Bluebird Bio Inc.’s elivaldogene autotemcel (eli-cel) gained U.S. approval late Sept. 16 for use in early active cerebral adrenoleukodystrophy (CALD), making it the firm’s second gene therapy to clear the FDA in as many months. Branded Skysona, eli-cel is expected to be available commercially by the end of 2022 and its launch will require only “incremental” company resources on top of those required for the ongoing launch of beta-thalassemia gene therapy Zynteglo (betibeglogene autotemcel), Bluebird said.
The U.S. NIH is not generally regarded as a wellspring of concepts and policies in the world of artificial intelligence (AI), but that perception may change soon thanks to the agency’s Bridge2AI program. The agency announced recently that it will drop $130 million into this program over four years in an effort to develop standards for data used in AI research, a key development for device makers seeking to sell products that use these complex algorithms.
The Biden administration’s views of mergers and acquisitions have veered sharply from those of the previous administration, but Jonathan Kanter, assistant U.S. attorney general, said recently that there is more to come. Kanter said the Department of Justice (DOJ) and the Federal Trade Commission (FTC) will shortly publish draft guidelines that would place the burden on the parties to these M&A transactions to prove the transaction is not anticompetitive, upending the historical presumption that the plaintiff is liable for demonstrating the anticompetitive nature of the proposed transaction.
Challenges scheduling time for a mammogram, frustration waiting for the exam itself and pain from the test have caused any number of women to cry. Namida Lab Inc. may take the inconvenience and anxiety out of breast health assessment with its Auria test, but the tears will stay. Like a growing number of assays, the test uses tear-based analytics to determine cancer risk.
With the science on aging advancing, it’s time for the U.S. to modernize its regulatory approval path for new longevity treatments, members of a House Science, Space and Technology subcommittee were told Sept. 15.
A new generation of chimeric antigen receptor (CAR) T-cell therapies with advanced functions could hold the answer to improved safety and efficacy for these effective but potentially dangerous cancer therapies, shows research led by Boston University. The scientists showed it is possible to add ‘on’ or ‘off’ switches to CAR T cells, which can be activated using oral drugs with a known safety profile.
Sometimes it is a good idea to go to the dark side, particularly for individuals with undiagnosed vision impairment. Dark adaptation is one of the first aspects of vision to become impaired by age-related macular degeneration (AMD), so identifying it at early stages can preserve sight. Heru Inc. recently launched a new modality for its wearable screening platform to quickly assess dark adaptation.
From the beginning of the monkeypox outbreak in the U.S. in May, the federal government has bungled the response, according to both Democratic and Republican members of the Senate Health, Education, Labor and Pensions (HELP) Committee.
The U.S. FDA has granted breakthrough device designation to Potrero Medical Inc. for its AKI Predict machine learning algorithm for the advanced prediction of acute kidney injury (AKI) associated with intra-abdominal hypertension (IAH) in intensive care patients recovering from cardiac surgery.
Pricing new drugs for the U.S. market, especially those treating rare diseases, is getting a lot more complex now that the Medicare inflation rebate is in play. The rebate provision in the newly enacted Inflation Reduction Act incentivizes companies to set higher launch prices for drugs that will be used by Medicare beneficiaries since their future price increases will be limited to the rate of inflation. Although some of the other drug pricing measures included in the new law won’t kick in for a few years, the Medicare inflation rebate is to become effective next year.
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