Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Cytrellis, Lifesignals, Luxsonic.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Aadi, Abbvie, Alexion, Astrazeneca, Beigene, Beximco, Eledon, Fidia, GSK, Incyte, Inhibikase, Iterum, Kyowa Kirin, Neoimmunetech, Otsuka, Polarityte, Saniona.
Medtronic plc launched the newest product in its coronary portfolio, the Prevail drug-coated balloon (DCB) catheter, in Europe following CE mark approval. The device is intended for use during minimally invasive procedures to open narrowed or clogged arteries in patients with coronary artery disease.
The FDA advisory hearing for the Transmedics Organ Care System (OCS) resulted in a unanimous vote in favor of the OCS’s safety and efficacy numbers, although there will be a considerable post-approval study requirement. The company was able to overcome a number of problems with the pivotal study that might otherwise have tanked the application, such as the lack of blinding of transplant surgeons, which the FDA said could have biased the determination of whether a liver was acceptable for transplant.
As the COVID-19 pandemic continues to impact the FDA’s inspection program, U.S. lawmakers are worrying about what that may mean for future drug approvals.
“We are . . . concerned that we have not yet seen the full impact of delayed inspections, particularly in the case of preapproval inspections,” the bipartisan leadership of the House Energy and Commerce Committee and its Health Subcommittee said in a July 22 letter to acting FDA Commissioner Janet Woodcock.
Shares of Iterum Therapeutics plc fell 40% July 26 after disclosing that the FDA issued a complete response letter (CRL) for its NDA for sulopenem etzadroxil/probenecid (oral sulopenem), an anti-infective compound, for urinary tract infections (UTIs). The agency determined the NDA cannot be approved in its present form.
Sinocelltech Group Ltd. won market approval from China’s NMPA for SCT-800, a B-domain deleted recombinant human coagulation factor VIII, for the prophylactic treatment of severe hemophilia A in adolescent and adult patients. This marks the first homegrown drug for treating hemophilia A in China.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Astrazeneca, Moderna, Rhythm.
Synapse Biomedical Inc. has won breakthrough device designation from the FDA for its Transaeris system, a diaphragm pacing system (DPS) for use in weaning patients off mechanical ventilation. The minimally invasive device has been in use during the COVID-19 pandemic under an emergency use authorization to prevent ventilator-induced diaphragm dysfunction – a condition that occurs following mechanical ventilation, which leaves the diaphragm weak from disuse.
RSS
