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CTI's Approval Prospects For Pacritinib In Myelofibrosis Look To Be Improving

 
• By Joseph Haas

Firm publishes final data from a Phase III study showing the safety-troubled JAK2/FLT3 inhibitor performs better than Jakafi in reducing spleen size. Ongoing dose-finding study will determine the regulatory path forward.

CTI BioPharma Corp. sounds optimistic that it can find a regulatory path forward for its safety-troubled pacritinib in myelofibrosis – and market analysts seem to agree – as the Seattle biotech awaits an interim look at a dose-response study intended to illustrate the drug's risk/benefit profile, even though pacritinib missed one of the co-primary endpoints in the final data from the Phase III PERSIST-2 study.

A JAK2/FLT3 inhibitor, pacritinib had already been submitted for approval at both the US FDA and the European Medicines Agency for myelofibrosis, an indication with a history of clinical failures and only one approved drug therapy, Incyte Corp./Novartis AG's JAK1/2 inhibitor Jakafi (ruxolitinib). Also see "Misery In Myelofibrosis: Pacritinib Setback A Boost For Jakafi" - Scrip, 28 March, 2017. Gilead Sciences Inc

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• By Michael McCaughan

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• By Sue Sutter and Bridget Silverman

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

 
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EU Wants Industry To Define ‘Trade Secrets’ Under Health Data Sharing Regulation

 
• By Eliza Slawther

The European Health Data Space Regulation is deliberately “vague” when it comes to defining trade secrets because the EU wants the pharma industry to make recommendations on safeguarding intellectual property, a policy officer for the European Commission says.

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• By Neena Brizmohun

The European Medicines Agency is investigating whether Valneva’s Ixchiq is safe to use in the elderly, following reports of 17 serious adverse events, including two cases resulting in death, in people aged 62 to 89 years who received the vaccine. This follows actions by US and French authorities last month regarding Ixchiq’s use in people over 65.

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• By Anju Ghangurde

As the US FDA expands unannounced foreign inspections building on pilots in India and China, experts expect higher scrutiny of overseas sites and perhaps even an industry shakeout in the longer term, though staffing and enforcement challenges could slow things down.