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While both Beam Therapeutics and Wave Life Sciences touted notable biomarker benefits for their respective alpha-1 antitrypsin deficiency assets, analysts said that Beam might have the efficacy advantage as Wave’s drug hits an efficacy “ceiling.”
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Biotech is increasingly financed, governed and regulated as though it were a mature pharmaceutical industry rather than a discovery system built around scientific uncertainty. Structural changes are needed to sustain the sector’s strategic innovation.
BioSpace examines how the FDA approval of Eli Lilly’s oral obesity drug Foundayo has ignited a key race with Novo Nordisk.
Nusano will bring a massive new radioisotope facility in Salt Lake City online by the end of the year, establishing a supply of starting materials for the next generation of radiopharmaceuticals.
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The Department of Health and Human Services is spinning its wheels, unable to establish steady leadership at three major divisions—the CDC and the FDA’s two primary review units.
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In this live panel discussion, speakers focused on the EU AI Act’s global regulatory implications for medical devices & QARA’s future. An executive summary is available.
In this live panel discussion, speakers navigate integrated ecosystems and the future of QARA. An executive summary is available.
In this live panel discussion, speakers explore artificial intelligence in medtech and practical realities in QARA. An executive summary is available.
After dropping $4 billion on a deal with the Japanese company last year, Merck is getting back some of its investment as Daiichi Sankyo buys into a Phase I/II T-cell engager therapy acquired from Harpoon Therapeutics.
Sangamo Therapeutics announced Tuesday it secured an exclusive licensing agreement with Roche’s Genentech, which is paying $50 million in near-term upfront fees and milestone payments to develop novel genomic medicines for neurodegenerative diseases.
Biotech entrepreneur Arie Belldegrun and former Roche CEO Franz Humer are part of the credit firm’s push to provide companies with another source of funding, Symbiotic Capital announced Tuesday.
Bayer’s surprising growth in the second quarter was driven in large part by two pharma products: the prostate cancer drug Nubeqa and the chronic kidney disease treatment Kerendia.
BioMarin Pharmaceuticals on Monday said it is restricting sales of its hemophilia A gene therapy to three countries in an effort to reduce costs and help the treatment become profitable by 2025.
The specialty pharmaceutical company has twice filed for bankruptcy in recent years, driven by opioid-related litigation. Mallinckrodt’s deal with CVC will allow it to pay off more than half of its net debt.
The FDA is looking for stronger overall survival data to back Actinium’s application for Iomab-B, an investigational therapy that will allow acute myeloid leukemia patients to receive bone marrow transplants.