More than a third of the money raised through biopharma financings in 2020 was raised by companies developing either a therapeutic or a vaccine for COVID-19, yet completely wiping away those totals still leaves the year with $76.8 billion, a full 12% more than the next highest year. Read More
LONDON – Efficacy data for Russia’s Sputnik V COVID-19 vaccine held steady at 91.4% in the second interim analysis, conducted after 39 confirmed cases of COVID-19 infection in 18,794 volunteers, seven days after they received the second dose.
Four days after receiving European approval, the FDA has followed suit for Alnylam Pharmaceuticals Inc.’s Oxlumo (lumasiran), the first treatment for primary hyperoxaluria type 1, an ultra-rare genetic disorder that contributes to kidney stones and deposits. Read More
PERTH, Australia – Immutep Ltd. completed a AU$29.6 million (US$21.72 million) placement that will allow the immunotherapy company to accelerate and broaden clinical development of its immuno-oncology and autoimmune programs. Read More
HONG KONG – Gemvax & Kael Co. Ltd. reported the full results from a phase II trial in Korea for GV-1001 (tertomotide), its telomerase modulator, in Alzheimer’s disease, showing a statistically significant improvement in neuropsychiatric inventory and an improvement trend in Alzheimer’s Disease Cooperative Study-Activities of Daily living, the study’s two secondary endpoints. Read More
The Pharmaceutical Research and Manufacturers Association (PhRMA) filed suit Nov. 23 in U.S. district court challenging the Trump administration’s final rule allowing the import of prescription drugs from Canada. Read More
The BCL6 degrader BI-3802 works by inducing polymerization of its target protein, which in turn triggers the addition of ubiquitin tags on the polymerized structure and degradation by the proteasome, scientists reported in the Nov. 18, 2020, issue of Nature. Read More
SHENZHEN – To accelerate the development of cell therapies, China’s NMPA has introduced a dual-track regulatory pathway that allows companies to seek an IND with data from investigator-initiated trials. Read More
SHENZHEN – While China is rather new in biotech innovation and still has potential for growth, industry insiders worry about the long-term sustainability of innovation. Speaking at a recent conference in the southern Chinese city of Shenzhen, various experts said sustaining innovation may depend on differentiation, globalization and reimbursement policies. Read More
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Apnimed, Bausch, Capricor, Celularity, City of Hope, GSK, Kubota, Oramed, Principia, RDIF, Reithera, Strongbridge, Targovax, Tolmar. Read More
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Alnylam, Appili, BMS, F-star, Mustang, Obseva, Polypid, Viatris. Read More
