LONDON – The EMA’s safety committee has concluded that unusual blood clots with low blood platelets are a rare side effect of Johnson & Johnson Inc.’s COVID-19 vaccine and that a warning should be added to the label. The decision is based on all available evidence, which currently consists of eight reports from the U.S. of serious cases of thrombosis, one of which was fatal. All cases were in people under 60 years of age, and within three weeks after vaccination, the majority in women. One case occurred during the clinical trials.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Amgen, Autolus, Cyclo, Erytech, GW, J&J, Kalvista, Lexeo, Pharmather, Seelos, Transcenta, Vincerx, Y-mabs.
The latest global regulatory news, changes and updates affecting biopharma, including: Enhertu gets first nod in Europe; At-home COVID-19 remedies sought; Fed Circuit: Appeal based on misreading of court’s decision; Russia expands access to certain pediatric treatments.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Active Biotech, Aerie, Agenus, Alk, Allogene, Anixa, Astellas, BMS, Curevac, Curis, Cytodyn, Eli Lilly, Istari, Mannkind, Mayne, Mithra, Sanofi, Seagen, Stuart, United, Xbiotech.
Agnovos Healthcare LLC, a company using regenerative medicine to treat localized effects of bone disease, has received the FDA’s nod for an IDE clinical trial to assess its AGN1 local osteo-enhancement procedure (LOEP) small-volume (SV) kit in patients with vertebral compression fractures (VCFs). The investigational device is intended to treat stable but painful VCFs via a minimally invasive procedure. The kit, which comes in the form of two single-use trays, contains a calcium-based, resorbable, triphasic implant material that is designed to align the pace of resorption with bone formation, providing treated vertebrae with immediate and durable protection.
If the FDA follows the advice of its Cellular, Tissue and Gene Therapies Advisory Committee, the U.S. could soon see its first approved islet transplant therapy, but few expect it to be broadly used. The adcom voted 14-9 April 15, with one abstention, that Celltrans Inc.’s donislecel, or cadaveric allogenic pancreatic islet cells, has an overall favorable risk-benefit profile for some patients with type 1 diabetes.
The latest global regulatory news, changes and updates affecting medical devices and technologies, including: BD Alaris pumps recalled over keypad problems.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Agnovos Healthcare, Canon Medical, Contego Medical, Deephealth.
Now drugmakers can gain instant access to hospitals in Hainan province right after their innovative drugs are approved by China’s National Medical Products Administration to skip market entry hurdles.
As COVID-19 deaths across the globe top 3 million, with more than 1 million in Europe alone, the global demand is increasing for mRNA vaccines, even as sponsors of adenovirus vaccines push back against ongoing safety concerns. Last week, the World Health Organization’s (WHO) Regional Office for Europe reported that the confirmed COVID-19 death toll for the region had surpassed 1 million, with 1.6 million new cases being reported every week. More than 171 million doses of COVID-19 vaccines have been administered in the region, translating to nearly 13% of the European population receiving one dose and close to 6% completing both doses of the vaccines.