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Regulatory
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1-10-abbott-heartmate3.png

Heartmate recall underscores systemic issues with VADs

July 2, 2024
By Mark McCarty
The U.S. FDA posted notice of a recall of the system monitor for the Heartmate left ventricular assist device by Abbott Laboratories, an action necessitated by reports of a series of malfunctions that may lead to inadvertent operator error.
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Edwards EVOQUE

Edwards urges CMS to mimic TMVR coverage for Evoque

July 2, 2024
By Mark McCarty
After snaring the U.S. FDA’s approval for the Evoque tricuspid valve device, Edwards Lifesciences Corp. petitioned the Centers for Medicare & Medicaid Services for a national coverage determination for transcatheter tricuspid valve replacement devices.
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Clinical data illustration
Endocrine/metabolic

Medipal and JCR move JR-446 toward clinic in Japan for mucopolysaccharidosis type IIIB

July 2, 2024
Medipal Holdings Corp. and JCR Pharmaceuticals Co. Ltd. have announced the completion of the clinical trial notification review by Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) for a phase I/II study of JR-446 for the treatment of mucopolysaccharidosis type IIIB (MPS IIIB; Sanfilippo syndrome type B).
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Gastric cancer
Cancer

Signet’s SIGX-1094 receives US IND clearance for diffuse gastric cancer

July 2, 2024
Signet Therapeutics Inc. has received IND clearance from the FDA for SIGX-1094 as a potential treatment for diffuse gastric cancer. A phase I trial is planned in patients with diffuse gastric cancer and other advanced solid tumors.
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Daiichi, Merck’s HER3-DXd gets CRL for lung cancer

July 2, 2024
By Karen Carey
Partners Daiichi Sankyo Co. Ltd. and Merck & Co. Inc. received a complete response letter (CRL) from the U.S. FDA for their first-in-class HER3-directed antibody-drug conjugate HER3-DXd (patritumab deruxtecan) to treat patients with locally advanced or metastatic EGFR-mutated non-small-cell lung cancer.
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EMA icons

EMA takes negative view on masitinib; Ocaliva, Translarna out

July 1, 2024
By Nuala Moran
Two drugs were pushed back by the EMA last week, with a recommendation that Ocaliva, currently the only second line standard of care for treating primary biliary cholangitis, be withdrawn from the market, and a refusal to grant conditional approval for masitinib in the treatment of amyotrophic lateral sclerosis.
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Yuhan nabs Ubix cancer drug for ₩150B; YH-35995 trial cleared

July 1, 2024
By Marian (YoonJee) Chu
Yuhan Corp., of Seoul, South Korea, has inked a ₩150 billion (US$108.6 million) deal with Korean biotech Ubix Therapeutics Inc. to gain exclusive global rights to UBX-103, Ubix’s oral small-molecule androgen receptor degrader for prostate cancer. Yuhan also announced July 1 that it gained the U.S. FDA’s nod to start a phase I study of a Gaucher disease drug candidate called YH-35995.
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US flag, gavel, book

US Supreme Court scuttles Chevron doctrine in landmark reversal

July 1, 2024
By Mark McCarty
In a ruling delivered June 28, the U.S. Supreme Court brought an end to four decades of a practice of judicial deference to federal government agencies in litigation under the Chevron doctrine, a practice that some argue has enabled regulatory mischief.
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Philips cardiac MRI scanner

Syntheticmr receives CE mark for SyMRI version 15

July 1, 2024
By Shani Alexander
Syntheticmr AB received CE marking for its next-generation brain imaging solution, SyMRI Neuro. The company hopes that version 15 of its SyMRI software, which provides quantitative data, automatic tissue segmentation and adjustable contrast weighted images from a scan, will transform diagnostic imaging.
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Ribbons of digital data

IMDRF takes up existing good machine learning practices

July 1, 2024
By Mark McCarty
A trio of regulators devised a series of good machine learning practices in 2021, a key point of consideration for many algorithms that will eventually be used in thousands of medical applications in the coming years.
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