The BioPharm Insight™ December Catalyst Monitor Spotlights 12 Key Development and Regulatory Events

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Companies with upcoming events to watch include Aegerion, NPS and Gilead.

BioPharm Insight’s monthly Catalyst Monitor analyzes the most material events in the sector during the upcoming month. The Catalyst Monitor tracks significant events and announcements such as FDA approvals, Advisory Committee (AdCom) meetings and expected key clinical results. To access the entire 40-page report, featuring proprietary investigative journalism relevant for each profiled event, sign up for a free demo or trial of BioPharm Insight.

Experts across the board seem to agree that Celsion’s ThermoDox for the treatment of hepatocellular carcinoma (HCC) may struggle to show progression-free survival (PFS) benefit, the trial’s primary endpoint. PFS in HCC has not been demonstrated to be a proper surrogate endpoint to OS. Regulatory authorities such as the FDA and the EMA could ask Celsion to conduct a confirmatory trial using OS as the primary endpoint before approving ThermoDox.

Up for approval at the end of December, Aegerion’s lomitapide demonstrated significant reduction in LDL levels in hoFH. Rates of fatty liver found in lomitapide’s Phase III assessment are troublesome and may lead to strict FDA monitoring requirements. NPS Pharmaceuticals’ Gattex will also likely see approval before the end of the year, and despite lingering cancer concerns, the GDAC voted unanimously to recommend approval in short bowel syndrome, which could make it the only therapeutic option for SBS.

Additional catalysts covered in this report include…..

  •     Gilead’s Phase III results for sofosbuvir in combination with ribavirin
  •     Omeros' OMS103HP Phase III data for postoperative inflammation in knee surgery
  •     Synergy’s Phase IIb results in Plecanatide

About BioPharm Insight
BioPharm Insight is the definitive guide to the global biopharma community. BioPharm Insight provides clients with an information edge by combining the most comprehensive real-time database of companies, drugs, contacts, M&A and licensing deals, forecasts and clinical trial data with proprietary forward-looking intelligence uncovered by an independent team of investigative journalists months or even years before it breaks in mainstream media. To learn more, visit http://www.biopharminsight.com.

About Infinata, Inc.
Featuring a comprehensive BioPharm Solutions Suite, unique Wealth Prospecting tools and innovative Custom Data Services, Infinata provides personalized technology solutions to turn information into insight. Infinata is a part of Mergermarket, a Financial Times Group company and a division of Pearson plc. To learn more, visit http://www.infinata.com.

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Holly Burke
Infinata
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