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Leqembi Iqlik can now be given at home throughout the entire course of treatment, setting it apart from Eli Lilly’s Kisunla, the only other anti-amyloid Alzheimer’s disease therapy on the market.
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FDA’s rare disease decisions are strongest when the patient community has a voice in advisory committee decisions.
The lineup at the Alzheimer’s Association International Conference will provide critical insight into where the industry is headed with regard to targets being explored to vanquish the elusive neurodegenerative disease.
Regulators on both sides of the Atlantic are pushing for the withdrawal of the rare disease treatment that accounted for just 1% of Amgen’s 2025 revenue. Nevertheless, Amgen continues to defend the medicine, which was acquired in the $3.7 billion buyout of ChemoCentryx.
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Congressional letters sent to the CEOs of Eli Lilly, Pfizer, Merck, BMS and AbbVie this week voicing concerns about the pharmas’ clinical trials in China highlight an ongoing discrepancy in how government and industry think about the rise of the Asian country’s biotech industry.
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While the FTC continues to review its $16.5 billion buy of Catalent, Novo Holdings announced Wednesday it has acquired a majority stake in Single Use Support, an Austrian life sciences tools company.
Following an initial rejection in 2023, Ascendis Pharma on Tuesday said it faces another regulatory bump in the road for TransCon PTH with a three-month delay in the ongoing FDA review.
After missing their initial target in March 2024, Eisai and Biogen have initiated a rolling BLA for a subcutaneous maintenance formulation of Leqembi, which could offer a more convenient dosing schedule for Alzheimer’s disease patients.
Bayer joined BMS in announcing major overhaul; Takeda drops up to $2 billion for an anti-amyloid drug from AC Immune; and BioSpace reflects on last week’s ASGCT meeting—the good, the bad and the ugly.
Learn how to discuss career gaps and how to be a great hiring manager and interviewer.
Dynavax Technologies announced Tuesday that the FDA issued a Complete Response Letter to the company’s sBLA to include a four-dose regimen of Heplisav-B vaccine for adult hemodialysis patients.
In Tuesday’s first-quarter 2024 financial results, Bayer reported a slight drop in sales amid its sweeping companywide restructuring that resulted in workforce reductions, while lowering its full-year earnings outlook.
With Monday’s agreement, AbbVie joins the industry’s growing interest in next-generation psychiatric therapies and looks to leverage Gilgamesh Pharmaceuticals’ research platform to discover novel neuroplastogens.
Cytokinetics released data Monday on aficamten, an oral small molecule inhibitor of cardiac myosin, showing it significantly boosted exercise capacity in patients with obstructive hypertrophic cardiomyopathy.
Presented at this week’s European Congress on Obesity, the two studies also demonstrate that Novo Nordisk’s Wegovy (semaglutide) provides cardiovascular benefits irrespective of starting weight and the amount of weight lost.