Israeli cell therapy specialist Neurogenesis Ltd., said new phase II data has shown that treatment with its autologous cell therapy candidate NG-01 in progressive multiple sclerosis (MS) patients led to an 80% to 90% reduction in disease progression at 12 months compared to a pretreatment period and a 90% reduction in relapses compared to placebo-treated patients. Read More
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. Read More
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. Read More
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. Read More
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. Read More
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. Read More
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. Read More
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. Read More
Preclinical startup Tavotek Biotherapeutics Ltd., with operations in Pennsylvania and Suzhou, China, boasts two technology platforms for discovering and developing molecular-targeted biologics for cancers and autoimmune diseases and is working to push its candidates, including a bispecific antibody, to the clinic next year. Read More
HONG KONG – Takeda Pharmaceutical Co. Ltd. received approval from Japan’s Ministry of Health, Labor and Welfare (MHLW) for an additional indication for its tyrosine kinase inhibitor, Cabometyx (cabozantinib), clearing the firm to manufacture and market 20-mg and 60-mg tablets for patients with unresectable hepatocellular carcinoma that has progressed after prior systemic therapy. Read More
Chinese biopharma Impact Therapeutics Inc. of Nanjing raised $50 million in a series C+ round on Nov. 30, two years after its $30 million series C round. Impact’s CEO Jun Bao told BioWorld that the majority of the proceeds would be used to take several programs forward. The financing round also paved the way toward an IPO. Read More
Biopharmas in Asia-Pacific raising money in public or private financings, including: Auris Medical, Burning Rock, Canbridge, ILC, I-Mab, Neuroglee, Olix, Perseus Proteomics, Sinovac, Sunshine. Read More
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 Read More
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. Read More
