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.
Manufacturing issues are the latest problem for Ultragenyx Pharmaceutical Inc. to solve after last week’s disappointment in a phase III study to treat brittle bones. The U.S. FDA gave the company a complete response letter (CRL) regarding the BLA for its gene therapy to treat Sanfilippo syndrome type A, saying it needs more details and improvements made about CMC after having finished manufacturing facility inspections.
China’s National Medical Products Administration approved Ascentage Pharma Group Corp. Ltd.’s Bcl-2 selective inhibitor lisaftoclax (APG-2575) for treating adults with chronic lymphocytic leukemia/small lymphocytic lymphoma who previously received at least one systemic therapy including Bruton’s tyrosine kinase inhibitors.
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.
Cochlear Ltd. heard good news from the U.S. FDA, as the agency approved its next-generation cochlear implant, the Nucleus Nexa System, the first smart cochlear implant system. Cochlear expects to launch the new products in the U.S. in the next few months, Brendan Murray, vice president for Cochlear Implant products portfolio and strategy told BioWorld.
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 U.K.’s National Institute for Health and Care Excellence (NICE) recommends the use of pulsed field ablation as an option to treat NHS patients with atrial fibrillation. NICE said evidence shows the procedure reduces atrial fibrillation and its symptoms, increases quality of life in the short term and raises no major safety concerns.
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.
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