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  • Idorsia receives Japanese PMDA approval of PIVLAZ (clazosentan sodium)150 mg

    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 Raises USD100 Million to Adapt Pharma Supply Chains to the Omicron Variant

    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.

  • VFMCRP receives EU approval for Tavneos for the treatment of ANCA-associated vasculitis

    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.

  • Oral penicillin, not injectable, advised for people with high-risk rheumatic heart disease

    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 authorizes PAXLOVIDTM for patients with mild to moderate COVID-19 at high risk of developing serious disease

    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 Shares In Vitro Efficacy of Novel COVID-19 Oral Treatment Against Omicron Variant

    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.

  • BiologyWorks k(now) COVID-19 Clinical Trial matches 99.1 percent accuracy to RT-PCR Tests

    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.

  • Nuclei-free Cells Prove Utility in Delivering Therapeutics to Diseased Tissues

    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.

  • Nanotherapy offers new hope for the treatment of Type 1 diabetes

    Individuals living with Type 1 diabetes must carefully follow prescribed insulin regimens every day, receiving injections of the hormone via syringe, insulin pump or some other device. And without viable long-term treatments, this course of treatment is a lifelong sentence.

  • Glenmark Pharmaceuticals receives ANDA tentative approval for Regadenoson Injection

    Glenmark Pharmaceuticals Inc., USA (Glenmark) has received tentative approval by the United States Food & Drug Administration (U.S. FDA) for Regadenoson Injection, 0.4 mg/5 mL (0.08 mg/mL) Single-Dose Pre-Filled Syringe, the generic version of Lexiscan®1 Injection, 0.4 mg/5 mL (0.08 mg/mL), of Astellas US, Inc.

    According to IQVIATM sales data for the 12 month period ending November 2021, the Lexiscan® Injection, 0.4 mg/5 mL (0.08 mg/mL) market2 achieved annual sales of approximately $659.9 million*.

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