The EMA has rejected the Alzheimer’s disease therapy Kisunla (donanemab) from Eli Lilly and Co., saying the benefits of the anti-amyloid antibody do not outweigh the risks of edema and hemorrhage in the brain, known as amyloid-related imaging abnormalities (ARIA).
A slow-down in EU medical device audits due to the long-delayed transition to the EU Medical Device Regulation is leading to increased applications to Australia as small businesses bypass Europe altogether.
The EMA’s Committee for Medicinal products for Human Use (CHMP) is standing by its opinion on Leqembi (lecanemab) after the European .mission pushed back against a recommendation in November 2024 that the Alzheimer’s disease drug be approved
The European Commission on Feb. 5 cleared Shanghai Henlius Biotech Inc.’s serplulimab (HLX-02) under the brand name of Hetronifly as a first-line combination therapy with carboplatin and etoposide to treat extensive-stage small-cell lung cancer.
The European Commission on Feb. 5 cleared Shanghai Henlius Biotech Inc.’s serplulimab (HLX-02) under the brand name of Hetronifly as a first-line combination therapy with carboplatin and etoposide to treat extensive-stage small-cell lung cancer.
EMA approval of the Alzheimer’s disease therapy Leqembi (lecanemab) has stalled once again, after the European Commission did not as usual nod through the agency’s recommendation, but told it to examine safety data that have recently become available.
Continuing a cascade of positive news for Stereotaxis Inc., the company reported the first order for its petite Genesisx robot in Europe. The system received CE mark in August, but management held off its launch until its Magic radiofrequency ablation catheter also received CE mark, which happened on Jan. 27. The two devices are used together to treat cardiac arrhythmias.
The EMA has started a review of Novo Nordisk A/S’ GLP-1 receptor agonist, semaglutide, after the Danish regulatory agency raised the possibility it causes an increased risk of suffering from an acute eye condition. After the first report in July 2024, the Danish regulator had received, by Dec. 10, 2024, a total of 19 reports of non-arteric anterior ischemic neuropathy, a rare condition that affects the small blood vessels at the front of the optic nerve. This can lead on to sudden vision loss and visual field defects.
The EMA recommended the highest number of approvals in the last 15 years in 2024, giving the nod to 114 drugs. That is amongst the highest number in the 30 years of the agency’s existence, said Steffen Thirstrup, the EMA’s chief medical officer.
Timing is everything. Just days after confirming a pause in the U.S. rollout of its Varipulse pulsed field ablation (PFA) catheter, Johnson & Johnson’s electrophysiology program received an epic reprieve from European regulators who granted the company’s dual-energy Thermacool Smarttouch SF catheter CE mark.
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