Pharma News

Marker Therapeutics, Inc a clinical-stage immuno-oncology company specializing in the development of next-generation T cell-based immunotherapies for the treatment of hematological malignancies and solid tumor indications, today announced that the United States Food and Drug Administration (FDA) Office of Orphan Products Development has granted Orphan Drug designation to MT-601, a multi-tumor-associated antigen (MultiTAA)-specific T cell product optimized for the treatment of patients with pancreatic cancer.

Idorsia Ltd and Idorsia Pharmaceuticals Japan today announce that the Japanese Pharmaceuticals and Medical Devices Agency (PMDA) has approved PIVLAZ™ (clazosentan sodium) 150 mg, a selective endothelin A (ETA) receptor antagonist, for the prevention of cerebral vasospasm, vasospasm-related cerebral infarction and cerebral ischemic symptoms after aneurysmal subarachnoid hemorrhage (aSAH). The PMDA approval of PIVLAZ is based on a dedicated Japanese Phase 3 program.

Apprentice.io has raised USD 100 million in Series C funding led by new investor Alkeon Capital Management, with repeat participation from Silverton Partners, Insight Partners, Pacific Western Bank, and new investment by Colorcon Ventures. The company will use the capital to help pharma manufacturers harden their supply chains to keep making patient-critical drugs and adapt vaccines to meet the evolving strains of COVID-19.

Vifor Fresenius Medical Care Renal Pharma announced that the European Commission has approved Tavneos in combination with a rituximab or cyclophosphamide regimen for the treatment of adult patients with severe, active granulomatosis polyangiitis (GPA) or microscopic polyangiitis (MPA), the two main forms of ANCA-associated vasculitis. The approval is consistent with expectations and overall follows the U.S. Food and Drug Administration (FDA) approval of Tavneos in October 2021 for the same indication.

A growing body of evidence indicates that some people thought to have an allergic response to injectable penicillin, the standard treatment for rheumatic heart disease, may instead be experiencing a cardiac reaction to the medicine, according to a new American Heart Association presidential advisory published today in Journal of the American Heart Association.

Health Canada has authorized the combination of two antiviral drugs, nirmatrelvir and ritonavir (brand name PAXLOVIDTM), to treat adults with mild to moderate COVID-19 who are at high risk of progressing to serious disease, including hospitalization or death. The active ingredient nirmatrelvir in PAXLOVIDTM works by stopping the virus from replicating.

Pfizer Inc shared results from multiple studies demonstrating that the in vitro efficacy of nirmatrelvir, the active main protease (Mpro) inhibitor of PAXLOVID (nirmatrelvir [PF-07321332] tablets and ritonavir tablets), is maintained against the SARS-CoV-2 variant Omicron. Taken together, these in vitro studies suggest that PAXLOVID has the potential to maintain plasma concentrations many-fold times higher than the amount required to prevent Omicron from replicating in cells.

The independent clinical trial, conducted by Locus Medicus in Athens, Greece, prospectively tested 330 patients with symptomatic and asymptomatic cases of COVID-19. For the study, staff at the clinical laboratory collected two bilateral anterior nasal swabs from each patient. Immediately after collection, one swab was tested in the lab’s standard of care CE-Mark RT-PCR test and the other swab was tested by BiologyWorks k(now). Results from the BiologyWorks k(now) molecular test were 99.1% in overall percent agreement with the results of the RT-PCR lab tests.

Researchers at University of California San Diego School of Medicine and Moores Cancer Center at UC San Diego Health report successfully removing the nucleus out of a type of ubiquitous cell, known as enucleation, then using the genetically engineered cell as a unique cargo-carrier to deliver therapeutics precisely to diseased tissues.