The U.S. FDA has lifted the clinical hold on Astellas Pharma Inc.’s Fortis phase I/II trial evaluating AAV gene replacement therapy AT-845 in adults with late-onset Pompe disease.
The Australian government has begun its closely watched independent review of the health technology assessment (HTA) process in the country, and it delivered a first peek at what it will consider. This independent review of the HTA system is the first of its kind in nearly 30 years.
The U.S. FDA granted breakthrough therapy designation to Abbisko Therapeutics Co. Ltd.’s colony-stimulating factor 1 receptor (CSF-1R) inhibitor, pimicotinib, for patients with tenosynovial giant cell tumors who are not able to have surgery.
Australian biotech company Ferronova Ltd. has secured AU$11 million (US$7.7 million) to advance its nanoparticle platform to assist surgeons more accurately locate and remove malignant cells during treatment of gastrointestinal and brain tumors.
The Australian government has begun its closely watched independent review of the health technology assessment (HTA) process in the country, and it delivered a first peek at what it will consider. This independent review of the HTA system is the first of its kind in nearly 30 years.
China’s National Medical Products Administration is grappling with how to regulate drugs that are sold online as it issued new provisions under the country’s Drug Administration Law that allows prescription drugs to be sold online for the first time.
ABVC Biopharma Inc is headquartered in San Francisco but it has its roots in Taiwan where it is digging into traditional medicine and validating it for the modern world. “There are a number of drugs that can’t be synthesized in the lab,” ABVC CEO Howard Doong told BioWorld, so he is going back to the original source of traditional Chinese medicines to validate them using traditional drug development models.
The discovery of two new sarcoma-specific pathways and 14 new genes that predispose people to heritable sarcomas could pave the way to managing cancer risk early via detection of these mutations for this rare type of cancer. Sarcomas are rare connective tissue malignancies mostly derived from embryonic mesoderm and affect younger people.
Vaxxas Pty. Ltd. and the Coalition for Epidemic Preparedness Innovations (CEPI) signed a partnership agreement to develop Vaxxas’ vaccine-patch delivery technology in a project that could end the need for frozen storage of mRNA vaccines.
The COVID-19 pandemic provided opportunities for companies that provide telehealth solutions, and Taiwan-based Faceheart Inc has developed video-based measurement software that allows patients to be screened remotely using artificial intelligence (AI).
