Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Altimmune, Arthex, Cumberland, Lakeshore, Mustang, Rapport.
Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: ADC Therapeutics, Aditum, Arctic Vision, Emergent, Leads, Clearside, Santen, Sarepta, Viracta.
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Ascelia, Ascletis, Impact, Neurocrine, Springworks, Werewolf, Xilio.
Reducing microglial activity in the presence of apolipoprotein E4 (APOE4) has uncovered a mechanism associated with the deposition of misfolded amyloid and tau in a novel mouse model of Alzheimer’s disease. By transplanting human neurons into the mouse brain and eliminating the mouse microglia, scientists at the Gladstone Institutes in San Francisco observed that amyloid and tau deposition was reduced. These results support therapeutic strategies that target APOE4 and microglia.
With the U.S. Congress sitting on its hands on reforms to the 340B drug discount program, states are stepping into the gap. While most state efforts have been aimed at forcing biopharma companies to give the federally mandated drug discounts to an increasing number of contract pharmacies, California is looking in a different direction. According to unofficial election results, a slim majority of the state’s voters said yes to Proposition 34, which would require certain providers that benefit from the drug discounts to spend at least 98% of their 340B revenues on direct patient care.
Eli Lilly and Co.’s chief scientific officer, Daniel Skovronsky, called peresolimab, the PD-1 agonist previously in the works by the firm for rheumatoid arthritis (RA), a “really interesting mechanism” – but not interesting enough.
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