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A few short days after announcing an FDA pivot on a separate asset, REGENXBIO is planning to test the agency’s apparent newfound rare disease outlook on another late-stage gene therapy.
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Speaking to media on Tuesday, BIO CEO John Crowley complimented China’s rise as a biotech powerhouse but said U.S. policy needs to protect and maintain America’s lead.
While merger and acquisition activity has been robust of late, frequent changes in guidance and leadership at the regulator add risk to any transaction.
With drug pricing now embedded in U.S. policy, business development teams in biotech and pharma are changing the way they strike deals, including acknowledging policy uncertainties with renegotiation clauses.
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If cell and gene therapy makers are going to achieve their mission to improve patients’ lives, the industry must come together to share information across stakeholders, from regulators to manufacturers to payers.
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Experts say the time is now to develop and provide widespread access to genetic medicines for the rarest diseases. What’s more, they say it is a moral imperative.
With U.S. election season now in full swing, BioSpace looks at pharmaceutical-associated campaign contributions. Plus, Q2 earnings, Adaptimmune’s big approval, an anticipated FDA decision on an MDMA-assisted treatment and more.
The size of the global immunology market is projected to nearly double by 2032 to a quarter of a trillion dollars. Here are this year’s standout deals in the space.
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.