Omeros, MannKind-United Therapeutics, and Revance Therapeutics were issued Complete Response Letters from the U.S. Food and Drug Administration.

Takeda

The U.S. Food and Drug Administration Antimicrobial Drugs Advisory Committee (AMDAC) voted unanimously to recommend use of Takeda Pharmaceutical Company Limited’s maribavir (TAK-620) for the treatment of refractory cytomegalovirus (CMV) infection and disease withgenotypic resistance to ganciclovir, valganciclovir, foscarnet or cidofovir in transplant recipients.

Sanofi is investing more into its transplant operations through a $1.9 billion merger deal with Kadmon Holdings, another biopharma company that develops therapies for diseases with large unmet medical needs.

Shares of Magenta Therapeutics were down after the company announced the U.S. Food and Drug Administration placed a clinical hold on its clinical program for acute myeloid leukemia and myelodysplastic syndrome.

The U.S. Food and Drug Administration approved Rezurock (belumosudil) as a new treatment option for anyone over 12 years of age with chronic graft-versus-host disease after two prior lines of therapy have failed. 

A follow-up study of 33 people who received Moderna Inc.’s Covid-19 vaccine in early trials show the antibodies it induced are still present six months after the second dose.

Denmark-based Genmab A/S announced positive topline data from the second part of the Phase III CASSIOPEIA trial evaluating daratumumab (marketed as Darzalex) monotherapy as maintenance treatment compared to observation for patients with newly diagnosed multiple myeloma that are eligible for autologous stem cell transplant.

Timothy Ray Brown, the first person known to be cured of HIV when he had a unique type of bone marrow transplant, died in California after relapsing with cancer.

Omeros Corp.’s experimental treatment helped six patients with acute respiratory distress syndrome caused by Covid-19 recover and get discharged from the hospital, sending the drug developer’s shares up 60%.

Roche received authorization from the U.S. Food and Drug Administration for the company’s cobas 6800/8800 diagnostic tests for transplant patients.