Sinocelltech Group Ltd. has reported positive interim data for two COVID-19 vaccine candidates, SCTV-01C and SCTV-01E, from phase III trials in the United Arab Emirates.
Astellas Pharma Inc. has invested $50 million in Taysha Gene Therapies Inc. in exchange for 15% of the company and exclusive options to in-license Taysha’s lead gene therapy candidates, TSHA-102 for Rett syndrome and TSHA-120 for giant axonal neuropathy.
Suzhou Zelgen Biopharmaceuticals Co. Ltd. reported a phase III trial testing the company’s deuterium-substituted sorafenib derivative donafenib in patients with progressive locally advanced or metastatic radioactive iodine-refractory differentiated thyroid cancer met its primary endpoint following a preplanned interim analysis which found the drug significantly prolonged median progression-free survival vs. a placebo.
Peking University researchers in collaboration with the NIH have discovered a new biochemical pathway related to a bacterium that eliminates nicotine in the intestine. The findings could lead to new ways to improve nonalcoholic fatty liver disease in smokers.
Celltrion Healthcare Inc. has signed a deal with Pinotbio Inc. to develop antibody-drug conjugates (ADCs) for up to 15 separate cancer targets incorporating the linker-payload platform technology Pinot-ADC. Celltrion could pay Pinotbio as much as ₩1.77 trillion (US$1.24 billion) to exercise options for all 15 targets in the collaboration. But, for starters, it will pay Pinotbio ₩1 billion up front.
Radiopharm Theranostics Ltd.’s phase II F-18 Pivalate positron emission tomography trial in brain metastases saw positive results with high uptake regardless of the origin of primary tumors, showing that Pivalate could be used to monitor brain metastases.
Biocytogen Pharmaceuticals Co. Ltd. subsidiary Eucure Biopharma Co. Ltd. has formed a partnership with Syncromune Inc. to combine Eucure’s YH-002 and two other active ingredients with Syncromune’s Syncrovax platform technology.
Inxmed Co. Ltd. has formed a partnership with Shanghai Huaota Biopharmaceutical Co. Ltd. to combine the former’s IN-10018 and the latter’s HB-0030 for the treatment of solid tumors by jointly running preclinical studies and clinical trials.
Australia’s TGA has opened a consultation on drug-device combination products to help sponsors understand the regulatory pathway through which their products will likely pass since these combination products may not fit within existing definitions for drugs, biologicals or medical devices.
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