Less than two weeks after Japan’s MHLW became the first regulatory agency to clear avacopan for anti-neutrophil cytoplasmic autoantibody (ANCA)-associated vasculitis, the FDA has followed suit. It cleared the oral, small-molecule C5aR antagonist for use as an adjunct therapy for adults with the two main forms of the rare autoimmune renal disease, granulomatosis with polyangiitis and microscopic polyangiitis, in combination with standard therapy. Read More
Allogene Therapeutics Inc. officials took many questions but had few answers during a conference call regarding the FDA’s clinical hold after the report of a chromosomal abnormality in ALLO-501A CAR T cells in a patient treated in the phase I/II Alpha2 study. Read More
A lack of toxicity and the shrinking of tumors were at the heart of new interim data produced from a two-stage phase II study by Relay Therapeutics Inc. The company reported that the oral small molecule RLY-4008, designed to elicit responses across a broad spectrum of resistance mutations and in multiple tumor types, selectively inhibited fibroblast growth factor receptor (FGFR) 2 in ways that are not limited by off-target toxicities of hyperphosphatemia (FGFR1) and diarrhea (FGFR4). Read More
Highlighting 2021's clear trajectory toward record IPO territory, Oct. 8 brought upsized market debuts for both Pyxis Oncology Inc. and Cognition Therapeutics Inc., raising $168 million and $45.2 million, respectively. Read More
The biopharma industry is full of amazing ideas, but getting funding for them and turning them into medicines for the real world is a huge challenge. As anyone in the industry knows, getting investors to back your company can be as challenging as getting the science to work and can take a significant amount of the company’s time and effort. Read More
It looks like Shanghai Miracogen Inc.’s antibody-drug conjugate (ADC) partnership with Synaffix BV is paying off as MRG-004A, an ADC designed to treat solid tumors, has entered a U.S. phase I/II trial to treat solid tumors. Read More
PERTH, Australia – After meeting with the FDA, Medlab Clinical Ltd. is reformulating its cannabinoid pain product into a synthetic formulation because the agency indicated it was more likely to register a synthetic compared to a botanic. Read More
New and updated preclinical and clinical data presented by biopharma firms at the American Association for Cancer Research virtual International Conference on Molecular Targets and Cancer Therapeutics, including: Aileron, Amgen, Amunix, Bridgebio, Clovis, Cogent, Curis, Deciphera, Essa, Forma, Gennao, Hummingbird, Ikena, Immunome, IMV, Kineta, Kinnate, Medicenna, Monte Rosa, Nuvalent, Oric, Phio, Prelude, Relay, Salarius, Second Genome, Spectrum, Turning Point. Read More
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Denali, Minervax, Ortho Regenerative, Recursion, Y-Mabs. Read More
