HONG KONG – Olix Pharmaceuticals Inc. has raised ₩41.5 billion (US$37.90 million) to support the company’s U.S. expansion and advance its pipeline globally.
New phase III data on Takeda Pharmaceutical Co. Ltd.'s TAK-620 (maribavir) for the treatment of transplant recipients with tough-to-treat cytomegalovirus (CMV) infections met the trial's primary endpoint, setting the company up to file an NDA for the oral antiviral in the first half of next year.
The extraordinary speed with which mRNA technology has delivered what appear to be safe and highly efficacious vaccines for preventing COVID-19 herald the start of a “golden age of vaccinology,” according to C. Buddy Creech, director of the vaccine research program at Vanderbilt University in Nashville and principal investigator on the phase III trial of Moderna Inc.’s mRNA-1273 COVID-19 vaccine.
LONDON – The first of 800,000 commercial doses of Pfizer Inc./Biontech SE’s COVID-19 vaccine arrived in the U.K., after the Medicines and Healthcare products Agency (MHRA) became the first regulator to grant conditional approval. A total of 1,500 immunization centers in the U.K. are preparing to receive the vaccine, with administration beginning Dec. 8.
Nearly a year after the SARS-CoV-2 virus first appeared in Wuhan, China, a ray of hope is shining on the world with high efficacy reported for four vaccines and U.S. emergency use authorizations granted to three more therapeutics.
The latest global regulatory news, changes and updates affecting biopharma, including: DEA gets on board with partial Rx fills; USPTO touts early results of amendment pilot; FDA posts combo product feedback final guidance.
TOKYO – Steadily over a decade and a half, Japan’s drugs and devices regulator has all but eliminated a huge drug lag that put the second largest drug market in the world well behind most others in terms of the time it took for approvals and patient access to innovative drugs.
Regulatory snapshots, including drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations in Asia-Pacific, including: Antengene, Ascentage, Biontech, Incannex Healthcare, Janssen-Cilag, LG Chem Life Sciences, Mesoblast, Moderna, Neuren, Pfizer, Regent Pacific, Rhizen, Shanghai Junshi, Telix, Transthera, Wanbang, Yiling.
Clinical updates from Asia, including trial initiations, enrollment status and data readouts and publications, including: Ampio, Apeiron, Appili, Ascletis, Astrazeneca, Beigene, Celularity, Dr. Reddy’s, Enlivex, Inovio, Junshi, Neurorx, Puretech Health, Relief, Senhwa, Sichuan Clover, Takeda, Therapeutics Solution, Zymeworks. Extra
RSS
