A Seattle-based startup has secured breakthrough device designation for its blood-based Alzheimer’s disease (AD) test. Altpep Corp.’s Soba-AD platform is designed to selectively detect toxic forms of amyloid-beta peptide associated with AD progression. The company said early data indicated the assay can detect AD before symptoms including cognitive impairment and neurodegeneration arise.
Ahead of U.S. President Joe Biden’s State of the Union address March 1 in which he gave a shoutout to his cancer moonshot initiative, the FDA released a trio of final guidances aimed at speeding the development of new cancer drugs. First launched in 2016 with the goal of doubling the rate of progress against cancer by making a decade worth of advances in five years, the moonshot was reignited last month with a new target following setbacks in cancer screenings and treatments during the COVID-19 pandemic. Now, Biden’s catch phrase is “ending cancer as we know it.”
Small American device manufacturers are more likely to sell their products only in the U.S., and thus the FDA proposal to more closely align the Quality System Regulation (QSR) with ISO 13485 would seem to place unwarranted demands on these companies.
The FDA has published an updated guidance for the appeals process at the Center for Devices and Radiological Health, but the issuance of that guidance did not happen in a vacuum. Mark Duval, president of Duval & Associates in Minneapolis, told BioWorld that industry is filing more appeals of premarket decisions of late, an uptick he said is an artifact of the practice of FDA reviewers more commonly asking for additional data for these applications.
Medtronic plc has launched a single-use device for outpatient-based treatment of chronic, obstructive Eustachian tube dysfunction (ETD). Medtronic’s FDA-approved Nuvent system is a manually controlled balloon catheter for insertion into the Eustachian tube canal. Once pressurized, the balloon expands and dilates the Eustachian tube canal to relieve symptoms of ETD.
Chinese investment in U.S. companies is dropping, but Chinese biopharma firms are increasingly eyeing licensing deals on early stage inventions patented by U.S. universities, Lin Sun-Hoffman, founding partner at Liu, Chen & Hoffman LLP, said during a Feb. 24 U.S. Patent and Trademark Office webinar on biopharma patents in China.
Despite Reata Pharmaceuticals Inc.’s complete response letter (CRL) for bardoxolone in treating kidney function loss in those with Alport syndrome, the street treated the company well on Feb. 28.
The U.S. Patent Trial and Appeal Board’s (PTAB) decision Feb. 28 that Broad Institute scientists were the first to invent the use of CRISPR/Cas9 genome editing in eukaryotic cells is just another chapter in the ongoing saga of who has patent rights to various elements of the CRISPR platform.
The U.S. FDA’s device center has posted a report on premarket review performance metrics under the current device user fee schedule, and the latest data show an 83% rate of deficiency in first-cycle reviews of PMA original filings in the last three months of calendar year 2021. That rate is down somewhat from the 91% rate seen in 2016, but is up substantially from the 63% major deficiency rate seen in 2018, the low-water mark for this metric for more than a decade.
The U.S. is making strides in addressing the drug and device supply chain vulnerabilities revealed by the COVID-19 pandemic, but there’s still a lot of work to do to reduce dependance on sole source suppliers and foreign manufacturing, according to a new Health and Human Services (HHS) report.
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