Required studies will assess the risks of ARIA and intracerebral hemorrhage, as well as safety in ApoE ε4 homozygotes. For the required registry-based study, the FDA suggests use of the ALZ-NET platform with no mention of CMS’ newly established registry, which may lack the level of detailed information needed to satisfy the drug regulator’s request.

Janssen and French biotech Dynacure take licenses to antisense candidates arising from Ionis’ Generation 2.5 technology. Merck and Cue sign autoimmune partnership, while Bayer and PeptiDream ink discovery pact.

Coronado Biosciences in-licenses and develops cancer drugs. One of its candidates is apogossypol, an inhibitor of Bcl-2 proteins that play a role in programmed cell death--a process that cancer cells manage to circumvent. Also in the start-up's pipeline: a less-toxic anthracycline and an agent that activates natural killer cells against residual cancer cells following treatment.