China’s Center for Drug Evaluation has released the guideline on developing oncology drugs with a clinical value-oriented approach, part of its ongoing efforts to encourage the development of truly innovative oncology drugs in China.
PERTH, Australia – Suda Pharmaceuticals Ltd. saw its stock shoot up nearly 44% on the heels of an oversubscribed AU$3.65 million (US$2.71 million) capital raise after acquiring a new invariant natural killer T (iNKT) cell therapy platform for oncology.
The China NMPA’s Center for Drug Evaluation accepted Lepu Biopharma Co. Ltd.’s new drug application (NDA) for anti-PD-1 antibody candidate HX-008 (pucotenlimab). That comes after the company filed for an IPO in Hong Kong.
The U.S. Centers for Medicare & Medicaid Services (CMS) had previously waded into a sea of opposition from device makers and medical societies alike in its proposal to eliminate the inpatient-only (IPO) list. The new administration at CMS has proposed to reverse that move and sustain the IPO, which should alleviate concerns that outpatient procedures will ding the reputations of these devices.
Having created a profitable preclinical services business, Biocytogen Pharmaceuticals Co. Ltd. is now working to develop its own pipeline of antibody therapeutics, recently inking a partnership with China Resources Biopharmaceutical Co. Ltd. to develop drugs for oncology and immunology indications and raising “tens of millions of dollars” in a new financing round to support the development of its antibody drugs.
Jiangsu Hengrui Medicine Co. Ltd. reported positive interim data from its phase III trial for SHR-3680, an androgen receptor antagonist, demonstrating that it reduced the risk of disease progression or death in metastatic hormone-sensitive prostate cancer patients with high-volume disease burden.
French biotech Pep-Therapy SAS is taking its potentially first-in-class cancer cell penetrating peptide technology into the clinic, after raising €5.4 million (US$6.4 million) in an extended series A funding round. The series A fundraiser initially brought in €2.6 million, but the extension brought in a further €1.6 million in equity from Anaxago, i&i Prague and Badge as well as a €1 million loan from Bpifrance.
RSS
