Monte Rosa Therapeutics Inc. plans a signal-verifying phase II trial next year after making known the positive interim data from an ongoing phase I/II trial testing molecular glue degrader MRT-2359 in combination with androgen receptor (AR) inhibitor Xtandi (enzalutamide, Astellas Pharma Inc.). The investigation targeted heavily pretreated patients with metastatic castration-resistant prostate cancer bearing AR mutations.
Two large deals and an acquisition, totaling about $4.64 billion in all, are helping wrap up what’s turning out to be a strong year. Through the first 11 months of 2025, biopharma dealmaking was robust with a collective value of $261.14 billion, the highest January through November total of the past seven years and well above 2024’s $201.35 billion. These three December deals helped revive the surge in dealmaking that had cooled in November.
Companion Spine SAS received premarket approval from the U.S. FDA for its DIAM spinal stabilization system, for treatment of degenerative disc disease. The approval comes as the company recently completed the acquisition of a number of assets from Xtant Medical Holdings Inc., including Paradigm Spine GmbH, as it continues to strengthen its position in providing solutions to treat spinal degenerative conditions.
The U.S. FDA announced Dec. 15 that it will take a more relaxed approach to device premarket applications using real-world evidence from data sources that lack individual patient-level data, a switch that might ease manufacturers’ efforts to expand a device’s labeled indication for use.
“If at first you don’t succeed, try, try again” seems to be the motto of U.S. lawmakers – at least when it comes to the bipartisan Biosecure Act. After missing a ride last year in the must-pass annual defense spending bill, a version of the bill that seeks to protect the genetic data of Americans while securing U.S. pharmaceutical supply chains made it into the 2026 National Defense Authorization Act, which is now just a Senate vote away from becoming law.
Formation Bio Inc. acquired ex-China rights to Lynk Pharmaceuticals Co. Ltd.’s oral TYK2-inhibitor, LNK-01006, for up to $605 million. The phase I-ready central nervous system (CNS) candidate will be developed at Formation’s newly formed subsidiary, Bleecker Bio.
“If at first you don’t succeed, try, try again” seems to be the motto of U.S. lawmakers – at least when it comes to the bipartisan Biosecure Act. After missing a ride last year in the must-pass annual defense spending bill, a version of the bill that seeks to protect the genetic data of Americans while securing U.S. pharmaceutical supply chains made it into the 2026 National Defense Authorization Act, which is now just a Senate vote away from becoming law.
A group of eight Democratic senators is asking biopharma companies to spill the beans about their private most-favored-nation pricing deals with U.S. President Donald Trump. Led by Sen. Ron Wyden, D-Ore., ranking member of the Senate Finance Committee, the senators sent letters Dec. 11 to Astrazeneca plc, Eli Lilly and Co., Novo Nordisk A/S and Pfizer Inc. seeking the details of those deals. While it’s difficult to discern how the deals will benefit patients, it’s clear the companies stand to gain a lot from the agreements, the letter asserted.
Nephrodite Inc.'s Holly, an implantable, continuous renal replacement system, received U.S. FDA breakthrough device designation as a novel and potentially life-changing treatment for end-stage kidney disease. The system is designed to enable continuous blood filtration and allow patients freedom to go about their days without frequent, hours-long visits to a dialysis clinic or being hooked up to a filtration system at home.
The U.S. FDA recently cleared two new medical devices to treat benign prostatic hyperplasia, offering men with enlarged prostates additional treatment options which are minimally invasive. The approvals include Proverum Medical Ltd.’s Provee System and Zenflow Inc.’s Zenflow Spring Implant and Delivery System, both are first-line interventional therapeutic options which offer relief to the millions of men living with the condition.
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