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While tovecimig met the main goal of progression-free survival in a Phase 2/3 trial, it did not improve overall survival.
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As cell and gene therapy leaders gathered in Maryland to discuss accelerating clinical trials in children, one “cutting edge” session focused on the need to expedite more bespoke gene editing treatments like the one that saved young KJ Muldoon.
Neal and Azbee awards have validated our approach to reporting on the industry at a time of unprecedented shifts at the FDA and other federal agencies.
The FDA is signaling change, but actual success depends on more than simply bringing in a new leader at the Center for Biologics Evaluation and Research; it requires accountability, transparency and consistent action.
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Doubling survival in pancreatic cancer, a long-fought rare disease approval, a massive IPO and ambitious biotech entrepreneurs have BioSpace Senior Editor Annalee Armstrong feeling upbeat about the biotech scene.
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The FDA initially placed the Phase III IDeate-Lung02 study on hold due to a “higher than expected” number of deaths in patients treated with ifinatamab deruxtecan.
AbbVie has also pledged to participate in TrumpRx and offer many of its products, including Humira, on a direct-to-patient basis. In exchange, the pharma secured exemptions from tariffs and other future pricing directives.
Drugmakers told the FDA that inflexible post-approval change requirements are among the top regulatory barriers to the reshoring of pharmaceutical manufacturing.
Former European Trade Commissioner Phil Hogan and former U.S. Senator Richard Burr, speaking on a panel at the J.P. Morgan Healthcare Conference, pushed to see a larger picture beyond the Trump administration’s year of chaos and confusion.
Mature biopharma deals are stealing all the headlines, but Bristol Myers Squibb’s Robert Plenge says the company’s deals with insitro, Orbital and more are building the future.
The deal, which sees AbbVie paying RemeGen $650 million upfront, gives the pharma ex-China rights to the biotech’s PD-1/VEGF bispecific antibody—a modality being targeted by companies including BMS, Merck and Pfizer.
While Moderna’s full-year sales landed in the upper end of its target range, Jefferies analysts said further reductions are needed if the biotech hopes to hit its 2028 break-even target.
The deal will see Novartis gain global rights over SciNeuro’s potentially disease-modifying anti-amyloid antibody, which leverages the latter’s proprietary shuttle platform to allow delivery into the brain.
FDA Commissioner Marty Makary called these changes “common-sense reforms” that could expedite the development of cell and gene therapies.
Aurora joins the clutch of companies linked to Nobel Prize winner and CRISPR trailblazer Jennifer Doudna.