Radiopharm Theranostics Ltd. announced a AU$70 million (US$46.69 million) institutional placement, and as part of that capital raise, radiopharma company Lantheus Holdings, Inc., has agreed to make an initial equity investment of AU$7.5 million.
The U.S. FDA approved three biosimilar products from Samsung Bioepis Co. Ltd., Tanvex Biopharma Inc. and Formycon AG as follow-on biologics to Stelara (ustekinumab), Neupogen (filgrastim) and Eylea (aflibercept), respectively, on June 28.
New single-step genome editing techniques that enable the insertion, inversion or deletion of long DNA sequences at specified genome positions have been demonstrated in bacteria.
Regulatory snapshots, including drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations in Asia-Pacific: Antengene, Astrazeneca, Biontech, GSK, Junshi, Otsuka, Simcere, Takeda.
Clinical updates from Asia, including trial initiations, enrollment status and data readouts and publications: Abbisko, Actinogen, Douglass, Eisai, Encell, Huadong, Innovent, Immutep, Recce, Sun Pharmaceutical, Takeda, Tiumbio.
Biopharma happenings in Asia-Pacific including deals and partnerships, grants, preclinical data and other news in brief: Alivexis, Ionis, Kactus, Melodia, Otsuka, Yoltech
Partners Daiichi Sankyo Co. Ltd. and Merck & Co. Inc. received a complete response letter (CRL) from the U.S. FDA for their first-in-class HER3-directed antibody-drug conjugate HER3-DXd (patritumab deruxtecan) to treat patients with locally advanced or metastatic EGFR-mutated non-small-cell lung cancer.
Merck Sharp & Dohme Corp. (MSD), known as Merck & Co. Inc. in the U.S. and Canada, terminated its potential $1.86 billion deal with San Diego-based Artiva Biotherapeutics Inc. for novel chimeric antigen receptor-natural killer cell therapies. GC Cell disclosed news of the terminated deal on the Korea Exchange near market close of June 25, saying it was notified by Artiva after the decision was reached by MSD’s internal decision makers.
Takeda Pharmaceutical Co. Ltd. is progressing mezagitamab to phase III trials after the CD38 monoclonal antibody showed rapid and sustained increases in platelet counts in patients with persistent or chronic primary immune thrombocytopenia (ITP) in a phase IIb trial.
In May, the U.S. FDA approved 11 new drugs, a significant drop from the 26 approvals in April, which was the sixth-highest monthly total since 2016. This also falls short of March’s record-setting 30 approvals, the highest number recorded by BioWorld.
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