While the U.S. Congress has yet to address the artificial line it created between biosimilars and interchangeables when it passed the Biologics Price Competition and Innovation Act in 2010, the FDA is erasing that distinction for all practical purposes.
Relation Therapeutics Ltd. will collaborate with Novartis AG in a $1.7 billion deal to develop multiple programs to find and advance targets for treating atopic diseases caused by immune dysregulation. Novartis will pay Relation an up-front amount, an equity investment and R&D funding of $55 million. It’s the company’s second deal with big pharma in the past 12 months.
The U.S. FDA’s remote regulatory assessment (RRA) program, the subject of a guidance the agency finalized in June 2025, is proving to be one of the trickier bits of navigation for makers of devices, drugs and biologics.
Almost a year since first filing its S-1 to return to public markets, Medline Inc. revealed the price range for the most awaited IPO of 2025. The massive medical device development and distribution company plans to offer 179 million shares at $26 to $30 per share, putting the total deal value at $5.37 billion at the upper end. At the top of the range, the IPO would rake in the superlatives: largest IPO of 2025, largest med-tech IPO ever and the largest venture capital exit in med tech. The offering range would value the company at up to $55 billion.
Teleflex Inc. reported plans to sell its Acute Care, Interventional Urology and OEM businesses to two buyers for $2.03 billion. Intersurgical Ltd. will acquire the Acute Care and Interventional Urology units for $530 million. Additionally, private equity firms Montagu and Kohlberg are buying its OEM contract manufacturing business for $1.5 billion.
Ireland is taking stock of the implications Trump administration tariffs and drug pricing policies hold for its world-leading biomanufacturing sector, which has been largely built on the back of investment by U.S. pharma companies – and is hugely reliant on exports to the U.S.
With new results from Wave Life Sciences Ltd., Structure Therapeutics Inc. and Ascletis Pharma Inc., obesity management drugs continue to move forward in producing weight loss and move the market.
On the heels of mixed phase III data from Agios Pharmaceuticals Inc. with mitapivat to treat sickle cell disease (SCD), Fulcrum Therapeutics Inc. wowed investors by way of initial results from the ongoing 20-mg dose cohort in the phase Ib Pioneer trial testing oral, once-daily fetal hemoglobin inducer pociredir.
Targeted therapies and immunotherapies continue to show better results than chemotherapy in investigator-initiated and company-sponsored cancer trials, and newer options demonstrate improvements over older ones, supporting potential shifts in how patients are treated.
While several targeted therapies are approved for acute myeloid leukemia, a 2023 U.K. study found that median survival following diagnosis was only about seven months, highlighting the need not only for new therapies, but for a faster regulatory strategy. At the American Society of Hematology’s 67th annual meeting in Orlando Dec. 6, researcher Jesse Tettero presented data supporting the use of a measurable residual disease (MRD) surrogate endpoint in acute myeloid leukemia (AML) research.
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