Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Abeona, Apic, Arcturus, I-Mab, Lexeo, Mycovia, Nrx, Pharmamar, Takeda, Xoma.
Interim data for Soberana-02, a Cuban COVID-19 conjugate vaccine, surpassed the threshold set by the WHO, according to the Finlay Institute of Vaccines (IFV) in Havana that developed it, although the results have not been peer reviewed.
Another shoe dropped on Oncopeptides AB when the U.S. FDA issued an alert July 28 citing trial data showing an increased risk of death with the company’s only marketed drug, Pepaxto, used in combination with dexamethasone to treat multiple myeloma. The agency said it’s continuing to evaluate the Ocean trial results and may hold a public meeting to discuss the safety findings and explore the continued marketing of Pepaxto (melphalan flufenamide), which was granted accelerated approval in February as a fifth-line treatment for relapsed or refractory multiple myeloma.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Betterlife, Day One, Hope, Kineta, Kronos, Lyndra, Merck, Petros, Sol-Gel, Ultragenyx.
PERTH, Australia – Australia was one of the first nations to slam its borders shut during the pandemic, praising its efforts in containing COVID-19 infections.
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.
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.
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