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.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Bioprotect.
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.
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.
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).
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.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Agilent, Boston Scientific, Medtronic, Paragonix, Susmed.
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.
The European Commission has granted CE mark approval to Medtronic plc for its Inceptiv closed-loop rechargeable spinal cord stimulator (SCS). The device is the first Medtronic SCS to sense an individual’s biological cues and make adjustments in real time to control pain all day long. Dublin-based Medtronic plans to launch Inceptiv in Europe in the coming months.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: BMS, Dizal, Immix, Nexcella, Pfizer.
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