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Regulatory
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China bans GSK from participating in volume-based tenders following failed GMP inspection

Nov. 1, 2022
By Tamra Sami
Shanghai’s State Medical Products Administration announced that GSK plc has been banned from participating in volume-based procurement tenders until April 29, 2024, after failing a good manufacturing practices (GMP) inspection at a contract manufacturing plant in Poland that makes products for China.
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Infant exam

RSV melee: Pfizer’s RSV vaccine hits a primary endpoint in race with AZ, Sanofi and GSK

Nov. 1, 2022
By Lee Landenberger
Pfizer Inc.’s bivalent prefusion vaccine for protecting newborns from severe respiratory syncytial virus (RSV) hit one of its two primary endpoints in its phase III study, which was good enough for the company to stop enrollment and plan to submit a BLA to the U.S. FDA by year-end. PF-06928316 is one of six RSV vaccines in active phase III development globally, which includes an Astrazeneca plc-Sanofi SA collaboration plus one from GSK plc. Pfizer’s is the only one developed for infants by way of maternal immunization and for older adults.
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Psychedelic drug illustration

Ausbiotech 2022: Psychedelics coming to clinics in Australia

Nov. 1, 2022
By Tamra Sami
The potential for psychedelics to deliver long-lasting benefits for people with anxiety, depression, post-traumatic stress disorder and addiction is being put to the test in Australia, where new research and discovery centers are adding to a global enterprise of nearly 100 clinical trials underway in the space.
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Regulatory actions for Nov. 1, 2022

Nov. 1, 2022
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Cerus, Curvafix, MIM Software.
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Regulatory actions for Nov. 1, 2022

Nov. 1, 2022
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Alzamend, Amicus, Antengene, Ardelyx, Cytodyn, Dyne, Santhera, TurnstoneAlzamend, Amicus, Antengene, Ardelyx, Cytodyn, Dyne,  Kyowa Kirin, Santhera and Turnstone.
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Patient receiving dialysis

FDA clears new tubing used in Fresenius hemodialysis machines

Oct. 31, 2022
By Mark McCarty
The U.S. FDA announced that it has cleared a new set of tubes used in hemodialysis machines made by Fresenius Medical Care AG & Co., of Bad Homburg, Germany, that are expected to overcome concerns about the previous tubes’ release of potentially toxic biphenyls. The agency acknowledged that it has no reports of adverse events related to the use of these chemicals in the silicone used to manufacture the tubes, stating that its action on this issue is driven solely by animal studies in the medical literature, none of which were cited in the FDA’s Oct. 28 announcement.
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China’s initiatives aimed at spurring device innovation have yet to be realized

Oct. 31, 2022
By Tamra Sami
China’s National Medical Products Administration (NMPA) established new medical device regulations earlier in the year aimed at spurring innovation and creating regulatory incentives, and although the regulation has shortened review and approval timelines, other benefits are less clear, experts said.
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Regulatory actions for Oct. 31, 2022

Oct. 31, 2022
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Abiomed, Broncus.
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Regulatory actions for Oct. 31, 2022

Oct. 31, 2022
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Abbvie, Almirall, Eli Lilly, Fosun Kite, Genmab, Gilead Sciences, Jiangsu Recbio Technology, Kite, Outlook, Pharming.
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Regulatory actions for Oct. 28, 2022

Oct. 28, 2022
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Allurion, Elekta, Syntheticmr.
Read More
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