Drug Development
Marty Makary, likely FDA commissioner under President Trump, appeared before Congress this week as the agency he’s set to lead continues to be rocked by sweeping changes and about-faces.
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Continuing our SCOPE 2025 coverage, Rohit Nambisan, CEO at Lokavant addresses not only current challenges, but the life sciences industry’s responsibility to maintain scientific integrity.
After the rejection of Lykos Therapeutics’ MDMA-based PTSD treatment tempered excitement for psychedelic therapeutics, a recent approval and positive data are generating new momentum, which experts expect to continue throughout 2025 and 2026.
Biopharma doubles down on immunology and inflammation as companies target new pathways and seek to improve on current options in inflammatory bowel disease, atopic dermatitis, myasthenia gravis and more.
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The news comes on the heels of promising Phase I/Ib data, which point to the potential of casdatifan as a more effective alternative to Merck’s Welireg in renal cell carcinoma.
Elisa Cascade, CPO at Advarra explains why addressing the challenges faced by clinical research sites is vital for improving patient trust and the overall viability of clinical trials.
AlgoTherapeutix blames a “strong placebo effect” for the mid-stage failure for its pain gel ATX01, but the company still believes in the promise of its candidate as Vertex Pharmaceuticals’ first-in-class drug Journavx opens up the non-opioid space.
Casdatifan’s progression-free survival benefits could help differentiate it from Merck’s Welireg in the kidney cancer arena, according to analysts at Truist Securities.
With its recent data drop for an oligonucleotide candidate, Dyne Therapeutics signals it may become a frontrunner in this disease space alongside Avidity Biosciences, Lupin and AMO Pharma.
The failure in adjuvant melanoma could cause BMS and Opdualag to miss out on a market opportunity that is nearly twice as large as its current approved indication, according to analysts.
The experts will assess unblinded data from BEACON-IPF to figure out why a data safety monitoring board recommended suspension of the idiopathic pulmonary fibrosis trial.
Without providing specific data, Sanofi on Thursday announced that the experimental vaccine did not significantly prevent invasive E. coli disease versus placebo.
The data, published in JAMA Psychiatry, add to the growing body of evidence supporting the use of GLP-1 receptor agonists for addictive disorders.
Jay Ferro, EVP, CIO, CPO & CTO at Clario discusses safety, trust and what keeps him up at night.