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Home » Topics » Regulatory

Regulatory
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Inflammatix Triverity test system

Inflammatix’s Triverity scores FDA clearance for ER sepsis test

Jan. 21, 2025
By Annette Boyle
Just a few weeks later than expected, Inflammatix Inc. secured U.S. FDA clearance of the Triverity test system for use in emergency triage of patients with suspected acute infection or sepsis. The molecular blood test is the first to identify bacterial and viral infections and provide an all-cause risk evaluation of the likelihood of developing severe illness.
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AI silhouette

Support for US AI policymaking gaining steam in Washington

Jan. 21, 2025
By Mark McCarty
The European Union has implemented legislation governing artificial intelligence (AI) with more on tap, but the U.S. has to date lagged in that area. However, the House of Representatives has assembled a bipartisan task force for AI, one of several developments suggesting that 2025 will be an even more AI-focused year than 2024.
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Health professional recording info from patient

CMS drafts guidance for use of real-world data in CED studies

Jan. 21, 2025
By Mark McCarty
Regulatory approval for medical products can rely on real-world data (RWD) typically only for expanded indications for use, but payers have been missing in action where this data source is concerned. The U.S. CMS has floated a guidance to facilitate the use of RWD in coverage decisions, providing a long-overdue update to Medicare clinical trial policy.
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Gavel and block with Chinese flag

China deepens drug, device reforms, aims to be global powerhouse

Jan. 21, 2025
By Tamra Sami
China is deepening its regulatory reforms of drugs and devices to foster a globally competitive innovation ecosystem to transform China from a major pharmaceutical manufacturer into a global pharmaceutical powerhouse.
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China gives nod to Innovent’s limertinib NDA for lung cancer

Jan. 17, 2025
By Tamra Sami
China’s National Medical Products Administration has given the green light to Innovent Biologics, Inc.’s and Jiangsu Aosaikang Pharmaceutical Co. Ltd.’s NDA for third-generation EGFR tyrosine kinase inhibitor limertinib, for treating adults with locally advanced or metastatic EGFR T790M-mutated non-small cell lung cancer.
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EMA investigating potential semaglutide link to eye disease

Jan. 17, 2025
By Nuala Moran
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.
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Dollar sign inside vial, syringe

CMS’ price negotiations take two: Ozempic, Xtandi among 15 drugs chosen

Jan. 17, 2025
By Karen Carey
In the final days of the Biden administration, the U.S. Department of Health and Human Services’ Centers for Medicare and Medicaid Services (CMS) laid out the latest 15 drugs that are subject to negotiated prices, with Novo Nordisk A/S’ GLP-1 drug Ozempic for type 2 diabetes topping the list, bringing Rybelsus and Wegovy along for the ride because they share the same active ingredient, semaglutide.
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Gilead, US end court battle over HIV PrEP patents

Jan. 16, 2025
By Mari Serebrov
After a five-year court battle in which Gilead Sciences Inc. scored several victories only to have the U.S. government appeal, Gilead has reached a settlement with the Department of Health and Human Services and the Department of Justice to resolve government claims that the company had infringed its patents covering the pre-exposure prophylaxis (PrEP) use of two Gilead HIV drugs.
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EU flag, pills, syringe

46 NCEs, 28 biosimilars among 114 drugs cleared by EMA in 2024

Jan. 16, 2025
By Nuala Moran
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.
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Illustration of Epstein-Barr virus particles

Atara sinks on Ebvallo CRL, seeks strategic alternatives

Jan. 16, 2025
By Karen Carey
Atara Biotherapeutics Inc. received a complete response letter (CRL) from the U.S. FDA for its lead product, Ebvallo (tabelecleucel), a breakthrough therapy for Epstein-Barr virus positive post-transplant lymphoproliferative disease that is already approved in the EU, the U.K. and Switzerland.
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