With an EU regulatory approval looking imminent for Pixuvri (pixantrone) and Phase III trials ongoing for that drug as well as tosedostat, CTI BioPharma Corp. might appear to have more than enough activity at the moment. But on April 19, it paid $30 million upfront to SBIO Pte. Ltd. for global rights to JAK2 inhibitor pacritinib, giving the Seattle-based biotech three Phase III candidates in blood cancer.
CTI Sees Ideal Pipeline Acquisition In JAK2 Inhibitor Abandoned By Onyx
Cell Therapeutics licenses Phase III pacritinib from Singapore’s S*BIO about a year after Onyx declined an option on the myelofibrosis candidate.
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Jonathan Blum, who was principal deputy administrator during the Biden Administration, explained the agency’s approach to setting up the price negotiation program and said changes likely will be implemented by the Trump Administration.
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The rollout of Trump’s plan has been a policy whiplash, but despite a 90-day pause on tariffs, the US president still appears to be holding a grudge with industry over drug pricing.
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The US FDA has deemed certain in vitro bioequivalence studies conducted by CRO Raptim Research “not acceptable” and raised concerns over its in vivo study methods.
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Sector-specific tariffs, including on pharmaceuticals, could be announced as early as this week.
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Massive layoffs and the biosimilar user fee program’s historic flirtation with the non-user fee spending requirements raise concerns that the FDA could lose its ability to collect BsUFA revenue, which could mean a fine or jail time for agency staff.
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The former principal deputy commissioner said the “decapitation” of senior leadership will make resolving internal disputes more difficult, which will slow application reviews. Woodcock also called the FDA layoffs a slow-moving catastrophe.