Clinical research
In two late-stage trials, the experimental oral drug evobrutinib was unable to significantly reduce annualized relapse rates in MS patients compared with Sanofi’s Aubagio tablets.
A combination of Roche’s investigational treatment with Ibrance and fulvestrant met its primary endpoint of progression-free survival in the first-line setting in treating PIK3CA-mutated breast cancer.
ALTO-300 was significantly more effective in major depressive disorder patients with a specific EEG biomarker than in those without, according to results from an Alto Neuroscience Phase IIa study.
EyePoint Pharmaceuticals’ treatment for wet age-related macular degeneration showed comparable results to Regeneron’s Eylea with a less frequent dosing regimen.
AbbVie’s $10.1 billion ImmunoGen buy and Altimmune’s Phase II win demonstrate that the antibody-drug conjugate market is red hot in cancer and GLP-1 drugs for weight loss are an absolute craze.
While Pfizer’s oral GLP-1 candidate met its primary endpoint in a Phase IIb obesity trial, twice-daily dosing of danuglipron resulted in high rates of adverse events including nausea, vomiting and diarrhea.
From the skin to the lungs to the central nervous system, biotech companies are making progress toward delivering RNA therapeutics to multiple targets throughout the body. But challenges remain.
Citing slow enrollment and low clinical rates, the late-stage “evidence trials” are being discontinued. AstraZeneca said there are no safety concerns and no impact on Lokelma’s current approved indication.
The company’s investigational c-Met protein directed antibody-drug conjugate showed a “compelling” overall response rate in patients with previously treated non-small cell lung cancer.
This week, the FDA could approve the first CRISPR-edited therapy in the U.S., while two other companies await decisions on topical drugs.
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