Shots:
The US FDA has approved Mimrylo (rusfertide) for the treatment of erythrocytosis in adults with polycythemia vera (PV)
Approval was backed by the P-III (VERIFY) trial (n=293), which met all efficacy endpoints, showing higher response rates, reduced need for phlebotomy & improvement in fatigue as measured by PROMIS Fatigue Short Form 8a
The VERIFY…
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The MHLW has approved Orzeyful (oveporexton) for the treatment of narcolepsy type 1 (NT1, narcolepsy with cataplexy) in adults
Approval was based on extensive data, incl. P-III (FirstLight & RadiantLight) trial assessing Orzeyful (BID) in NT1 pts over 12wks, where FirstLight randomized 168 pts to 3 arms (2mg, 1mg & PBO) & RadiantLight randomized…
Shots:
The US FDA has approved Orzeyful (oveporexton) for the treatment of narcolepsy type 1 (NT1, narcolepsy with cataplexy) in adults. DEA scheduling decision is expected within 90 days, after which it will be available through a specialty pharmacy
Approval was based on extensive data, incl. P-III (FirstLight & RadiantLight) trial assessing Orzeyful (BID) in…
Shots:
Merck & Co., Roche, and Johnson & Johnson emerged as the leading pharmaceutical companies by R&D expenditure in 2025, investing $15.78B, $15.49B, and $14.66B, respectively. Continued investments in late-stage clinical programs, pipeline expansion, advanced technologies, and strategic business development reinforced their commitment to driving pharmaceutical innovation
Global biopharmaceutical R&D investment continues to accelerate as…
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AbbVie led the global immunology market with $30.4B in immunology revenue in 2025, followed by Sanofi ($19.08B) and Johnson & Johnson ($15.72B). Continued demand for biologics and targeted therapies across autoimmune and inflammatory diseases supported strong commercial performance among leading companies.
The global immunology market, valued at $108.4B in 2024, is projected to…
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Takeda has reported the 2 P-III (Latitude PsO 3001 & PsO 3002) trial results assessing zasocitinib (QD, PO) in 693 & 1108 adults, respectively, with mod. to sev. PsO, where both studies showed improved NAPSI scores vs PBO at 16wks.
Trials also showed that 77% (3001) & 74% (3002) pts reached ssPGA 0/1 response…
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The US FDA has approved Lipfendra (20mg, PO) as an adjunct to lifestyle intervention to reduce LDL-C in adults with hypercholesterolemia, incl. HeFH, based on 2 P-III trials (CORALreef Lipids & CORALreef HeFH) assessing it vs PBO
At Wk. 24 in Lipids trial, Lipfendra reduced LDL-C by 57% vs a 3% increase from…
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Insilico Medicine has entered into a strategic collaboration agreement with Takeda to advance clinically differentiated drug candidates across Takeda's therapeutic areas, using Insilico’s Pharma.AI platform
Insilico will lead AI-driven discovery, while Takeda will advance selected candidates through clinical development & hold exclusive worldwide rights to develop, manufacture, & commercialize resulting therapeutics
As per the…
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Boltz has partnered with Takeda to deploy its biomolecular AI platform across Takeda’s research organization, providing discovery teams access to proprietary foundation models, incl. BoltzMol-1 & BoltzProt-1, to accelerate AI-driven drug discovery
The platform is designed to support in-silico molecular design, enabling structure prediction, affinity estimation, and generative design to enhance AI-driven drug discovery…
Shots:
The Takeda's P-III (FirstLight & RadiantLight) trial assessed oveporexton (BID) in NT1 pts over 12wks, where FirstLight randomized 168 pts to 3 arms (2mg, 1mg & PBO), while RadiantLight randomized 105 pts to two arms (2mg & PBO); regulatory filing is under review in the US (priority review), China & Japan
At Wk. 12,…

