News
As cell and gene therapy leaders gathered in Maryland to discuss accelerating clinical trials in children, one âcutting edgeâ session focused on the need to expedite more bespoke gene editing treatments like the one that saved young KJ Muldoon.
FEATURED STORIES
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.
Approved Thursday via the FDAâs Commissionerâs National Priority Voucher program, Otarmeni is the first gene therapy for hearing lossâand the first treatment to target an underlying cause of the condition.
With a greenlight for ibogaine to enter clinical testing and three unnamed products set to receive Commissionerâs National Priority Vouchers this week, itâs full speed ahead for psychedelics. But will sidestepping normal regulatory protocols actually be a net negative for the field?
FROM OUR EDITORS
Read our takes on the biggest stories happening in the industry.
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.
THE LATEST
BMO analysts say Eli Lilly is well-positioned to maintain its lead in the ballooning weight loss space, predicting âstrengthening leadership in obesity and beyondâ as portfolios expand and patient access improves.
Biopharma companiesâincluding AstraZeneca, BioNTech and Agiosâpeered farther into the future on the second day of JPM, setting both revenue and R&D targets through the end of the decade.
AstraZeneca is relying on several upcoming products to help hit its target of $80 billion in revenue by 2030, including drugs for hypertension, breast cancer and generalized myasthenia gravis, all of which are currently under FDA review.
A more detailed review of data by the FDA showed that GLP-1 drugs do not increase the risk of suicidal ideation or behavior.
AbbVie and Novartis strike billion-dollar pacts while attendees at the J.P. Morgan Healthcare Conference await that one big M&A deal and Merck teases limitless buying capacity; Eli Lilly readies for potential orforglipron launch while Novo Nordisk laments compounders; the IPO window cracks open; and the FDA concludes that GLP-1s do not pose a suicide risk.
Speaking to BioSpace at the J.P. Morgan Healthcare Conference, Novartisâ chief dealmaker Ronny Gal explains why the Swiss pharma hasnât acquired a GLP-1, and why it probably wonât.
There hasnât been a headline-stealing deal at J.P. Morgan yet. Nevertheless, the mood is positive amid green shoots and a flurry of dealmaking to end 2025.
Merck CEO Rob Davis expressed high confidence during the companyâs J.P. Morgan presentation on Monday, revealing that the company is open to deals in the range of âmulti tens of billions of dollars.â
Acadia Pharmaâs Catherine Owen Adams is one of the founders of a group of small- to mid-cap biotechs advocating against a âpeanut butter blanketâ approach to drug pricing for small companies.
Johnson & Johnsonâs second facility in Wilson, North Carolina, is part of a $55 billion push to make all advanced medicines used in the U.S. domestically.