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Regulatory
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Musculoskeletal

Vyne’s BD2-selective BET inhibitor cleared by FDA for phase I

May 7, 2024
Vyne Therapeutics Inc. has received IND clearance from the FDA allowing it to initiate a first-in-human phase Ia study of VYN-202, an oral small-molecule BD2-selective BET inhibitor for autoimmune diseases.
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CMS on deck for round 2 of US Rx price negotiations

May 6, 2024
By Mari Serebrov
With round 1 not yet completed, the U.S. Centers for Medicare & Medicaid Services (CMS) already is prepping for round 2 of the Medicare negotiations mandated by the 2022 Inflation Reduction Act. While the negotiation process will expand to Part B drugs in the future, round 2, like the first cycle, will be limited to single-source Part D drugs that account for some of the highest Medicare expenditures. However, the number of drugs selected for the next cycle could grow from the current 10 to up to 15
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US FDA recommends logic model as REMS framework

May 6, 2024
Checking off another item on its PDUFA VII to-do list, the U.S. FDA is releasing a draft guidance on using a logic model framework for risk evaluation and mitigation strategies (REMS).
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Coin inserted into Australian map

Australia investing AU$1.89B for new research, clinical trials

May 6, 2024
By Tamra Sami
The Australian government is investing AU$1.89 billion (US$1.25 billion) in what it is calling a “once-in-a generation transformation” of health and medical research in Australia with $1.4 billion tagged for new research for the Medical Research Future Fund.
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US PTO taking up artificial intelligence’s patent noise problem

May 6, 2024
By Mark McCarty
Recent advances in artificial intelligence (AI) have generated a tsunami of popular dystopian musings, but the U.S. Patent and Trademark Office (PTO) has its own concerns about AI’s impact on intellectual property.
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Masimo Stork

Masimo’s Stork takes flight with FDA’s over-the-counter clearance

May 6, 2024
By Annette Boyle
Masimo Corp.’s pride and joy, the Stork baby monitor, achieved a new developmental milestone with U.S. FDA clearance for over-the-counter marketing. The agency cleared Stork, which monitors key vital signs including oxygen saturation level, pulse rate and skin temperature, for use on a prescription basis in December. It has been available in the U.S. as a health and wellness device since August 2023.
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Art concept for gene therapy research

UK MHRA expects to up-classify some AI device software

May 6, 2024
By Mark McCarty
The U.K. Medicines and Health Care Products Regulatory Agency (MHRA) is among the regulators across the globe that are scrambling to keep pace with artificial intelligence (AI) in medical devices, releasing an April 30, 2024, paper on its own approach. One of the key considerations in this paper is that MHRA expects to up-classify some AI-enabled device software functions in its ongoing regulatory revamp, a prediction that suggests a more stringent premarket path for these products in the years ahead.
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Woman holding smartphone coughing

UK’s NICE grants conditional coverage to a single COPD app

May 6, 2024
By Mark McCarty
The U.K. National Institute for Health and Care Excellence has posted an early value assessment review of digital technologies for the management of chronic obstructive pulmonary disease, giving the conditional nod to only one technology — the Mycopd app by London-based My Mhealth Ltd.
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Silhouette of head, brain
Neurology/psychiatric

Swedish clearance for phase I study of IRL-757 for apathy in Parkinson’s disease

May 6, 2024
Irlab Therapeutics AB has obtained clearance from the Swedish Medical Products Agency to initiate a phase I study of IRL-757, which is being developed as a treatment to counteract apathy in Parkinson’s disease and other neurological conditions.
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Blood cells and bacteria

Cytovale’s Intellisep rules out sepsis in 97.5% of cases

May 3, 2024
By Annette Boyle
Cytovale Inc. has posted a feverish run of wins lately. The company gained U.S. FDA clearance for its Intellisep rapid test for sepsis in January 2023, raised $84 million in a series C in November and just published results showing the test has negative predictive value of 97.5%.
Read More
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