EISAI CO

Bruce Albala, a key figure in Alzheimer's disease drug development, passed away during his 40th wedding anniversary in Greece. Known for his work on β-secretase inhibitors, Albala led Eisai's BACE program, guiding elenbecestat through Phase 3 trials. Despite elenbecestat's limited success, Albala's pragmatic approach and advocacy for safer BACE inhibitor doses were highly regarded. He transitioned to academia in 2019, focusing on improving AD clinical trial efficiency.

FDA considers removing oral phenylephrine from OTC guidelines due to lack of efficacy, not safety concerns. Public comments invited until May 7, 2025, before final decision. Phenylephrine is in many nasal decongestants like Sudafed and Mucinex. FDA's proposal does not affect nasal spray decongestants.

Eisai reduces Leqembi sales forecast to JPY 42.5 billion from JPY 56.5 billion due to sluggish uptake. The drug, partnered with Biogen, faces regulatory setbacks in EU and Australia and reimbursement issues. Eisai hopes new formulations and the AHEAD 3-45 trial results will boost sales.

Since Leqembi's approval in 2023, neurologists have learned: 1) it takes 5 months on average to start treatment; 2) Black and Hispanic Americans are underrepresented; 3) most U.S. infusions occur in urban centers; 4) Japan treats more patients with fewer ARIA cases; 5) blood tests aren't yet adequate for confirming Alzheimer's biomarkers.

BrightSpring Health Services announces CareMed selected as national specialty pharmacy partner for Leqembi®, an FDA-approved Alzheimer's treatment showing efficacy in slowing cognitive decline over 18 months in Phase III trials.

Cassava Sciences is advancing simufilam through a phase 3 trial, despite SEC controversy over past data integrity. The company aims to release trial results soon, with new leadership emphasizing transparency and ethical practices. The success of simufilam, Cassava's only asset, hinges on these results, which will face heightened scrutiny due to previous data issues.

FDA approves Caris Life Sciences' MI Cancer Seek as companion diagnostic for multiple cancer drugs across six cancer types, including solid tumours, breast cancer, colorectal cancer, melanoma, non-small cell lung cancer, and endometrial carcinoma. The assay uses whole exome sequencing (WES) and whole transcriptome sequencing (WTS) for molecular profiling of solid tumours.

The global IV hydration therapy market is expected to grow from USD 2.71 billion in 2024 to USD 5.84 billion by 2034, driven by rising demand for preventative and wellness services. North America dominated the market in 2023, while Asia Pacific is projected to grow the fastest. Key segments include energy boosters, skin care, medicated and non-medicated components, and hospitals & clinics and home healthcare end-uses. AI and technological advancements are aiding market growth.

Cognition Therapeutics presented data from its Phase II SHINE trial showing CT1812 significantly slowed cognitive decline in mild-to-moderate Alzheimer’s patients with low baseline plasma p-tau217 levels, with 95% slowing measured by ADAS-Cog 11 and 108% by MMSE. The company plans to discuss Phase III with the FDA in 2025, considering subgroup recruitment strategies and dosing, while facing funding challenges.