While the emergency use authorization (EUA) the FDA granted Aug. 23 for convalescent plasma remains a political talking point, the agency moved ahead Sept. 2, issuing an updated, immediately effective guidance on the use of convalescent plasma to treat COVID-19 patients in ongoing clinical trials, on an expanded access basis or under the EUA.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Aeon, Cytodyn, Innovent, Nippon Shinyaku.
In March, when a district court ruled in favor of two ANDA filers in Amarin Corp. plc’s patent litigation case regarding its fish oil cardiovascular therapy franchise, Vascepa (icosapent ethyl), CEO John Thero said an appeal was a strong possibility.
It turns out that determining who gets a COVID-19 vaccine first can be nearly as challenging as developing the vaccine itself. The timeline is a big part of the challenge.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Dompé, Mesoblast, Mustang, Oblato, Pharmacyte.
With a potential COVID-19 vaccine moving closer to reality and the U.S government signing contracts for millions of potential doses, an unresolved question is who should be at the front of the line to get those first doses.
The first weekly therapy for adult growth hormone deficiency (GHD) has arrived in the U.S. with FDA approval for Novo Nordisk A/S' Sogroya (somapacitan). It’s the first of Novo's regulatory filings for the medicine, also submitted in the EU and Japan, to win approval. Sogroya replaces endogenous growth hormone in adults who don't produce enough of it. Novo said it is working to finalize plans to make the therapy available and has not yet disclosed pricing.
Two days ahead of its Sept. 3 PDUFA date, Bristol Myers Squibb Co. received the FDA’s approval for Onureg, an oral form of azacitidine, for continuing treatment of adults with acute myeloid leukemia (AML). The indication is specifically for patients achieving first complete remission (CR) or CR with incomplete blood count recovery following intensive induction chemotherapy and who are not able to complete intensive curative therapy. BMS said Onureg is the first and only FDA-approved continued AML treatment for patients in complete remission.
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