News
The FDA plans to hold an advisory committee meeting to discuss Capricor Therapeuticsâ application for deramiocel, which the agency rejected last July. The news surprised CEO Linda MarbĂĄn, who told BioSpace the FDA has not communicated any issues of concern with the companyâs resubmitted application.
FEATURED STORIES
Dual and even triple or quadruple track processes have come roaring back in 2026 thanks to a glut of M&A that has refilled investorsâ wallets. Big Pharma is being put on notice that time is critical if they want to acquire.
Policymaking at FDA has been anything but business as usual under the Trump administration, but former regulators cite the agencyâs new investigational new drug pilot program as a sign of normalcy.
The FDAâs recently altered outlook on the evidence required for approval of rare disease drugs could have immediate benefits for companies including Skyhawk Therapeutics, Capricor Therapeutics and Biohaven.
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If cell and gene therapy makers are going to achieve their mission to improve patientsâ lives, the industry must come together to share information across stakeholders, from regulators to manufacturers to payers.
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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.