The U.S. FDA recently posted three alerts under the agency’s early alert program, including an alert for the V6 and V8 versions of the Sigma Spectrum infusion pumps by Baxter International Inc., which was the result of a mix-up in software installation.
Once again, U.S. legislative reforms to rein in pharmacy benefit manager (PBM) business practices missed a ride to finally becoming law. This time, they were kicked out of the Trump administration’s budget reconciliation bill that was signed into law July 4. House Resolution 1, as first passed in the lower chamber, included a few PBM reforms, but they were deleted from the Senate version that ultimately became law because the parliamentarian ruled they didn’t meet the restrictions placed on reconciliation measures.
The complete remission of a testicular cancer patient receiving Mink Therapeutics Inc.’s allogeneic, off-the-shelf invariant natural killer T-cell therapy Agent-797 with nivolumab drove the company’s shares up by 730% July 11. The results, published in Nature’s Oncogene, described the complete, durable remission of a 49-year-old man with a germ cell neoplasm, showing no evidence of disease two years after receiving a single infusion.
Astrazeneca plc reported results from its BaxHTN phase III trial showing aldosterone synthase inhibitor (ASI) baxdrostat met primary and secondary endpoints in patients with uncontrolled or treatment-resistant hypertension. The news marks a positive outcome of the company’s $1.8 billion gamble on Cincor Pharma Inc. in 2023, and keeps baxdrostat in the race with Mineralys Therapeutics Inc., which has said it anticipates a pre-NDA meeting this year for its ASI, lorundrostat, after reporting pivotal hypertension data in March 2025.
Companies in the life sciences must tread carefully when it comes to the Anti-Kickback Statute, but a recent advisory opinion by the Office of Inspector General lends little clarity on the point.
The National Institutes of Health has opened another front in its cost cutting drive, saying it will cap the fees science journals charge for publishing papers authored by researchers it funds.
Capricor Therapeutics Inc. received a complete response letter (CRL) from the U.S. FDA on the BLA for deramiocel to treat cardiomyopathy in Duchenne muscular dystrophy patients. The company’s CEO said the letter was unexpected.
The med tech patent wars opened a new front in the region of screening tests for colorectal cancer, pitting Exact Sciences Corp., of Madison, Wisc., against St. Louis-based Geneoscopy Inc.
It’s been more than seven years in coming, but the U.S. FDA is at last making public at least some of the complete response letters (CRLs) it’s sent to drug and biologic sponsors to notify them of deficiencies in their approval applications.
Nearly six years after Ichnos Sciences Inc. launched operations, a subsidiary of the now-named Ichnos Glenmark Innovation (IGI) Inc. has signed with Abbvie Inc. a global licensing partnership for trispecific antibody ISB-2001 worth $1.925 billion plus royalties. ISB-2001, which targets BCMA, CD38 and CD3, is in a phase I trial for relapsed/refractory multiple myeloma and has orphan drug and fast track status in the U.S
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