Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Bioxcel, Calliditas, Histogen, Melinta, Oryzon, Pharmaessentia, Tetra.
The latest global regulatory news, changes and updates affecting biopharma, including: FDA launches EUA safety dashboard; Fed Circuit claims mandamus jurisdiction in IPR institution; Comment period reopened on Orange Book patents.
Remegen Co. Ltd.’s RC-18 (telitacicept) was granted conditional approval for systemic lupus erythematosus (SLE), marking the first NDA approval for the company that launched the world’s biggest biotech IPO last year.
FDA approvals in February nearly doubled those of the prior month, although biopharma regulatory data, aside from efforts targeting COVID-19, continue to decline.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Eisai, J&J, RDIF, Sanofi, Takeda.
What started with Austrian regulators suspending use of one batch of Astrazeneca plc’s COVID-19 vaccine has expanded into precautionary holds in Denmark and other EU countries as PRAC, the EMA’s safety committee, investigates whether blood clots, which have resulted in at least two deaths in Europe, are connected to the vaccine.
Oncology drugs that have racked up a number of indications through accelerated approvals are losing some of those indications as the result of an FDA industrywide evaluation of confirmatory trials that didn’t back up the approvals.
Aveo Oncology Inc. CEO Michael Bailey said the shifting treatment paradigm in renal cell carcinoma (RCC) represents “an advantageous opportunity” for the company with Fotivda (tivozanib), approved March 10 for adults with relapsed or refractory, advanced disease who have received two or more systemic therapies.
Positive COVID-19 efficacy numbers from Vir Biotechnology Inc. and Glaxosmithkline plc (GSK) has prompted them to immediately seek an emergency use authorization (EUA) with the FDA and similar authorizations in other countries for their monoclonal antibody, VIR-7831. Meanwhile, the phase III Remdacta study of Actemra/RoActemra (tocilizumab) plus Veklury (remdesivir) vs. placebo plus Veklury, from Roche Holding AG and Gilead Sciences Inc., missed its primary endpoint in treating hospitalized patients with severe COVID-19 pneumonia receiving standard of care.
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