For biopharma, 2019 can be described as a terrific year – with a few asterisks. The financial markets were flourishing, with venture capital dollars, in particular, flowing to the sector, while dealmaking reached historic proportions. Meanwhile, scientific breakthroughs led the way as cell and gene therapies gained ground, the first signs of success emerged with new technologies like CRISPR and the long-awaited promise of genomics found its way to the front lines of health care.
The therapeutic value of LSD, the psychedelic muse behind countless books, music and works of visual art, has hit an altogether more prosaic milestone, albeit toward a still far-out end: A phase I study, sponsored by U.K.-based Eleusis Pharmaceuticals Ltd., found low doses safe and well-tolerated, setting the stage for new tests of the approach as a disease-modifying therapy for Alzheimer’s disease (AD).
Machine learning and artificial intelligence (AI) are already being actively used in drug discovery to evaluate potential binding of small-molecule drugs to proteins, but there's potential for the technologies to be used on the development side as well, especially in hard-to-treat diseases such as Alzheimer's disease.
There is no FDA-approved medication for Alzheimer’s disease. But there is some hope that if the blood-brain barrier could be more easily penetrated by drug candidates they would prove more effective. That is the line of research being pursued by Israeli company Insightec Ltd. via its Exablate Neuro that provides low-intensity focused ultrasound treatment.
SAN DIEGO – Smaller companies looking to move their Alzheimer’s disease drugs into late-stage testing as quickly as possible are eschewing cognitive endpoints that can take years to readout for biomarkers and functional assays of brain activity.
SAN DIEGO – Following up on its October announcement that it would file for FDA approval of beta-amyloid-targeting aducanumab, Biogen Inc. presented the final dataset for the phase III Emerge and Engage studies at the 12th Clinical Trials on Alzheimer’s Disease Meeting.
Optina Diagnostics, of Montreal, and the Wagner Macula & Retina Center are collaborating on a clinical study using Optina's Retinal Deep Phenotyping (RDP) platform to screen for Alzheimer's disease. The program will put the platform into nine community eye clinics in Virginia and North Carolina.
Within the first few minutes of a key opinion leader webinar on Alzheimer's disease sponsored by AC Immune SA, CEO Andrea Pfeifer brought up the decision by Biogen Inc. to file for regulatory approval of amyloid beta targeter aducanumab in early AD, based on results from a subset of patients in the phase III study called Engage.
BEIJING – Chinese drug regulators granted conditional approval to Shanghai Green Valley (Group) Co. Ltd.'s marine-derived oligosaccharide, GV-971, to treat Alzheimer's disease (AD), but required further trials to prove the drug's efficacy after marketing.
BEIJING – Chinese drug regulators granted conditional approval to Shanghai Green Valley (Group) Co. Ltd.'s marine-derived oligosaccharide, GV-971, to treat Alzheimer's disease (AD), but required further trials to prove the drug's efficacy after marketing.
