A month away from the PDUFA decision date for a Leqembi (lecanemab) subcutaneous autoinjector to be used for maintenance dosing for those with early Alzheimer’s disease, Eisai Co. Ltd. and Biogen Inc. presented clinical data at the Alzheimer's Association International Conference (AAIC) 2025 in Toronto, showing comparable efficacy and safety to the FDA-approved intravenous formulation. Read More
President Donald Trump sent letters July 31 to the CEOs of 17 major drug manufacturers doing business in the U.S., giving them 60 days to comply with his May 12 executive order (EO) on most-favored-nation (MFN) pricing. The EO appealed to drug companies to undertake MFN pricing voluntarily to end the freeloading in which other developed countries pay, on average, three times less than Americans are charged for the same medicines. Read More
Alterity Therapeutics Ltd. helped develop a new neuroimaging biomarker called the multiple system atrophy index (MSA-AI), which looks to be a more reliable biomarker for tracking disease progression of MSA. Developed using deep learning methods, the MSA-AI offers a superior, objective and quantifiable measure of brain atrophy in MSA patients. Read More
Chinese scientists have discovered a common mechanism by which structurally distinct proteins elicit an allergic reaction, showing they cause the formation of pores in epithelial airway cells. That allows calcium ions to enter and trigger a type II immune cascade, which results in the release of histamine from mast cells. Read More
Around 10 million people globally live with the life-threatening human T-cell lymphotropic virus type-1 (HTLV-1), yet it remains a poorly understood disease that currently has no preventative treatments and no cure. That could soon change after Australian researchers discovered that existing HIV drugs can suppress transmission of the HTLV-1 virus in mice. Read More
Soligenix Inc.’s phase IIa study of SGX-945 (dusquetide) for treating oral ulcers in those with Behçet's disease showed biological efficacy in the proof-of-concept study. The positive results propelled the company’s stock (NASDAQ:SNGX) a hefty 134% higher on July 31, with shares closing at $2.93 each. Read More
The BioWorld Drug Developers Index (BDDI) rebounded in the second quarter, ending the first half (H1) of 2025 up 1.23% after being down 7.36% at the end of March and 5.52% at April’s close. The BDDI continued to track just below the Dow Jones Industrial Average, which gained 3.64% in H1, and outperformed the Nasdaq Biotechnology Index, which ended June down 1.92%. Read More
The Senate Appropriations Committee met July 31 to markup legislation that would fund the Department of Health and Human Services – including an additional $400 million for the National Institutes of Health. The increase in NIH funding repudiates the Trump administration’s efforts to drastically cut those appropriations, which is an outcome marking a clear win for companies in the life sciences. Read More
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Abbvie, Aclaris, Aerorx, Biogen, Cardiff, Eisai, Eli Lilly, Kane, Newamsterdam, Tenaya, Vyne. Read More
Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Allianthera, Dr. Falk, Dxvx, Evotec, Kissei, Poxel, Sandoz, Viridian. Read More
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Actio, Kedrion, Neuvivo, Sanofi, Vivace. Read More
