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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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Lexington, Mass.-based Agenus withdrew its Biologics License Application for balstilimab from the U.S. FDA. The drug is a PD-1 inhibitor or checkpoint inhibitor.
Late Thursday, Athira announced that Kawas had resigned from her position as CEO and president of the company.
Two months after being ousted by the Whitehead Institute over allegations of sexual harassment, prominent cell biology researcher David Sabatini has filed a counter lawsuit.
The FDA placed a clinical hold on Tryp Therapeutics’ Phase IIa trial for eating disorders, including binge eating disorder and hypothalamic obesity.
Skin health logged major wins this week after two companies announced positive clinical trial results.
Earlier this month, Catalent announced plans to add 500–600 jobs in Bloomington, Ind., one of its Moderna and Johnson & Johnson COVID-19 vaccine manufacturing sites.
The designation is based on data from two Phase I trials, which showed the drug to be safe, demonstrating early efficacy.
The CDC supported the FDA’s approval of mixing and matching vaccines, where eligible populations can take a booster shot from another brand different from their initial series.
The upcoming changes will be less disruptive but will have far-reaching consequences throughout the pharmaceutical supply chain.
Biopharma and life sciences companies strengthen their leadership teams and boards with these Movers & Shakers.