Using his new platform as chair of the U.S. Senate Health, Education, Labor and Pensions Committee, Sen. Bernie Sanders (I-Vt.) is again pushing the Biden administration to reinstate, and strengthen, a “reasonable pricing clause” in all future research agreements involving government agencies, especially those funding drug R&D.
China’s NMPA granted a green light to China Medical System Holdings Ltd.’s tildrakizumab injection to treat adults with moderate to severe plaque psoriasis who are candidates for systemic therapy or phototherapy. Sold under the brand name Ilumetri, tildrakizumab is a humanized lgG1/κ monoclonal antibody designed to selectively bind to the p19 subunit of interleukin-23 (IL-23) and inhibit its interaction with the IL-23 receptor to block the release of pro-inflammatory cytokines and chemokines.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Neoteryx, Smith & Nephew.
U.S. federal authorities continue to wrap up cases in connection with COVID fraud, the latest of which yielded a $30 million fine for a single defendant accused of fraud and money laundering.
The need to reauthorize the U.S. Pandemic and All-Hazards Preparedness Act (PAHPA) prompted a June 13 hearing in the House of Representatives, but a major fissure appeared between the Republican and Democratic Parties regarding FDA’s authorities for managing drug shortages.
Cardiorenal SAS reported it has been granted a breakthrough device designation by the U.S. FDA for its Tenor at-home blood potassium measuring device. The Tenor smart device combines multiple technologies, app and cloud capabilities to assist patients with chronic kidney disease in measuring their blood potassium levels from home, obtaining results in under five minutes.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Astrazeneca, Bloomsbury, Lantern, Merck & Co., Neobiosis, Pharmala, Phathom.
It didn’t take long for the filing of a second constitutional challenge to the U.S. Inflation Reduction Act’s price negotiations for prescription drugs. In the wake of a similar suit filed three days earlier by Merck & Co. Inc., the Chamber of Commerce filed a complaint June 9 in the U.S. District Court for the Southern District of Ohio.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Corneat Vision, Neuronetics.
The U.S. Environmental Protection Agency (EPA) has proposed a more stringent set of requirements for the use of ethylene oxide for sterilization of a variety of products, including medical devices, a proposal that is expected to increase the cost of operating these facilities.
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