Researchers have retrospectively divided more than 16,000 non-small-cell lung cancer (NSCLC) patients with EGFR mutations into four structure-based subgroups, and looked at how the members of each subgroup fared depending on which EGFR inhibitor they were given.
Sight Sciences Inc. may have visions of a substantial settlement following Ivantis Inc.’s $60 million settlement with Glaukos Corp. this week or the Menlo Park, Calif.-based company may have its sights set on knocking a competitor out of the market entirely. Both are possible outcomes of the suit Sight Sciences announced this morning that alleges infringement of four of its patents by Ivantis for its Hydrus Microstent. Sight Sciences makes the Omni surgical system, which competes with the Hydrus and the Glaukos Istent in the minimally invasive glaucoma surgery (MIGS) space.
The FDA reported the elevation of its information technology (IT) office to an agency-level office, a move that gives the agency a heightened priority for eliminating some of the balkanization of computer systems.
Special purpose acquisition companies (SPACs) have been making headlines recently in the life sciences, but these entities practice a business model that leaves some observers uneasy. Gary Gensler, chairman of the U.S. Securities and Exchange Commission (SEC), told a Senate committee recently that the risks to investors in SPACs has prompted him to ask his staff to come up with some proposals to increase transparency to investors, potentially leading to additional compliance costs for these entities.
After three years of litigation and nearly a decade of skirmishes, Ivantis Inc. settled with Glaukos Corp. for $60 million to be paid in two installments, with the first $30 million due by Dec. 31, 2021, and the second $30 million by Dec. 31, 2022. In addition, Irvine, Calif.-based Ivantis will pay Glaukos a 10% royalty through April 26, 2025, on sales of Ivantis’ Hydrus Microstent in the U.S. or international sales supplied out of the U.S. With just two weeks to go until their scheduled court date of Sept. 28, the companies finally saw eye-to-eye, reaching a cross-licensing agreement and hammering out a covenant to refrain from future litigation regarding the technologies involved in the Hydrus or Glaukos’s Istent, both used to treat glaucoma.
The U.S. Federal Trade Commission (FTC) has taken a more assertive stance regarding enforcement of several considerations, most conspicuously about mergers and acquisitions. However, the agency’s push for less cumbersome processes has now been applied to a host of considerations pertinent to the life sciences, including bias found in artificial intelligence algorithms, abuse of drug patents, and repairs for medical equipment, a signal that more frequent and more rapid FTC enforcement is on the near horizon.
The U.S. Centers for Medicare & Medicaid Services (CMS) has withdrawn the rule for the Medicare Coverage of Innovative Technologies (MCIT) program, an action that predates the agency’s self-imposed deadline of December 2021 by three months. The agency cited some previously discussed issues with the rule, but the move was blasted by industry as thwarting the support of the majority of stakeholders.
Cala Health Inc. is moving quickly to establish leadership in treatment for essential tremor with its recent inclusion in the International Essential Tremor Foundation (IETF) guidelines as the only non-pharmacological, non-surgical treatment recommended and positive treatment results from a real-world study. “We’re very pleased with the validation from IETF and the research presented at MDS that demonstrates the impactful benefit of our therapy for those suffering from essential tremor,” said Kate Rosenbluth, founder and chief science officer of Cala Health.
There are few guidelines of any sort that are specific to artificial intelligence (AI) for medical devices, but that doesn’t mean there are no signposts for developers. There are existing product marketing authorizations that offer some insights, but the FDA’s Bakul Patel said a risk stratification guidance by the International Medical Device Regulators Forum (IMDF) is an example of a non-AI blueprint for how the FDA will ultimately approach regulation of AI.
The NIH and CDC granted researchers at the Feinstein Institutes for Medical Research at Northwell Health $700,000 to investigate an in-the-ear stimulator as a treatment for post-traumatic stress disorder (PTSD) in first responders to the attack on the World Trade Center 20 years ago. The researchers will enroll 30 World Trade Center first responders with chronic PTSD in a sham-controlled trial to test the effectiveness of a device that uses transcutaneous auricular stimulation of the vagus nerve, which has shown promise in preclinical studies.