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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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Despite exceptional regional hubs and research strength, investors say Europe still needs more integrated incubators, smarter regulation and broader pools of patient capital to keep breakthrough companies growing at home.
Commitments in obesity- and diabetes-focused deals reached $22 billion in the first quarter of 2026—already eclipsing last year’s total of $20.3 billion, according to a new J.P. Morgan report.
After Revolution Medicines’ drug candidate doubled survival in a Phase 3 pancreatic cancer study, the biotech is hoping to attract more investor money, with new plans for a $2 billion stock and debt offering.
In recent months, Anthropic has been building more and more ties with the biopharma industry, including partnerships with Big Pharma companies such as Sanofi, Novo Nordisk and AbbVie.
The trend of fewer companies letting employees go, which began in the fourth quarter of last year, has continued. However, more employees were on the chopping block in Q1 2026 than in Q1 2025, due mainly to one company’s cuts.
In this whitepaper, BioSpace reviews the major trends impacting the CDMO sector and the evolving relationship between sponsors and providers. We examine the key qualities pharma and biotech should consider in CDMO selection, and how the macroeconomic and macrodevelopment factors affecting the space play a role in this selection.
Leading Beeline Medicines’ pipeline is afimetoran, which is in Phase 2 development for systemic lupus erythematosus with data expected later this year.
After divorcing Denali Therapeutics earlier this month, Takeda is now splitting up with Veritas In Silico, pulling back from a partnership that advanced novel small-molecule drugs targeting mRNA.
The FDA is asking Eli Lilly to submit cardiovascular and liver safety data from an ongoing Phase 3 trial of Foundayo by July.
Johnson and Johnson kicked off first-quarter earnings season with a “modest” beat and an ambitious goal; Replimune failed again to gain approval for its advanced melanoma therapy, as analysts tout increased accountability brought by the FDA’s new policy of publicizing complete response letters; and Revolution Medicines’ pancreatic cancer candidate doubled survival in one of cancer’s most intractable foes.