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BioWorld - Monday, June 1, 2026
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Robert Califf with American flag
Regulatory Convergence 2022

Califf still pounding on misinformation despite FDA’s regulatory failures

Sep. 12, 2022
By Mark McCarty
U.S. FDA commissioner Robert Califf resurrected a litany of complaints about medical product misinformation, including vaccinations for the COVID-19 pandemic, in a televised presentation heard by attendees at the Regulatory Affairs Professional Society (RAPS) annual conference here in Phoenix, where the daytime high temperatures are hovering at or near the century mark.
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Human colon cancer cells.

Exact Sciences and Grail show benefits of multi-cancer early detection screening at ESMO

Sep. 12, 2022
By Annette Boyle
Some of the most exciting news out of the European Society for Medical Oncology Congress 2022 in Paris surrounded the rapidly evolving field of multi-cancer early detection (MCED), which offers the dual benefits of identifying malignancies at a more easily treated local stage and enabling screening for the 70% of cancers that lack recommended screening tests.
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Gamma secretase protein complex

ESMO 2022: For gamma secretase inhibitors, a better second act in cancer?

Sep. 12, 2022
By Anette Breindl
The gamma secretase inhibitor nirogacestat (Springworks Therapeutics Inc.) reduced the risk of disease progression by roughly 70% in a randomized placebo-controlled phase III trial in patients with desmoid tumors.
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ESMO 2022: Slicing away at KRAS, one trial at a time

Sep. 12, 2022
By Anette Breindl
Data presented Sept. 9 at the European Society of Medical Oncology 2022 Congress showed impressive effects for KRAS inhibitors. But they also illustrated their limitations. Earlier-stage trials and researcher presentations, meanwhile, suggested ways those limitations might be addressed. Results from the Codebreak 200 study, presented in the day’s Presidential Symposium, were typical of the best that targeted therapies have to offer: large effects for brief time periods.
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Natural killer cell attacking cancer cell

ESMO 2022: First phase III success for cell therapy in solid tumors

Sep. 12, 2022
By Anette Breindl
Scientifically at least, the biggest story coming out of the European Society for Medical Oncology (ESMO) 2022 Congress is the success of cell therapy in solid tumors. “During this ESMO, there is a lot of novelty coming from T-cell therapies,” John Haanen told the audience at his joint keynote speech with Ton Schumacher – so much so that Haanen and Schumacher, both group leaders at the Netherlands Cancer Institute, left antibodies out of their keynote session in order to do justice to the advances in cell therapies.
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ESMO 2022: Catalym’s first-in-class GDF-15 inhibitor shows signs of activity in late-stage cancer patients

Sep. 12, 2022
By Cormac Sheridan
Catalym GmbH reported in an oral session at the European Society for Medical Oncology meeting in Paris that its first-in-class growth differentiation factor 15 inhibitor, visugromab, demonstrated preliminary signs of efficacy in a heavily pretreated group of cancer patients who were resistant or refractory to checkpoint inhibitors.
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Conference data for Sept. 12, 2022: ESMO

Sep. 12, 2022
New and updated preclinical and clinical data presented by biopharma firms at the European Society for Medical Oncology Congress 2022, including: Adaptimmune, Curelab, Novartis.
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mRNA on digital background
Endocrine/Metabolic

Moderna develops mRNA therapy for argininosuccinic aciduria

Sep. 12, 2022
Proof of concept has been achieved for a therapy for argininosuccinic aciduria consisting of human argininosuccinic lyase (ASL) mRNA encapsulated in lipid nanoparticles (ASL-LNPs).
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Lab sample and bone marrow illustration
Cancer

Discovery of novel LIMK inhibitors for osteosarcoma therapy

Sep. 12, 2022
Researchers from CNRS and the Université d'Orléans presented the discovery of novel inhibitors of LIM kinases (LIMKs) as potential therapeutic candidates for the treatment of osteosarcoma (OS).
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Abstract molecules illustration
Cancer

RP-6306: a first-in-class, orally available and selective PKMYT1 inhibitor for the treatment of CCNE1-amplified tumors

Sep. 12, 2022
The PKMYT1 kinase has emerged as a promising therapeutic target for CCNE1-amplified cancers, after a recently reported genome-scale CRISPR/Cas9-based screen identified its inhibition as synthetically lethal for CCNE1 amplification.
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