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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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Shares of Exicure, Inc. are falling after the company announced a strategic initiative that casts doubts on its future developmental programs.
The FDA ordered Avidity Biosciences to halt clinical trial enrollment after a patient suffered a “serious adverse event” testing the company’s candidate drug for myotonic dystrophy type 1.
The FDA has granted a rolling review to CRISPR Therapeutics and Vertex’s exa-cel, a potential one-time treatment for sickle cell disease and transfusion-dependent beta-thalassemia.
During an R&D presentation Tuesday, Transgene executives and oncology experts highlighted promising therapeutic progress in its programs - focusing on its developmental cancer vaccines.
Colossal started the “de-extinction” of the thylacine, commonly known as the Tasmania tiger. Now with a $30 million investment, this technology is gaining more traction.
The U.S. Equal Employment Opportunity Commission filed a lawsuit Monday against Eli Lilly and Co. alleging the company refused to hire older workers for sales representative positions.
Sanofi has inked a licensing deal with Scribe Therapeutics to develop novel natural killer (NK) cell therapies for cancer using Scribe’s CRISPR genome editing technology.
In the ongoing proxy battle between London-based Mereo BioPharma Group and Rubric Capital Management, Mereo outlined the outcome of the most recent negotiations, which Rubric rejected.
MassBioEd partners with developers in Boston to train and employ more workers in a burgeoning Genetown life sciences industry desperate for skilled labor. Meanwhile, Biogen clears real-estate space.
Daiichi Sankyo won approval in Japan for Ezharmia, making it the first dual inhibitor of EZH1 and EZH2 to receive regulatory approval for ATL.