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Regulatory
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Regulatory actions for Aug. 28, 2023

Aug. 28, 2023
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Akeso, Ausper, Ausperbio, Everest, Janssen, Pfizer, Sandoz.
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Duett Vascular Graph System

Aquedeon gets FDA nod for pivotal trial of vascular graft system

Aug. 28, 2023
By Meg Bryant
The U.S. FDA has given Aquedeon Medical Inc. the green light to conduct an IDE clinical trial of its Duett vascular graft system. The device is designed to improve outcomes in surgical thoracic aortic procedures by simplifying treatment of target vessels and reducing overall procedure time.
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China in red on globe

China issues draft rules to enhance device classification and ensure quality and safety

Aug. 28, 2023
By Doris Yu
Two new sets of draft guidelines in China aim to strengthen and streamline registration systems while clearly spelling out additional rules for device makers to ensure quality management and controls, including strengthening controls over any outsourced manufacturing and calling of makers of implantable devices to manufacture in house.
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Regulatory actions for Aug. 28, 2023

Aug. 28, 2023
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Bioprotect.
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3D illustration of tumor
Immuno-oncology

Harbour Biomed’s ADC HBM-9033 receives FDA clearance to enter clinic for advanced solid tumors

Aug. 28, 2023
Harbour Biomed Ltd. has received FDA clearance of its IND application to commence a phase I trial of HBM-9033 in advanced solid tumors. Developed in collaboration with Medilink Therapeutics (Suzhou) Co. Ltd., HBM-9033 is an antibody-drug conjugate that specifically targets human mesothelin (MSLN), an upregulated tumor-associated antigen in various solid tumors, including mesothelioma, ovarian cancer, lung cancer, breast cancer and pancreatic cancers. The fully human monoclonal antibody in HBM-9033, generated from the Harbour Mice platform, binds preferably to membrane bond MSLN over soluble MSLN, which minimizes the interference of the shedding MSLN on the binding and internalization of the membrane bond MSLN.
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Big pharma piles on; Astrazeneca latest to file lawsuit over IRA

Aug. 25, 2023
With the U.S. Centers for Medicare & Medicaid Services soon expected to publish the list of 10 drugs selected for the first round of the Inflation Reduction Act’s (IRA) price negotiations, Astrazeneca plc is the latest to file a challenge. It’s the first non-U.S.-headquartered company to do so and, unlike the other challenges, Astrazeneca’s complaint focuses on the impact to the Orphan Drug Act (ODA). In a statement, the Cambridge, U.K.-based firm said the “drug price negotiation provisions of the IRA run headlong into the goals” of the ODA.
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Closeup of wheelchair

With Sandoz’s MS approval, a biosimilar goes after big game

Aug. 25, 2023
By Lee Landenberger
Biosimilars continue to pose cheaper alternatives to their established, blockbuster counterparts. The U.S. FDA has approved Tyruko (natalizumab-sztn) from Sandoz Inc., the generics business of Novartis AG. It is the first approved biosimilar to Biogen Inc.’s blockbuster Tysabri (natalizumab), an injectable monoclonal antibody for treating adults with relapsing forms of multiple sclerosis (MS).
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Regulatory actions for Aug. 25, 2023

Aug. 25, 2023
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Akebia, Alentis, Astrazeneca, Bioxytran, Collegium, Comanche, Gilead, Merck, Novaliq, Taysha Gene Therapies.
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Regulatory actions for Aug. 25, 2023

Aug. 25, 2023
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Agilent, Boston Scientific, Medtronic, Paragonix, Susmed.
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Fraud blocks under magnifying glass

US DOJ announces two new field offices for COVID fraud enforcement

Aug. 25, 2023
By Mark McCarty
The U.S. Department of Justice (DOJ) has been aggressively pursuing fraud perpetrated on the American public in connection with the COVID-19 pandemic, but the formal end of the U.S. public health emergency might seem to suggest that these efforts would be winding down. Nonetheless, deputy attorney general Lisa Monaco has announced that DOJ will open two new strike force offices under the agency’s COVID fraud operations, making clear that the agency is still intent on chasing down fraudsters across the U.S.
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