Neurodegenerative disease and cognitive decline cannot be explained by a single process. Beta-amyloid plaques, hyperphosphorylated tau, alpha-synuclein, activated microglia and astrocytes, altered receptors such as TREM2, mitochondrial dysfunction, epigenetic changes and cerebrovascular alterations all seem to contribute to the development of dementia in Alzheimer’s disease (AD). While scientists attempt to address each of these elements, prevention is growing as a primary goal.
It’s déjà vu all over again for Aldeyra Therapeutics Inc., which disclosed its third complete response letter (CRL) for dry eye disease candidate reproxalap, with the U.S. FDA citing a lack of substantial and consistent evidence of efficacy.
Regulatory snapshots for biopharma and med tech, including global submissions and approvals, and other regulatory decisions and designations: Argo, Astrazeneca, Cogent, Glafabra, Koru Medical, Novartis, Roche, Sun, Telix.
Biopharma and med-tech happenings, including deals and partnerships, and other news in brief: Arrotex, Caris, Cipla, Commave, Fennec, George, PRG S&T, Senseonics, Sentynl, Zevra, Zydus.
Clinical updates for biopharma and med tech, including data readouts and publications: Alessa, Almirall, Bayer, Biomarin, Biomea, Cytomx, Eledon, Eli Lilly, J&J, Nasus, Relay, Sarepta, Structure.
Biopharma and med-tech companies raising money in public or private financings, including: Acumen, Alto, Biovie, JATT II, Option, Outlook, Sharp, Unnatural Products, Zenas.
In the opening sessions of this year’s ESMO Targeted Anticancer Therapies Congress, Elena Garralda, director of the Molecular Therapeutics Research Unit at Vall d’Hebron Institute of Oncology in Barcelona, described ESMO TAT as “the house of phase I,” a fitting label for a meeting centered on translational research and early drug development, where first-in-human data and new trial designs help shape the next generation of cancer therapies.
The GLP-1 fight has moved from injectables to pills, and Structure Therapeutics Inc. is in the ring with phase III-ready aleniglipron. According to the Bay Area biotech, its oral once-daily glucagon-like peptide-1 (GLP-1) drug candidate, aleniglipron, demonstrated an absolute weight loss of “up to 39 pounds” in the 44-week Access II trial.
Australia has released the first clinical practice guideline for the appropriate use of methylenedioxymethamphetamine-assisted psychotherapy for post-traumatic stress disorder, but clinicians caution that evidence, infrastructure and access remain works in progress.