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Biogen’s Qalsody won FDA approval in 2023 to treat a rare, genetic form of amyotrophic lateral sclerosis. On Tuesday, QurAlis presented interim Phase 2 data showing the potential of a similar drug to more broadly treat the neurodegenerative disease.
As Q1 earnings arrive, three biotechs have big quarters ahead, with two—Amylyx and Neumora Therapeutics—betting at least partly on novel assets for obesity.
Comprehending the spate of recent rejections in the cell and gene therapy space may require looking no further than early-stage clinical trials of candidates from REGENXBIO, Excision BioTherapeutics and Intellia Therapeutics.
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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.
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Exelixis’ next-generation tyrosine kinase inhibitor zanzalintinib is being tested for colorectal cancer, renal cell carcinoma and head-and-neck cancer, with several readouts slated for the second half of 2025.
Recently appointed HHS Secretary Robert F. Kennedy Jr. in 2018 helped bring several cases against vaccine maker Merck, alleging injury linked to its HPV shot Gardasil.
Merck’s Keytruda may be the most talked about drug facing loss of exclusivity but it’s far from the only one, as several of the industry’s top-performers are losing key market protections. Some companies are more prepared than others.
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.
The FDA is mired in uncertainty with some staffers losing their jobs over the weekend and more potentially to come, vaccines and psychedelic therapies could be facing very different futures under newly confirmed HHS Secretary Robert F. Kennedy, Jr., Moderna continues its downward revenue slide and Merck, Regeneron, BMS and more face strong patent headwinds.
The partnership splits the rights to Stoke’s epilepsy antisense oligonucleotide, with up to $385 million in potential payments due to Stoke.