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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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All told, CytomX Therapeutics now stands to receive up to $4 billion over the course of its partnership with Regeneron, if all milestones are met.
Alnylam Pharmaceuticals will leverage Inceptive Nucleics’ generative machine learning models to accelerate the development of RNA interference therapies.
In this episode of Denatured, you’ll be hearing from Daniel Gil, CEO of Pelage Pharmaceuticals and Francisco Ramírez-Valle, senior vice president of immunology discovery at Eli Lilly. We dive into the long-overlooked hair loss space, exploring why true innovation has lagged, how a regenerative approach aims to reactivate dormant follicles and what early proof-of-concept means for patients.
Looking for a biopharma job? Check out the BioSpace list of 12 top companies hiring life sciences professionals like you.
It’s not unusual for it to take unemployed biopharma professionals awhile to land new jobs. Three experts discuss when employment gaps are an issue and how to explain them to prospective employers.
FDA inspectors found that Medline, which raised billions of dollars last year, failed to prevent repeat bacterial contamination of finished drug products.
Revolution Medicines stole the show at the 2026 American Society of Clinical Oncology meeting as full data from its pancreatic cancer drug lived up to expectations, while Summit and Akeso proved the PD-(L)1/VEGF mechanism and Eli Lilly showed that its in vivo CAR T bet is paying off.
NewLimit is pressing the gas, speeding into clinical trials much sooner than expected after lab research showed its epigenetic reprogramming asset reversed aging in human liver cells.
Celcuity’s gedatolisib doubled progression-free survival versus standard of care in certain patients with advanced breast cancer. Still, the biotech’s stock dropped more than 25% Tuesday.
Travere Therapeutics will gain an exclusive license to the oral BTK inhibitor civorebrutinib, which analysts at Guggenheim Securities said could be “complementary” to the biotech’s IgA nephropathy drug Filspari.