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Jumble Of Endpoints For Ophthalmic Surgery Analgesics Coming Into Focus At Panel Session

 
• By Martin Berman-Gorvine

FDA's Dermatologic and Ophthalmic Drugs Advisory Committee may help provide guidance in the increasingly competitive therapeutic space of postoperative ocular pain.

Varying endpoints in studies of drugs to treat pain and inflammation following eye surgery may be guided toward an officially suggested harmonization, following the Feb. 27 meeting of FDA's Dermatologic and Ophthalmic Drugs Advisory Committee.

Three products currently in the pipeline, Iconix Biosciences Inc. IBI-10090, Bausch & Lomb Inc.'s mapracorat and Omeros Corp.'s OMS-302, all have slightly different endpoints in ongoing or just-completed trials

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UK Health Data Research Service Looks ‘Encouraging’ For Industry, But Implementation Details Will Be Key

 
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Marcus Vass and Vladimir Murovec of international law firm Osborne Clarke tell the Pink Sheet what the government's planned HDRS might mean for industry, and how it compares with the European Health Data Space.

EU Health Data Space May Speed Up R&D Through Access To Multi-Omics & Clinical Record Data

 
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What The EMA Can Teach HTA Bodies About Joint Clinical Assessments

 
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EU-level joint clinical assessments conducted under the Health Technology Assessment Regulation need to be more flexible when it comes to evidence requirements, according to experts speaking at a gene and cell therapy conference.

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US FDA Guidance Roadblock: Writing Continues, But Publication Has Slowed Or Stopped

 
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Unlocking Opportunities: How To Engage With The EMA On Animal Testing Alternatives

 
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EU Pharma Reform: Exclusivity Vouchers Alone Are Insufficient Incentive For Antimicrobials, Industry Says

 
• By Eliza Slawther

European pharma trade associations EFPIA and EUCOPE outline their respective views on how the EU’s pharma legislation overhaul should tackle antimicrobial resistance, and why transferable exclusivity vouchers alone will not suffice as incentives.