Citing what it called poor study design and execution coupled with a lack of follow-up data, the FDA’s Oncologic Drugs Advisory Committee voted 13-2 against recommending approval of Steba Biotech SA’s NDA for Tookad (padeliporfin dipotassium) for injection in men with localized early stage prostate cancer.
PERTH, Australia – Sydney-based Immutep Ltd. reported positive interim data for its phase II basket trial in non-small-cell lung cancer (NSCLC) and head and neck squamous cell carcinoma for its lead immunotherapy in combination with Merck & Co. Inc.’s anti-PD-1 therapy, Keytruda (pembrolizumab).
Updated results from IMV Inc.’s ongoing phase II trial of DPX-Survivac to treat advanced recurrent ovarian cancer show the company’s lead candidate was active and well-tolerated in patients.
BEIJING – Chinese biosimilar maker Bio-Thera Solutions Ltd., of Guangzhou, on Feb. 21 launched a pre-revenue listing on Shanghai’s STAR market to reap $241 million at a valuation of almost $2 billion.
Bicycle Therapeutics plc said Roche Holding AG's Genentech Inc. has agreed to pay $30 million up front for rights to develop and commercialize up to four potential immuno-oncology therapies using the company's bicyclic peptide platform. Bicycle will be responsible for all discovery and lead optimization, while Genentech will take up R&D beyond that.
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