What does it mean for a confirmatory trial to be “underway”? That’s a question that’s been plaguing some drug sponsors, especially those in the ultra-rare disease space, since the U.S. Congress, in 2023, gave the FDA the authority to require that a confirmatory trial be underway at the time accelerated approval is granted.

Stressing the importance of integrity in taxpayer-funded biomedical research, the U.S. Department of Justice reported that Athira Pharma Inc. has agreed to pay more than $4 million to resolve False Claims Act allegations that it failed to report potential research misconduct to the NIH and the Department of Health and Human Services’ Office of Research Integrity in grant applications and progress reports.

The curtain is coming down on one of Europe’s longest-established biopharmas, with Novartis AG announcing it is to shut Morphosys AG’s facilities, following its 2024 acquisition of the one-time antibody pioneer for $2.9 billion. The closure of sites in the U.S. and Germany by the end of 2025 will affect 330 employees.

Dimerix Ltd. and Fuso Pharmaceutical Industries Ltd. signed a license agreement for the development and commercialization of Dimerix’s phase III candidate, DMX-200, for the treatment of focal segmental glomerulosclerosis in Japan for ¥10.5 billion (US$66.5 million) plus royalties.

The antibody-drug conjugate (ADC) arena continues to ring up deals, as Avenzo Therapeutics Inc. signed an exclusive license agreement with Duality Biotherapeutics Inc., whereby Avenzo will develop, manufacture and commercialize AVZO-1418/DB-1418, described as a potential best-in-class EGFR/HER3 bispecific ADC, globally (excluding greater China).

Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: I-Mab, JCR, Lpoxy, Modalis, Naya, Portage, Rakovina, Xortx, Xeno.