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Specialty Pharma Dominates Epilepsy Market, But Does It Have Resources To Develop Disease-Modifying Agents?

 
• By Bridget Silverman

Upsher-Smith’s recent acquisition of research boutique Proximagen highlights the dynamics of the market: specialty pharma extending dominance and introducing new agents to the market, while most early R&D activity originates at small firms. But it may be difficult for this combination of players to bring forth the game-changing therapies that are needed, given the technical challenges of the disease space.

The epilepsy field offers a telling look at some of the larger trends in pharmaceutical research and development in the post-blockbuster era: specialty companies have emerged to dominate as big pharma has retreated from the difficult therapeutic space, but most discovery is coming from small companies that need to find partners to bring their innovations forward.

The advance of specialty pharmaceutical companies toward dominance in epilepsy R&D continued with the June 13 announcement of Upsher-Smith...

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• By Eliza Slawther

Clinical trial sponsors in the rare disease space face “big safety demands” from regulators, which can be challenging for those with limited resources. A CRO founder makes the case for “embedding automation” into the clinical trial process to keep pace with regulatory requirements.

Elegy For SACHRP: US HHS Research Protection Panel Tackled Tough Pediatric Trial Questions

 
• By Bridget Silverman

The termination of the HHS Secretary’s Committee on Human Research Protections closed an important forum for discussing pediatrics and pregnancy in clinical trial design, a former SACHRP chair said.

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• By Kate Rawson

Expanded funding for cost recovery could dovetail with FDA Commissioner Martin Makary’s idea for a “conditional approval” pathway based on a plausible mechanism of action.

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UK MHRA: Bacteriophage Developers Wanted ‘More Clarity’ On UK Framework

 
• By Eliza Slawther

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LDT Final Act? US FDA Will Not Appeal District Court Decision Vacating Final Rule

 
• By Brian Bossetta

The US FDA ended efforts to regulate lab-developed tests as medical devices for now when it did not appeal a decision from the Eastern District of Texas that tossed out the agency's final rule.