Shanghai Henlius Biotech Inc.’s self-developed Hanbeitai (bevacizumab biosimilar) has received marketing approval from China’s NMPA. It was approved for the treatment of metastatic colorectal cancer and unresectable, locally advanced, recurrent, or metastatic non-squamous non-small-cell lung cancer.
It’s been more than six years since the FDA’s first approval of an oncolytic virus – Amgen Inc.’s melanoma drug Imlygic (talimogene laherparepvec) – and it’s easy to argue that progress in the field has been overshadowed by success with other immunotherapy types such as checkpoint inhibitors. Though the FDA hasn’t approved any more oncolytic viruses since then, Phoenix-based Oncomyx Therapeutics Inc. is one of several companies trying to change that.
Tot Biopharm International Co. Ltd.’s self-developed Pusintin (bevacizumab), a biosimilar to Roche Holding AG’s Avastin, has won marketing approval from China’s NMPA. It was approved for the treatment of patients with advanced, metastatic, or recurrent non-squamous non-small-cell lung cancer and those with metastatic colorectal cancer.
Beyondspring Pharmaceuticals Inc. said it received a complete response letter from the FDA regarding the NDA for plinabulin, the company’s lead asset. The FDA said results of a phase III registrational trial were strong enough to show benefit but a second trial is needed to satisfy the agency.
Prelude Corp. (dba Preludedx) reported positive results from the SweDCIS randomized trial showing its DCISionrt test predicts radiation benefit for lowering 10-year local invasive breast cancer risk. The prognostic, artificial intelligence (AI)-based tool assesses and predicts the benefit of radiotherapy for women with ductal carcinoma in situ (DCIS) following breast-conserving surgery (BCS).
Life sciences VC Apple Tree Partners has launched its first U.K.-based portfolio company, providing $53 million in series A funding for immunology specialist Adendra Therapeutics Ltd.
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