The fate of three cancer drugs, and possibly the future financial health of their sponsors, could be on the line Sept. 22 and 23 as the U.S. FDA’s Oncologic Drugs Advisory Committee (ODAC) takes a hard look at the safety-efficacy data for Spectrum Pharmaceuticals Inc.’s Pozenveo, Oncopeptides AB’s Pepaxto and Secura Bio Inc.’s Copiktra. First up in the triple-header is Pozenveo (poziotinib), which is seeking accelerated approval as a second-line treatment for patients with locally advanced or metastatic non-small-cell lung cancer harboring HER2 exon 20 insertion mutations confirmed by an FDA-approved test. Read More
Basilea Pharmaceutica Ltd., having advanced a first-in-class cancer drug through preclinical studies, is selling some rights and sublicensing others for the dual-kinase inhibitor to Sillajen Inc. Read More
Shares of Renovacor Inc. (NYSE:RCOR) closed at $2.18, up 28 cents, or 14.7%, on word that Rocket Pharmaceuticals Inc. is acquiring the firm in an all-stock transaction valued at $53 million. Rocket, of Cranbury, N.J., said “compelling” preclinical data generated by Cambridge, Mass.-based Renovacor validates an AAV-based transgene replacement strategy for BLC2 athanogene 3 dilated cardiomyopathy. Read More
The May 2014 approval of Takeda Pharmaceutical Co. Ltd.’s Entyvio (vedolizumab) brought welcome news in the form of an important mechanism of action for patients with ulcerative colitis and Crohn’s disease, but also means a burdensome course of administration – 30 minutes’ worth of infusion every six weeks, a drawback that other developers are trying to remedy. Standouts among the up-and-comers are Morphic Holding Inc., with an oral candidate that works through the same mechanism of action as Entyvio, and Protagonist Therapeutics Inc. Read More
Startup Avelos Therapeutics Inc. raised $8 million in series A funding that will launch the company’s biomarker-driven cancer therapy pipeline using its synthetic lethality platform. Participating in the series A funding were SV Investment, UTC Investment, Quad Investment Management, Timepolio Asset Management, Mirae Asset Venture Investment and Mirae Asset Capital. Read More
New hires and promotions in the biopharma industry, including: Bavarian Nordic, Chroma Medicine, Generation, Harpoon, Humacyte, Ilya, Oxford Drug Design, Q32. Read More
Biopharmas raising money in public or private financings, including: Akero, Allakos, Ideaya, Immunoscape, Rhythm, Therapeutic Solutions, Third Harmonic and Virios. Read More
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Biogen, Cellresearch, Corium, Neurosense, Novartis, Polypid, Revance, Trevi, Virios. Read More
Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Cytoreason, Bavarian Nordic, Celsion, Elicio, Immunesensor, Imunon, Menarini, Moat, Novo Nordisk, Octagon. Read More
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Beigene, Biontech, Bridgebio, Sentynl, Cellevolve, Decibel, Junshi, Mediwound, Pfizer, Verismo, Veru, Xpira. Read More
