The 2025 edition of Clarivate’s Drugs to Watch features 11 candidates or approved therapeutics that may well revolutionize treatments or become blockbusters. The 12th annual report has a strong track record. Twelve of the 13 drugs from the 2024 Drugs to Watch report have been approved and launched.
The BioWorld Insider podcast is a monthly dive into the business and science of drug development. Conversations with CEOs and BioWorld analysts in the past 12 months have included a wide range of chats with experts who are shaping the future.
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.
Strong interim safety and efficacy data from Hoth Therapeutics Inc.’s phase IIa study of HT-001 helped boost the company’s stock (NASDAQ:HOTH) on Jan. 7 as shares rose 178% to close at $2.28 each.
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).
About four years after launch, Orna Therapeutics Inc. signed its second major deal, this time validating the lipid nanoparticle delivery technology it acquired through its Renagade Therapeutics Inc. buyout in May 2024, with Vertex Pharmaceuticals Inc. seeking next-generation approaches for hemoglobinopathies.
China’s health regulator gave conditional approval to Platinum Life Excellence Biotech Co. Ltd.’s amimestrocel injection (hUC-MSC PLEB-001, Ruibosheng) as the nation’s first human umbilical cord-derived mesenchymal stem cell therapy to treat steroid-refractory acute graft-vs.-host disease on Jan. 2, 2025.
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