precisionmedicineonline1h
Biogen Says It's 'Doubling Down' on Alzheimer's Disease at JPM
Despite initial slow sales, the firm's CEO cited areas for Leqembi's growth and ambitions for an antisense oligonucleotide ...
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Adaptimmune to File for Lete-Cel FDA Approval Following Cuts and Restructuring
The firm is aiming to break even on its cash flow by 2027 by narrowing its focus on its sarcoma treatments and pipeline candidates with greatest potential.
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Olema Oncology Laying Groundwork for 2027 Launch of Palazestrant
The firm aims to advance two breast cancer therapies in HR-positive, HER2-negative advanced breast cancer this year.
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OIG Recommends Changes in FDA Accelerated Approval After Flagging Concerns With Aduhelm, Other Drugs
The OIG recommended that the FDA define factors that would trigger an application's review by an agency council, which the agency disagreed with.
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First Ascent Biomedical Nabs $6M Investment to Advance Functional Precision Medicine Platform
The firm will use the funds to establish a commercial lab and continue advancing its AI- and sequencing-based platform for personalizing cancer treatment.
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Hutchmed's Orpathys Approved in China for First-Line MET-Altered NSCLC
This latest approval for Orpathys in NSCLC makes the drug available in both the first- and second-line settings.
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FDA Accepts Eisai's BLA for Subcutaneous Leqembi Maintenance Dosing
The agency expects to issue a decision by Aug. 31, and it is slated to decide on maintenance dosing for an intravenous form of the drug later this month.