A development deal with Biogen Inc. could eventually bring City Therapeutics Inc. about $1 billion in milestone payments. It’s a step in the direction the company had been going: looking for the right partners, including those from big pharma. Privately held City Therapeutics is getting $46 million in the deal. That includes $16 million as an up-front payment and an investment of $30 million in exchange for a City Therapeutics convertible note.
The U.S. FDA approved Phraxis Inc.’s Endoforce Connector for endovascular venous anastomosis, which eliminates the need for surgical dissection for individuals undergoing hemodialysis for kidney failure. The device is designed to reduce tissue trauma and improve long-term graft performance.
Edwards Lifesciences Corp. released new economic and clinical data on severe aortic stenosis (AS) demonstrating intervening in a patient with the disease before symptoms develop can reduce costs to the health care system by $36,000. Data also shows earlier intervention can also lead to fewer follow-ups and hospitalizations for heart failure, after treatment.
The Trump administration nominated John Squires of the firm of Dilworth Paxson to take the post of director of the Patent and Trademark Office, but the appointment faces a few hurdles.
In what represents their first patenting, researchers from New York’s Stony Brook University filed for protection for development of a system and method that uses computer vision to analyze microscale facial movements in order to objectively help diagnose, monitor, and treat disorders of consciousness.
It’s been nearly five years since the U.S. FDA, under the first Trump administration, issued a final rule and guidance on state importation plans (SIP) for importing less expensive prescription drugs from Canada. Yet only one state, Florida, has an approved SIP. In hopes of adding to that number, the FDA is enhancing its drug importation program to ease the way for states and tribes to bring prescription medicines in from Canada, at Canadian prices.
Imunon Inc. soared by 179% on the heels of phase II Ovation 2 data showing that its IMNN-001 immunotherapy led to a 13-month increase in overall survival among women with ovarian cancer. Patients in the intent-to-treat population, receiving the drug plus standard-of-care neoadjuvant and adjuvant chemotherapy (N/ACT), achieved median overall survival (OS) at 46 months vs. 33 months with N/ACT alone. Increased activity was seen among patients treated with poly ADP-ribose polymerase inhibitors, with the median OS not yet reached after more than five years vs. 37 months in the control arm.
The recent emphasis on eliminating animal studies for preclinical studies of U.S. FDA-regulated products amplifies a long-standing concern, but the U.S. Government Accountability Office raised the question of whether organ-on-a-chip methods are ready to fill the gap.
Hinge Health Inc.’s flexibility produced big rewards as the digital therapy company for physical rehabilitation finally began trading on the NYSE under the symbol HNGE on May 22 after delaying its IPO twice. Hinge co-founders Daniel Perez and Gabriel Mecklenburg rang the opening bell for the stock exchange to celebrate the offering’s $437 million haul.
U.S. FDA commissioner Marty Makary appeared at the May 22 Senate Appropriations Committee with the news the White House proposed an FDA budget for fiscal 2026 of $6.8 billion including user fees. This is a cut of 11.5% that will not likely go over well on Capitol Hill as the FY 2026 budget process unwinds.
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