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Judge's gavel with US flag

Athira to pay $4M to resolve research misconduct allegations

Jan. 8, 2025
By Mari Serebrov
Stressing the importance of integrity in taxpayer-funded biomedical research, the U.S. Department of Justice reported that Athira Pharma Inc. 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.
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Wooden stamp with China flag

China’s NMPA clears country’s first mesenchymal stem cell therapy

Jan. 8, 2025
By Marian (YoonJee) Chu
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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Close-up of injector pen in hands

Amid booming market, US FDA advises on obesity drug development

Jan. 8, 2025
By Mari Serebrov
With obesity drugs taking the U.S. and global markets by storm and more than 100 clinical programs currently in progress for the drugs, the U.S. FDA released a draft guidance Jan. 7 to help sponsors develop drugs and biologics for weight reduction and long-term maintenance of body weight.
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Magnifying glass, FDA concept image

Citing growing interest, FDA advises on ocular imaging drugs

Jan. 8, 2025
By Mari Serebrov
Continuing a spate of beginning-of-the-year guidance, the U.S. FDA released a draft guidance on developing drugs for optical imaging.
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Xeltis-Axess-vascular-access-conduit-8jan25jpg.jpg

Xeltis completes enrollment in EU pivotal trial for vascular access conduit

Jan. 8, 2025
By Shani Alexander
Xeltis BV completed enrollment in the EU pivotal trial for its restorative vascular access conduit, Axess. The prospective study will investigate the patency, safety and performance of Axess in adult patients with end-stage renal disease requiring vascular access to start or maintain hemodialysis therapy.
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Neurology/psychiatric

Solid Biosciences gains IND clearance for Friedreich’s ataxia gene therapy

Jan. 8, 2025
Solid Biosciences Inc. has gained IND clearance from the FDA for SGT-212 for the treatment of Friedreich’s ataxia (FA).
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Heart illustration
Cardiovascular

Cyclarity’s UDP-003 to enter clinic for acute coronary syndrome

Jan. 8, 2025

Cyclarity Therapeutics Inc. has obtained regulatory approval to begin a first-in-human trial of UDP-003. 


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Immuno-oncology

SYS-6045 cleared for clinic in China for advanced solid tumors

Jan. 8, 2025
CSPC Pharmaceutical Group Ltd.’s antibody-drug conjugate SYS-6045 has been granted clearance by China’s National Medical Products Administration (NMPA) to enter clinical trials.
Read More
Lungs
Respiratory

SYH-2059 to enter trials in China for interstitial lung disease

Jan. 8, 2025
CSPC Pharmaceutical Group Ltd. has obtained clearance from China’s National Medical Products Administration (NMPA) to conduct clinical trials in China of SYH-2059 tablets for interstitial lung disease, including idiopathic pulmonary fibrosis and progressive pulmonary fibrosis.
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US FDA weighs in on timing of confirmatory trials

Jan. 7, 2025
By Mari Serebrov
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.
Read More
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