of success for demonstrating efficacy on a sign of dry eye disease. Initial Phase III study missed ocular redness measure.

Clinical Trials Drug Approval Standards
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